Human Medicines Authorised/Transfer Pending Products
This list was last updated on Friday, June 16, 2017
Please Note
The contents of the table are believed to be correct at the time of compilation. The HPRA makes no representations or warranties about and disclaim all liability for the content,
accuracy, completeness or suitability of the information contained in the table for any purpose whatsoever and the information is made available to the public for information purposes
only.
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
0.9% W/V
SODIUM
CHLORIDE
INJECTION BP
8.4% W/V
SODIUM
BICARBONATE
ABACAVIR/LAM
IVUDINE
CLONMEL
ABACAVIR/LAM
IVUDINE MYLAN
ABACAVIR/LAM
IVUDINE
ROWEX
ABACAVIR/LAM
IVUDINE TEVA
B. Braun Medical
Limited
PA0179/002/013
0.9 %w/v
Solution for
Injection
B05XA03
-SODIUM
CHLORIDE
B. Braun Medical
Limited
PA0179/006/001
8.4 %w/v
Intravenous Inf
Solution
B05XA02
Clonmel
Healthcare Ltd
PA0126/284/001
600/300 Milligram
Film Coated
Tablet
J05AR02
-SODIUM
HYDROGEN
CARBONATE
-LAMIVUDINE
-Per Oral
Generics (UK)
Limited
Rowex Ltd
PA0405/088/001
600/300 Milligram
J05AR02
-LAMIVUDINE
-Per Oral
PA0711/251/001
600/300 Milligram
Film Coated
Tablet
Film Coated
Tablet
-LAMIVUDINE
-Per Oral
Teva B.V.
PA1986/014/001
600/300 Milligram
Tablets
J05AR02
-LAMIVUDINE
ABASAGLAR
Eli Lilly
Nederland B.V.
EU/1/14/944/005008
100 Units/ml
A10AE04
-INSULIN
GLARGINE
ABASAGLAR
Eli Lilly
Nederland B.V.
EU/1/14/944/001004
100 Units/ml
Solution for
injection in prefilled pen
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
ABIDEC
MULTIVITAMIN
Chefaro Ireland
DAC
PA1186/001/001
25 Millilitre
Oral Drops
Solution
A11BA
-Per Oral
ABILIFY
Otsuka
Pharmaceutical
Europe Ltd
EU/1/04/276/033035
1 Mg/Ml
Oral Solution
N05AX12
-RETINOL
PALMITATE
ERGOCALCIFE
ROL
-THIAMINE
HYDROCHLORI
DE
-RIBOFLAVIN
SODIUM
PHOSPHATE
-PYRIDOXINE
HYDROCHLORI
DE
-NICOTINAMIDE
-ASCORBIC
ACID
-ARIPIPRAZOLE
10 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
7.5 Mg/Ml
Solution for
Injection
N05AX12
-ARIPIPRAZOLE
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
ABILIFY
ABILIFY
ABILIFY
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Interchangeable
List Code:
IC0092-047-019
EU/1/04/276/024026
Interchangeable
List Code:
IC0092-002-056
EU/1/04/276/036
EU/1/04/276/001005
Article 10(1) Generic
Application
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
-Per Oral
-Subcutaneous
-Subcutaneous
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0092-001-056
Human Medicines Authorised/Transfer Pending Products
Page 1 of 608
Trade Name
ABILIFY
ABILIFY
ABILIFY
ABILIFY
ABILIFY
ABILIFY
MAINTENA
ABILIFY
MAINTENA
ABRAXANE
Licence Holder Licence
Number
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Celgene Europe
Ltd
EU/1/04/276/006010
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
15 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
30 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
300 Milligram
Pdr+Solv for
Susp for Inj
N05AX12
-ARIPIPRAZOLE
Article 8(3) - Full
new Application
-Intra-Muscular
EU/1/13/882/002
,004
400 Milligram
Pdr+Solv for
Susp for Inj
N05AX12
-ARIPIPRAZOLE
Article 8(3) - Full
new Application
-Intra-Muscular
EU/1/07/428/001
5 Mg/Ml
Powder for
suspension for
infusion
L01CD01
-PACLITAXEL
(FORMULATED
AS ALBUMIN
BOUND
NANOPARTICL
ES)
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
Article 8(3) - Full
new Application
-Intra-venous
Interchangeable
List Code:
IC0092-002-056
EU/1/04/276/011015
Interchangeable
List Code:
IC0092-032-056
EU/1/04/276/016020
Interchangeable
List Code:
IC0092-033-056
EU/1/04/276/027029
Interchangeable
List Code:
IC0092-032-056
EU/1/04/276/030032
Interchangeable
List Code:
IC0092-033-056
EU/1/13/882/001
,003
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/1-2
1000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/3-4
2000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/5-6
3000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/7-8
4000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/9-10
5000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/1112
6000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/1314
8000
International Unit
Solution for
Injection
B03XA01
ABSEAMED
Medice
Arzneimittel
Putter GmbH
EU/1/07/412/1516
10,000
International Unit
Solution for
Injection
B03XA01
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Page 2 of 608
Trade Name
ABSEAMED
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
EU/1/07/412/02122
20000/0.5 IU/ML
Solution for
Injection
B03XA01
-EPOETIN ALFA
EU/1/07/412/02324
30000/0.75 IU/M
Solution for
Injection
B03XA01
-EPOETIN ALFA
EU/1/07/412/02526
40000/1 IU/ML
Solution for
Injection
B03XA01
-EPOETIN ALFA
ABSTRAL
Medice
Arzneimittel
Putter GmbH
Medice
Arzneimittel
Putter GmbH
Medice
Arzneimittel
Putter GmbH
Kyowa Kirin Ltd
PA1049/006/002
100 Microgram
Tablet Sublingual
N02AB03
ABSTRAL
Kyowa Kirin Ltd
PA1049/006/003
200 Microgram
Tablet Sublingual
N02AB03
ABSTRAL
Kyowa Kirin Ltd
PA1049/006/004
300 Microgram
Tablet Sublingual
N02AB03
ABSTRAL
Kyowa Kirin Ltd
PA1049/006/005
400 Microgram
Tablet Sublingual
N02AB03
ABSTRAL
Kyowa Kirin Ltd
PA1049/006/006
600 Microgram
Tablet Sublingual
N02AB03
ABSTRAL
Kyowa Kirin Ltd
PA1049/006/007
800 Microgram
Tablet Sublingual
N02AB03
ACCOFIL
Accord
Healthcare
Limited
Accord
Healthcare
Limited
AstraZeneca UK
Limited
Pfizer Healthcare
Ireland
EU/1/14/946/001002
30/0.5
Microgram/ML
L03AA02
EU/1/14/943/003004
48/0.5
Microgram/ML
L03AA02
-FILGRASTIM
PA0970/001/001
20 Milligram
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Tablets
-FENTANYL, AS
CITRATE SALT
-FENTANYL, AS
CITRATE SALT
-FENTANYL, AS
CITRATE SALT
-FENTANYL, AS
CITRATE SALT
-FENTANYL, AS
CITRATE SALT
-FENTANYL, AS
CITRATE SALT
-FILGRASTIM
R03DC01
-ZAFIRLUKAST
-Per Oral
PA0822/007/001
5 Milligram
Film Coated
Tablet
C09AA06
-Per Oral
ACCUPRO
Pfizer Healthcare
Ireland
PA0822/007/002
10 Milligram
Film Coated
Tablet
C09AA06
ACCUPRO
Pfizer Healthcare
Ireland
PA0822/007/003
20 Milligram
Film Coated
Tablet
C09AA06
ACCUPRO
Pfizer Healthcare
Ireland
PA0822/007/004
40 Milligram
Film Coated
Tablet
C09AA06
ACCUPRO 10
MG FILMCOATED
TABLETS
ACCUPRO 20
MG FILMCOATED
TABLETS
ACCUPRO 5 MG
FILM-COATED
TABLETS
ACCURETIC
PCO
Manufacturing
PPA0465/135/00
2
10 Milligram
Film Coated
Tablet
C09AA06
-QUINAPRIL
HYDROCHLORI
DE
-QUINAPRIL
HYDROCHLORI
DE
-QUINAPRIL
HYDROCHLORI
DE
-QUINAPRIL
HYDROCHLORI
DE
-QUINAPRIL
HYDROCHLORI
DE
PCO
Manufacturing
PPA0465/135/00
3
20 Milligram
Film Coated
Tablet
C09AA06
PCO
Manufacturing
PPA0465/135/00
1
5 Milligram
Film Coated
Tablet
C09AA06
Pfizer Healthcare
Ireland
PA0822/008/002
20/12.5 Milligram
Tablets
C09BA06
ACCUSOL 35
Nikkiso Belgium
bvba
PA2021/001/001
N/A
Solution for
Haemofiltration
B05ZB
ABSEAMED
ABSEAMED
ACCOFIL
ACCOLATE
ACCUPRO
Human Medicines Authorised/Transfer Pending Products
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Routes of
Administration
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Sublingual
-Sublingual
-Sublingual
-Sublingual
-Sublingual
-Sublingual
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-QUINAPRIL
HYDROCHLORI
DE
PPA
-Per Oral
-QUINAPRIL
HYDROCHLORI
DE
-QUINAPRIL
HYDROCHLORI
DE
HYDROCHLOR
OTHIAZIDE
-SODIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
ANHYDROUS
-SODIUM
BICARBONATE
PPA
-Per Oral
Page 3 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
ACCUSOL 35
POTASSIUM
Nikkiso Belgium
bvba
PA2021/002/001
2 mmol/L
solution for
haemodialysis/h
aemofiltration
B05ZB
ACCUSOL 35
POTASSIUM
Nikkiso Belgium
bvba
PA2021/002/002
4 mmol/L
solution for
haemodialysis/h
aemofiltration
B05ZB
ACEOMEL
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Les Laboratoires
Servier
PA0126/094/001
12.5 Milligram
Tablets
C09AA01
-SODIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
ANHYDROUS
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-GLUCOSE
ANHYDROUS
-SODIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
ANHYDROUS
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-GLUCOSE
ANHYDROUS
-CAPTOPRIL
PA0126/094/002
25 Milligram
Tablets
C09AA01
-CAPTOPRIL
PA0126/094/003
50 Milligram
Tablets
C09AA01
-CAPTOPRIL
PA0568/018/001
5/5 mg/mg
Tablets
C09BB04
Article 10b Fixed
Combination
-Per Oral
Interchangeable
List Code:
IC0041-012-002
PA0568/018/002
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
5/10 mg/mg
Tablets
C09BB04
Article 10b Fixed
Combination
-Per Oral
Interchangeable
List Code:
IC0041-013-002
PA0568/018/003
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
10/5 mg/mg
Tablets
C09BB04
Article 10b Fixed
Combination
-Per Oral
Interchangeable
List Code:
IC0041-016-002
PA0568/018/004
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
10/10 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
Article 10b Fixed
Combination
-Per Oral
5/5 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
PPA
-Per Oral
5/10 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
PPA
-Per Oral
10/5 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
PPA
-Per Oral
ACEOMEL
ACEOMEL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
Les Laboratoires
Servier
Les Laboratoires
Servier
Les Laboratoires
Servier
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0041-017-002
PPA1463/065/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0041-012-002
PPA1463/065/00
2
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0041-013-002
PPA1463/065/00
3
Interchangeable
List Code:
IC0041-016-002
Human Medicines Authorised/Transfer Pending Products
Page 4 of 608
Trade Name
ACERYCAL
Licence Holder Licence
Number
IMED Healthcare
Ltd.
PPA1463/065/00
4
ACERYCAL
Primecrown 2010
Ltd
Interchangeable
List Code:
IC0041-017-002
PPA1633/035/00
1
ACERYCAL
Primecrown 2010
Ltd
ACERYCAL
Strength
Dosage Form ATC
Active
Ingredients
10/10 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
5/5 Milligram
Tablets
C09BB04
PPA1633/035/00
2
5/10 Milligram
Tablets
C09BB04
Primecrown 2010
Ltd
PPA1633/035/00
3
10/5 Milligram
Tablets
C09BB04
ACERYCAL
Primecrown 2010
Ltd
PPA1633/035/00
4
10/10 Milligram
Tablets
C09BB04
ACERYCAL
PCO
Manufacturing
PPA0465/283/00
1
5/5 mg/mg
Tablets
C09BB04
PCO
Manufacturing
Interchangeable
List Code:
IC0041-012-002
PPA0465/283/00
2
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
10/10 mg/mg
Tablets
C09BB04
LTT Pharma
Limited
Interchangeable
List Code:
IC0041-017-002
PPA1562/071/00
1
5/5 mg/mg
Tablets
LTT Pharma
Limited
Interchangeable
List Code:
IC0041-012-002
PPA1562/071/00
2
5/10 mg/mg
LTT Pharma
Limited
Interchangeable
List Code:
IC0041-013-002
PPA1562/071/00
3
LTT Pharma
Limited
Interchangeable
List Code:
IC0041-016-002
PPA1562/071/00
4
PCO
Manufacturing
Interchangeable
List Code:
IC0041-017-002
PPA0465/283/00
3
PCO
Manufacturing
Interchangeable
List Code:
IC0041-013-002
PPA0465/283/00
4
Rowex Ltd
Rowex Ltd
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACERYCAL
ACIC
ACIC COLD
SORE
ACICLOVIR
SYRI Limited, t/a
Thame
Laboratories
Legal Basis
PPA
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
PPA
-Per Oral
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
PPA
-Per Oral
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
PPA
-Per Oral
10/5 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
PPA
-Per Oral
10/10 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESYLATE
PPA
-Per Oral
5/10 mg/mg
Tablets
C09BB04
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESILATE
PPA
-Per Oral
10/5 mg/mg
Tablets
C09BB04
PPA
-Per Oral
Interchangeable
List Code:
IC0041-016-002
PA0711/017/001
PA0711/017/006
-PERINDOPRIL
ARGININE
-AMLODIPINE
BESILATE
5 Per Cent
5 %w/w
Cream
Cream
D06BB03
D06BB03
-ACICLOVIR
-ACICLOVIR
PA1861/014/002
400/5 Mg/Ml
Oral Suspension
J05AB01
-ACICLOVIR
Human Medicines Authorised/Transfer Pending Products
Article 10c Informed Consen
Article 10(1) Generic
Application
-Topical
-Cutaneous
-Per Oral
Page 5 of 608
Trade Name
ACICLOVIR
ACICLOVIR
ACICLOVIR
CLARIS
ACIDEX
ACLASTA
ACNECIDE 5%
W/W GEL
ACNECIDE
WASH 5 % W/W
GEL
ACNISAL 2%
W/W
CUTANEOUS
SOLUTION
ACONITE
ACONITE
ACTELSAR HCT
ACTELSAR HCT
ACTELSAR HCT
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Intra-venous
SYRI Limited, t/a
Thame
Laboratories
Hospira UK
Limited
Claris
Lifesciences (UK)
Limited
Pinewood
Laboratories Ltd,
PA1861/014/001
200/5 Mg/Ml
Oral Suspension
J05AB01
-ACICLOVIR
PA0437/044/001
25 Mg/Ml
J05AB01
PA1389/014/001
25 Mg/Ml
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
-ACICLOVIR
SODIUM
-ACICLOVIR
PA0281/075/001
Milligram
Oral Suspension
B05CB04
Novartis
Europharm
Limited
Galderma (UK)
Ltd
Galderma (UK)
Ltd
EU/1/05/308/001
5/100 Micromol
Solution for
Infusion
M05BA08
PA0590/007/001
5 %w/w
Gel
D10AE01
PA0590/007/003
5 %w/w
Gel
D10AE01
Alliance
Pharmaceuticals
Ltd.
PA0943/008/001
2 %w/w
Cutaneous
Solution
D02AC
Weleda (UK)
Limited
A. Nelson &
Company Limited
Actavis Group
PTC ehf
HOR0407/013/0
01
HOR1149/001/0
01
EU/1/13/817/001013
6C & 30C
Tablets
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0050-099-014
EU/1/13/817/014028
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0050-081-014
EU/1/13/817/029041
Interchangeable
List Code:
IC0050-100-014
PA2131/001/001
J05AB01
6C-MM N/A
40/12.5 mg/mg
Tablets
C09DA07
80/12.5 mg/mg
Tablets
C09DA07
80/25 mg/mg
Tablets
10mcg/0.5m
Microgram/ML
-Per Oral
-BENZOYL
PEROXIDE
-BENZOYL
PEROXIDE
HYDROUS
-SALICYLIC
ACID
-ACONITUM
NAPELLUS
-ACONITUM
NAPELLUS
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
Article 10(1) Generic
Application
-Per Oral
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
Article 10(1) Generic
Application
-Per Oral
Pdr+Solv for Soln
for Inj
J07AG51
-HAEMOPHILUS
INFLUENZAE
TYPE B,
CONJUGATE
WITH TETANUS
PROTEIN
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-TRIPROLIDINE
HYDROCHLORI
DE
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-TRIPROLIDINE
HYDROCHLORI
DE
ACT-HIB
Sanofi Pasteur
Europe
ACTIFED
Imbat Limited
PPA1151/210/00
1
60/2.5 Milligram
Tablets
R01BA02
ACTIFED
McNeil
Healthcare
(Ireland) Ltd
PA0823/006/003
60/2.5 Milligram
Tablets
R01BA02
Human Medicines Authorised/Transfer Pending Products
-SODIUM
BICARBONATE
-SODIUM
ALGINATE
-CALCIUM
CARBONATE
-ZOLEDRONIC
ACID
Routes of
Administration
-Per Oral
-Per Oral
Page 6 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
ACTIFED
30MG/1.25MG
PER 5ML
SYRUP
McNeil
Healthcare
(Ireland) Ltd
PA0823/006/002
30/1.25 MG/5ml
Syrup
R01BA02
ACTILYSE
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
PCO
Manufacturing
PCO
Manufacturing
Novo Nordisk A/S
PA0007/043/003
10 Milligram
B01AD02
PA0007/043/001
20 Milligram
B01AD02
-ALTEPLASE
PA0007/043/002
50 Milligram
B01AD02
-ALTEPLASE
PA0007/043/005
2 Milligram
B01AD02
-ALTEPLASE
PA0678/061/002
200 Milligram
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Film Coated
Tablet
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-TRIPROLIDINE
HYDROCHLORI
DE
-ALTEPLASE
M01AE01
-IBUPROFEN
-Per Oral
PA0749/195/001
200 Microgram
Lozenges
N02AB03
-Oromucosal
PA0749/195/002
400 Microgram
Lozenges
N02AB03
PA0749/195/003
600 Microgram
Lozenges
N02AB03
PA0749/195/004
800 Microgram
Lozenges
N02AB03
PA0749/195/005
1200 Microgram
Lozenges
N02AB03
PA0749/195/006
1600 Microgram
Lozenges
N02AB03
PPA0465/407/00
1
PPA0465/407/00
2
PA0218/052/001
200 Microgram
Lozenges
N02AB03
400 Microgram
Lozenges
N02AB03
1 / 0.5 Milligram
Film Coated
Tablet
G03FA01
ACTIVELLE
PCO
Manufacturing
PPA0465/199/00
1
1/0.5 Anhyd
Milligrams
Film Coated
Tablet
G03FA01
ACTONEL
Warner Chilcott
UK Limited
PA1635/001/001
5 Milligram
Film Coated
Tablet
M05BA07
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-ESTRADIOL
HEMIHYDRATE
NORETHISTER
ONE ACETATE
-ESTRADIOL
HEMIHYDRATE
NORETHISTER
ONE ACETATE
-RISEDRONATE
SODIUM
Interchangeable
List Code:
IC0068-001-003
PA1635/001/002
30 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
Interchangeable
List Code:
IC0068-033-003
PA1635/001/004
75 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
Interchangeable
List Code:
IC0068-028-003
PA1635/002/001
35/500 Milligram
Film Coated
Tablet
M05BB04
-Per Oral
Interchangeable
List Code:
IC0068-125-003
PA1635/001/003
-RISEDRONATE
SODIUM
-CALCIUM
CARBONATE
35 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
-Per Oral
ACTILYSE
ACTILYSE
ACTILYSE
CATHFLO
ACTIPROFEN
ACTIQ
ACTIQ
ACTIQ
ACTIQ
ACTIQ
ACTIQ
ACTIQ
ACTIQ
ACTIVELLE
ACTONEL
ACTONEL
ACTONEL
COMBI
ACTONEL ONCE
A WEEK
Warner Chilcott
UK Limited
Warner Chilcott
UK Limited
Warner Chilcott
UK Limited
Warner Chilcott
UK Limited
-Per Oral
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
PPA
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Interchangeable
List Code:
IC0068-124-003
Human Medicines Authorised/Transfer Pending Products
Page 7 of 608
Trade Name
ACTONEL ONCE
A WEEK
ACTONEL ONCE
A WEEK
ACTONEL ONCE
A WEEK
Licence Holder Licence
Number
Primecrown 2010
Ltd
Clear Pharmacy
PCO
Manufacturing
ACTONEL ONCE
A WEEK
ACTONEL ONCE
A WEEK 35MG
FILM-COATED
TABLETS
ACTONEL PLUS
CA & D
Warner Chilcott
UK Limited
IMED Healthcare
Ltd.
PPA1633/002/00
1
Interchangeable
List Code:
IC0068-124-003
PPA1596/001/00
1
Interchangeable
List Code:
IC0068-124-003
PPA0465/165/00
1
Interchangeable
List Code:
IC0068-124-003
PA1635/001/005
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
35 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
PPA
-Per Oral
35 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
PPA
-Per Oral
35 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
PPA
-Per Oral
35 Milligram
Tablets GastroResistant
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
Article 8(3) - Full
new Application
PPA
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
PPA1463/023/00
1
35 Milligram
Warner Chilcott
UK Limited
PA1635/003/001
35 + 1000/880 IU
Milligram
Granules
Effervescent
M05BB04
ACTONEL PLUS
CA & D
PCO
Manufacturing
PPA0465/305/00
1
35mg/1000m
Unknown
M05BB07
ACTOS
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Novo Nordisk A/S
EU/1/00/150/011
45 Milligram
Tablets
A10BG03
-RISEDRONATE
SODIUM
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-RISEDRONATE
SODIUM
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-PIOGLITAZONE
EU/1/00/150/001
15 Base
Milligrams
15mg Base
Milligrams
15mg Base
Milligrams
30mg Base
Milligrams
30mg Base
Milligrams
30mg Base
Milligrams
%v/v
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
Solution for
Injection
Suspension for
Injection
A10AD01
Solution for
Injection
Solution for
Injection
Eye Drops
Solution
A10AB01
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-KETOROLAC
TROMETAMOL
Eye Drops
Solution
Eye Drops
Solution
Tablet Prolonged
Release
Capsules, Soft
S01BC05
ACTOS
ACTOS
ACTOS
ACTOS
ACTOS
ACTOS
ACTRAPHANE
ACTRAPHANE
30
Novo Nordisk A/S
ACTRAPID
Novo Nordisk A/S
ACTRAPID
Novo Nordisk A/S
ACULAR
ACULAR
Allergan
Pharmaceuticals
Ireland
PCO
Manufacturing
Imbat Limited
ADALAT
Imbat Limited
ADALAT 10 MG
SOFT
CAPSULES
Bayer Limited
ACULAR
EU/1/00/150/002
EU/1/00/150/003
EU/1/00/150/004
EU/1/00/150/005
EU/1/00/150/006
EU/1/02/229/001035
EU/1/02/229/036037
40 IU/ML
EU/1/02/230/016017
EU/1/02/230/001015
PA0148/057/001
40/100 IU/ML
PPA0465/287/00
1
PPA1151/142/00
1
PPA1151/047/00
2
PA1410/025/002
0.5 %w/v
Human Medicines Authorised/Transfer Pending Products
IU/ML
0.5 %w/v
0.5 %w/v
30 Milligram
10 Milligram
M05BA07
A10AD01
A10AB01
S01BC05
C08CA05
-KETOROLAC
TROMETAMOL
-KETOROLAC
TROMETAMOL
-NIFEDIPINE
C08CA05
-NIFEDIPINE
S01BC05
-Per Oral
-Per Oral
-Subcutaneous
-Intra-venous
-Subcutaneous
-Ocular
PPA
-Ocular
PPA
-Ocular
PPA
-Per Oral
Page 8 of 608
Trade Name
ADALAT 5 MG
SOFT
CAPSULES
ADALAT LA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Bayer Limited
PA1410/025/001
5 Milligram
Capsules, Soft
C08CA05
-NIFEDIPINE
Tablet Prolonged
Release
Tablets
C08CA05
-NIFEDIPINE
PPA
-Per Oral
C08CA05
-NIFEDIPINE
PPA
-Per Oral
-NIFEDIPINE
PPA
C08CA05
-NIFEDIPINE
PPA
C08CA05
-NIFEDIPINE
PPA
-Per Oral
C08CA05
-NIFEDIPINE
PPA
-Per Oral
C08CA05
-NIFEDIPINE
PPA
-Per Oral
C08CA05
-NIFEDIPINE
PPA
Clear Pharmacy
C08CA05
-NIFEDIPINE
PPA
ADALAT LA
Clear Pharmacy
C08CA05
-NIFEDIPINE
PPA
ADALAT LA 20
MG
PROLONGEDRELEASE
TABLET
ADALAT LA 30
MG
PROLONGEDRELEASE
TABLET
ADALAT LA 30
MG
PROLONGEDRELEASE
TABLETS
ADALAT LA 60
MG
PROLONGEDRELEASE
TABLET
ADALAT
RETARD
ADALAT
RETARD
ADALAT
RETARD 10 MG
PROLONGEDRELEASE
TABLETS.
ADALAT
RETARD 20 MG
PROLONGEDRELEASE FILMCOATED
ADALAT
RETARD 20MG
PROLONGEDRELEASE
TABLETS
ADASUVE
Bayer Limited
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
C08CA05
ADALAT LA
PPA0465/012/00
7
PPA0465/012/00
6
PPA1562/036/00
2
PPA1562/036/00
3
PPA1463/058/00
1
PPA1463/058/00
2
PPA1463/058/00
3
PPA1596/035/00
1
PPA1596/035/00
2
PPA1596/035/00
3
PA1410/025/005
20 Milligram
ADALAT LA
PCO
Manufacturing
PCO
Manufacturing
LTT Pharma
Limited
LTT Pharma
Limited
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
Clear Pharmacy
C08CA05
-NIFEDIPINE
Bayer Limited
PA1410/025/006
30 Milligram
Tablet Prolonged
Release
C08CA05
-NIFEDIPINE
PCO
Manufacturing
PPA0465/012/00
5
30 Milligram
Tablets
C08CA05
-NIFEDIPINE
Bayer Limited
PA1410/025/007
60 Milligram
Tablet Prolonged
Release
C08CA05
-NIFEDIPINE
Imbat Limited
20 Milligram
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
C08CA05
-NIFEDIPINE
PPA
LTT Pharma
Limited
Bayer Limited
PPA1151/047/00
1
PPA1562/036/00
5
PA1410/025/003
C08CA05
-NIFEDIPINE
PPA
C08CA05
-NIFEDIPINE
PCO
Manufacturing
PPA0465/012/00
3
20 Milligram
Tablets
C08CA05
-NIFEDIPINE
Bayer Limited
PA1410/025/004
20 mg Milligram
Tablet Prolonged
Release
C08CA05
-NIFEDIPINE
Ferrer
Internacional, S.A
Ferrer
Internacional, S.A
Takeda Global
R&D Centre
Europe Limited
Eli Lilly
Nederland B.V.
EU/1/13/823/001
4.5 Milligram
N05AH01
-LOXAPINE
EU/1/13/823/002
9.1 Milligram
Powder for
Inhalation
Powder for
Inhalation
Pdr/Conc/Soln for
Infus
N05AH01
-LOXAPINE
L01XC12
-BRENTUXIMAB
VEDOTIN
Film Coated
Tablet
G04BE08
-TADALAFIL
ADALAT LA
ADALAT LA
ADALAT LA
ADALAT LA
ADALAT LA
ADALAT LA
ADASUVE
ADCETRIS
ADCIRCA
(PREVIOUSLY
TADALAFIL
LILLY)
60 Milligram
30 Milligram
60 Milligram
20 Milligram
30 Milligram
60 Milligram
30 Milligram
20 Milligram
60 Milligram
20mg Milligram
20 Milligram
10 mg Milligram
EU/1/12/794/001
EU/1/08/476/001004
Human Medicines Authorised/Transfer Pending Products
50
20 Milligram
-Per Oral
-Per Oral
PPA
-Per Oral
PPA
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Inhalation
Article 10c Informed Consen
-Per Oral
-Inhalation
-Intra-venous
Page 9 of 608
Trade Name
ADCORTYL
INTRAARTICULAR/INT
RADERMAL
INJECTION
ADCORTYL
INTRAARTICULAR/INT
RA-DERMAL
INJECTION
ADCUS
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
PA0002/018/003
10 Mg/Ml
Suspension for
Injection
D07AB09
TRIAMCINOLO
NE ACETONIDE
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
PA0002/018/002
10 Mg/Ml
Suspension for
Injection
D07AB09
TRIAMCINOLO
NE ACETONIDE
Focus
Pharmaceuticals
Ltd
Fresenius Kabi
Limited
PA1338/007/001
3 Mg/Ml
Solution for
Infusion
C01EB10
-ADENOSINE
PA0566/005/001
170. 133.5 14.0
g/20ml
Concentrate for
Soln for Inf
B05XA30
ADDITRACE N
Fresenius Kabi
Limited
PA0566/015/002
N/A
Concentrate for
Soln for Inf
B05XA31
ADDITRACE,
CONCENTRATE
FOR SOLUTION
FOR INFUSION
Fresenius Kabi
Limited
PA0566/015/001
10 Millilitre
Concentrate for
Soln for Inf
B05XA31
ADEMPAS
Bayer AG
0.5 Milligram
Bayer AG
Film Coated
Tablet
Film Coated
Tablet
C02KX05
ADEMPAS
EU/1/13/907/001003
EU/1/13/907/004006
-POTASSIUM
PHOSPHATE
MONOBASIC
-SODIUM
PHOSPHATE
DIBASIC
DIHYDRATE
-POTASSIUM
HYDROXIDE
-CHROMIC
CHLORIDE
HEXAHYDRATE
-CUPRIC
CHLORIDE
DIHYDRATE
-FERRIC
CHLORIDE
HEXAHYDRATE
-MANGANESE
CHLORIDE
TETRAHYDRAT
E
-POTASSIUM
IODIDE
-SODIUM
FLUORIDE
-SODIUM
MOLYBDATE
DIHYDRATE
-SODIUM
SELENITE
ANHYDROUS
-ZINC
CHLORIDE
-FERRIC
CHLORIDE
HEXAHYDRATE
-ZINC
CHLORIDE
-MANGANESE
CHLORIDE
TETRAHYDRAT
E
-CUPRIC
CHLORIDE
DIHYDRATE
-POTASSIUM
IODIDE
-CHROMIUM
TRICHLORIDE
HEXAHYDRATE
-SODIUM
SELENITE
-SODIUM
MOLYBDATE
DIHYDRATE
-SODIUM
FLUORIDE
-RIOCIGUAT
C02KX05
-RIOCIGUAT
ADDIPHOS
Human Medicines Authorised/Transfer Pending Products
1 Milligram
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
-Intra-venous
Article 10a Bibliographical
App
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
Page 10 of 608
Trade Name
Licence Holder Licence
Number
ADEMPAS
Bayer AG
ADEMPAS
Bayer AG
ADEMPAS
Bayer AG
ADENOCOR
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Wockhardt UK
Limited
ADENOSINE
Strength
EU/1/13/907/007009
EU/1/13/907/010012
EU/1/13/907/013015
PA0540/139/001
1.5 Milligram
PA1339/034/001
Dosage Form ATC
Active
Ingredients
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Solution for
Injection
C02KX05
-RIOCIGUAT
C02KX05
-RIOCIGUAT
C02KX05
-RIOCIGUAT
C01EB10
-ADENOSINE
3 Mg/Ml
Solution for
Injection
C01EB10
-ADENOSINE
2 Milligram
2.5 Milligram
3 Mg/Ml
ADENOSINE
Wockhardt UK
Limited
PA1339/035/001
30 Mg/Ml
Solution for
Infusion
C01EB10
-ADENOSINE
ADENOSINE
Fresenius Kabi
Limited
PA0566/068/001
3 Mg/Ml
Solution for
Injection
C01EB10
-ADENOSINE
ADENOSINE
Focus
Pharmaceuticals
Ltd
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
GlaxoSmithKline
Biologicals S.A.
PA1338/008/001
3 Mg/Ml
Solution for
Injection
C01EB10
-ADENOSINE
EU/1/08/447/001002
80 Milligram
Film Coated
Tablet
M04AA03
-FEBUXOSTAT
EU/1/08/447/003004
120 Milligram
Film Coated
Tablet
M04AA03
-FEBUXOSTAT
PA1688/001/005
180 Milligram
C08DB01
PA1688/001/001
90 Milligram
PA1688/001/002
120 Milligram
PA1688/001/003
180 Milligram
PA1688/001/006
240 Milligram
PA1688/001/007
300 Milligram
PA1688/001/004
120 Milligram
EU/1/09/578/001
3.75/0.5
Microgram/ML
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Suspension and
Emulsion for
emulsion for
injection
PA0073/035/001
1:1000 Micromol
Solution for
Injection
C01CA24
ADRENALINE
(1:10,000)
Mercury
Pharmaceuticals
(Ireland) Ltd
Laboratoire
AGUETTANT
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-PURIFIED
ANTIGEN
FRACTIONS OF
INACTIVATED
SPLIT VIRIONS
A/VIETNAM/119
4/2004 NIBRG-14
(H5N1)
-ADRENALINE
(EPINEPHRINE)
PA1968/002/001
1 Mg/Ml
C01CA24
-EPINEPHRINE
BITARTRATE
ADRENALINE
(EPINEPHRINE)
1:1,000 MINIJET
ADRENALINE
(EPINEPHRINE)
MINIJET
International
Medication
Systems (UK) Ltd
International
Medication
Systems (UK) Ltd
PA0255/002/002
1 Mg/Ml
Solution for
injection in prefilled syringe
Solution for
Injection
C01CA24
-EPINEPHRINE
PA0255/002/003
Mg/Ml
Sterile Solution
C01CA24
-EPINEPHRINE
ADENURIC
ADENURIC
ADIZEM - XL
ADIZEM-SR
ADIZEM-SR
ADIZEM-SR
ADIZEM-XL
ADIZEM-XL
ADIZEM–XL
ADJUPANRIX
ADRENALINE
Human Medicines Authorised/Transfer Pending Products
C08DB01
C08DB01
C08DB01
C08DB01
C08DB01
C08DB01
J07BB02
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-Muscular
Article 10a Bibliographical
App
-Intra-Muscular
-Intra-venous
Page 11 of 608
Trade Name
ADROVANCE
Licence Holder Licence
Number
Merck Sharp and
Dohme Limited
EU/1/06/364/001004
Strength
Dosage Form ATC
M05BB03
Interchangeable
List Code:
IC0052-102-002
EU/1/07/387/1-2
-ALENDRONIC
ACID
COLECALCIFE
ROL
0.5 Milligram
L04AD02
-TACROLIMUS
-Per Oral
L04AD02
-TACROLIMUS
-Per Oral
L04AD02
-TACROLIMUS
-Per Oral
L04AD02
-TACROLIMUS
D10AA02
METHYLPREDN
ISOLONE
ACEPONATE
METHYLPREDN
ISOLONE
ACEPONATE
METHYLPREDN
ISOLONE
ACEPONATE
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-RECOMBINANT
COAGULATION
FVIII (OCTOCOG
ALFA)
-IBUPROFEN
ADVAGRAF
Astellas Pharma
Europe BV
EU/1/07/387/3-6
1 Milligram
ADVAGRAF
Astellas Pharma
Europe BV
EU/1/07/387/7-8
5 Milligram
ADVAGRAF
Astellas Pharma
Europe BV
EU/1/07/387/1113
3 Milligram
ADVANTAN
0.1%W/W FATTY
OINTMENT
Bayer Limited
PA1410/070/003
0.1%w/w %w/w
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Ointment
ADVANTAN
0.1%W/W
OINTMENT
Bayer Limited
PA1410/070/002
0.1%w/w %w/w
Ointment
D10AA02
ADVANTAN
CREAM
Bayer Limited
PA1410/070/001
0.1%w/w %w/w
Cream
D10AA02
ADVATE
Baxter
EU/1/03/271/007
250 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVATE
Baxter
EU/1/03/271/008
500 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVATE
Baxter
EU/1/03/271/010
1500
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVATE
Baxter
EU/1/03/271/009
1000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVATE
Baxter
EU/1/03/271/005
2000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVATE
Baxter
EU/1/03/271/006
3000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVATE
Baxter
EU/1/03/271/1-4
250 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
ADVIL
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
PA0822/163/002
200 Milligram
Coated Tablets
M01AE01
PA0822/164/001
200/30 Milligram
Coated Tablets
M01AE51
Pfizer Healthcare
Ireland
PA0822/163/001
200 Milligram
Capsule
M01AE01
Human Medicines Authorised/Transfer Pending Products
-IBUPROFEN
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-IBUPROFEN
Article 10c Informed Consen
Routes of
Administration
Tablets
Astellas Pharma
Europe BV
ADVIL
LIQUIGELS,
200MG
CAPSULES
Legal Basis
70/2800 mg/IU
ADVAGRAF
ADVIL COLD &
FLU
Active
Ingredients
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Topical
-Topical
-Topical
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
Page 12 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ADVIL SINUS
RELIEF
Pfizer Healthcare
Ireland
PA0822/164/002
200/30 Milligram
Capsules, Soft
M01AE51
AERINAZE
Schering Plough
Europe
EU/1/07/399/001006
2.5/120 Milligram
Tablets
R01BA52
AERIUS
SP Europe
EU/1/00/160/6169
0.5 Mg/Ml
Oral Solution
R06AX27
AERIUS
SP Europe
EU/1/00/160/3748
2.5 Milligram
Orodispersible
Tablet
R06AX27
AERIUS
SP Europe
EU/1/00/160/4960
5 Milligram
Orodispersible
Tablet
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/015
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/016
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/017
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/018
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/019
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/020
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/021
0.5 Mg/Ml
Syrup
R06AX27
AERIUS
SP Europe
EU/1/00/160/023
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/024
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/025
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/026
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/027
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/028
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/029
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/030
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/031
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/032
5 Milligram
Oral Lyophilisate
R06AX27
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-IBUPROFEN
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
DESLORATIDIN
E
PSEUDOEPHE
DRINE SULFATE
DESLORATADI
NE,
MICRONIZED
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 13 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
AERIUS
SP Europe
EU/1/00/160/033
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/034
5 Milligram
Oral Lyophilisate
R06AX27
AERIUS
SP Europe
EU/1/00/160/001
5mg Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/002
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/003
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/004
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/005
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/006
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/007
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/008
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/009
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/010
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/011
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/012
5 Milligram
Tablets
R06AX27
AERIUS
SP Europe
EU/1/00/160/013
5 Milligram
Tablets
R06AX27
AERIUS
Merck Sharp and
Dohme Limited
EU/1/00/160/014
0.5mg/ml Mg/Ml
Syrup
R06AX27
AERIUS
SP Europe
EU/1/00/160/022
5 Milligram
Oral Lyophilisate
R06AX27
AERIVIO
SPIROMAX
Teva B.V.
EU/1/16/1122/00
1-002
500 Microgram
Inhalation
Powder, Capsule
R03AK06
AFINITOR
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Seqirus S.r.l.
EU/1/09/538/004
10 Milligram
Tablets
L01XE10
EU/1/09/538/001
5 Milligram
Tablets
L01XE10
EU/1/09/538/009010
2.5 Milligram
Tablets
R06AX27
-RAD N BHT
EU/1/10/658/001002
75 Mcg/Dose
Suspension for
Injection
J07BB02
CSL Behring
GmbH
CSL Behring
GmbH
CSL Behring
GmbH
CSL Behring
GmbH
EU/1/16/1158/00
1
EU/1/16/1158/00
7
EU/1/16/1158/00
6
EU/1/16/1158/00
5
250 International
Unit
3000
International Unit
2500
International Unit
2000
International Unit
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
B02BD02
-H5N1
(A/VIETNAM/11
94/2004)
-LONOCTOCOG
ALFA
-LONOCTOCOG
ALFA
-LONOCTOCOG
ALFA
-LONOCTOCOG
ALFA
AFINITOR
AFINITOR
AFLUNOV
AFSTYLA
AFSTYLA
AFSTYLA
AFSTYLA
Human Medicines Authorised/Transfer Pending Products
B02BD02
B02BD02
B02BD02
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-EVEROLIMUS
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(3) Hybrid
Application
-Inhalation
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Intra-Muscular
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Page 14 of 608
Trade Name
AFSTYLA
AFSTYLA
AFSTYLA
AFTER BITE
3.5% W/V
CUTANEOUS
EMULSION
AGERDEX
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
CSL Behring
GmbH
CSL Behring
GmbH
CSL Behring
GmbH
Tender Limited
EU/1/16/1158/00
4
EU/1/16/1158/00
3
EU/1/16/1158/00
2
PA1039/001/001
1500
International Unit
1000
International Unit
500 International
Unit
3.5 %w/v
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Cutaneous
Emulsion
B02BD02
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/088/001
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
52,2.2 and 6.7413.2 %w/w
Granules
A06AB56
-ISPAGHULA
-ISPAGHULA
HUSKS
-CASSIA SENNA
-TINCTURE
FROM AGNUS
CASTUS FRUIT
A/CALIFORNIA/
7/2009
(H1N1)PDM09LIKE STRAIN
(A/CALIFORNIA/
7/2009, X-181)
-A/HONG
KONG/4801/2014
(H3N2) - LIKE
STRAIN
(A/HONG
KONG/4801/201
4, NYMC X263B)
B/BRISBANE/60
/2008 - LIKE
STRAIN
(B/BRISBANE/6
0/2008)
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-BIPERIDEN
HYDROCHLORI
DE
B02BD02
B02BD02
AGIOLAX
Madaus GmbH
Interchangeable
List Code:
IC0011-039-003
PA1288/002/001
AGNUS CASTUS
Bioforce (UK) Ltd
TR0725/017/001
AGRIPPAL
Seqirus S.r.l.
PA2032/001/001
N/A
Suspension for
Injection
J07BB02
AIREXAR
SPIROMAX
Teva B.V.
EU/1/16/1123/00
1-002
500/50
Powder for
Inhalation
R03AK06
AIRFLUSAL
FORSPIRO
Lexon (UK) Ltd
PPA1097/009/00
1
50/250
Microgram
Powder for
Inhalation
R03AK06
AIRFLUSAL
FORSPIRO
Lexon (UK) Ltd
PPA1097/009/00
2
50/500
Microgram
Powder for
Inhalation
R03AK06
AIRFLUSAL
FORSPIRO
Rowex Ltd
PA0711/237/001
50/250
Microgram
Powder for
Inhalation
R03AK06
AIRFLUSAL
FORSPIRO
Rowex Ltd
PA0711/237/002
50/500
Microgram
Powder for
Inhalation
R03AK06
AIRFLUSAL MDI
Rowex Ltd
PA0711/270/001
25
microgram/125
Microgram
Pressurised
Inhalation
Suspension
R03AK06
AIRFLUSAL MDI
Rowex Ltd
PA0711/270/002
25
microgram/250
Microgram
Pressurised
Inhalation
Suspension
R03AK06
AKINETON
Laboratorio
Farmaceutico
S.I.T., Srl
PA1253/001/001
2 Milligram
Tablets
N04AA02
Human Medicines Authorised/Transfer Pending Products
Oral Drops
Solution
-LONOCTOCOG
ALFA
-LONOCTOCOG
ALFA
-LONOCTOCOG
ALFA
-AMMONIA
Legal Basis
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Routes of
Administration
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
Article 10(3) Hybrid
Application
-Inhalation
-Inhalation
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
-Per Oral
Page 15 of 608
Trade Name
AKINETON
RETARD
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Laboratorio
Farmaceutico
S.I.T., Srl
Helsinn Birex
Pharmaceuticals
Limited
PA1253/002/001
4 Milligram
Tablet Prolonged
Release
N04AA02
EU/1/15/1001/00
1
300mg/0.50
Milligram
Capsules Hard
A04AA05
ALACARE
Photonamic
GmbH & Co. KG
PA2071/001/001
8 Milligram
Medicated
Plaster
L01XD04
ALBUNORM 20
Octapharma
Limited
PA0521/016/002
200 g/l
Solution for
Infusion
B05AA01
ALBUNORM 5%
Octapharma
Limited
PA0521/016/001
50 g/l
Solution for
Infusion
B05AA01
ALBUREX
CSL Behring
GmbH
PA0800/008/001
50 g/l
Solution for
Infusion
B05AA01
ALBUREX
CSL Behring
GmbH
PA0800/008/002
200 g/l
Solution for
Infusion
B05AA01
-ALBUMIN
HUMAN
ALCARTIS
EGIS
Pharmaceuticals
PLC
PA1470/005/001
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Interchangeable
List Code:
IC0092-001-056
PA1470/005/002
10 Milligram
Tablets
N05AX12
Interchangeable
List Code:
IC0092-002-056
PA1470/005/003
15 Milligram
Tablets
Interchangeable
List Code:
IC0092-032-056
PA1470/005/004
30 Milligram
Interchangeable
List Code:
IC0092-033-056
PA1470/005/005
AKYNZEO
ALCARTIS
ALCARTIS
ALCARTIS
ALCARTIS
ALCARTIS
ALCARTIS
ALCARTIS
EGIS
Pharmaceuticals
PLC
EGIS
Pharmaceuticals
PLC
EGIS
Pharmaceuticals
PLC
EGIS
Pharmaceuticals
PLC
EGIS
Pharmaceuticals
PLC
EGIS
Pharmaceuticals
PLC
EGIS
Pharmaceuticals
PLC
-BIPERIDEN
HYDROCHLORI
DE
-NETUPITANT
PALONOSETRO
N (AS
HYDROCHLORI
DE)
-5AMINOLEVULIN
IC ACID
HYDROCHLORI
DE
-HUMAN
PLASMA
PROTEIN NOT
CONTAINING
LESS THAN 96%
HUMAN
ALBUMIN
-HUMAN
PLASMA
PROTEIN NOT
CONTAINING
LESS THAN 96%
HUMAN
ALBUMIN
-HUMAN
ALBUMIN
Legal Basis
Routes of
Administration
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Cutaneous
-Intra-venous
-Intra-venous
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10(1) Generic
Application
-Intra-venous
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
5 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-001-056
PA1470/005/006
Article 10(1) Generic
Application
10 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-002-056
PA1470/005/007
Article 10(1) Generic
Application
15 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-032-056
PA1470/005/008
Article 10(1) Generic
Application
30 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0092-033-056
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Per Oral
Page 16 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ALDACTONE
PCO
Manufacturing
PPA0465/418/00
1
25 Milligram
Film Coated
Tablet
C03DA01
ALDACTONE
Primecrown 2010
Ltd
PPA1633/030/00
1
25 Milligram
Film Coated
Tablet
C03DA01
ALDACTONE
Imbat Limited
PPA1151/197/00
1
25 Milligram
Film Coated
Tablet
C03DA01
ALDACTONE
LTT Pharma
Limited
PPA1562/133/00
1
25 Milligram
Film Coated
Tablet
C03DA01
ALDACTONE
Pfizer Healthcare
Ireland
PA0822/110/003
100 Milligram
Tablets
C03DA01
ALDACTONE
Pfizer Healthcare
Ireland
PA0822/110/001
25 Milligram
Tablets
C03DA01
ALDACTONE
Pfizer Healthcare
Ireland
PA0822/110/002
50 Milligram
Tablets
C03DA01
ALDARA
ALDOMET
Meda AB
Aspen Pharma
Trading Limited
Aspen Pharma
Trading Limited
Genzyme Europe
B.V.
Roche
Registration
Limited
Rowex Ltd
EU/1/98/080/001
PA1691/012/001
5% w/w %w/w
250 mg Milligram
Cream
Coated Tablets
PA1691/012/002
500 mg Milligram
EU/1/03/253/01-3
500 U Units/ml
EU/1/16/1169/00
1
PA0711/259/001
ALDOMET
ALDURAZYME
ALECENSA
ALENDRONATE
/COLECALCIFE
ROL ROWEX
Teva Pharma
B.V.
ALENDRONATE
/COLECALCIFE
ROL TEVA
Teva Pharma
B.V.
ALENDRONIC
ACID
WPR Healthcare
Limited
D06BB10
C02AB01
Coated Tablets
C02AB01
-METHYLDOPA
-Per Oral
A16AB05
-LARONIDASE
150 Milligram
Solution for
Infusion
Capsules Hard
L01XE36
Article 8(3) - Full
new Application
-Per Oral
70/5600 mg/IU
Tablets
M05BB03
Article 10(1) Generic
Application
-Per Oral
70/2800 mg/IU
Tablets
M05BB03
Article 10b Fixed
Combination
-Per Oral
70/5600 mg/IU
Tablets
M05BB03
Article 10b Fixed
Combination
-Per Oral
70 Milligram
Tablets
M05BA04
-ALECTINIB
HYDROCHLORI
DE
COLECALCIFE
ROL
-ALENDRONATE
SODIUM
TRIHYDRATE
-ALENDRONATE
SODIUM
MONOHYDRATE
COLECALCIFE
ROL
-ALENDRONATE
SODIUM
MONOHYDRATE
COLECALCIFE
ROL
-ALENDRONIC
ACID
Interchangeable
List Code:
IC0051-101-002
PA1436/004/001
70 Milligram
Tablets
M05BA04
-SODIUM
ALENDRONATE
Interchangeable
List Code:
IC0051-101-002
PA0711/102/001
Article 10(1) Generic
Application
70 Milligram
Tablets
M05BA04
-Per Oral
Interchangeable
List Code:
IC0051-101-002
PA1390/035/002
-ALENDRONATE
SODIUM
TRIHYDRATE
70 Milligram
Tablets
M05BA04
-ALENDRONIC
ACID
-Per Oral
PA0749/196/001
PA0749/196/002
Interchangeable
List Code:
IC0052-103-002
Bluefish
Pharmaceuticals
AB
ALENDRONIC
ACID ONCE
WEEKLY
Rowex Ltd
ALENDRONIC
ACID ONCE
WEEKLY
Accord
Healthcare
Limited
Routes of
Administration
-Per Oral
Interchangeable
List Code:
IC0052-102-002
ALENDRONIC
ACID BLUEFISH
ONCE WEEKLY
Legal Basis
SPIRONOLACT
ONE
SPIRONOLACT
ONE
SPIRONOLACT
ONE
SPIRONOLACT
ONE
SPIRONOLACT
ONE
SPIRONOLACT
ONE
SPIRONOLACT
ONE
-IMIQUIMOD
-METHYLDOPA
Interchangeable
List Code:
IC0052-103-002
ALENDRONATE
/COLECALCIFE
ROL TEVA
Active
Ingredients
PPA0565/058/00
1
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0051-101-002
Human Medicines Authorised/Transfer Pending Products
Page 17 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
ALEXETTE
Gedeon Richter
Plc
PA1330/009/001
0.02/3 Milligram
Film Coated
Tablet
G03AA12
ALFU
Milpharm Limited
PA1050/022/001
10 Milligram
Tablet Prolonged
Release
G04CA01
ALFUZOSIN
HYDROCHLORI
DE ROWEX
ALIMEMAZINE
TARTRATE
Rowex Ltd
PA0711/083/002
10 Milligram
Tablet Prolonged
Release
G04CA01
Kinedexe UK
Limited
PA2062/001/003
7.5 MG/5ml
Syrup
R06AD01
ALIMEMAZINE
TARTRATE
Kinedexe UK
Limited
PA2062/001/001
10 Milligram
Film Coated
Tablet
R06AD01
ALIMEMAZINE
TARTRATE
Kinedexe UK
Limited
PA2062/001/002
30 MG/5ml
Syrup
R06AD01
ALIMTA
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Bayer Limited
EU/1/04/290/001
500mg Milligram
L01BA04
EU/1/04/290/002
100 Milligram
L01BA04
-PEMETREXED
PA1410/032/001
324/1744/965
Milligram
Pdr/Conc/Soln for
Infus
Pdr for Soln for
Infusion
Tablets
Effervescent
-TRIMEPRAZINE
(ALIMEMAZINE)
TARTRATE
-PEMETREXED
N02BA01
PA1691/004/002
2 Milligram
L01AA03
PA1691/004/001
50 Milligram
L01AA03
-MELPHALAN
EU/1/07/401/1215
EU/1/07/401/7-11
27 Milligram
A08AB01
-ORLISTAT
A08AB01
-ORLISTAT
PA0176/031/001
100 Milligram
Film Coated
Tablet
Pdr+Solv for soln
for Inf
Tablets
Chewable
Tablets
Chewable
Tablets
M04AA01
-ALLOPURINOL
PA0176/031/002
300 Milligram
Tablets
M04AA01
-ALLOPURINOL
ALLOPURINOL
TEVA
Aspen Pharma
Trading Limited
Aspen Pharma
Trading Limited
Glaxo Group
Limited
Glaxo Group
Limited
Actavis UK
Limited
Actavis UK
Limited
Teva Pharma
B.V.
ACETYLSALICY
LIC ACID
-SODIUM
BICARBONATE
-CITRIC ACID
-MELPHALAN
PA0749/099/001
100 Milligram
Tablets
M04AA01
-ALLOPURINOL
ALLOPURINOL
TEVA
Teva Pharma
B.V.
PA0749/099/003
300 Milligram
Tablets
M04AA01
-ALLOPURINOL
ALMOGRAN
Almirall, S.A.
PA0968/001/001
12.5 Milligram
N02CC05
-ALMOTRIPTAN
ALMOTRIPTAN
Chanelle Medical
PA0688/028/001
12.5 Milligram
Film Coated
Tablet
Film Coated
Tablet
N02CC05
-ALMOTRIPTAN
MALATE
ALOMIDE 0.1 %
W/V EYE
DROPS,
SOLUTION
ALOPUR
Novartis
Pharmaceuticals
UK Ltd
PA0013/126/001
0.1 %w/v
Eye Drops
Solution
S01GX05
-LODOXAMIDE
TROMETHAMIN
E
Rowex Ltd
PA0711/154/002
300 Milligram
Tablets
M04AA01
-ALLOPURINOL
ALOPUR
Rowex Ltd
PA0711/154/001
100 Milligram
Tablets
M04AA01
-ALLOPURINOL
ALOXI
Helsinn Birex
Pharmaceuticals
Limited
EU/1/04/306/2-3
500 Microgram
Capsules, Soft
A04AA05
ALOXI
Helsinn Birex
Pharmaceuticals
Limited
EU/1/04/306/001
250 MG/5ml
Solution for
Injection
A04AA05
PALONOSETRO
N (AS
HYDROCHLORI
DE)
PALONOSETRO
N (AS
HYDROCHLORI
DE)
ALIMTA
ALKA-SELTZER
ALKERAN
ALKERAN
ALLI
ALLI
ALLOPURINOL
ALLOPURINOL
Human Medicines Authorised/Transfer Pending Products
60 Milligram
DROSPIRENON
E
ETHINYLESTRA
DIOL
-ALFUZOSIN
HYDROCHLORI
DE
-ALFUZOSIN
HYDROCHLORI
DE
-TRIMEPRAZINE
(ALIMEMAZINE)
TARTRATE
-ALIMEMAZINE
TARTRATE
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10c Informed Consen
Article 10c Informed Consen
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
Page 18 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
ALPHADERM 1%
& 10% W/W
CREAM
Alliance
Pharmaceuticals
Ltd.
PA0943/004/001
1/10 %w/w
Cream
D07XA01
ALPHAGAN
PA0148/006/001
0.2 %w/v
Eye Drops
Solution
S01EA05
Lexon (UK) Ltd
ALPHAGAN EYE
DROPS
SOLUTION
ALPRAZOLAM
Eurodrug Ltd
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
S01EA05
ALPHAGAN
DPR1473/002/0
01
DPR0465/002/0
01
PPA0465/413/00
1
DPR1328/020/0
01
PPA1097/015/00
1
DPR1392/044/0
01
0.2 %w/v
ALPHAGAN
Allergan
Pharmaceuticals
Ireland
McDowell
Pharmaceuticals
PCO
Manufacturing
PCO
Manufacturing
B & S Healthcare
Rowex Ltd
PA0711/140/001
0.25 Milligram
Tablets
N05BA12
-ALPRAZOLAM
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0094-145-002
PA0711/140/002
Article 10(1) Generic
Application
0.50 Milligram
Tablets
N05BA12
-ALPRAZOLAM
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0094-040-002
PA0711/140/003
Article 10(1) Generic
Application
1 Milligram
Tablets
N05BA12
-ALPRAZOLAM
-Per Oral
Interchangeable
List Code:
IC0094-039-002
EU/1/16/1098/00
1
Article 10(1) Generic
Application
250 International
Unit
Pdr+Solv for Soln
for Inj
B02BD04
Article 8(3) - Full
new Application
-Intra-venous
EU/1/16/1098/00
5
3000
International Unit
Pdr+Solv for Soln
for Inj
B02BD04
Article 8(3) - Full
new Application
-Intra-venous
EU/1/16/1098/00
4
2000
International Unit
Pdr+Solv for Soln
for Inj
B02BD04
Article 8(3) - Full
new Application
-Intra-venous
EU/1/16/1098/00
3
1000
International Unit
Pdr+Solv for Soln
for Inj
B02BD04
Article 8(3) - Full
new Application
-Intra-venous
EU/1/16/1098/00
2
500 International
Unit
Pdr+Solv for Soln
for Inj
B02BD04
Article 8(3) - Full
new Application
-Intra-venous
EU/1/07/390/1-4
1 %w/w
Ointment
D06AX13
EFTRENONAC
OG ALFA
EFTRENONAC
OG ALFA
EFTRENONAC
OG ALFA
EFTRENONAC
OG ALFA
EFTRENONAC
OG ALFA
-RETAPAMULIN
PA1876/002/001
50,000
International Unit
Oral Solution
A11CC05
COLECALCIFE
ROL
COLECALCIFE
ROL
CONCENTRATE
(OILY FORM)
COLECALCIFE
ROL
CONCENTRATE
(OILY FORM)
COLECALCIFE
ROL
COLECALCIFE
ROL
COLECALCIFE
ROL
Article 10a Bibliographical
App
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
Article 10a Bibliographical
App
-Per Oral
ALPHAGAN
ALPHAGAN
ALPHAGAN
ALPRAZOLAM
ALPRAZOLAM
ALPROLIX
ALPROLIX
ALPROLIX
ALPROLIX
ALPROLIX
ALTARGO
ALTAVITA D3
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Glaxo Group
Limited
Consilient Health
Limited
0.2 Per Cent
0.2 %w/v
0.2 %w/v
0.2 %w/v
0.2 %w/v
S01EA05
S01EA
S01EA05
S01EA05
S01EA05
ALTAVITAD3
Consilient Health
Limited
PA1876/004/003
25,000
International Unit
Capsules, Soft
A11CC05
ALTAVITAD3
Consilient Health
Limited
PA1876/004/004
50,000
International Unit
Capsules, Soft
A11CC05
ALTAVITAD3
Consilient Health
Limited
PA1876/004/001
400 International
Unit
Unknown
A11CC05
ALTAVITAD3
Consilient Health
Limited
PA1876/002/002
25,000
International Unit
Oral Solution
A11CC05
Human Medicines Authorised/Transfer Pending Products
HYDROCORTIS
ONE
-UREA
-BRIMONIDINE
TARTRATE
-BRIMONIDINE
TARTRATE
-BRIMONIDINE
TARTRATE
-BRIMONIDINE
TARTRATE
-BRIMONIDINE
TARTRATE
-BRIMONIDINE
TARTRATE
-BRIMONIDINE
TARTRATE
-Cutaneous
-Per Oral
-Per Oral
Page 19 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
ALTAVITAD3
Consilient Health
Limited
PA1876/005/001
1000
International Unit
Capsules, Soft
A11CC05
ALTAVITAD3
Consilient Health
Limited
PA1876/005/002
7000
International Unit
Capsules, Soft
A11CC05
ALTAVITAD3
Consilient Health
Limited
PA1876/004/002
800 International
Unit
Capsules, Soft
A11CC05
ALTAVITAD3
Consilient Health
Limited
PA1876/007/001
5,600
International Unit
Capsules, Soft
A11CC05
ALVERINE
CITRATE
Blackrock
Pharmaceuticals
Limited
Blackrock
Pharmaceuticals
Limited
Auden Mckenzie
(Pharma Division)
Ltd
Auden Mckenzie
(Pharma Division)
Ltd
Laboratoires
Mayoly Spindler
PA2013/001/001
60 Milligram
Capsules Hard
A03AX08
PA2013/001/002
120 Milligram
Capsules Hard
A03AX08
-ALVERINE
CITRATE
PA1352/010/002
120 Milligram
Capsules Hard
A03AX08
-ALVERINE
CITRATE
PA1352/010/001
60 Milligram
Capsules Hard
A03AX08
-ALVERINE
CITRATE
PA1993/001/001
60 Milligram
Capsules Hard
A03AX08
-ALVERINE
CITRATE
AstraZeneca UK
Limited
AstraZeneca UK
Limited
Teva Pharma
B.V.
PA0970/064/001
80 Microgram
R03BA08
-CICLESONIDE
PA0970/064/002
160 Microgram
R03BA08
-CICLESONIDE
PA0749/203/003
13.3/24
Pressurised
Inhalation Soln
Pressurised
Inhalation Soln
Transdermal
Patch
N06DA03
-RIVASTIGMINE
BASE
AMARYL
Imbat Limited
1 Milligram
Tablets
A10BB12
AMARYL
Imbat Limited
2 Milligram
Tablets
AMARYL
Imbat Limited
4 Milligram
AMARYL 1 MG
TABLET
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
GlaxoSmithKline
Biologicals S.A.
PPA1151/063/00
1
PPA1151/063/00
2
PPA1151/063/00
3
PA0540/028/001
ALVERINE
CITRATE
ALVERINE
CITRATE 120MG
CAPSULES
ALVERINE
CITRATE 60MG
CAPSULES
ALVERINE
MAYOLY
SPINDLER
ALVESCO
ALVESCO
ALZTEV
AMARYL 3 MG
TABLET
AMBIRIX
Routes of
Administration
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Transdermal
-GLIMEPIRIDE
Article 10(1) Generic
Application
PPA
A10BB12
-GLIMEPIRIDE
PPA
Tablets
A10BB12
-GLIMEPIRIDE
PPA
1.0 mg Milligram
Tablets
A10BB12
-GLIMEPIRIDE
-Per Oral
PA0540/028/003
3.0mg Milligram
Tablets
A10BB12
-GLIMEPIRIDE
-Per Oral
EU/1/02/224/001
%v/v
Suspension for
Injection
J07BC20
-HEPATIT A
VIRUS ANTIGEN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HEPATIT A
VIRUS ANTIGEN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HEPATIT A
VIRUS ANTIGEN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HEPATIT A
VIRUS ANTIGEN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-Intra-Muscular
AMBIRIX
GlaxoSmithKline
Biologicals S.A.
EU/1/02/224/002
Per Cent
Suspension for
Injection
J07BC20
AMBIRIX
GlaxoSmithKline
Biologicals S.A.
EU/1/02/224/003
Per Cent
Suspension for
Injection
J07BC20
AMBIRIX
GlaxoSmithKline
Biologicals S.A.
EU/1/02/224/004
Per Cent
Suspension for
Injection
J07BC20
Human Medicines Authorised/Transfer Pending Products
COLECALCIFE
ROL
COLECALCIFE
ROL
CHOLECALCIF
EROL (02)
COLECALCIFE
ROL
CONCENTRATE
(OILY FORM)
-ALVERINE
CITRATE
Legal Basis
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
Page 20 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
AMBIRIX
GlaxoSmithKline
Biologicals S.A.
EU/1/02/224/005
Per Cent
Suspension for
Injection
J07BC20
AMBISOME
LIPOSOMAL
AMPHOTERICIN
B 50MG
POWDER FOR
AMBROBENE
Gilead Sciences
International
PA0911/001/001
50 Milligram
Infus/Pdr/Oral
Soln
J02AA01
Teva Pharma
B.V.
PA0749/158/001
3 Mg/Ml
Oral Solution
R05CB06
AMBROBENE
EXTRA
STRENGTH
AMELUZ
Teva Pharma
B.V.
PA0749/158/002
6 Mg/Ml
Oral Solution
R05CB06
Biofrontera
Bioscience
GmbH
EU/1/11/740/001
78 mg/g
Gel
L01XD04
AMETOP 40
MG/G GEL
Smith & Nephew
Healthcare
Limited
Amgen Europe
B.V.
PA0768/001/001
40 mg/g
Gel
N01BA03
EU/1/16/1164/00
1
20 Milligram
Solution for
Injection
L04AB04
-AMBROXOL
HYDROCHLORI
DE
-AMBROXOL
HYDROCHLORI
DE
-5AMINOLEVULIN
IC ACID
HYDROCHLORI
DE
-TETRACAINE
HYDROCHLORI
DE
-ADALIMUMAB
AMGEVITA
Amgen Europe
B.V.
EU/1/16/1164/00
2-009
40 Milligram
Solution for
Injection
L04AB04
-ADALIMUMAB
AMIDEX
Clonmel
Healthcare Ltd
PA0126/189/001
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
Interchangeable
List Code:
IC0011-039-003
PA0048/004/004
100 mg/2ml
Solution for
Injection
J01GB06
-AMIKACIN
SULFATE
PA0073/099/001
25 Mg/Ml
Solution for
Injection
R03DA05
PA0566/002/002
10 % N/A
Solution for
Infusion
B05BA01
AMINOPHYLLIN
E HYDRATE
-ISOLEUCINE
-LEUCINE
-LYSINE
ACETATE
-DLMETHIONINE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-TAURINE
AMGEVITA
AMIKIN
AMINOPHYLLIN
E HYDRATE
AMINOVEN 16
Bristol-Myers
Squibb (Holdings)
Limited
Mercury
Pharmaceuticals
(Ireland) Ltd
Fresenius Kabi
Limited
Human Medicines Authorised/Transfer Pending Products
Legal Basis
-HEPATIT A
VIRUS ANTIGEN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-AMPHOTERICIN
B
Routes of
Administration
-Intra-Muscular
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
-Per Oral
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(1) Generic
Application
-Subcutaneous
-Per Oral
-Cutaneous
-Subcutaneous
-Per Oral
Page 21 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
AMINOVEN 16
Fresenius Kabi
Limited
PA0566/002/005
10% Unknown
Solution for
Infusion
B05BA01
AMINOVEN 25
Fresenius Kabi
Limited
PA0566/002/006
15% N/A
Solution for
Infusion
B05BA01
AMINOVEN 25
Fresenius Kabi
Limited
PA0566/002/003
15 % Unknown
Solution for
Infusion
B05BA01
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-ISOLEUCINE
-LEUCINE
-LYSINE
ACETATE
-DLMETHIONINE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-TAURINE
-ISOLEUCINE
-LEUCINE
-LYSINE
ACETATE
-DLMETHIONINE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-TAURINE
-ISOLEUCINE
-LEUCINE
-LYSINE
ACETATE
-DLMETHIONINE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-TAURINE
Page 22 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
AMINOVEN 3.5%
GLUCOSE/ELE
CTROLYTES
Fresenius Kabi
Limited
PA0566/014/001
3.5 Per Cent
Solution for
Infusion
B05BA10
AMINOVEN 8
Fresenius Kabi
Limited
PA0566/002/001
5 % N/A
Solution for
Infusion
B05BA01
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-TYROSINE
-ISOLEUCINE
-LEUCINE
-LYSINE
HYDROCHLORI
DE
-METHIONINE,
ACTIVE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TAURINE
-GLUCOSE
MONOHYDRATE
-SODIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-ZINC
CHLORIDE
-ISOLEUCINE
-LEUCINE
-LYSINE
ACETATE
-DLMETHIONINE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-TAURINE
Legal Basis
Routes of
Administration
-Intra-venous
Page 23 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
AMINOVEN 8
Fresenius Kabi
Limited
PA0566/002/004
5% N/A
Solution for
Infusion
B05BA01
AMIODARONE
Stragen UK
Limited
PA1294/005/001
50 Mg/Ml
Concentrate for
Soln for Inj
C01BD01
AMISULPRIDE
Focus
Pharmaceuticals
Ltd
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Takeda UK
Limited
Clonmel
Healthcare Ltd
PA1338/006/001
100 Mg/Ml
Oral Solution
N05AL05
-ISOLEUCINE
-LEUCINE
-LYSINE
ACETATE
-DLMETHIONINE
PHENYLALANIN
E
-THREONINE
-TRYPTOPHAN,
L-VALINE
-ARGININE
-HISTIDINE
-ALANINE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-TAURINE
-AMIODARONE
HYDROCHLORI
DE
-AMISULPRIDE
PA0577/182/001
50 Milligram
Tablets
N05AL05
-AMISULPRIDE
PA0577/182/002
200 Milligram
Tablets
N05AL05
PA0577/125/001
50 Milligram
Tablets
PA0577/125/003
200 Milligram
PA1547/011/001
AMISULPRIDE
AMISULPRIDE
AMISULPRIDE
MYLAN
AMISULPRIDE
MYLAN
AMITIZA
AMITRIPTYLINE
25 MG FILMCOATED
TABLETS
AMITRIPTYLINE
HYDROCHLORI
DE
AMITRIPTYLINE
HYDROCHLORI
DE
AMITRIPTYLINE
HYDROCHLORI
DE
AMITRIPTYLINE
HYDROCHLORI
DE
AMITRIPTYLINE
HYDROCHLORI
DE
AMLODE
AMLODE
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-AMISULPRIDE
Article 10(1) Generic
Application
-Per Oral
N05AL05
-AMISULPRIDE
Article 10(1) Generic
Application
-Per Oral
Tablets
N05AL05
-AMISULPRIDE
Article 10(1) Generic
Application
-Per Oral
24 Microgram
Capsules, Soft
A06AX03
Article 8(3) - Full
new Application
-Per Oral
PA0126/041/001
25 Milligram
Film Coated
Tablet
N06AA09
LUBIPROSTONE
-AMITRIPTYLINE
HYDROCHLORI
DE
Wockhardt UK
Limited
PA1339/024/001
25/5 Milligram
Oral Solution
N06AA09
PA1339/024/002
50/5 Milligram
Oral Solution
N06AA09
SYRI Limited, t/a
Thame
Laboratories
SYRI Limited, t/a
Thame
Laboratories
SYRI Limited, t/a
Thame
Laboratories
Rowex Ltd
PA1861/004/001
10 MG/5ml
Oral Solution
N06AA09
PA1861/004/002
25 MG/5ml
Oral Solution
N06AA09
PA1861/004/003
50 MG/5ml
Oral Solution
N06AA09
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Per Oral
Wockhardt UK
Limited
PA0711/138/001
5 Milligram
Tablets
C08CA01
-AMITRIPTYLINE
HYDROCHLORI
DE
-AMITRIPTYLINE
HYDROCHLORI
DE
-AMITRIPTYLINE
HYDROCHLORI
DE
-AMITRIPTYLINE
HYDROCHLORI
DE
-AMITRIPTYLINE
HYDROCHLORI
DE
-AMLODIPINE
BESYLATE
Interchangeable
List Code:
IC0045-001-008
PA0711/138/002
10 Milligram
Tablets
C08CA01
Rowex Ltd
-AMLODIPINE
BESYLATE
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0045-002-008
Human Medicines Authorised/Transfer Pending Products
Page 24 of 608
Trade Name
AMLODIPINE
AMLODIPINE
AMLODIPINE
AMLODIPINE
AMLODIPINE
AMLODIPINE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
PA0688/009/001
5 Milligram
Capsules Hard
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0045-001-008
PA0688/009/002
10 Milligram
Capsules Hard
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA0312/035/001
1 Mg/Ml
Oral Solution
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-047-019
PA0312/035/002
Article 10(3) Hybrid
Application
2 Mg/Ml
Oral Solution
C08CA01
-AMLODIPINE
BESILATE
Article 10(3) Hybrid
Application
-Per Oral
5 Milligram
Tablets
C08CA01
-AMLODIPINE
AS AMLODIPINE
BESILATE
-Per Oral
10 Milligram
Tablets
C08CA01
-AMLODIPINE
AS AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA1063/051/001
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
Rosemont
Pharmaceuticals
Ltd
Rosemont
Pharmaceuticals
Ltd
WPR Healthcare
Limited
WPR Healthcare
Limited
PPA0565/059/00
1
Interchangeable
List Code:
IC0045-001-008
PPA0565/059/00
2
Niche Generics
Limited
AMLODIPINE
Niche Generics
Limited
PA1063/051/002
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
AMLODIPINE
AUROBINDO
Milpharm Limited
PA1050/005/001
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
Milpharm Limited
Interchangeable
List Code:
IC0045-001-008
PA1050/005/002
10 Milligram
Tablets
C08CA01
Interchangeable
List Code:
IC0045-002-008
PA1436/016/001
5 Milligram
Tablets
Interchangeable
List Code:
IC0045-001-008
PA1436/016/002
10 Milligram
Interchangeable
List Code:
IC0045-002-008
PA0126/258/001
AMLODIPINE
BLUEFISH
AMLODIPINE
BLUEFISH
AMLODIPINE
CLONMEL
AMLODIPINE
CLONMEL
AMLODIPINE
FAIR-MED
AMLODIPINE
FAIR-MED
Routes of
Administration
Chanelle Medical
AMLODIPINE
AMLODIPINE
AUROBINDO
Legal Basis
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Fair-Med
Healthcare
GmbH
Fair-Med
Healthcare
GmbH
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
C08CA01
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
Tablets
C08CA01
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
5 Milligram
Tablets
C08CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA0126/258/002
-AMLODIPINE
BESILATE
-AMLODIPINE
10 Milligram
Tablets
C08CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA1789/006/001
-AMLODIPINE
BESILATE
-AMLODIPINE
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA1789/006/002
Article 10(1) Generic
Application
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0045-002-008
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
Page 25 of 608
Trade Name
AMLODIPINE
KRKA
AMLODIPINE
KRKA
AMLODIPINE
MYLAN
AMLODIPINE
MYLAN
AMLODIPINE
PFIZER
AMLODIPINE
PFIZER
AMLODIPINE
TEVA
AMLODIPINE
TEVA
AMLODIPINE
THAME
AMLODIPINE
THAME
AMLODIPINE/V
ALSARTAN
CLONMEL
Licence Holder Licence
Number
Krka d.d., Novo
mesto
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1347/034/001
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA1347/034/002
Article 10(1) Generic
Application
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA0577/133/001
Article 10(1) Generic
Application
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA0577/133/002
Article 10(1) Generic
Application
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Pfizer Limited
Interchangeable
List Code:
IC0045-002-008
PA0019/055/001
Article 10(1) Generic
Application
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
Article 10c Informed Consen
-Per Oral
Pfizer Limited
Interchangeable
List Code:
IC0045-001-008
PA0019/055/002
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
Article 10c Informed Consen
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA0749/067/001
5 Milligram
Tablets
C08CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA0749/067/002
-AMLODIPINE
AS AMLODIPINE
BESILATE
10 Milligram
Tablets
C08CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA1861/007/001
-AMLODIPINE
AS AMLODIPINE
BESILATE
5 MG/5ml
Oral Solution
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-047-019
PA1861/007/002
Article 10(1) Generic
Application
10 MG/5ml
Oral Solution
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
PA0126/274/001
5/80 Milligram
Film Coated
Tablet
C09DB01
-AMLODIPINE
-VALSARTAN
Interchangeable
List Code:
IC0042-087-003
PA0126/274/002
Article 10(1) Generic
Application
Article 10(1) Generic
Application
5/160 Milligram
Film Coated
Tablet
C09DB01
-AMLODIPINE
-VALSARTAN
-Per Oral
Interchangeable
List Code:
IC0042-086-003
PA0126/274/003
Article 10(1) Generic
Application
10/160 Milligram
Film Coated
Tablet
C09DB01
-AMLODIPINE
-VALSARTAN
-Per Oral
Interchangeable
List Code:
IC0042-084-003
PA1347/055/001
Article 10(1) Generic
Application
5/80 Milligram
Film Coated
Tablet
C10BX09
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0042-087-003
PA1347/055/002
-VALSARTAN
-AMLODIPINE
AS AMLODIPINE
BESILATE
5/160 Milligram
Film Coated
Tablet
C10BX09
-VALSARTAN
-AMLODIPINE
AS AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
Krka d.d., Novo
mesto
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Teva Pharma
B.V.
Teva Pharma
B.V.
SYRI Limited, t/a
Thame
Laboratories
SYRI Limited, t/a
Thame
Laboratories
Clonmel
Healthcare Ltd
AMLODIPINE/V
ALSARTAN
CLONMEL
Clonmel
Healthcare Ltd
AMLODIPINE/V
ALSARTAN
CLONMEL
Clonmel
Healthcare Ltd
AMLODIPINE/V
ALSARTAN
KRKA
Krka d.d., Novo
mesto
AMLODIPINE/V
ALSARTAN
KRKA
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0042-086-003
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Page 26 of 608
Trade Name
Licence Holder Licence
Number
AMLODIPINE/V
ALSARTAN
KRKA
Krka d.d., Novo
mesto
AMLODIPINE/V
ALSARTAN
KRKA
Krka d.d., Novo
mesto
AMLODIPINE/V
ALSARTAN
KRKA
AMLODIPINE/V
ALSARTAN
MYLAN
AMLODIPINE/V
ALSARTAN
MYLAN
AMLODIPINE/V
ALSARTAN
MYLAN
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1347/055/003
10/160 Milligram
Film Coated
Tablet
C10BX09
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0042-084-003
PA1347/055/004
-VALSARTAN
-AMLODIPINE
AS AMLODIPINE
BESILATE
5/320 Milligram
Film Coated
Tablet
C10BX09
Article 10(3) Hybrid
Application
-Per Oral
Krka d.d., Novo
mesto
PA1347/055/005
10/320 Milligram
Film Coated
Tablet
C10BX09
Article 10(3) Hybrid
Application
-Per Oral
Mylan S.A.S.
EU/1/16/1092/00
1-013
5 mg/80 Milligram
Film Coated
Tablet
C09DB01
-VALSARTAN
-AMLODIPINE
AS AMLODIPINE
BESILATE
-VALSARTAN
-AMLODIPINE
AS AMLODIPINE
BESILATE
-VALSARTAN
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0042-087-003
EU/1/16/1092/02
7-039
10 mg/160
Milligram
Film Coated
Tablet
C09DB01
-VALSARTAN
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0042-084-003
EU/1/16/1092/01
4-026
5 mg/160
Milligram
Film Coated
Tablet
C09DB01
-VALSARTAN
-AMLODIPINE
BESILATE
Article 10(1) Generic
Application
-Per Oral
5/80 Milligram
Film Coated
Tablet
C09DB01
-AMLODIPINE
BESILATE
-VALSARTAN
Article 10(1) Generic
Application
-Per Oral
Mylan S.A.S.
Mylan S.A.S.
AMLODIPINE/V
ALSARTAN
ROWEX
Rowex Ltd
Interchangeable
List Code:
IC0042-086-003
PA0711/253/001
AMLODIPINE/V
ALSARTAN
ROWEX
Rowex Ltd
Interchangeable
List Code:
IC0042-087-003
PA0711/253/002
5/160 Milligram
Film Coated
Tablet
C09DB01
Article 10(1) Generic
Application
-Per Oral
AMLODIPINE/V
ALSARTAN
ROWEX
Rowex Ltd
Interchangeable
List Code:
IC0042-086-003
PA0711/253/003
-AMLODPINE
BESILATE
-VALSARTAN
10/160 Milligram
Film Coated
Tablet
C09DB01
Article 10(1) Generic
Application
-Per Oral
AMLODIPINE/V
ALSARTAN
TEVA
Teva B.V.
Interchangeable
List Code:
IC0042-084-003
PA1986/013/001
-AMLODPINE
BESILATE
-VALSARTAN
5/80 Milligram
Film Coated
Tablet
C09DB01
Article 10(1) Generic
Application
-Per Oral
AMLODIPINE/V
ALSARTAN
TEVA
Teva B.V.
Interchangeable
List Code:
IC0042-087-003
PA1986/013/002
-VALSARTAN
-AMLODIPINE
BESILATE
5/160 Milligram
Film Coated
Tablet
C09DB01
Article 10(1) Generic
Application
-Per Oral
AMLODIPINE/V
ALSARTAN
TEVA
Teva B.V.
Interchangeable
List Code:
IC0042-086-003
PA1986/013/003
-VALSARTAN
-AMLODIPINE
BESILATE
10/160 Milligram
Film Coated
Tablet
C09DB01
Article 10(1) Generic
Application
-Per Oral
AMLOTAN
Athlone
Laboratories Ltd
Interchangeable
List Code:
IC0042-084-003
PA0298/015/001
-VALSARTAN
-AMLODIPINE
BESILATE
5 Milligram
Tablets
C08CA01
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA0298/015/002
-AMLODIPINE
MESILATE
MONOHYDRATE
10 Milligram
Tablets
C08CA01
-Per Oral
Interchangeable
List Code:
IC0045-002-008
EU/1/99/120/001
-AMLODIPINE
MESILATE
MONOHYDRATE
500mg Milligram
Tablets
A16AX03
-SODIUM
PHENYLBUTYR
ATE
-Per Oral
AMLOTAN
AMMONAPS
Athlone
Laboratories Ltd
Swedish Orphan
International AB
Human Medicines Authorised/Transfer Pending Products
Page 27 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
AMMONAPS
Swedish Orphan
International AB
EU/1/99/120/004
940 mg/g %v/v
Granules
A16AX03
AMMONAPS
Swedish Orphan
International AB
EU/1/99/120/002
500mg Milligram
Tablets
A16AX03
AMMONAPS
Swedish Orphan
International AB
EU/1/99/120/003
940 mg/g %v/v
Granules
A16AX03
AMOCLAV
Rowex Ltd
PA0711/162/001
125/31.25
MG/5ml
Powder for Oral
Suspension
J01CR02
Rowex Ltd
Interchangeable
List Code:
IC0037-071-034
PA0711/162/002
250/125 Milligram
Film Coated
Tablet
Rowex Ltd
Interchangeable
List Code:
IC0037-074-014
PA0711/162/003
500125 Milligram
AMOCLAV
AMOCLAV
Active
Ingredients
Legal Basis
Routes of
Administration
-SODIUM
PHENYLBUTYR
ATE
-SODIUM
PHENYLBUTYR
ATE
-SODIUM
PHENYLBUTYR
ATE
-AMOXICILLIN
-CLAVULANIC
ACID
-Per Oral
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID
-Per Oral
Film Coated
Tablet
J01CR02
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
TRIHYDRATE
-AMOROLFINE
Interchangeable
List Code:
IC0037-073-014
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
-Cutaneous
-Per Oral
AMOROLFINE
Chanelle Medical
PA0688/031/001
5 Per Cent
Medicated Nail
Lacquer
D01AE16
AMOXICILIN/CL
AVULANIC ACID
KRKA
Krka d.d., Novo
mesto
PA1347/044/001
500 / 125
Milligram
Film Coated
Tablet
J01CR02
AMOXICILLIN
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
DSM Sinochem
Pharmaceuticals
Netherlands B.V.
PA0126/282/001
250 Milligram
Capsules Hard
J01CA04
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED WITH
MICROCRYSTA
LLINE
CELLULOSE
(1:1))
-AMOXICILLIN
PA0126/282/002
500 Milligram
Capsules Hard
J01CA04
-AMOXICILLIN
PA0126/282/003
125mg/5ml Mg/M
J01CA04
-AMOXICILLIN
PA0126/282/004
250mg/5ml Mg/M
J01CA04
-AMOXICILLIN
PA1832/001/001
250 Milligram
Powder for Oral
Suspension
Powder for Oral
Suspension
Capsules Hard
J01CA04
-AMOXICILLIN
(AS
TRIHYDRATE)
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10(1) Generic
Application
DSM Sinochem
Pharmaceuticals
Netherlands B.V.
PA1832/001/002
500 Milligram
Capsules Hard
J01CA04
-AMOXICILLIN
(AS
TRIHYDRATE)
Article 10(1) Generic
Application
-Per Oral
DSM Sinochem
Pharmaceuticals
Netherlands B.V.
PA1832/002/001
500/125 Milligram
Film Coated
Tablet
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED WITH
MICROCRYSTA
LLINE
CELLULOSE
(1:1))
Article 10(1) Generic
Application
-Per Oral
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
DSM SINOCHEM
PHARMACEUTI
CALS
AMOXICILLIN
DSM SINOCHEM
PHARMACEUTI
CALS
AMOXICILLIN/C
LAVULANIC
ACID DSMSINOCHEM
Interchangeable
List Code:
IC0037-073-014
Interchangeable
List Code:
IC0037-073-014
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 28 of 608
Trade Name
Licence Holder Licence
Number
AMOXICILLIN/C
LAVULANIC
ACID DSMSINOCHEM
DSM Sinochem
Pharmaceuticals
Netherlands B.V.
PA1832/002/002
AMOXICILLIN/C
LAVULANIC
ACID
SINOCHEM DSM
DSM Sinochem
Pharmaceuticals
Netherlands B.V.
PA1832/003/001
AMOXIL
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Mercury
Pharmaceuticals
Ltd
AMSIDINE
AMYVID
Strength
Dosage Form ATC
875/125 Milligram
Film Coated
Tablet
J01CR02
500/125 Milligram
Film Coated
Tablet
J01CR02
PA1077/033/006
3 Grams
J01CA04
PA1077/033/005
125/1.25 Millilitre
PA1077/033/004
500 Milligram
PA0899/038/001
10 Mg/Ml
Powder for Oral
Suspension
Powder for Oral
Suspension
Pdr for Soln
Inj/Inf
Solution for
Injection
NordMedica A/S
PA1828/001/001
50 Mg/Ml
L01XX01
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Pfizer Healthcare
Ireland
EU/1/12/805/001002
EU/1/12/805/003004
PA0822/165/001
800 MBq/ml
Concentrate and
solvent for
solution for
infusion
Solution for
Injection
Solution for
Injection
Film Coated
Tablet
ANADIN EXTRA
Pfizer Healthcare
Ireland
PA0822/166/001
300/200/45
Milligram
Film Coated
Tablet
N02BA51
ANADIN
MAXIMUM
STRENGTH
Pfizer Healthcare
Ireland
PA0822/165/002
500/32 Milligram
Capsules Hard
N02BA51
ANAFRANIL
Novartis
Pharmaceuticals
UK Ltd
PA0013/084/001
50 Milligram
Capsule
N06AA04
ANAFRANIL
Novartis
Pharmaceuticals
UK Ltd
PA0013/084/002
10 Milligram
Capsule
N06AA04
ANAFRANIL
Novartis
Pharmaceuticals
UK Ltd
PA0013/084/003
25 Milligram
Capsule
N06AA04
ANAFRANIL SR
Novartis
Pharmaceuticals
UK Ltd
PA0013/084/006
75 Milligram
Tablets
N06AA04
ANAPEN
Lincoln Medical
Ltd
Lincoln Medical
Ltd
PA1072/001/002
0.3 Milligram
PA1072/001/001
0.15 Milligram
Solution for
Injection
Solution for
Injection
AMOXIL
PAEDIATRIC
AMOXIL VIALS
AMPRES
AMYVID
ANADIN
ANALGESIC
ANAPEN
JUNIOR
Human Medicines Authorised/Transfer Pending Products
Routes of
Administration
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
C01CA24
-FLORBETAPIR
(18F)
-FLORBETAPIR
(18F)
ACETYLSALICY
LIC ACID
-CAFFEINE
ACETYLSALICY
LIC ACID
-PARACETAMOL
-CAFFEINE
ACETYLSALICY
LIC ACID
-CAFFEINE
CLOMIPRAMINE
HYDROCHLORI
DE
CLOMIPRAMINE
HYDROCHLORI
DE
CLOMIPRAMINE
HYDROCHLORI
DE
CLOMIPRAMINE
HYDROCHLORI
DE
-EPINEPHRINE
C01CA24
-EPINEPHRINE
Interchangeable
List Code:
IC0037-073-014
325/15 Milligram
Legal Basis
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED WITH
MICROCRYSTA
LLINE
CELLULOSE
(1:1))
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED :
CELLULOSE,
MICROCRYSTA
LLINE(1:1))
-AMOXICILLIN
TRIHYDRATE
-AMOXICILLIN
TRIHYDRATE
-AMOXICILLIN
SODIUM
CHLOROPROC
AINE
HYDROCHLORI
DE
-AMSACRINE
Interchangeable
List Code:
IC0037-072-003
1900 MBq/ml
Active
Ingredients
J01CA04
J01CA04
N01BA04
V09AX05
V09AX05
N02BA51
-Per Oral
-Intrathecal
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 29 of 608
Trade Name
ANASTROZOLE
ANASTROZOLE
ANASTROZOLE
ANASTROZOLE
ANASTROZOLE
ANASTROZOLE
BLUEFISH
ANASTROZOLE
SYNTHON
ANASTROZOLE
TEVA
Licence Holder Licence
Number
Rowa
Pharmaceuticals
Limited
WPR Healthcare
Limited
Fresenius Kabi
Oncology Plc
Actavis Group
PTC ehf
Accord
Healthcare
Limited
Bluefish
Pharmaceuticals
AB
Synthon BV
Teva Pharma
B.V.
PA0074/068/001
Strength
Dosage Form ATC
Legal Basis
Film Coated
Tablet
L02BG03
-ANASTROZOLE
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
Interchangeable
List Code:
IC0011-039-003
PA1422/010/001
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTRAZOLE
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PA1380/073/001
Article 10(1) Generic
Application
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PA1390/028/001
Article 10(1) Generic
Application
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PA1436/010/001
Article 10(1) Generic
Application
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PA0840/004/001
Article 10(1) Generic
Application
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
Interchangeable
List Code:
IC0011-039-003
PA0749/028/001
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PA1914/001/001
Article 10(1) Generic
Application
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
Article 10(1) Generic
Application
-Per Oral
0.9/0.1/0.
Unknown
Oromucosal
Solution
N01BB52
-LIDOCAINE
HYDROCHLORI
DE
CHLOROCRES
OL
CETYLPYRIDINI
UM CHLORIDE
-ETHANOL
-FLUCYTOSINE
Interchangeable
List Code:
IC0011-039-003
PPA0565/060/00
1
Zaphyr
Pharmaceuticals
Ireland Limited
ANBESOL
ANAESTHETIC
ANTISEPTIC
Alliance
Pharmaceuticals
Ltd.
ANCOTIL
Meda Health
Sales Ireland
Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA1332/030/001
2.5/250
Solution for
Infusion
J02AX01
PA0678/043/001
22.6 17.4 19.5
%w/w
Powder
Effervescent
A06AD04
ANDREWS
LIVER SALTS
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0678/043/001
22.6 17.4 19.5
%w/w
Powder
Effervescent
A09AB04
ANDROCUR 100
MG TABLETS
Bayer Limited
PA1410/001/001
100 Milligram
Tablets
G03HA01
Interchangeable
List Code:
IC0011-039-003
PA0943/020/001
Human Medicines Authorised/Transfer Pending Products
-SODIUM
BICARBONATE
-CITRIC ACID
-MAGNESIUM
SULPHATE
DIHYDRATE
-SODIUM
BICARBONATE
-CITRIC ACID
-MAGNESIUM
SULPHATE
DIHYDRATE
CYPROTERONE
ACETATE
Article 10(1) Generic
Application
Routes of
Administration
1 Milligram
ANASTROZOLE
ZAPHYR
PHARMACEUTI
CALS
ANDREWS
LIVER SALTS
Active
Ingredients
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
Page 30 of 608
Trade Name
ANDROGEL
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Laboratoires
Besins
International
Laboratoires
Besins
International
GlaxoSmithKline
(Ireland) Limited
PA1054/001/001
25 Milligram
Gel
G03BA03
PA1054/001/002
50 Milligram
Gel
G03BA03
PA1077/052/001
50 Mg/Ml
Solution for Inj/Inf
M03AB01
Cheplapharm
Arzneimittel
GmbH
Bayer Limited
PA1868/002/001
500
Micrograms/5ml
Solution for Inj/Inf
V03AB25
PA1410/013/001
1, 2 Milligram
Film Coated
Tablet
G03FA17
The Medicines
Company UK
Limited
Dermal
Laboratories Ltd
EU/1/04/289/001
250 mg Milligram
Pdr for Soln
Inj/Inf
B01AE06
PA0278/007/001
20 %w/v
Cutaneous
Solution
D11AA
ANORO ELLIPT
Glaxo Group
Limited
EU/1/14/898/001003
55mcg/22
Microgram
Powder for
Inhalation
R03AL03
ANTABUSE 400
MG
EFFERVESCEN
T TABLETS
ANTEPSIN
Actavis Group
PTC ehf
PA1380/008/001
400 Milligram
Tablets
Effervescent
N07BB01
-ALUMINIUM
CHLORIDE
HEXAHYDRATE
-UMECLIDINIUM
BROMIDE
-VILANTEROL
TRIFENATATE
-DISULFIRAM
PA0950/001/001
1 g/5ml
Oral Suspension
A02BX02
-SUCRALFATE
-Per Oral
PA0950/001/003
1 Grams
Tablets
A02BX02
-SUCRALFATE
-Per Oral
PA0540/092/001
2 %w/w
Cream
D04AA02
-MEPYRAMINE
MALEATE
ANTI-HIST
ALLERGY
Chugai Pharma
UK Ltd
Chugai Pharma
UK Ltd
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Clonmel
Healthcare Ltd
PA0126/267/001
10 Milligram
Film Coated
Tablet
R06AE07
ANTI-HIST
ALLERGY
Clonmel
Healthcare Ltd
PA0126/267/002
1 Mg/Ml
Oral Solution
R06AE07
ANTISEPTIC
THROAT
LOZENGES
ORANGE &
MENTHOL
ANUGESIC HC
CREAM
The Boots
Company Plc
PA0004/055/001
0.6 Milligram
Lozenges
R02AA20
-CETIRIZINE
DIHYDROCHLO
RIDE
-CETRIZINE
DIHYDROCHLO
RIDE
AMYLMETACRE
SOL
Pfizer Healthcare
Ireland
PA0822/009/001
0 Unknown
Cream
C05AA01
ANUSOL
McNeil
Healthcare
(Ireland) Ltd
PA0823/023/001
2.14/1.8/1 Grams
Cream
C05AX04
ANUSOL
McNeil
Healthcare
(Ireland) Ltd
PA0823/023/002
Ointment
C05AX04
ANDROGEL
ANECTINE
ANEXATE
ANGELIQ
ANGIOX
(BIVALIRUDIN)
ANHYDROL
FORTE
ANTEPSIN
ANTHISAN
CREAM 2% W/W
Human Medicines Authorised/Transfer Pending Products
TESTOSTERON
E
TESTOSTERON
E
SUXAMETHONI
UM CHLORIDE
-FLUMAZENIL
-ESTRADIOL
DROSPIRENON
E
-BIVALIRUDIN
-PRAMOCAINE
HYDROCHLORI
DE
-BISMUTH
OXIDE
-ZINC OXIDE
-BENZYL
BENZOATE
HYDROCORTIS
ONE ACETATE
-BALSAM PERU
-BISMUTH
OXIDE
-BALSAM PERU
-ZINC OXIDE
-BISMUTH
SUBGALLATE
-BISMUTH
OXIDE
-BALSAM PERU
-ZINC OXIDE
-Per Oral
Article 8(3) - Full
new Application
-Inhalation
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Topical
Page 31 of 608
Trade Name
Licence Holder Licence
Number
ANUSOL
McNeil
Healthcare
(Ireland) Ltd
PA0823/023/003
ANUSOL HC
McNeil
Healthcare
(Ireland) Ltd
PA0823/040/003
ANUSOL HC
McNeil
Healthcare
(Ireland) Ltd
ANXICALM
ANXICALM
ANXICALM
APFEN PLUS
APHTHEAL
APIDRA
APIDRA
APIS MEL
APIS MEL
APODESPAN PR
APO-GO
AMPOULES
APO-GO PEN
APO-GO PFS
APOMORPHINE
HYDROCHLORI
DE
APRESOLINE
APROK
Strength
Dosage Form ATC
Suppositories
C05AX04
N/A
Ointment
D07BA
PA0823/040/004
%w/w
Suppositories
C05AA01
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Meda Health
Sales Ireland
Limited
Sanofi-Aventis
Deutschland
GmbH
Aventis Pharma
Deutschland
GmbH
A. Nelson &
Company Limited
Weleda (UK)
Limited
Accord
Healthcare
Limited
Britannia
Pharmaceuticals
Ltd
Britannia
Pharmaceuticals
Ltd
Britannia
Pharmaceuticals
Ltd
Pharmaceuticals
Sales &
Development
Sweden AB
(PharmSwed)
Amdipharm
Limited
PA0126/011/001
2 mg Milligram
Tablets
PA0126/011/002
5 mg Milligram
PA0126/011/003
Laboratoires
Thea
Active
Ingredients
Legal Basis
Routes of
Administration
N05BA01
-BISMUTH
OXIDE
-ZINC OXIDE
-BALSAM PERU
-BISMUTH
SUBGALLATE
HYDROCORTIS
ONE ACETATE
-BENZYL
BENZOATE
-BISMUTH
SUBGALLATE
-BISMUTH
OXIDE
-BALSAM PERU
-ZINC OXIDE
HYDROCORTIS
ONE ACETATE
-BENZYL
BENZOATE
-BISMUTH
OXIDE
-BALSAM PERU
-ZINC OXIDE
-BISMUTH
SUBGALLATE
-DIAZEPAM
-Per Oral
Tablets
N05BA01
-DIAZEPAM
-Per Oral
10 mg Milligram
Tablets
N05BA01
-DIAZEPAM
-Per Oral
PA0678/109/001
200/12.8
Milligram
Film Coated
Tablet
N02BE51
PA1332/037/001
5 %w/w
Oromucosal
Paste
A01AD07
-IBUPROFEN
-CODEINE
PHOSPHATE
HEMIHYDRATE
-AMLEXANOX
EU/1/04/285/021036
100 Units/ml
Solution for
Injection
A10AB06
-INSULIN
GLULISINE
EU/1/04/285/1-20
100 IU/ml IU/ML
Solution for
Injection
A10AB06
-INSULIN
GLULISINE
HOR1149/002/0
01
HOR0407/047/0
01
PA1390/042/002
4X-MM
Pillules
6C-200C &
Tablets
50/200 Milligram
Tablet Prolonged
Release
N04BA02
PA0356/010/002
10 Mg/Ml
Solution for
Injection
N04BC07
PA0356/010/001
10 Mg/Ml
Solution for Inj/Inf
N04BC07
PA0356/010/003
5 Mg/Ml
Solution for
Infusion
N04BC07
PA1807/001/001
5 Mg/Ml
Solution for
Infusion
N04BC07
PA1142/015/001
20 Milligram
Pdr/Conc/Soln/In
j/Inf
C02DB02
PA1107/006/001
50 Base
Milligrams
Pdr for Soln for
Injection
S01AA27
Human Medicines Authorised/Transfer Pending Products
-APIS
MELLIFICA
-APIS
MELLIFICA
-CARBIDOPA
-LEVODOPA
-APOMORPHINE
HYDROCHLORI
DE
-APOMORPHINE
HYDROCHLORI
DE
-APOMORPHINE
HYDROCHLORI
DE
-APOMORPHINE
HYDROCHLORI
DE
HEMIHYDRATE
-HYDRALAZINE
HYDROCHLORI
DE
-CEFUROXIME
SODIUM
Article 10a Bibliographical
App
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 8(3) - Full
new Application
-Subcutaneous
Article 10(1) Generic
Application
-Subcutaneous
Article 10a Bibliographical
App
-Intra-ocular
Page 32 of 608
Trade Name
APROVEL
APROVEL
APROVEL
APROVEL
APROVEL
APROVEL
APROVEL
APROVEL
APROVEL
APTIVUS
APTIVUS
AQUASEPT
SKIN
CLEANSER
AQUEOUS
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARANESP
ARAVA
ARAVA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Sanofi Pharma
Bristol-Myers
Squibb SNC
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Ayrton Saunders
Ltd
EU/1/97/046/001
75 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/004
150 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/007
300 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/002
75 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/003
75 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/005
150 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/006
150 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/008
300 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/046/009
300 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/05/315/001
250 Milligram
Capsules, Soft
J05AE09
-TIPRANAVIR
EU/1/05/315/002
100 Mg/Ml
Oral Solution
J05AE09
-TIPRANAVIR
PA0501/007/001
2 %w/v
Cutaneous
Solution
D08AE04
-TRICLOSAN
Ovelle Limited
PA0206/021/001
30 %w/w
Cream
D02AX
-Topical
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
EU/1/01/185/003004
EU/1/01/185/005006
EU/1/01/185/007008
EU/1/01/185/009010
EU/1/01/185/011012
EU/1/01/185/013014
EU/1/01/185/015016
EU/1/01/185/017018
EU/1/01/185/019020
EU/1/01/185/021022
EU/1/01/185/031032
EU/1/01/185/001002
EU/1/99/118/002
15 Microgram
B03XA02
10 Milligram
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Tablets
L04AA13
-EMULSIFYING
WAX
-WHITE SOFT
PARAFFIN
-PARAFFIN,
LIQUID
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-DARBEPOETIN
ALFA
-LEFLUNOMIDE
EU/1/99/118/003
10 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
Human Medicines Authorised/Transfer Pending Products
20 Microgram
30 Microgram
30 Microgram
50 Microgram
60 Microgram
80 Microgram
100 Microgram
150 Microgram
300 Microgram
500 Microgram
10 Microgram
B03XA02
B03XA02
B03XA02
B03XA02
B03XA02
B03XA02
B03XA02
B03XA02
B03XA02
B03XA
B03XA02
-Per Oral
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Per Oral
Page 33 of 608
Trade Name
ARAVA
ARAVA
ARAVA
ARAVA
ARAVA
ARAVA
ARAVA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
Licence Holder Licence
Number
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
LTT Pharma
Limited
LTT Pharma
Limited
Imbat Limited
ARCOXIA
Primecrown 2010
Ltd
Primecrown 2010
Ltd
Primecrown 2010
Ltd
Clear Pharmacy
ARCOXIA
Clear Pharmacy
ARCOXIA
B & S Healthcare
ARCOXIA
B & S Healthcare
ARCOXIA
B & S Healthcare
ARCOXIA
IMED Healthcare
Ltd.
B & S Healthcare
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
Imbat Limited
ARCOXIA
Imbat Limited
ARCOXIA
LTT Pharma
Limited
Chemilines
Healthcare
(Ireland) Limited
Chemilines
Healthcare
(Ireland) Limited
LTT Pharma
Limited
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
EU/1/99/118/004
10 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
EU/1/99/118/006
20 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
EU/1/99/118/007
20 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
EU/1/99/118/008
20 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
EU/1/99/118/001
10 mg Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
EU/1/99/118/005
20 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
EU/1/99/118/009
100 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
-Per Oral
DPR1463/020/0
01
DPR1463/020/0
02
PPA0465/176/00
2
PPA0465/176/00
3
PPA0465/176/00
1
PPA1562/080/00
1
PPA1562/080/00
2
PPA1151/137/00
3
DPR1633/009/0
01
DPR1633/009/0
02
DPR1633/009/0
03
PPA1596/043/00
1
PPA1596/043/00
2
DPR1328/026/0
01
DPR1328/026/0
04
DPR1328/026/0
05
DPR1463/020/0
03
DPR1328/026/0
06
PPA1463/041/00
1
PPA1463/041/00
2
PPA1151/137/00
1
PPA1151/137/00
2
PPA1562/080/00
3
PPA1915/011/00
1
60 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
PPA
M01AH05
-ETORICOXIB
PPA
M01AH05
-ETORICOXIB
PPA
M01AH05
-ETORICOXIB
PPA
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
-Per Oral
M01AH05
-ETORICOXIB
-Per Oral
M01AH05
-ETORICOXIB
-Per Oral
M01AH05
-ETORICOXIB
-Per Oral
M01AH05
-ETORICOXIB
-Per Oral
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
PPA
-Per Oral
M01AH05
-ETORICOXIB
PPA
M01AH05
-ETORICOXIB
PPA
M01AH05
-ETORICOXIB
PPA1915/011/00
2
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
PPA1562/080/00
4
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
Human Medicines Authorised/Transfer Pending Products
90 Milligram
90 Milligram
120 Milligram
60 Milligram
60 Milligram
90 Milligram
90 Milligram
60 Milligram
90 Milligram
120 Milligram
60 Milligram
90 Milligram
30 Milligram
60 Milligram
90 Milligram
120 Milligram
120 Milligram
60 Milligram
90 Milligram
30 Milligram
60 Milligram
30 Milligram
60 Milligram
-Per Oral
Page 34 of 608
Trade Name
Licence Holder Licence
Number
ARCOXIA
Imbat Limited
ARCOXIA
Merck Sharp &
Dohme BV,
Merck Sharp &
Dohme BV,
Merck Sharp &
Dohme BV,
Merck Sharp &
Dohme BV,
Primecrown 2010
Ltd
Primecrown 2010
Ltd
Primecrown 2010
Ltd
Primecrown 2010
Ltd
PCO
Manufacturing
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA
ARCOXIA 30MG
FILM COATED
TABLETS
ARCOXIA FILM
COATED
TABLETS
ARCOXIA FILM
COATED
TABLETS
ARCOXIA FILM
COATED
TABLETS
ARELIX
ARELOGER
ARELOGER
ARGENT. NIT.
ARGENTUM
NITRICUM
(ARGENT. NIT.)
ARICEPT
ARICEPT
ARICEPT
ARICEPT
ARICEPT
Strength
PPA1151/137/00
4
PA1997/001/001
120 Milligram
PA1997/001/002
60 Milligram
PA1997/001/003
90 Milligram
PA1997/001/004
120 Milligram
PPA1633/045/00
1
PPA1633/045/00
4
PPA1633/045/00
2
PPA1633/045/00
3
PPA0465/176/00
4
30 Milligram
Eurodrug Ltd
DPR1392/056/0
01
Eurodrug Ltd
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
M01AH05
-ETORICOXIB
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
DPR1392/056/0
02
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
Eurodrug Ltd
DPR1392/056/0
03
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
Sanofi-Aventis
Ireland Limited
T/A SANOFI
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
A. Nelson &
Company Limited
Weleda (UK)
Limited
PA0540/030/003
6 Milligram
Tablets
C03CA03
-PIRETANIDE
-Per Oral
PA0577/057/001
7.5 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
PA0577/057/002
15 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
HOR1149/003/0
01
HOR0407/001/0
01
6C - MM
Infus/Pdr/Oral
Soln
Tablets
-ARGENTUM
NITRICUM
-ARGENTUM
NITRICUM
-Per Oral
Pfizer Healthcare
Ireland
PA0822/002/003
5 Milligram
Orodispersible
Tablet
N06DA02
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA0822/002/004
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Orodispersible
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
-Per Oral
10 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
PPA
-Per Oral
5 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
PPA
-Per Oral
5 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
Pfizer Healthcare
Ireland
Imbat Limited
Imbat Limited
Pfizer Healthcare
Ireland
Interchangeable
List Code:
IC0062-002-015
PPA1151/037/00
2
Interchangeable
List Code:
IC0062-002-015
PPA1151/037/00
1
Interchangeable
List Code:
IC0062-001-015
PA0822/002/001
Interchangeable
List Code:
IC0062-001-015
Human Medicines Authorised/Transfer Pending Products
30 Milligram
120 Milligram
60 Milligram
90 Milligram
30 Milligram
6C & 30C
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
-Per Oral
Page 35 of 608
Trade Name
ARICEPT
ARICEPT
ARICEPT
ARICEPT
ARICEPT
ARICEPT
ARICEPT
ARICLAIM
ARICLAIM
ARICLAIM
(RETHERA)
ARIMIDEX
ARIMIDEX
ARIMIDEX
Licence Holder Licence
Number
Pfizer Healthcare
Ireland
Clear Pharmacy
Clear Pharmacy
PA0822/002/002
5 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
PPA
-Per Oral
5 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
-Per Oral
10 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
-Per Oral
5 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
-Per Oral
10 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
-Per Oral
30 Milligram
Capsules GastroResistant
N06AX21
-DULOXETINE
HYDROCHLORI
DE
Article 8(3) - Full
new Application
-Per Oral
60 Milligram
Capsules GastroResistant
N06AX21
-DULOXETINE
HYDROCHLORI
DE
Article 8(3) - Full
new Application
-Per Oral
Interchangeable
List Code:
IC0091-127-006
EU/1/04/283/1-6
40mg Milligram
N06AX21
PA0970/003/001
1 Milligram
Capsules GastroResistant
Film Coated
Tablet
L02BG03
-ANASTROZOLE
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
PPA
-Per Oral
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTRAZOLE
PPA
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PPA1596/047/00
1
Interchangeable
List Code:
IC0062-001-015
PPA1596/047/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0062-002-015
PPA0465/426/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0062-001-015
PPA0465/426/00
2
Clear Pharmacy
Routes of
Administration
-DONEPEZIL
HYDROCHLORI
DE
LTT Pharma
Limited
IMED Healthcare
Ltd.
Legal Basis
N06DA02
Interchangeable
List Code:
IC0062-001-015
PPA1562/129/00
2
Eli Lilly
Nederland B.V.
AstraZeneca UK
Limited
Active
Ingredients
Film Coated
Tablet
LTT Pharma
Limited
Eli Lilly
Nederland B.V.
Dosage Form ATC
10 Milligram
Interchangeable
List Code:
IC0062-002-015
PPA1562/129/00
1
Eli Lilly
Nederland B.V.
Strength
Interchangeable
List Code:
IC0062-002-015
EU/1/04/283/8-10
Interchangeable
List Code:
IC0091-033-006
EU/1/04/283/1112
Interchangeable
List Code:
IC0011-039-003
PPA1463/070/00
1
Interchangeable
List Code:
IC0011-039-003
PPA1596/050/00
1
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0011-039-003
Human Medicines Authorised/Transfer Pending Products
Page 36 of 608
Trade Name
ARIMIDEX
ARIMIDEX
ARIPIL
ARIPIL
ARIPIPRAZOLE
ARIPIPRAZOLE
ARIPIPRAZOLE
Licence Holder Licence
Number
Imbat Limited
PCO
Manufacturing
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Sandoz GmbH
Sandoz GmbH
Sandoz GmbH
ARIPIPRAZOLE
Sandoz GmbH
ARIPIPRAZOLE
Sandoz GmbH
ARIPIPRAZOLE
ARIPIPRAZOLE
ACCORD
ARIPIPRAZOLE
ACCORD
ARIPIPRAZOLE
ACCORD
Wockhardt UK
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
PPA1151/161/00
1
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTRAZOLE
PPA
-Per Oral
1 Milligram
Film Coated
Tablet
L02BG03
-ANASTROZOLE
PPA
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PA0577/099/001
5 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA0577/099/002
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
1 Mg/Ml
Oral Solution
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0011-039-003
PPA0465/218/00
1
Interchangeable
List Code:
IC0062-002-015
EU/1/15/1029/00
1-014
Interchangeable
List Code:
IC0092-001-056
EU/1/15/1029/01
5-028
Interchangeable
List Code:
IC0092-002-056
EU/1/15/1029/02
9-042
Interchangeable
List Code:
IC0092-032-056
EU/1/15/1029/04
3-047
EU/1/15/1029/04
8-061
Interchangeable
List Code:
IC0092-033-056
PA1339/058/001
Interchangeable
List Code:
IC0092-047-019
EU/1/15/1045/00
7-012
Interchangeable
List Code:
IC0092-002-056
EU/1/15/1045/01
3-018
Interchangeable
List Code:
IC0092-032-056
EU/1/15/1045/01
9-022
-Per Oral
Interchangeable
List Code:
IC0092-033-056
Human Medicines Authorised/Transfer Pending Products
Page 37 of 608
Trade Name
ARIPIPRAZOLE
ACCORD
ARIPIPRAZOLE
CLONMEL
ARIPIPRAZOLE
CLONMEL
ARIPIPRAZOLE
CLONMEL
ARIPIPRAZOLE
CLONMEL
ARIPIPRAZOLE
CLONMEL
ARIPIPRAZOLE
CLONMEL
ARIPIPRAZOLE
FOCUS
ARIPIPRAZOLE
FOCUS
ARIPIPRAZOLE
FOCUS
ARIPIPRAZOLE
FOCUS
ARIPIPRAZOLE
MILPHARM
ARIPIPRAZOLE
MILPHARM
ARIPIPRAZOLE
MILPHARM
ARIPIPRAZOLE
MILPHARM
Licence Holder Licence
Number
Accord
Healthcare
Limited
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0092-001-056
PA0126/266/001
5 Milligram
Tablets
N04BD02
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-001-056
PA0126/266/002
Article 10(1) Generic
Application
10 Milligram
Tablets
N04BD02
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-002-056
PA0126/266/002
Article 10(1) Generic
Application
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-002-056
PA0126/266/003
Article 10(1) Generic
Application
15 Milligram
Tablets
N04BD02
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-032-056
PA0126/266/004
Article 10(1) Generic
Application
30 Milligram
Tablets
N04BD02
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-033-056
PA0126/266/004
Article 10(1) Generic
Application
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-033-056
PA1980/001/001
Article 10(1) Generic
Application
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-001-056
PA1980/001/002
Article 10(1) Generic
Application
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-002-056
PA1980/001/003
Article 10(1) Generic
Application
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-032-056
PA1980/001/004
Article 10(1) Generic
Application
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0092-033-056
PA1050/026/001
Article 10(1) Generic
Application
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0092-001-056
PA1050/026/002
Article 10(1) Generic
Application
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0092-002-056
PA1050/026/003
Article 10(1) Generic
Application
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0092-032-056
PA1050/026/004
Article 10(1) Generic
Application
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Focus Care
Pharmaceuticals
B.V.
Focus Care
Pharmaceuticals
B.V.
Focus Care
Pharmaceuticals
B.V.
Focus Care
Pharmaceuticals
B.V.
EU/1/15/1045/00
1-006
Strength
Interchangeable
List Code:
IC0092-033-056
Human Medicines Authorised/Transfer Pending Products
Page 38 of 608
Trade Name
ARIPIPRAZOLE
MYLAN
PHARMA
ARIPIPRAZOLE
MYLAN
PHARMA
ARIPIPRAZOLE
MYLAN
PHARMA
ARIPIPRAZOLE
MYLAN
PHARMA
ARIPIPRAZOLE
TEVA
ARIPIPRAZOLE
TEVA
ARIPIPRAZOLE
TEVA
ARIPIPRAZOLE
TEVA
Licence Holder Licence
Number
Mylan S.A.S.
Active
Ingredients
Legal Basis
Routes of
Administration
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0092-033-056
PA1986/019/001
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0092-001-056
PA1986/019/002
Article 10(1) Generic
Application
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0092-002-056
PA1986/019/003
Article 10(1) Generic
Application
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0092-032-056
PA1986/019/004
Article 10(1) Generic
Application
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-033-056
PA1066/002/001
Article 10(1) Generic
Application
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-001-056
PA1066/002/002
Article 10(1) Generic
Application
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-002-056
PA1066/002/003
Article 10(1) Generic
Application
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-032-056
PA1066/002/004
Article 10(1) Generic
Application
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-033-056
PA1339/058/002
Article 10(1) Generic
Application
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-001-056
PA1339/058/003
Article 10(1) Generic
Application
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Mylan S.A.S.
Mylan S.A.S.
ARIPIPRAZOLE
UNIVERSAL
FARMA
Universal Farma
S.L.
ARIPIPRAZOLE
UNIVERSAL
FARMA
Universal Farma
S.L.
ARIPIPRAZOLE
UNIVERSAL
FARMA
Universal Farma
S.L.
ARIPIPRAZOLE
UNIVERSAL
FARMA
Universal Farma
S.L.
ARIPIPRAZOLE
WOCKHARDT
Wockhardt UK
Limited
ARIPIPRAZOLE
WOCKHARDT
Dosage Form ATC
5 Milligram
Mylan S.A.S.
Wockhardt UK
Limited
EU/1/15/1005/00
1-003
Strength
Interchangeable
List Code:
IC0092-001-056
EU/1/15/1005/00
4-006
Interchangeable
List Code:
IC0092-002-056
EU/1/15/1005/00
7-009
Interchangeable
List Code:
IC0092-032-056
EU/1/15/1005/01
0-012
Interchangeable
List Code:
IC0092-002-056
Human Medicines Authorised/Transfer Pending Products
Page 39 of 608
Trade Name
ARIPIPRAZOLE
WOCKHARDT
ARIPIPRAZOLE
WOCKHARDT
ARIPIPRAZOLE
ZENTIVA
ARIPIPRAZOLE
ZENTIVA
ARIPIPRAZOLE
ZENTIVA
ARIPIPRAZOLE
ZENTIVA
ARIPIPRAZOLE
ZENTIVA
ARIPIPRAZOLE
ZENTIVA
ARIPIPRAZOLE
ZENTIVA
Licence Holder Licence
Number
Wockhardt UK
Limited
Wockhardt UK
Limited
Zentiva k.s.
Zentiva k.s.
Zentiva k.s.
Zentiva k.s.
Zentiva k.s.
Zentiva k.s.
Zentiva k.s.
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1339/058/004
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-032-056
PA1339/058/005
Article 10(1) Generic
Application
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
5 Milligram
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
5mg/2.5 Milligram
Tablet Prolonged
Release
N02AA55
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0092-033-056
EU/1/15/1009/02
1-023
Interchangeable
List Code:
IC0092-002-056
EU/1/15/1009/01
6-020
Interchangeable
List Code:
IC0092-033-056
EU/1/15/1009/01
1-015
Interchangeable
List Code:
IC0092-032-056
EU/1/15/1009/00
6-010
Interchangeable
List Code:
IC0092-002-056
EU/1/15/1009/00
1-005
Interchangeable
List Code:
IC0092-001-056
EU/1/15/1009/02
7-029
Interchangeable
List Code:
IC0092-033-056
EU/1/15/1009/02
4-026
ARISTIGA
Ethypharm
Interchangeable
List Code:
IC0092-032-056
PA0549/017/001
ARISTIGA
Ethypharm
PA0549/017/004
40mg/20
Milligram
Tablet Prolonged
Release
N02AA55
ARISTIGA
Ethypharm
PA0549/017/003
20mg/10
Milligram
Tablet Prolonged
Release
N02AA55
ARISTIGA
Ethypharm
PA0549/017/002
10mg/5 Milligram
Tablet Prolonged
Release
N02AA55
Human Medicines Authorised/Transfer Pending Products
Page 40 of 608
Trade Name
ARITAVI
ARITAVI
Licence Holder Licence
Number
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1380/177/001
30 Milligram
Capsules GastroResistant
N06AX21
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-033-006
PA1380/177/002
-DULOXETINE
HYDROCHLORI
DE
60 Milligram
Capsules GastroResistant
N06AX21
-DULOXETINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Solution for
Injection
B01AX05
Solution for
Injection
B01AX05
FONDAPARINUX
SODIUM
FONDAPARINUX
SODIUM
FONDAPARINUX
SODIUM
FONDAPARINUX
SODIUM
FONDAPARINUX
SODIUM
FONDAPARINUX
SODIUM
FONDAPARINUX
SODIUM
-CINNARIZINE
DIMENHYDRIN
ATE
-PEMETREXED
DIACID
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
ARIXTRA
Aspen Pharma
Trading Limited
Interchangeable
List Code:
IC0091-127-006
EU/1/02/206/29,
30,34
ARIXTRA
Aspen Pharma
Trading Limited
EU/1/02/206/1517,21
ARIXTRA
Aspen Pharma
Trading Limited
EU/1/02/206/31,
32,35
Mg/Ml
Solution for
Injection
B01AX05
ARIXTRA
Aspen Pharma
Trading Limited
EU/1/02/206/14,22,23
2.5mg/0.5m %v/v
Solution for
Injection
B01AX05
ARIXTRA
Aspen Pharma
Trading Limited
EU/1/02/206/58,18,24-26
%v/v
Solution for
Injection
B01AX05
ARIXTRA
Aspen Pharma
Trading Limited
EU/1/02/206/911,27,28,33
Solution for
Injection
B01AX05
ARIXTRA
Aspen Pharma
Trading Limited
EU/1/02/206/1214,19-20
Solution for
Injection
B01AX05
ARLEVERT
Hennig
Arzneimittel
GmbH & Co KG
PA1238/001/001
20/40 Milligram
Tablets
N07CA52
ARMISARTE
(PREVIOSULY
PEMETREXED
ACTAVIS)
ARNICA
Actavis Group
PTC ehf
EU/1/15/1063/00
1-003
25 Mg/Ml
Concentrate for
Soln for Inf
L01BA04
A. Nelson &
Company Limited
Weleda (UK)
Limited
A. Nelson &
Company Limited
HOR1149/004/0
01
PA0407/001/001
6X-MM %v/v
%v/w
Ointment
HOR1149/031/0
01
6X-MM
Tablets
Weleda (UK)
Limited
LTT Pharma
Limited
IMED Healthcare
Ltd.
Haemato Pharm
AG
Pfizer Healthcare
Ireland
PCO
Manufacturing
Imbat Limited
HOR0407/014/0
01
PPA1562/155/00
1
PPA1463/069/00
1
PPA1841/001/00
1
PA0822/111/001
6C & 30C
Tablets
25 Milligram
Coated Tablets
L02BG06
-ARNICA
MONTANA
-ARNICA
MONTANA
-ARNICA
MONTANA
(GHP)
-ARNICA
MONTANA
-EXEMESTANE
25 Milligram
Tablets
L02BG06
-EXEMESTANE
PPA
-Per Oral
25 Milligram
Coated Tablets
L02BG06
-EXEMESTANE
PPA
-Per Oral
25mg Milligram
Tablets
L02BG06
-EXEMESTANE
PPA0465/236/00
1
PPA1151/178/00
1
PA1809/025/001
25 Milligram
Coated Tablets
L02BG06
-EXEMESTANE
PPA
25 Milligram
Coated Tablets
L02BG06
-EXEMESTANE
PPA
125
Mcg/Acutuation
R03BA05
-FLUTICASONE
PROPIONATE
R03BA05
-FLUTICASONE
PROPIONATE
A07DA03
A07DA03
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-ACIDUM
ARSENICOSUM
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
PPA
ARNICA
ARNICA
ARNICA TABLETS
AROMASIN
AROMASIN
AROMASIN
AROMASIN
AROMASIN
AROMASIN
ARQUIST
Cipla (EU)
Limited
ARQUIST
Cipla (EU)
Limited
PA1809/025/002
250
Mcg/Acutuation
ARRET
PCO
Manufacturing
PPA0465/155/00
1
2 Milligram
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Capsules Hard
ARRET 2 MG
HARD
CAPSULES.
ARSEN. ALB.
McNeil
Healthcare
(Ireland) Ltd
A. Nelson &
Company Limited
PA0823/053/001
2mg Milligram
Capsule
HOR1149/005/0
01
6C - MM
Pillules
Human Medicines Authorised/Transfer Pending Products
M02AX10
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
Article 10b Fixed
Combination
-Per Oral
Article 10(3) Hybrid
Application
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Inhalation
-Inhalation
-Per Oral
-Per Oral
Page 41 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
ARSENICUM
ALBUM
ARSENICUM
ALBUM (ARSEN.
ALB.)
ARTELAC
Helios
Homeopathy Ltd
Weleda (UK)
Limited
HOR1154/004/0
01
HOR0407/002/0
01
6c-200c
6C & 30C
Tablets
Bausch & Lomb
UK Limited
PA0555/007/001
3.2 Mg/Ml
Eye Drops
Solution
S01XA20
ARTELAC
PRESERVATIVE
FREE SDU
ARTELAC
PRESERVATIVE
FREE SINGLE
DOSE UNIT
ARTELAC
PRESERVATIVE
FREE SINGLE
DOSE UNIT
ARTELAC
PRESERVATIVE
FREE SINGLE
DOSE UNIT
ARTHRIMEL
IMED Healthcare
Ltd.
PPA1463/099/00
1
3.2 Mg/Ml
Eye Drops
Solution
S01XA20
Imbat Limited
PPA1151/207/00
1
3.2 Mg/Ml
Eye Drops
Solution
S01XA20
LTT Pharma
Limited
PPA1562/102/00
1
3.2 Mg/Ml
Eye Drops
Solution
S01XA20
HYPROMELLOS
E
Bausch & Lomb
UK Limited
PA0555/007/002
3.2 Mg/Ml
Eye Drops
Solution
S01XA20
HYPROMELLOS
E
Phoenix Labs
PA1113/011/001
500 Milligram
Film Coated
Tablet
M01AX05
-Per Oral
ARTHRIMEL
Phoenix Labs
PA1113/011/002
750 Milligram
Film Coated
Tablet
M01AX05
ARTHRIMEL
Phoenix Labs
PA1113/011/003
1500 Milligram
Film Coated
Tablet
M01AX05
ARTHROTEC
Imbat Limited
PPA1151/199/00
1
50/0.2 Milligram
Modified-release
Tablets
M01AB55
-GLUCOSAMINE
SULFATE
SODIUM
CHLORIDE
-GLUCOSAMINE
SULPHATE
SODIUM
CHLORIDE
-GLUCOSAMINE
SULPHATE
SODIUM
CHLORIDE
-DICLOFENAC
SODIUM
-MISOPROSTOL
75/0.2 Milligram
Modified-release
Tablets
M01AB55
-DICLOFENAC
SODIUM
-MISOPROSTOL
-Per Oral
Interchangeable
List Code:
IC0058-113-021
PA0822/112/002
75/0.2 Milligram
Modified-release
Tablets
M01AB55
-Per Oral
Interchangeable
List Code:
IC0058-113-021
PA0822/112/001
-DICLOFENAC
SODIUM
-MISOPROSTOL
50/0.2 Milligram
Modified-release
Tablets
M01AB55
-DICLOFENAC
-MISOPROSTOL
-Per Oral
50/0.2 Milligram
Modified-release
Tablets
M01AB55
-DICLOFENAC
SODIUM
-MISOPROSTOL
PPA
-Per Oral
75/0.2 Milligram
Modified-release
Tablets
M01AB55
-DICLOFENAC
SODIUM
-MISOPROSTOL
PPA
-Per Oral
75 Milligram
Modified-release
Tablets
M01AB55
-DICLOFENAC
SODIUM
-MISOPROSTOL
ARTHROTEC
ARTHROTEC
ARTHROTEC
ARTHROTEC
ARTHROTEC
ARTHROTEC
Imbat Limited
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Interchangeable
List Code:
IC0058-109-021
PPA1151/199/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0058-109-021
PPA0465/114/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0058-109-021
PPA0465/114/00
2
LTT Pharma
Limited
Interchangeable
List Code:
IC0058-113-021
PPA1562/179/00
1
Human Medicines Authorised/Transfer Pending Products
-ARSENICUM
ALBUM
-ARSENICUM
ALBUM
Routes of
Administration
-Per Oral
-Per Oral
HYPROMELLOS
E
HYPROMELLOS
E
HYPROMELLOS
E
-Ocular
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 42 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ARTICHOKE MILK THISTLE
COMPLEX
TABLETS
Bioforce (UK) Ltd
TR0725/015/001
ARTISS
SOLUTIONS
FOR SEALANT
Baxter
Healthcare
Limited
PA0167/131/001
4 ml
Solution for
Sealant
B02BC
ARTISS
SOLUTIONS
FOR SEALANT
Baxter
Healthcare
Limited
PA0167/131/001
4 ml
Solution for
Sealant
V03AK
ARYTHMOL
Mylan IRE
Healthcare
Limited
PA2010/001/001
150 Milligram
Film Coated
Tablet
C01BC03
ARYTHMOL
Mylan IRE
Healthcare
Limited
PA2010/001/002
300 Milligram
Film Coated
Tablet
C01BC03
ARZERRA
EU/1/10/625/1-2
100 Milligram
Concentrate for
Soln for Inf
L01XC10
PA1966/001/001
162.5 Milligram
Capsule
B01AC06
PA2018/001/003
500 Milligram
Suppositories
PA2018/001/001
400 Milligram
PA2018/001/002
800 Milligram
ASACOLON
Novartis
Europharm
Limited
New Haven
Pharma (UK)
Limited
Tillotts Pharma
GmbH
Tillotts Pharma
GmbH
Tillotts Pharma
GmbH
Lexon (UK) Ltd
400 Milligram
ASACOLON
Lexon (UK) Ltd
PPA1097/008/00
1
PPA1097/008/00
2
Tablets GastroResistant
Tablets GastroResistant
Tablets GastroResistant
Tablets GastroResistant
ASACARD
ASACOLON
ASACOLON
ASACOLON
Human Medicines Authorised/Transfer Pending Products
Tablets
800 Milligram
Active
Ingredients
Legal Basis
Routes of
Administration
-DRY EXTRACT
FROM FRESH
CYNARA
SCOLYMUS L.
LEAVES (1:3031)
EXTRACTION
SOLVENT:ETHA
NOL 65% V/V
-DRY EXTRACT
FROM SILYBUM
MARIANUM L.
GAERTN
FRUITS (1:2.02.1) EXTRATION
SOLVENT
ETHANOL 58%
V/V
-DRY EXTRACT
FROM FRESH
DANDELION
ROOT&HERB(T
ARAXACUM
OFFICINALIS
WEB) (1:17-18)
EXTRACTION
SOLVENT:ETHA
NOL 51%
-DRY EXTRACT
FROM PEUMUS
BOLDUS
MOLINA (1:1011)
EXTRACTION
SOLVENT:ETHA
NOL 70% V/V
-HUMAN
FIBRINOGEN
-HUMAN
THROMBIN
-CALCIUM
CHLORIDE
DIHYDRATE
-APROTININ
-HUMAN
FIBRINOGEN
-HUMAN
THROMBIN
-CALCIUM
CHLORIDE
DIHYDRATE
-APROTININ
PROPAFENONE
HYDROCHLORI
DE
PROPAFENONE
HYDROCHLORI
DE
-OFATUMUMAB
-Per Oral
-Per Oral
A07EC02
ACETYLSALICY
LIC ACID
-MESALAZINE
A07EC02
-MESALAZINE
-Per Oral
A07EC02
-MESALAZINE
A07EC02
-MESALAZINE
-Per Oral
A07EC02
-MESALAZINE
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Rectal
Page 43 of 608
Trade Name
Licence Holder Licence
Number
ASACOLON
Imbat Limited
ASACOLON
GASTRORESISTANT
TABLETS
ASASANTIN
RETARD
Imbat Limited
Strength
PPA1151/107/00
3
PPA1151/107/00
1
800 Milligram
Imbat Limited
PPA1151/128/00
1
ASASANTIN
RETARD
Boehringer
Ingelheim Limited
ASMANEX
TWISTHALER
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Tablets GastroResistant
Tablets GastroResistant
A07EC02
-MESALAZINE
A07EC02
-MESALAZINE
PPA
200/25 mg/mg
Capsules
Modified Release
B01AC30
PPA
PA0007/013/002
200/25 mg/mg
Capsules
Modified Release
B01AC30
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Bayer Limited
PA1286/039/002
200 Microgram
Inhalation
Powder, Capsule
R03BA07
-DIPYRIDAMOLE
ACETYLSALICY
LIC ACID
-DIPYRIDAMOLE
ACETYLSALICY
LIC ACID
-MOMETASONE
FUROATE
PA1286/039/003
400 Microgram
Inhalation
Powder, Capsule
R03BA07
-MOMETASONE
FUROATE
PA1410/037/001
300 Milligram
Tablets
Effervescent
N02BA01
ASPIRIN
Clonmel
Healthcare Ltd
PA0126/246/001
75 Milligram
Tablets GastroResistant
B01AC06
ASPIRIN EC
PCO
Manufacturing
PA0465/057/001
300 Milligram
Tablets GastroResistant
N02BA01
ASPIRIN KRKA
75 MG GASTRORESISTANT
TABLETS
ASPIRIN
ROWEX
Krka d.d., Novo
mesto
PA1347/070/001
75 Milligram
Gastro-resistant,
prolonged
release granules
B01AC06
ACETYLSALICY
LIC ACID
ACETYLSALICY
LIC ACID
ACETYLSALICY
LIC ACID
ACETYLSALICY
LIC ACID
Rowex Ltd
PA0711/247/001
75 Milligram
Tablets GastroResistant
B01AC06
ASTEPRO
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Intrapharm
Laboratories
Limited
AstraZeneca UK
Limited
PA1332/039/002
1.5 Mg/Ml
Nasal Spray
Solution
R01AC03
PA1332/039/001
1 Mg/Ml
Nasal Spray
Solution
R01AC03
PA0997/001/001
250
Microgram/ML
Oral Drops
Solution
A11CC02
PA0970/030/004
16 Milligram
Tablets
C09CA06
Interchangeable
List Code:
IC0009-038-002
PA0970/030/002
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-008-002
PA0970/030/003
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
ASMANEX
TWISTHALER
ASPIRIN
ASTEPRO
AT 10
ATACAND
ATACAND
ATACAND
ATACAND
ATACAND
AstraZeneca UK
Limited
AstraZeneca UK
Limited
PCO
Manufacturing
Interchangeable
List Code:
IC0009-009-002
PPA0465/116/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0009-038-002
PPA0465/116/00
3
400 Milligram
ACETYLSALICY
LIC ACID
-AZELASTINE
HYDROCHLORI
DE
-AZELASTINE
HYDROCHLORI
DE
DIHYDROTACH
YSTEROL
-CANDESARTAN
CILEXETIL
-Per Oral
-Per Oral
-Per Oral
Article 10c Informed Consen
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
Article 8(3) - Full
new Application
-Per Oral
Article 10(3) Hybrid
Application
-Nasal
-Nasal
-Per Oral
Interchangeable
List Code:
IC0009-008-002
Human Medicines Authorised/Transfer Pending Products
Page 44 of 608
Trade Name
ATACAND
ATACAND
ATACAND
ATACAND
ATACAND
ATACAND
ATACAND 8 MG
TABLETS
ATACAND PLUS
ATACAND PLUS
ATACAND PLUS
ATACAND PLUS
ATACAND PLUS
ATACAND PLUS
Licence Holder Licence
Number
IMED Healthcare
Ltd.
PPA1463/031/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0009-009-002
PPA1463/031/00
2
Imbat Limited
Imbat Limited
Imbat Limited
PPA
-Per Oral
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
PPA
-Per Oral
16/12.5 Milligram
Tablets
C09DA06
PPA
-Per Oral
Interchangeable
List Code:
IC0029-036-002
PA0970/031/002
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
16/12.5 Milligram
Tablets
C09DA06
Interchangeable
List Code:
IC0029-036-002
PA0970/031/001
8/12.5 Milligram
Tablets
C09DA06
16/12.5 Milligram
Tablets
C09DA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
16/12.5 Milligram
Tablets
C09DA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
16/12.5 Milligram
Tablets
C09DA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
Interchangeable
List Code:
IC0009-038-002
PPA1151/109/00
1
Interchangeable
List Code:
IC0009-038-002
PPA1151/109/00
2
Interchangeable
List Code:
IC0009-008-002
PPA1151/109/00
3
PCO
Manufacturing
Interchangeable
List Code:
IC0009-009-002
PPA0465/117/00
1
IMED Healthcare
Ltd.
Routes of
Administration
-CANDESARTAN
CILEXETIL
PCO
Manufacturing
Imbat Limited
Legal Basis
C09CA06
Interchangeable
List Code:
IC0009-008-002
PPA0465/116/00
1
Chemilines
Healthcare
(Ireland) Limited
Active
Ingredients
Tablets
IMED Healthcare
Ltd.
AstraZeneca UK
Limited
Dosage Form ATC
8 Milligram
Interchangeable
List Code:
IC0009-009-002
PPA1463/031/00
3
AstraZeneca UK
Limited
Strength
Interchangeable
List Code:
IC0029-058-002
PPA1915/006/00
1
Interchangeable
List Code:
IC0029-036-002
PPA1151/110/00
1
Interchangeable
List Code:
IC0029-036-002
PPA1463/053/00
1
Interchangeable
List Code:
IC0029-036-002
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 45 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
ATAZANAVIR
MYLAN
Mylan S.A.S.
EU/1/16/1091/00
1-003
150 Milligram
Capsules Hard
J05AE08
-ATAZANAVIR
SULFATE
ATAZANAVIR
MYLAN
Mylan S.A.S.
EU/1/16/1091/00
7-010
300 Milligram
Capsules Hard
J05AE08
-ATAZANAVIR
SULFATE
ATAZANAVIR
MYLAN
Mylan S.A.S.
EU/1/16/1091/00
4-006
200 Milligram
Capsules Hard
J05AE08
-ATAZANAVIR
SULFATE
ATAZANAVIR
TEVA
Teva B.V.
PA1986/028/001
150 Milligram
Capsules Hard
J05AE08
-ATAZANAVIR
SULFATE
ATAZANAVIR
TEVA
Teva B.V.
PA1986/028/002
200 Milligram
Capsules Hard
J05AE08
-ATAZANAVIR
SULFATE
ATAZANAVIR
TEVA
Teva B.V.
PA1986/028/003
300 Milligram
Capsules Hard
J05AE08
-ATAZANAVIR
SULFATE
ATECOR
Rowex Ltd
PA0711/003/001
25 Milligram
C07AB03
-ATENOLOL
ATECOR
Rowex Ltd
PA0711/003/002
50 Milligram
C07AB03
-ATENOLOL
ATECOR
Rowex Ltd
PA0711/003/003
100 Milligram
C07AB03
-ATENOLOL
ATECOR CT
Rowex Ltd
PA0711/020/001
50/12.5 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
C07CB03
ATECOR CT
Rowex Ltd
PA0711/020/002
100/25 Milligram
Film Coated
Tablet
C07CB03
ATENETIC
Generics (UK)
Limited
PA0405/031/001
50/12.5 Milligram
Coated Tablets
C07CB03
ATENETIC
Generics (UK)
Limited
PA0405/031/002
100/25 Milligram
Coated Tablets
C07CB03
ATENI
PA0405/019/001
50 Milligram
C07AB03
PA0405/019/002
100 Milligram
C07AB03
-ATENOLOL
PA0073/117/003
25 Milligram
Film Coated
Tablet
Film Coated
Tablet
Tablets
C07AB03
-ATENOLOL
PA0073/117/001
50 Milligram
Film Coated
Tablet
C07AB03
-ATENOLOL
PA0073/117/002
100 Milligram
Film Coated
Tablet
C07AB03
-ATENOLOL
PA1861/016/001
5 Mg/Ml
Oral Solution
C07AB03
-ATENOLOL
ATENOLOL
ACTAVIS
Generics (UK)
Limited
Generics (UK)
Limited
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
SYRI Limited, t/a
Thame
Laboratories
Actavis Group
PTC ehf
-ATENOLOL
CHLORTALIDO
NE
-ATENOLOL
CHLORTALIDO
NE
-ATENOLOL
CHLORTALIDO
NE
-ATENOLOL
CHLORTALIDO
NE
-ATENOLOL
PA1380/105/001
25 Milligram
Film Coated
Tablet
C07AB03
-ATENOLOL
ATENOLOL
ACTAVIS
Actavis Group
PTC ehf
PA1380/105/002
50 Milligram
Film Coated
Tablet
C07AB03
-ATENOLOL
ATENOLOL
ACTAVIS
Actavis Group
PTC ehf
PA1380/105/003
100 Milligram
Film Coated
Tablet
C07AB03
-ATENOLOL
ATENOMEL
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
PA0126/069/001
50 mg Milligram
Tablets
C07AB03
-ATENOLOL
PA0126/069/002
100 mg Milligram
Tablets
C07AB03
-ATENOLOL
PA0126/069/003
25mg Milligram
Tablets
C07AB03
-ATENOLOL
-Per Oral
PA0822/090/002
4 Mg/Ml
N05BA06
-LORAZEPAM
-Intra-venous
PA0822/090/001
1 Milligram
Solution for
Injection
Tablets
N05BA06
-LORAZEPAM
ATENI
ATENOGEN
ATENOGEN
ATENOGEN
ATENOLOL
ATENOMEL
ATENOMEL
ATIVAN
ATIVAN
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 46 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/001
10 Milligram
Capsules Hard
N06BA09
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/002
18 Milligram
Capsules Hard
N06BA09
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/003
25 Milligram
Capsules Hard
N06BA09
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/004
40 Milligram
Capsules Hard
N06BA09
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/005
60 Milligram
Capsules Hard
N06BA09
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/006
80 Milligram
Capsules Hard
N06BA09
ATOMOXETINE
Actavis Group
PTC ehf
PA1380/186/007
100 Milligram
Capsules Hard
N06BA09
ATORVAS
Rowex Ltd
PA0711/180/001
10 Milligram
Film Coated
Tablet
C10AA05
Rowex Ltd
Interchangeable
List Code:
IC0001-002-003
PA0711/180/002
20 Milligram
Film Coated
Tablet
Rowex Ltd
Interchangeable
List Code:
IC0001-003-003
PA0711/180/003
40 Milligram
Rowex Ltd
Interchangeable
List Code:
IC0001-004-003
PA0711/180/004
ATORVAS
ATORVAS
ATORVAS
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
Dexcel-Pharma
Limited
Dexcel-Pharma
Limited
Dexcel-Pharma
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
Active
Ingredients
Legal Basis
Routes of
Administration
-ATOMOXETINE
HYDROCHLORI
DE
-ATOMOXETINE
HYDROCHLORI
DE
-ATOMOXETINE
HYDROCHLORI
DE
-ATOMOXETINE
HYDROCHLORI
DE
-ATOMOXETINE
HYDROCHLORI
DE
-ATOMOXETINE
HYDROCHLORI
DE
-ATOMOXETINE
HYDROCHLORI
DE
ATORVASTATIN
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
C10AA05
ATORVASTATIN
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
C10AA05
ATORVASTATIN
Article 10(1) Generic
Application
-Per Oral
80 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA0895/010/001
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA0895/010/002
ATORVASTATIN
CA, HEMIHYDRATE SALT
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA0895/010/003
ATORVASTATIN
CA, HEMIHYDRATE SALT
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA1339/031/001
ATORVASTATIN
CA, HEMIHYDRATE SALT
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA1339/031/002
ATORVASTATIN
CALCIUM
TRIHYDRATE
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA1339/031/003
ATORVASTATIN
CALCIUM
TRIHYDRATE
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA1339/031/004
ATORVASTATIN
CALCIUM
TRIHYDRATE
80 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
TRIHYDRATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 47 of 608
Trade Name
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ACTAVIS
ATORVASTATIN
ACTAVIS
Licence Holder Licence
Number
Ranbaxy Ireland
Limited
Ranbaxy Ireland
Limited
Ranbaxy Ireland
Limited
Ranbaxy Ireland
Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0408/090/001
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA0408/090/002
ATORVASTATIN
CALCIUM
TRIHYDRATE
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA0408/090/003
ATORVASTATIN
CALCIUM
TRIHYDRATE
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA0408/090/004
ATORVASTATIN
CALCIUM
TRIHYDRATE
80 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
TRIHYDRATE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
-Per Oral
20 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
-Per Oral
40 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
-Per Oral
80 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
-Per Oral
WPR Healthcare
Limited
Interchangeable
List Code:
IC0001-005-003
PPA0565/061/00
1
WPR Healthcare
Limited
Interchangeable
List Code:
IC0001-002-003
PPA0565/061/00
2
WPR Healthcare
Limited
Interchangeable
List Code:
IC0001-003-003
PPA0565/061/00
3
WPR Healthcare
Limited
Interchangeable
List Code:
IC0001-004-003
PPA0565/061/00
4
Chanelle Medical
Interchangeable
List Code:
IC0001-005-003
PA0688/021/001
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0001-002-003
PA0688/021/002
ATORVASTATIN
CALCIUM
TRIHYDRATE
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0001-003-003
PA0688/021/003
ATORVASTATIN
CALCIUM
TRIHYDRATE
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0001-004-003
PA0688/021/004
ATORVASTATIN
CALCIUM
TRIHYDRATE
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA1380/017/001
ATORVASTATIN
CALCIUM
TRIHYDRATE
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA1380/017/002
ATORVASTATI
N-CALCIUM
20 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATI
N-CALCIUM
Article 10(1) Generic
Application
-Per Oral
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0001-003-003
Human Medicines Authorised/Transfer Pending Products
Page 48 of 608
Trade Name
ATORVASTATIN
ACTAVIS
ATORVASTATIN
ACTAVIS
ATORVASTATIN
CLONMEL
ATORVASTATIN
CLONMEL
ATORVASTATIN
CLONMEL
ATORVASTATIN
CLONMEL
ATORVASTATIN
KRKA
ATORVASTATIN
KRKA
ATORVASTATIN
KRKA
ATORVASTATIN
KRKA
ATORVASTATIN
MYLAN
ATORVASTATIN
MYLAN
ATORVASTATIN
MYLAN
ATORVASTATIN
MYLAN
ATORVASTATIN
PFIZER
Licence Holder Licence
Number
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Pfizer Ireland
Pharmaceuticals
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1380/017/003
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA1380/017/006
ATORVASTATI
N-CALCIUM
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA0126/271/001
ATORVASTATIN
CALCIUM
TRIHYDRATE
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA0126/271/002
ATORVASTATIN
CALCIUM
TRIHYDRATE
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA0126/271/003
ATORVASTATIN
CALCIUM
TRIHYDRATE
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA0126/271/004
ATORVASTATIN
CALCIUM
TRIHYDRATE
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA1347/023/001
ATORVASTATIN
CALCIUM
TRIHYDRATE
10 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA1347/023/002
ATORVASTATIN
CALCIUM
20 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA1347/023/003
ATORVASTATIN
CALCIUM
40 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA1347/009/004
ATORVASTATIN
CALCIUM
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA0577/118/001
ATORVASTATIN
CALCIUM
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA0577/118/002
ATORVASTATIN
CALCIUM
TRIHYDRATE
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA0577/118/003
ATORVASTATIN
CALCIUM
TRIHYDRATE
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA0577/118/004
ATORVASTATIN
CALCIUM
TRIHYDRATE
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA1740/002/001
ATORVASTATIN
CALCIUM
TRIHYDRATE
10 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
Human Medicines Authorised/Transfer Pending Products
Page 49 of 608
Trade Name
ATORVASTATIN
PFIZER
ATORVASTATIN
PFIZER
ATORVASTATIN
PFIZER
ATORVASTATIN
PHARMATHEN
ATORVASTATIN
PHARMATHEN
ATORVASTATIN
PHARMATHEN
ATORVASTATIN
PHARMATHEN
ATORVASTATIN
TEVA
ATORVASTATIN
TEVA
ATORVASTATIN
TEVA
ATORVASTATIN
TEVA
ATOSIBAN
ATOSIBAN SUN
ATOSIBAN SUN
ATOVAQUONE/
PROGUANIL
ATOVAQUONE/
PROGUANIL
HYDROCHLORI
DE
Licence Holder Licence
Number
Pfizer Ireland
Pharmaceuticals
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1740/002/002
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA1740/002/003
ATORVASTATIN
CALCIUM
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA1740/002/004
ATORVASTATIN
CALCIUM
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Pharmathen S.A.
Interchangeable
List Code:
IC0001-005-003
PA1368/013/001
ATORVASTATIN
CALCIUM
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Pharmathen S.A.
Interchangeable
List Code:
IC0001-002-003
PA1368/013/002
ATORVASTATIN
CALCIUM
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Pharmathen S.A.
Interchangeable
List Code:
IC0001-003-003
PA1368/013/003
ATORVASTATIN
CALCIUM
40 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
-Per Oral
Pharmathen S.A.
Interchangeable
List Code:
IC0001-004-003
PA1368/013/004
Article 10(1) Generic
Application
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA0749/110/001
ATORVASTATIN
CALCIUM
10 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA0749/110/002
ATORVASTATIN
CALCIUM
20 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA0749/110/003
ATORVASTATIN
CALCIUM
40 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA0749/110/004
ATORVASTATIN
CALCIUM
80 Milligram
Film Coated
Tablet
C10AA05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA1390/100/001
ATORVASTATIN
CALCIUM
37.5 MG/5ml
Concentrate for
Soln for Inf
G02CX01
-ATOSIBAN
-Intra-venous
EU/1/13/852/001
6.75/0.9 Mg/Ml
Solution for
Injection
G02CX01
-ATOSIBAN
Article 10(1) Generic
Application
Article 10(1) Generic
Application
EU/1/13/852/002
37.5/5 Mg/Ml
Concentrate for
Soln for Inf
G02CX01
-ATOSIBAN
Article 10(1) Generic
Application
-Intra-venous
PPA1562/177/00
1
250/100 Milligram
Film Coated
Tablet
P01BB51
PA0405/062/001
250/100 Milligram
Film Coated
Tablet
P01BB51
-ATOVAQUONE
-PROGUANIL
HYDROCHLORI
DE
-ATOVAQUONE
-PROGUANIL
HYDROCHLORI
DE
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Accord
Healthcare
Limited
Sun
Phamaceutical
Industries Europe
B.V.
Sun
Phamaceutical
Industries Europe
B.V.
LTT Pharma
Limited
Generics (UK)
Limited
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 50 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
ATOZET
Merck Sharp and
Dohme Limited
PA0035/097/001
10 /10 Milligram
Film Coated
Tablet
C10BA05
ATOZET
Merck Sharp and
Dohme Limited
PA0035/097/002
10 / 20 Milligram
Film Coated
Tablet
C10BA05
ATOZET
Merck Sharp and
Dohme Limited
PA0035/097/003
10 / 40 Milligram
Film Coated
Tablet
C10BA05
ATOZET
Merck Sharp and
Dohme Limited
PA0035/097/004
10 / 80 Milligram
Film Coated
Tablet
C10BA05
ATRACURIUM
Hikma
Farmaceutica
(Portugal) SA
Novartis
Europharm
Limited
PA1217/011/001
10 Mg/Ml
Solution for
Injection
M03AC04
EU/1/07/403/001
5 Mg/Ml
Solution for
Infusion
L01BB07
-NELARABINE
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
EU/1/07/430/001
600/200/24
Milligram
Film Coated
Tablet
J05AR06
ATROGEL
ARNICA
Bioforce (UK) Ltd
TR0725/001/001
ATROPINE
INJECTION BP
MINIJET
ATROPINE
SULFATE
AGUETTANT
ATROPINE
SULFATE
AGUETTANT
ATROPINE
SULPHATE
International
Medication
Systems (UK) Ltd
Laboratoire
AGUETTANT
PA0255/006/002
100
Microgram/ML
Solution for
Injection
A03BA01
PA1968/003/001
0.1 Mg/Ml
Laboratoire
AGUETTANT
PA1968/003/002
0.2 Mg/Ml
Mercury
Pharmaceuticals
(Ireland) Ltd
Bioforce (UK) Ltd
PA0073/036/001
600
Microgram/ML
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
Injection
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
PA0007/002/007
GTC
Biotherapeutics
UK Limited
EU/1/06/355/1-3
ATRIANCE
5MG/ML
SOLUTION FOR
INFUSION
ATRIPLA
ATROSAN
DEVIL'S CLAW
ATROVENT 250
UDVS
ATROVENT 500
UDVS
ATROVENT
INHALER CFCFREE
ATRYN
TR0725/003/001
PA0007/002/004
PA0007/002/010
Human Medicines Authorised/Transfer Pending Products
Routes of
Administration
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10(1) Generic
Application
-Intra-venous
-EFAVIRENZ
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
FUMARATE
-ARNICA
MONTANA L.
FLOWERS (DER
1:20)
-ATROPINE
SULFATE
Article 10b Fixed
Combination
-Per Oral
A03BA01
-ATROPINE
SULFATE
A03BA01
-ATROPINE
SULFATE
Article 10a Bibliographical
App
Article 10a Bibliographical
App
A03BA01
-ATROPINE
SULFATE
Gel
Film Coated
Tablet
250
Microgram/ML
500mcg/2ml
Microgram
20 Mcg/Dose
Solution for
Inhalation
Nebuliser
Solution
Pressurised
Inhalation Soln
R03BB01
1750
International Unit
Pdr for Soln for
Infusion
B01AB02
R03BB01
R03BB01
-EZETIMIBE,
MICRONIZED
ATORVASTATIN
ATORVASTATIN
CALCIUM
TRIHYDRATE
-EZETIMIBE,
MICRONIZED
ATORVASTATIN
CALCIUM
TRIHYDRATE
-EZETIMIBE,
MICRONIZED
ATORVASTATIN
ATORVASTATIN
CALCIUM
TRIHYDRATE
-EZETIMIBE,
MICRONIZED
ATORVASTATIN
ATORVASTATIN
CALCIUM
TRIHYDRATE
-ATRACURIUM
BESILATE
Legal Basis
-DRY EXTRACT
OF THE DRIED
ROOTS OF
DEVIL'S CLAW
(PH.EUR.)
-IPRATROPIUM
BROMIDE
-IPRATROPIUM
BROMIDE
-IPRATROPIUM
BROMIDE
-Cutaneous
-Intra-Muscular
-Intra-venous
-Intra-venous
-Per Oral
-Inhalation
-Inhalation
-ANTITHROMBIN
ALFA
Page 51 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
AUBAGIO
sanofi-aventis
groupe
EU/1/13/838/001005
14 Milligram
Film Coated
Tablet
L04AA31
AUDAVAL
Auden Mckenzie
(Pharma Division)
Ltd
Auden Mckenzie
(Pharma Division)
Ltd
Auden Mckenzie
(Pharma Division)
Ltd
PA1352/020/002
0.1 %w/w
Ointment
D07AC01
PA1352/020/003
0.025 %w/w
Cream
D07AC01
PA1352/020/004
0.025 %w/w
Ointment
D07AC01
AUDAX
GR Lane Health
Products Ltd
PA0257/058/001
20/12.6 %w/v
Ear Drops
Solution
S02DA30
AUGMENTIN
Imbat Limited
PPA1151/050/00
3
500/125 Milligram
Film Coated
Tablet
J01CR02
250/125 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0037-074-014
PA1077/093/007
250/125 Milligram
Interchangeable
List Code:
IC0037-074-014
PA1077/019/003
Interchangeable
List Code:
IC0037-073-014
PA1077/019/005
AUDAVAL RD
AUDAVAL RD
AUGMENTIN
AUGMENTIN
AUGMENTIN
AUGMENTIN
Imbat Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Interchangeable
List Code:
IC0037-073-014
PPA1151/050/00
1
AUGMENTIN
DUO
GlaxoSmithKline
(Ireland) Limited
Imbat Limited
AUGMENTIN
INTRAVENOUS
GlaxoSmithKline
(Ireland) Limited
AUGMENTIN
INTRAVENOUS
GlaxoSmithKline
(Ireland) Limited
PA1077/019/002
Interchangeable
List Code:
IC0037-076-034
PPA1151/050/00
2
Interchangeable
List Code:
IC0037-076-034
PA1077/093/001
PA1077/093/002
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
TERIFLUNOMID
E
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
(AS
BETAMETHASO
NE)
-CHOLINE
SALICYLATE
-GLYCEROL
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
Article 8(3) - Full
new Application
-Per Oral
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Cutaneous
PPA
-Per Oral
J01CR02
-AMOXICILLIN
-CLAVULANIC
ACID
PPA
-Per Oral
Tablets
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
-Per Oral
500/125 Milligram
Film Coated
Tablet
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
-Per Oral
875/125 Milligram
Film Coated
Tablet
J01CR02
-Per Oral
400/57 MG/5ml
Powder for Oral
Suspension
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
400/57 MG/5ml
Powder for Oral
Suspension
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
500/100 Milligram
Pdr for Soln
Inj/Inf
J01CR02
1000/200
Milligram
Pdr for Soln
Inj/Inf
J01CR02
-AMOXICILLIN
SODIUM
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
SODIUM
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
Interchangeable
List Code:
IC0037-072-003
AUGMENTIN
DUO
Active
Ingredients
-Cutaneous
-Cutaneous
-Per Oral
PPA
-Per Oral
-Intra-venous
-Intra-venous
Page 52 of 608
Trade Name
AUGMENTIN
PAEDIATRIC
Licence Holder Licence
Number
Active
Ingredients
Powder for Oral
Suspension
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
400/57 MG/5ml
Powder for Oral
Suspension
J01CR02
Interchangeable
List Code:
IC0037-076-034
EU/1/07/434/0013
EU/1/04/300/001002
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
27.5 Microgram
Nasal Spray
Suspension
Concentrate for
Soln for Inf
R01AD08
-FLUTICASONE
FUROATE
-BEVACIZUMAB
PA2131/002/001
160 D-ant. %v/v
Solution for
Injection
J07BC02
-HEPATIT A
VIRUS ANTIGEN
Bayer Limited
PA1410/027/001
400 Milligram
Film Coated
Tablet
J01MA14
AVELOX
Bayer Limited
PA1410/027/002
400/250 Mg/Ml
Solution for
Infusion
J01MA14
AVELOX
Bayer Limited
PA1410/027/003
400/250 Mg/Ml
Solution for
Infusion
J01MA14
AVELOX
PCO
Manufacturing
PPA0465/230/00
1
400 Milligram
Film Coated
Tablet
J01MA14
AVELOX
LTT Pharma
Limited
PPA1562/158/00
1
400 Milligram
Film Coated
Tablet
J01MA
AVENACALM
AVENA SATIVA
ORAL DROPS
Bioforce (UK) Ltd
TR0725/012/001
940mg/1ml
Milligram
Liquid
AVODART
Imbat Limited
0.5 Milligram
Capsules, Soft
G04CB02
AVODART
B & S Healthcare
0.5 Milligram
Capsules, Soft
G04CB02
AVODART
Clear Pharmacy
0.5 Milligram
Capsules, Soft
AVODART
0.5 Milligram
AVONEX
IMED Healthcare
Ltd.
LTT Pharma
Limited
PCO
Manufacturing
GlaxoSmithKline
(Ireland) Limited
Biogen Idec Ltd
PPA1151/124/00
1
PPA1328/134/00
1
PPA1596/002/00
1
PPA1463/038/00
1
PPA1562/131/00
1
PPA0465/211/00
1
PA1077/104/001
-MOXIFLOXACIN
HYDROCHLORI
DE
-MOXIFLOXACIN
HYDROCHLORI
DE
-MOXIFLOXACIN
HYDROCHLORI
DE
-MOXIFLOXACIN
HYDROCHLORI
DE
-MOXIFLOXACIN
HYDROCHLORI
DE
-TINCTURE
FROM
PRESSED JUICE
FROM AVENA
SATIVA L,
HERBA REC
(FRESH OAT
HERB),(1:1.2)
-DUTASTERIDE
AVONEX
AXID
AXSAIN
AVAMYS
AVASTIN
AVAXIM
INACTIVATED
HEPATITIS A
VACCINE
AVELOX
AVODART
AVODART
AVODART
AXURA
AXURA
IMED Healthcare
Ltd.
Glaxo Group
Limited
Roche
Registration
Limited
Sanofi Pasteur
Europe
PA1077/093/004
Dosage Form ATC
125/31.25
MG/5ml
AUGMENTINDUO
GlaxoSmithKline
(Ireland) Limited
Strength
Interchangeable
List Code:
IC0037-071-034
PPA1463/015/00
2
25mg/ml Mg/Ml
L01XC07
Legal Basis
Routes of
Administration
-Per Oral
PPA
-Per Oral
-Intra-nasal
-Per Oral
PPA
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-DUTASTERIDE
PPA
-Per Oral
G04CB02
-DUTASTERIDE
PPA
-Per Oral
Capsules, Soft
G04CB02
-DUTASTERIDE
PPA
-Per Oral
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
-Per Oral
EU/1/97/033/002
30 Microgram
L03AB07
Biogen Idec Ltd
EU/1/97/033/003
%v/v
Flynn Pharma Ltd
Cephalon UK
Limited
Merz
Pharmaceuticals
GmbH
PA1226/004/001
PA0827/004/001
150 Milligram
0.075 %w/w
Pdr+Solv for soln
for Inf
Solution for
Injection
Capsules Hard
Cream
A02BA04
M02AB01
-INTERFERON
BETA - 1A
-INTERFERON
BETA - 1A
-NIZATIDINE
-CAPSAICIN
-Per Oral
-Topical
EU/1/02/218/16
5+10+15+20
Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
Article 8(3) - Full
new Application
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
Article 8(3) - Full
new Application
-Per Oral
Merz
Pharmaceuticals
GmbH
Interchangeable
List Code:
IC0022-106-003
EU/1/02/218/1722
L03AB07
-Per Oral
PPA
-Per Oral
Interchangeable
List Code:
IC0022-003-003
Human Medicines Authorised/Transfer Pending Products
Page 53 of 608
Trade Name
AXURA
AXURA
AXURA
AXURA
Licence Holder Licence
Number
Merz
Pharmaceuticals
GmbH
Merz
Pharmaceuticals
GmbH
Merz
Pharmaceuticals
GmbH
Merz
Pharmaceuticals
GmbH
Strength
Dosage Form ATC
Active
Ingredients
10 Micromol
Oral Drops
Solution
N06DX01
-MEMANTINE
-Per Oral
EU/1/02/218/5-6
5 Milligram
Infus/Pdr/Oral
Soln
N06DX01
-Per Oral
Interchangeable
List Code:
IC0022-107-019
EU/1/02/218/006
-MEMANTINE
HYDROCHLORI
DE
10 Micromol
Oral Drops
Solution
N06DX01
-Per Oral
EU/1/02/218/1-3
10 Milligram
Film Coated
Tablet
N06DX01
Interchangeable
List Code:
IC0022-002-003
PA0749/213/001
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
180 Milligram
Tablets GastroResistant
L04AA06
Teva Pharma
B.V.
AXYMPA
Teva Pharma
B.V.
PA0749/213/002
360 Milligram
Tablets GastroResistant
L04AA06
AZACTAM
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Gedeon Richter
Plc
PA0002/052/002
1 Grams
Pdr for Soln
Inj/Inf
J01DF01
MYCOPHENOL
ATE SODIUM
MYCOPHENOL
ATE SODIUM
-AZTREONAM
PA0002/052/003
2 Grams
Pdr for Soln
Inj/Inf
J01DF01
-AZTREONAM
PA1330/010/001
75 Microgram
Film Coated
Tablet
G03AC09
-DESOGESTREL
AZARGA 10
MG/ML + 5
MG/ML EYE
DROPS,
SUSPENSION
AZATHIOPRINE
50MG FILMCOATED
TABLETS
AZECORT
Alcon
Laboratories (UK)
Ltd
EU/1/08/482/1-2
10/5 Micromol
Eye Drops
Suspension
S01ED51
-BRINZOLAMIDE
-TIMOLOL
MALEATE
Relon Chem
Limited
PA1128/004/001
50 Milligram
Film Coated
Tablet
L04AX01
Meda Health
Sales Ireland
Limited
PA1332/046/001
137/50
Microgram
Nasal Spray
Suspension
R01AD58.
AZELASTINE
Meda Health
Sales Ireland
Limited
Brown & Burk UK
Ltd
PA1332/010/001
0.5 Mg/Ml
Eye Drops
Solution
S01GX07
PA1648/003/001
0.5 Mg/Ml
Eye Drops
Solution
S01GX07
Teva B.V.
EU/1/04/304/1-7
1 Milligram
Tablets
N04BD02
AZITHROMYCIN
ACTAVIS
Actavis Group
PTC ehf
PA1380/138/001
250 Milligram
Film Coated
Tablet
J01FA10
AZITHROMYCIN
CLONMEL
AZITHROMYCIN
KRKA
Clonmel
Healthcare Ltd
Krka d.d., Novo
mesto
PA0126/150/001
250 Milligram
J01FA10
PA1347/047/001
250 Milligram
Film Coated
Tablet
Film Coated
Tablet
AZITHROMYCIN
TEVA
Teva Pharma
B.V.
PA0749/039/002
250 Milligram
Film Coated
Tablet
J01FA10
-AZITHROMYCIN
DIHYDRATE
AZOMYR
Schering Plough
Europe
EU/1/00/157/3546
2.5 Milligram
Orodispersible
Tablet
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/4758
5 Milligram
Orodispersible
Tablet
R06AX27
DESLORATIDIN
E
DESLORATIDIN
E
AZALIA
AZELASTINE
HYDROCHLORI
DE
AZILECT
Routes of
Administration
EU/1/02/218/004
AXYMPA
AZACTAM
Legal Basis
Human Medicines Authorised/Transfer Pending Products
J01FA10
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-AZATHIOPRINE
Article 10(1) Generic
Application
-Per Oral
-AZELASTINE
HYDROCHLORI
DE
-FLUTICASONE
PROPIONATE
-AZELASTINE
HYDROCHLORI
DE
-AZELASTINE
HYDROCHLORI
DE
-RASAGILINE
MESILATE
-AZITHROMYCIN
DIHYDRATE
Article 10b Fixed
Combination
-Nasal
Article 10(3) Hybrid
Application
-Intra-ocular
-AZITHROMYCIN
MONOHYDRATE
-AZITHROMYCIN
DIHYDRATE
-Per Oral
-Ocular
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Page 54 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/5967
0.5 Mg/Ml
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/014
0.5mg/ml Mg/Ml
Syrup
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/002
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/003
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/004
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/005
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/006
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/007
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/008
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/009
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/010
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/011
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/012
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/013
5 Milligram
Tablets
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/022
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/001
5 Milligram
Tablets
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/015
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/016
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/017
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/018
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/019
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/020
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Merck Sharp and
Dohme Limited
EU/1/00/157/021
0.5 Mg/Ml
Syrup
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/023
5 Milligram
Oral Lyophilisate
R06AX27
Human Medicines Authorised/Transfer Pending Products
R06AX27
Active
Ingredients
DESLORATADI
NE,
MICRONIZED
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 55 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
AZOMYR
Schering Plough
Europe
EU/1/00/157/024
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/025
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/026
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/027
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/028
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/029
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/030
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/031
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/032
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/033
5 Milligram
Oral Lyophilisate
R06AX27
AZOMYR
Schering Plough
Europe
EU/1/00/157/034
5 Milligram
Oral Lyophilisate
R06AX27
AZOPT
Alcon
Laboratories (UK)
Ltd
Alcon
Laboratories (UK)
Ltd
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Laboratoires
Thea
Ipsen Biopharm
Limited
EU/1/00/129/002
10 Mg/Ml
Eye Drops
Suspension
EU/1/00/129/001
10 Mg/Ml
PA0577/122/001
SYRI Limited, t/a
Thame
Laboratories
Generics (UK)
Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Imbat Limited
AZOPT EYE
DROPS
AZROMAX
AZYTER
AZZALURE
BACLOFEN
BACLOPAR
BACTROBAN
BACTROBAN
BACTROBAN
Active
Ingredients
Legal Basis
Routes of
Administration
-Per Oral
S01EC04
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
-BRINZOLAMIDE
Eye Drops
Suspension
S01EC04
-BRINZOLAMIDE
-Ocular
250 Milligram
Film Coated
Tablet
J01FA10
-AZITHROMYCIN
MONOHYDRATE
PA1107/004/001
15 mg/g
S01AA26
PA1609/001/001
10 Speywood
units / Millilitre
Eye Drops
Solution
Pdr for Soln for
Injection
PA1861/019/001
5 MG/5ml
Oral Solution
M03BX01
-AZITHROMYCIN
DIHYDRATE
-CLOSTRIDIUM
BOTULINUM
TOXIN TYPE A
HAEMAGGLUTI
NIN COMPLEX
-BACLOFEN
PA0405/029/001
10 Milligram
Tablets
M03BX01
-BACLOFEN
PA1077/094/001
2 %w/w
Ointment
D06AX09
-MUPIROCIN
PA1077/094/002
2.0 %w/w
Nasal Ointment
R01AX06
PPA1151/169/00
1
PPA0465/312/00
1
2 Base %w/w
Nasal Ointment
D06AX09
2.0 %w/w
Nasal Ointment
R01AX06
-MUPIROCIN
CALCIUM
-MUPIROCIN
CALCIUM
-MUPIROCIN
CALCIUM
M03AX01
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Ocular
Article 10(1) Generic
Application
-Per Oral
-Ocular
Article 8(3) - Full
new Application
-Intra-Muscular
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Nasal
PPA
-Nasal
BACTROBAN
NASAL
OINTMENT
BANDIDA
PCO
Manufacturing
Actavis Group
PTC ehf
PA1380/183/001
150 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
BARACLUDE
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
EU/1//06/343/01
0.5 Milligram
Tablets
J05AF10
-ENTECAVIR
-Per Oral
EU/1/06/343/05
0.05 Mg/Ml
Oral Solution
J05AF10
-ENTECAVIR
-Per Oral
BARACLUDE
Human Medicines Authorised/Transfer Pending Products
-Nasal
Article 10(1) Generic
Application
-Per Oral
Page 56 of 608
Trade Name
BARACLUDE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Bristol Myers
Squibb Pharma
EEIG
AJ Vaccines A/S
EU/1/06/343/02,
04,07
1.0 Milligram
Tablets
J05AF10
-ENTECAVIR
-Per Oral
PA2160/003/001
%v/v
Pdr+Solv for
Susp for Inj
J07AN01
-Intra-dermal
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Norton Waterford
PA0623/004/001
Powder +
Solvent/Suspens
ion/Intravesical
Use
L03AX03
MYCOBACTERI
UM BOVIS
(BCG) STAM
1331
-BCG BACTERIA
ATTENUATED
STRAIN RIVM
PA0436/021/012
250
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
BECLAZONE
CFC-FREE
INHALER
Norton Waterford
PA0436/021/009
50
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
BECLAZONE
CFC-FREE
INHALER
Norton Waterford
PA0436/021/010
100
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
BECLAZONE
EASI BREATHE
CFC-FREE
INHALER
BECLAZONE
EASI BREATHE
CFC-FREE
INHALER
BECLAZONE
EASI BREATHE
CFC-FREE
INHALER
BECLAZONE
INHALER CFC
FREE
Norton Waterford
PA0436/021/013
50
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
Norton Waterford
PA0436/021/014
100
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
Norton Waterford
PA0436/021/016
250
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
Norton Waterford
PA0436/021/011
200 %v/v
Pressurised
Inhalation
Suspension
R03BA01
BECLAZONE
INHALER EASI
BREATHE CFCFREE
Norton Waterford
PA0436/021/015
200 Microgram
Pressurised
Inhalation Soln
R03BA01
BECLONEB
Chiesi
Farmaceutici
S.p.A.
PA0584/003/001
400mcg/1ml
Microgram/ML
Nebuliser
Solution
R03BA01
BECLONEB
Chiesi
Farmaceutici
S.p.A.
PA0584/003/002
800mcg/2ml
Microgram/ML
Nebuliser
Solution
R03BA01
BECLOSPIN
Chiesi
Farmaceutici
S.p.A.
PA0584/004/001
400mcg/1ml
Microgram/ML
Nebuliser
Solution
R03BA01
BECLOSPIN
Chiesi
Farmaceutici
S.p.A.
PA0584/004/002
800mcg/2ml
Microgram/ML
Nebuliser
Solution
R03BA01
BECONASE
HAYFEVER
Chefaro Ireland
DAC
PA1186/008/001
50 Mcg/Dose
Nasal Spray
Suspension
R03BA01
BECOTIDE
EVOHALER
Imbat Limited
PPA1151/204/00
1
250 Microgram
Pressurised
Inhalation Soln
R03BA01
BECOTIDE
EVOHALER
Imbat Limited
PPA1151/204/00
2
50 Microgram
Pressurised
Inhalation Soln
R03BA01
BCG VACCINE
SSI
BCG-MEDAC
BECLAZONE
CFC-FREE
INHALER
Human Medicines Authorised/Transfer Pending Products
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
ANHYDROUS
BECLOMETASO
NE
DIPROPIONATE
ANHYDROUS
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
MONOHYDRATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
-Per Oral
-Per Oral
-Per Oral
-Inhalation
-Inhalation
-Per Oral
-Inhalation
-Nasal
Page 57 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
BECOTIDE
EVOHALER
GlaxoSmithKline
(Ireland) Limited
PA1077/042/006
50 Microgram
Pressurised
Inhalation Soln
R03BA01
BECOTIDE
EVOHALER
GlaxoSmithKline
(Ireland) Limited
PA1077/042/007
100 Microgram
Pressurised
Inhalation Soln
R03BA01
BECOTIDE
EVOHALER
GlaxoSmithKline
(Ireland) Limited
PA1077/042/009
250 Microgram
Pressurised
Inhalation Soln
R03BA01
BECOTIDE
EVOHALER
PCO
Manufacturing
PPA0465/041/00
6
250 Microgram
Pressurised
Inhalation Soln
R03BA01
BECOTIDE
EVOHALER
PCO
Manufacturing
PPA0465/041/00
5
50
Mcg/Acutuation
Pressurised
Inhalation Soln
R03BA01
BELKYRA
Allergan
Pharmaceuticals
International
Limited
A. Nelson &
Company Limited
Cuxson Gerrard
& Company Ltd
PA2103/003/001
10 Mg/Ml
Solution for
Injection
D11AX
HOR1149/006/0
01
PA0229/004/001
6C-MM %v/v
0.25% %w/w
Medicated
Plaster
BELLADONNA
TABLETS
BEMFOLA
Weleda (UK)
Limited
Finox Biotech AG
HOR0407/019/0
01
EU/1/13/909/001005
6C & 30C
Milligram
600IU/44
Microgram
Tablets
Solution for
Injection
G03GA05
BENDAMUSTIN
Accord
Healthcare
Limited
PA1390/095/001
25 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTIN
Accord
Healthcare
Limited
PA1390/095/002
100 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTIN
Actavis Group
PTC ehf
PA1380/163/001
25 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTIN
Actavis Group
PTC ehf
PA1380/163/002
100 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTIN
Generics (UK)
Limited
PA0405/072/001
25 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTIN
Generics (UK)
Limited
PA0405/072/002
100 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTINE
HCL
Fresenius Kabi
Oncology Plc
PA1422/018/001
25 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTINE
HCL
Fresenius Kabi
Oncology Plc
PA1422/018/002
100 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
BENDAMUSTINE
MEDAC
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
PA0623/015/001
25 Milligram
Pdr/Conc/Soln for
Infus
L01A
BELLADONNA
BELLADONNA
Human Medicines Authorised/Transfer Pending Products
M02AX10
Active
Ingredients
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
-DEOXYCHOLIC
ACID
-ATROPA
BELLADONNA
-BELLADONNA
ALKALOIDS
-ATROPINE
-ATROPA
BELLADONNA
-ATROPA
BELLADONNA
-FOLLITROPIN
ALFA
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
Legal Basis
Routes of
Administration
PPA
PPA
Article 8(3) - Full
new Application
-Subcutaneous
-Per Oral
-Per Oral
Article 10(4) Similar Biological
App
Article 10(1) Generic
Application
-Subcutaneous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
Page 58 of 608
Trade Name
BENDAMUSTINE
MEDAC
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0623/015/002
100 Milligram
Pdr/Conc/Soln for
Infus
L01A
BENDAMUSTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Intra-venous
BENEFIX
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Pfizer Limited
EU/1/97/047/008
-Intra-venous
EU/1/97/047/007
BENEFIX
Pfizer Limited
EU/1/97/047/004
BENEFIX
Pfizer Limited
EU/1/97/047/005
BENEFIX
Pfizer Limited
EU/1/97/047/006
BENEFIX
Pfizer Limited
EU/1/97/047/009
BENEPALI
Samsung Bioepis
UK Limited
EU/1/15/1074/00
1
L04AB01
-NONACOG
ALFA
-NONACOG
ALFA
-NONACOG
ALFA
-NONACOG
ALFA
-NONACOG
ALFA
-NONACOG
ALFA
-ETANERCEPT
Article 8(3) - Full
new Application
Pfizer Limited
BENEPALI
Samsung Bioepis
UK Limited
EU/1/15/1074/00
2
50 Milligram
L04AB01
-ETANERCEPT
BENETOR
Daiichi Sankyo
Ireland Ltd
Daiichi Sankyo
Ireland Ltd
Daiichi Sankyo
Ireland Ltd
Daiichi Sankyo
Ireland Ltd
PA1595/001/001
10 Milligram
C09CA08
PA1595/001/002
20 Milligram
PA1595/001/003
40 Milligram
PA1595/002/001
20/12.5 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Solution for
injection in prefilled syringe
Solution for
injection in prefilled pen
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
B02BD04
BENEFIX
3000
International Unit
2000
International Unit
250 International
Unit
500 International
Unit
1000
International Unit
1500
International Unit
50 Milligram
BENETOR PLUS
Daiichi Sankyo
Ireland Ltd
PA1595/002/002
20/25 Milligram
Film Coated
Tablet
C09DA08
BENETOR PLUS
Daiichi Sankyo
Ireland Ltd
PA1595/002/003
40/12.5 Milligram
Film Coated
Tablet
C09DA08
BENETOR PLUS
Daiichi Sankyo
Ireland Ltd
PA1595/002/004
40/25 Milligram
Film Coated
Tablet
C09DA08
BENLYSTA
GlaxoSmithKline
(Ireland) Limited
McNeil
Healthcare
(Ireland) Ltd
EU/1/11/700/001002
PA0823/031/001
120 Milligram
Pdr for Soln for
Infusion
Syrup
L04AA26
-OLMESARTAN
MEDOXOMIL
-OLMESARTAN
MEDOXOMIL
-OLMESARTAN
MEDOXOMIL
-OLMESARTAN
MEDOXOMIL
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
HYDROCHLOR
OTHIAZIDE
-BELIMUMAB
R05CA03
-GUAIFENESIN
-Per Oral
McNeil
Healthcare
(Ireland) Ltd
PA0823/001/001
5/0.625mg/
MG/5ml
Syrup
R05X
-Per Oral
McNeil
Healthcare
(Ireland) Ltd
PA0823/021/001
7.0/0.55 MG/5ml
Syrup
R06AA02
McNeil
Healthcare
(Ireland) Ltd
PA0823/017/001
14 / 1.1 MG/5ml
Syrup
R06AA02
DEXTROMETH
ORPHAN
HYDROBROMID
E
-TRIPROLIDINE
HYDROCHLORI
DE
DIPHENHYDRA
MINE
HYDROCHLORI
DE
-LEVOMENTHOL
DIPHENHYDRA
MINE
HYDROCHLORI
DE
-LEVOMENTHOL
BENETOR
BENETOR
BENETOR PLUS
BENYLIN
CHILDREN’S
CHESTY
COUGH
BENYLIN
CHILDRENS
COUGHS AND
COLDS
BENYLIN
CHILDREN'S
DRY COUGHS
SYRUP
DIPHENHYDRA
MI
BENYLIN
COUGH
MEDICINE
Human Medicines Authorised/Transfer Pending Products
50mg / 5ml N/A
B02BD04
B02BD04
B02BD04
B02BD04
B02BD09
C09DA08
C09CA08
C09DA08
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
-Intra-venous
-Subcutaneous
-Subcutaneous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-Intra-venous
-Per Oral
Page 59 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
BENYLIN DAY &
NIGHT
McNeil
Healthcare
(Ireland) Ltd
PA0823/019/001
500/60 & 25
Milligram
Tablets
N02BE51
BENYLIN DRY
COUGHS
SYRUP DIPHENYDRAM
INE
HYDROCHLORI
DE/DEXTROME
THORPHAN
HYDROBROMID
E/LEVOMENTH
OL
BENYLIN DUAL
ACTION DRY PSEUDOEPHE
DRINE/DEXTRO
METHORPHAN/
TRIPROLIDINE
McNeil
Healthcare
(Ireland) Ltd
PA0823/014/001
14/6.5/2 per 5ml
%v/v
Syrup
R06AA52
McNeil
Healthcare
(Ireland) Ltd
PA0823/001/002
30/10/1.25
Milligram
Syrup
R01BA52
BENYLIN FOUR
FLU
McNeil
Healthcare
(Ireland) Ltd
PA0823/034/002
500/12.5/22.5
Milligram
Film Coated
Tablet
N02BE51
BENYLIN FOUR
FLU
Imbat Limited
PPA1151/130/00
1
500 12.5 22.5
Milligram
Film Coated
Tablet
N02BE51
BENYLIN
MUCUS RELIEF
250 MG/5 ML
SYRUP
BENYLIN NONDROWSY DRY
COUGHS
McNeil
Healthcare
(Ireland) Ltd
PA0823/035/001
250mg/5ml
Millilitre
Syrup
R05CB03
McNeil
Healthcare
(Ireland) Ltd
PA0823/029/001
7.5 MG/5ml
Syrup
R05DA09
BENYLIN NONDROWSY FOR
CHESTY
COUGHS
BENYLIN
PHLEGM
COUGH
McNeil
Healthcare
(Ireland) Ltd
PA0823/020/001
100/1.1mg/
MG/5ml
Syrup
R05CA03
McNeil
Healthcare
(Ireland) Ltd
PA0823/063/001
100 / 1.1 MG/5ml
Syrup
R05CA03
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-PARACETAMOL
DIPHENHYDRA
MINE
HYDROCHLORI
DE
-PARACETAMOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
DIPHENHYDRA
MINE
HYDROCHLORI
DE
DEXTROMETH
ORPHAN
HYDROBROMID
E
-LEVOMENTHOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
DEXTROMETH
ORPHAN
HYDROBROMID
E
-TRIPROLIDINE
HYDROCHLORI
DE
DIPHENHYDRA
MINE
HYDROCHLORI
DE
-PARACETAMOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
DIPHENHYDRA
MINE
-PARACETAMOL
PSEUDOEPHE
DRINE
CARBOCISTEIN
E
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
DEXTROMETH
ORPHAN
HYDROBROMID
E
-GUAIFENESIN
-LEVOMENTHOL
-GUAIFENESIN
-LEVOMENTHOL
Article 10c Informed Consen
-Per Oral
Page 60 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
BENYLIN
PHLEGM
COUGH & COLD
MULTI-RELIEF
TABLETS
Wrafton
Laboratories Ltd.
t/a Perrigo
PA1120/001/001
250/100/5
Milligram
Tablets
N02BE51
BENYLIN
PHLEGM
COUGH
MENTHOL
BENYLIN
PHLEGM
COUGH PLUS
DECONGESTA
NT
McNeil
Healthcare
(Ireland) Ltd
PA0823/066/001
100/5 Mg/Ml
Oral Solution
R05CA03
McNeil
Healthcare
(Ireland) Ltd
PA0823/043/001
100mg/5ml
30mg/5ml %v/v
Syrup
R01BA52
BENZALKONIUM
CHLORIDE
RECKITT
BENCKISER
BENZYL
BENZOATE
APPLICATION
BEPANTISEPTIC
FIRST AID
Reckitt Benckiser
Ireland Ltd
PA0979/049/001
0.20 %w/w
Cutaneous Spray
Solution
D08AJ01
Ovelle Limited
PA0206/023/001
25 %w/v
Cutaneous
Emulsion
P03AX01
-BENZYL
BENZOATE
Bayer Limited
PA1410/047/001
1.2/0.25 %w/w
Cream
D08AC52
BERIPLEX P/N
CSL Behring
GmbH
PA0800/010/001
250 IU/ML
Pdr+Solv for Soln
for Inj
B02BD01
BERIPLEX P/N
CSL Behring
GmbH
PA0800/010/002
500 IU/ML
Pdr+Solv for Soln
for Inj
B02BD01
BERIPLEX P/N
CSL Behring
GmbH
PA0800/010/003
1000 IU/ML
Pdr+Solv for Soln
for Inj
B02BD01
BEROMUN
Boehringer
Ingelheim
International
GmbH
EU/1/99/097/001
1 mg Milligram
Pdr for Soln for
Infusion
L03AX11
-PHENOL
CHLORHEXIDIN
E
DIGLUCONATE
(AS
CHLORHEXIDIN
E
DIGLUCONATE
SOLUTION (20%
W/V) PH.EUR.
-FACTOR II
ACTIVITY
-FACTOR VII
ACTIVITY
-FACTOR X
ACTIVITY
-FACTOR IX
ACTIVITY
-PROTEIN C
ACTIVITY
-PROTEIN S
ANTIGEN
-FACTOR II
ACTIVITY
-FACTOR VII
ACTIVITY
-FACTOR X
ACTIVITY
-FACTOR IX
ACTIVITY
-PROTEIN C
ACTIVITY
-PROTEIN S
ANTIGEN
-FACTOR II
ACTIVITY
-FACTOR VII
ACTIVITY
-FACTOR X
ACTIVITY
-FACTOR IX
ACTIVITY
-PROTEIN C
ACTIVITY
-PROTEIN S
ANTIGEN
-TUMOUR
NECROSIS
FACTOR ALFA
1A
Human Medicines Authorised/Transfer Pending Products
-PARACETAMOL
-GUAIFENESIN
PHENYLEPHRI
NE
HYDROCHLORI
DE
-GUAIFENESIN
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-GUAIFENESIN
BENZALKONIUM
CHLORIDE
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Cutaneous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Page 61 of 608
Trade Name
BETACAP
SCALP
APPLICATION
BETACAP
SCALP
APPLICATION
BETADINE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Dermal
Laboratories Ltd
PA0278/019/001
%w/w
Cutaneous
Solution
D07AC01
Eurodrug Ltd
DPR1392/042/0
01
0.1 %w/w
Cutaneous
Solution
D07AC01
Ayrton Saunders
Ltd
Ayrton Saunders
Ltd
PA0501/006/007
4 %w/v
Shampoo
D08AG02
PA0501/006/006
10 %w/w
Ointment
D08AG02
BETADINE
ALCOHOLIC
100MG/ML
CUTANEOUS
SOLUTION
BETADINE
ANTISEPTIC
PAINT
BETADINE DRY
POWDER
BETADINE
GARGLE &
MOUTHWASH
BETADINE SKIN
CLEANSER
BETADINE
SURGICAL
SCRUB
BETAFERON
Ayrton Saunders
Ltd
PA0501/006/001
10.0 %w/v
Cutaneous
Solution
D08AG02
Ayrton Saunders
Ltd
PA0501/006/002
10 %w/v
Cutaneous
Solution
D08AG02
-POVIDONEIODINE
Ayrton Saunders
Ltd
Ayrton Saunders
Ltd
PA0501/006/004
25 mg/g
D08AG02
PA0501/006/005
1 %w/v
Cutaneous Spray
Powder
Mouth Wash
-POVIDONEIODINE
-POVIDONEIODINE
Ayrton Saunders
Ltd
Ayrton Saunders
Ltd
PA0501/006/008
4 %w/v
D08AG02
PA0501/006/009
7.5 %w/v
Cutaneous
Solution
Cutaneous
Solution
Bayer AG
EU/1/95/003/001
0.25 Mg/Ml
L03AB08
BETAFERON
Bayer AG
EU/1/95/003/002
0.25 Mg/Ml
BETAFERON
Bayer AG
EU/1/95/003/003
mg/ml Mg/Ml
BETAFERON
Bayer AG
EU/1/95/003/004
mg/ml Mg/Ml
BETAGAN
Allergan
Pharmaceuticals
Ireland
Allergan
Pharmaceuticals
Ireland
PA0148/040/001
0.5 %w/v
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Eye Drops
Solution
PA0148/040/004
0.5 %w/v
Eye Drops
Solution
S01ED03
B & S Healthcare
DPR1328/001/0
01
0.5 %w/v
Eye Drops
Solution
S01ED03
-LEVOBUNOLOL
HYDROCHLORI
DE
Milpharm Limited
PA1050/024/001
8 Milligram
Tablets
N07CA01
Article 10(1) Generic
Application
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0084-009-002
PA1050/024/002
-BETAHISTINE
DIHYDROCHLO
RIDE
16 Milligram
Tablets
N07CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0084-038-002
PA1390/038/001
-BETAHISTINE
DIHYDROCHLO
RIDE
8 Milligram
Tablets
N07CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0084-009-002
PA1390/038/002
-BETAHISTINE
DIHYDROCHLO
RIDE
16 Milligram
Tablets
N07CA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0084-038-002
PA0970/032/001
-BETAHISTINE
DIHYDROCHLO
RIDE
1 Mg/Ml
C07AB02
PA0644/001/001
160 Milligram
Solution for
Injection
Prolonged
Release
Capsules
-METOPROLOL
TARTRATE
-PROPRANOLOL
HYDROCHLORI
DE
BETADINE
BETAGAN 0.5 %
W/V UNIT DOSE
EYE DROPS,
SOLUTION
BETAGAN UNIT
DOSE EYE
DROPS
SOLUTION
BETAHISTINE
AUROBINDO
BETAHISTINE
AUROBINDO
BETAHISTINE
DIHYDROCHLO
RIDE
Accord
Healthcare
Limited
BETAHISTINE
DIHYDROCHLO
RIDE
Accord
Healthcare
Limited
BETALOC
AstraZeneca UK
Limited
Tillomed
Laboratories
Limited
BETAPROGRANE
Human Medicines Authorised/Transfer Pending Products
D08AG02
D08AG02
L03AB08
L03AB08
L03AB08
S01ED03
C07AA05
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
-POVIDONEIODINE
-IODINATED
POVIDONE
PH.EUR.
-POVIDONEIODINE
Routes of
Administration
-Topical
-POVIDONEIODINE
-POVIDONEIODINE
-INTERFERON
BETA-1B
-INTERFERON
BETA-1B
-INTERFERON
BETA-1B
-INTERFERON
BETA-1B
-LEVOBUNOLOL
HYDROCHLORI
DE
-LEVOBUNOLOL
HYDROCHLORI
DE
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Intra-venous
-Per Oral
Page 62 of 608
Trade Name
Licence Holder Licence
Number
Strength
BETAPROGRANE
LTT Pharma
Limited
PPA1562/182/00
1
160 Milligram
BETMIGA
Astellas Pharma
Europe BV
Astellas Pharma
Europe BV
RPH
Pharmaceuticals
AB
EU/1/12/809/001007
EU/1/12/809/008014
PA1638/001/003
25 Milligram
BETNESOL
RPH
Pharmaceuticals
AB
PA1638/001/001
BETNESOL-N
RPH
Pharmaceuticals
AB
BETNOVATE
Dosage Form ATC
Prolonged
Release
Capsules
Tablet Prolonged
Release
Tablet Prolonged
Release
Soluble tablet
C07AA05
0.1 %w/v
Ear/Eye Drops,
solution
S01BA06
PA1638/002/001
0.1% w/v 3500
IU/ml %w/v
Ear/Eye Drops,
solution
S03CA06
GlaxoSmithKline
(Ireland) Limited
PA1077/001/001
0.1 %w/w
Cream
D07AC01
BETNOVATE
GlaxoSmithKline
(Ireland) Limited
PA1077/001/002
0.1 %w/w
Ointment
D07AC01
BETNOVATE RD
(READY
DILUTED)
BETNOVATE RD
(READY
DILUTED)
BETNOVATE
SCALP
APPLICATION
BETNOVATE-C
0.1% / 3 % W/W
CREAM
GlaxoSmithKline
(Ireland) Limited
PA1077/001/004
0.025 %w/w
Cream
D07AC01
GlaxoSmithKline
(Ireland) Limited
PA1077/001/005
0.025 %w/w
Ointment
D07AC01
GlaxoSmithKline
(Ireland) Limited
PA1077/001/003
0.1 Base %w/v
Cutaneous
Solution
D07AC01
GlaxoSmithKline
(Ireland) Limited
PA1077/002/001
0.1 / 3.0 %w/w
Cream
D07BC01
BETOPTIC
PCO
Manufacturing
PPA0465/143/00
1
0.5% %w/v
Eye Drops
Solution
S01ED02
BETOPTIC
Imbat Limited
PPA1151/170/00
1
0.5 Base %w/v
Eye Drops
Solution
S01ED02
BETOPTIC
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
RPH
Pharmaceuticals
AB
PCO
Manufacturing
PA0013/127/001
0.5 %w/v
Eye Drops
Solution
S01ED02
PA0013/127/002
0.25 %w/v
Eye Drops
Suspension
S01ED02
PA1638/009/001
0.1 %w/w
Cutaneous Foam
D07AC01
PPA0465/209/00
1
1 (0.1%) mg/g
Cutaneous Foam
D07AC01
BEVACOMB
Teva B.V.
PA1986/040/001
5/80 Milligram
Film Coated
Tablet
BEVACOMB
Teva B.V.
PA1986/040/002
5/160 Milligram
Film Coated
Tablet
BEVACOMB
Teva B.V.
PA1986/040/003
10/160 Milligram
Film Coated
Tablet
BETMIGA
BETNESOL
BETOPTIC
SUSPENSION
SINGLE DOSE
BETTAMOUSSE
BETTAMOUSSE
Human Medicines Authorised/Transfer Pending Products
50 Milligram
500 Microgram
G04BD12
G04BD12
H02AB01
Active
Ingredients
-PROPRANOLOL
HYDROCHLORI
DE
-MIRABEGRON
(YM178)
-MIRABEGRON
(YM178)
BETAMETHASO
NE SODIUM
PHOSPHATE
BETAMETHASO
NE SODIUM
PHOSPHATE
BETAMETHASO
NE SODIUM
PHOSPHATE
-NEOMYCIN
SULFATE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE VALERATE
-CLIOQUINOL
-BETAXOLOL
HYDROCHLORI
DE
-BETAXOLOL
HYDROCHLORI
DE
-BETAXOLOL
HYDROCHLORI
DE
-BETAXOLOL
HYDROCHLORI
DE
BETAMETHASO
NE VALERATE
BETAMETHASO
NE
-VALSARTAN
-AMLODIPINE
BESILATE
-VALSARTAN
-AMLODIPINE
BESILATE
-VALSARTAN
-AMLODIPINE
BESILATE
Legal Basis
Routes of
Administration
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Ocular
-Ocular
-Topical
-Topical
PPA
PPA
-Cutaneous
PPA
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 63 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
BEXSERO
GSK Vaccines
S.r.l.
EU/1/12/812/001004
0.5 Millilitre
Suspension for
Injection
J07AH09
BICALUTAMIDE
Fresenius Kabi
Oncology Plc
PA1422/006/002
150 Milligram
Film Coated
Tablet
L02BB03
-RECOMBINANT
NEISSERIA
MENINGITIDIS
SEROGROUP B
NHBA FUSION
PROTEIN
-RECOMBINANT
NEISSERIA
MENINGITIDIS
SEROGROUP B
NADA FUSION
PROTEIN
-RECOMBINANT
NEISSERIA
MENINGITIDIS
SEROGROUP B
FHBP FUSION
PROTEIN
-OUTER
RMEMBRANE
VESICLES
(OMV)
-BICALUTAMIDE
BICALUTAMIDE
Fresenius Kabi
Oncology Plc
PA1422/006/001
50 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
BICALUTAMIDE
Accord
Healthcare
Limited
Actavis Group
PTC ehf
PA1390/009/001
50 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
PA1380/153/001
50 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
Fair-Med
Healthcare
GmbH
Fair-Med
Healthcare
GmbH
Teva Pharma
B.V.
PA1789/001/001
50 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
PA1789/001/002
150 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
PA0749/032/001
50 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
PA0865/004/002
15mg Milligram
Film Coated
Tablet
C09AA15
-ZOFENOPRIL
CALCIUM
-Per Oral
PA0865/004/003
30mg Milligram
Film Coated
Tablet
C09AA15
-ZOFENOPRIL
CALCIUM
-Per Oral
PA0865/004/004
60mg Milligram
Film Coated
Tablet
C09AA15
-ZOFENOPRIL
CALCIUM
-Per Oral
PA0865/004/001
7.5mg Milligram
Film Coated
Tablet
C09AA15
-ZOFENOPRIL
CALCIUM
-Per Oral
PA0865/013/001
30/12.5 Milligram
Tablets
C09BA15
-Per Oral
BILUTA
Rowex Ltd
PA0711/100/001
50 Milligram
L02BB03
BINOCRIT
Sandoz GmbH
EU/1/07/410/1-2
1000
International Unit
Film Coated
Tablet
Solution for
Injection
-ZOFENOPRIL
CALCIUM
HYDROCHLOR
OTHIAZIDE
-BICALUTAMIDE
-Intra-venous
-Subcutaneous
BINOCRIT
Sandoz GmbH
EU/1/07/410/3-4
2000
International Unit
Solution for
Injection
B03XA01
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
BICALUTAMIDE
ACTAVIS
BICALUTAMIDE
FAIR-MED
BICALUTAMIDE
FAIR-MED
BICALUTAMIDE
TEVA
BIFRIL 15 MG
FILM-COATED
TABLETS
BIFRIL 30MG
FILM-COATED
TABLETS
BIFRIL 60 MG
FILM-COATED
TABLETS.
BIFRIL 7.5 MG
FILM-COATED
TABLETS
BIFRIL PLUS
Human Medicines Authorised/Transfer Pending Products
B03XA01
Article 8(3) - Full
new Application
-Intra-Muscular
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Subcutaneous
Page 64 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
BINOCRIT
Sandoz GmbH
EU/1/07/410/5-6
3000
International Unit
Solution for
Injection
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/7-8
4000
International Unit
Solution for
Injection
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/9-10
5000
International Unit
Solution for
Injection
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/1112
6000
International Unit
Solution for
Injection
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/13014
8000
International Unit
Solution for
Injection
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/1516
10000
International Unit
Solution for
Injection
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/2122
20000/0.5 IU/ML
B03XA01
BINOCRIT
Sandoz GmbH
EU/1/07/410/2324
30000/0.75 IU/M
B03XA01
-EPOETIN ALFA
BINOCRIT
Sandoz GmbH
EU/1/07/410/2526
40000/1 IU/ML
B03XA01
-EPOETIN ALFA
BINOSTO ONCE
WEEKLY
Clonmel
Healthcare Ltd
PA0126/280/001
70 Base
Milligrams
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Tablets
Effervescent
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-EPOETIN ALFA
M05BA04
BIOPOIN
Teva GmbH
EU/1/09/565/1-2
1000/0.5 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/3-4
2000/0.5 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/5-6
3000/0.5 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/7-8
4000/0.5 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/9-10
5000/0.5 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/1116
10000/1.0 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/1722
20000/1.0 IU/ML
Solution for
Injection
B03XA01
BIOPOIN
Teva GmbH
EU/1/09/565/2328
30000/1.0 IU/ML
Solution for
Injection
B03XA01
BIPHOZYL
Gambro Lundia
AB
PA0785/009/001
22 N/A
solution for
haemodialysis/h
aemofiltration
B05ZB
-SODIUM
ALENDRONATE
TRIHYDRATE
(MICRONISED)
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-DISODIUM
PHOSPHATE
DEHYDRATE
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(1) Generic
Application
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Per Oral
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Article 10a Bibliographical
App
-Intra-venous
Page 65 of 608
Trade Name
BISOCOR
BISOCOR
Licence Holder Licence
Number
Niche Generics
Limited
Niche Generics
Limited
Strength
Dosage Form ATC
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA1063/013/002
10 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
522/68/64
Milligram
Tablets
Chewable
A02AC01
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-LIGHT
MAGNESIUM
CARBONATE
-CALCIUM
CARBONATE
-MAGNESIUM
CARBONATE
LIGHT
-SODIUM
BICARBONATE
-BROMHEXINE
HYDROCHLORI
DE
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-002-014
PA0100/047/001
BISODOL
EXTRA STRONG
MINT
Forest
Laboratories UK
Ltd
PA0100/046/001
522/68/64
Milligram
Tablets
Chewable
A02AC01
BISOLVON
Boehringer
Ingelheim Limited
PA0007/025/002
4 MG/5ml
Oral Solution
R05CB02
BISOP
Rowex Ltd
PA0711/159/001
1.25 Milligram
Film Coated
Tablet
C07AB07
Rowex Ltd
Interchangeable
List Code:
IC0065-044-014
PA0711/159/002
2.5 Milligram
Film Coated
Tablet
C07AB07
Rowex Ltd
Interchangeable
List Code:
IC0065-018-014
PA0711/159/003
3.75 Milligram
Film Coated
Tablet
Rowex Ltd
Interchangeable
List Code:
IC0065-108-014
PA0711/159/004
5 Milligram
Rowex Ltd
Interchangeable
List Code:
IC0065-001-014
PA0711/159/005
Rowex Ltd
BISOP
BISOP
BISOP
BISOPINE
BISOPINE
BISOPROLOL
Niche Generics
Limited
Niche Generics
Limited
Accord
Healthcare
Limited
Routes of
Administration
5 Milligram
Forest
Laboratories UK
Ltd
BISOP
Legal Basis
PA1063/013/001
BISODOL
ANTACID
BISOP
Active
Ingredients
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-BISOPROLOL
FUMARATE
Article 10(1) Generic
Application
-Per Oral
C07AB07
-BISOPROLOL
FUMARATE
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
Article 10(1) Generic
Application
-Per Oral
7.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-041-003
PA0711/159/006
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-002-014
PA1063/009/001
Article 10(1) Generic
Application
5 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA1063/009/002
10 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-002-014
PA1390/114/001
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
Interchangeable
List Code:
IC0065-018-014
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
-Per Oral
Page 66 of 608
Trade Name
BISOPROLOL
BISOPROLOL
BISOPROLOL
FUMARATE
BISOPROLOL
FUMARATE
BISOPROLOL
FUMARATE
BISOPROLOL
FUMARATE
BISOPROLOL
FUMARATE
BISOPROLOL
FUMARATE
Licence Holder Licence
Number
Accord
Healthcare
Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1390/114/002
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA1390/114/003
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0065-002-014
PA0688/014/001
Article 10(1) Generic
Application
1.25 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0065-044-014
PA0688/014/002
Article 10(1) Generic
Application
2.5 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0065-018-014
PA0688/014/003
Article 10(1) Generic
Application
3.75 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0065-108-014
PA0688/014/004
Article 10(1) Generic
Application
5 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0065-001-014
PA0688/014/005
Article 10(1) Generic
Application
10 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-002-014
PA1063/044/001
Article 10(1) Generic
Application
2.5 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-018-014
PA1380/086/001
Article 10(1) Generic
Application
5 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA1380/086/002
Article 10(1) Generic
Application
10 Milligram
Tablets
C07AB07
-BISOPROLOL
FUMARATE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
-Per Oral
Accord
Healthcare
Limited
Niche Generics
Limited
BISOPROLOL
FUMARATE
ACTAVIS
Actavis Group
PTC ehf
BISOPROLOL
FUMARATE
ACTAVIS
Actavis Group
PTC ehf
BISOPROLOL
HEMIFUMARAT
Genthon BV
Interchangeable
List Code:
IC0065-002-014
PA0740/007/002
BISOPROLOL
HEMIFUMARATE
GENTHON
Genthon BV
Interchangeable
List Code:
IC0065-002-014
PA0740/007/001
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
BISOPROLOL
KRKA
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0065-001-014
PA1347/031/001
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-018-014
PA1347/031/002
Article 10(1) Generic
Application
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA1347/031/003
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
Article 10(1) Generic
Application
-Per Oral
BISOPROLOL
KRKA
BISOPROLOL
KRKA
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0065-002-014
Human Medicines Authorised/Transfer Pending Products
Page 67 of 608
Trade Name
BISOPROLOL
MYLAN
BISOPROLOL
MYLAN
BISOPROLOL
MYLAN
BISOPROLOL
MYLAN
BISOPROLOL
MYLAN
BISOPROLOL
MYLAN
Licence Holder Licence
Number
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0577/153/001
1.25 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-044-014
PA0577/153/002
Article 10(1) Generic
Application
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-018-014
PA0577/153/003
Article 10(1) Generic
Application
3.75 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-108-014
PA0577/153/004
Article 10(1) Generic
Application
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA0577/153/005
Article 10(1) Generic
Application
7.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-041-003
PA0577/153/006
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-002-014
PA1809/024/001
Article 10(1) Generic
Application
250 Milligram
Pdr/Conc/Soln/In
j/Inf
B01AE06
-BIVALIRUDIN
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Vaginal
BIVALIRUDIN
CIPLA
Cipla (EU)
Limited
BLINCYTO
Amgen Europe
B.V.
EU/1/15/1047/00
1
12.5
Microgram/ML
Pdr/Conc/Soln for
Infus
L01XC19
BLISSEL
Italfarmaco S.A.
PA2102/001/001
50 Micrograms/g
Vaginal Gel
G03CA04
BLINATUMOMA
B
-ESTRIOL
BLISTEX COLD
SORE CREAM
BLISTEX RELIEF
D.D.D. Limited
PA0302/012/001
100 mg/g
Cream
D06BB11
-DOCOSANOL
D.D.D. Limited
PA0302/004/001
0.270 6.040
0.494 %w/w
Cream
D11AX
-Topical
BLOPRESS
Takeda UK
Limited
Takeda UK
Limited
PA1547/001/001
2 Milligram
Tablets
C09CA01
PA1547/001/002
4 Milligram
Tablets
C09CA01
-STRONG
AMMONIA
SOLUTION
-AMMONIA
SOLUTION,
ARAMATIC
-PHENOL,
LIQUEFIED
-CANDESARTAN
CILEXETIL
-CANDESARTAN
CILEXETIL
Interchangeable
List Code:
IC0009-008-002
PA1547/001/003
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-009-002
PA1547/001/004
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-038-002
PA1547/001/005
32 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-037-002
PA1547/002/003
32/12.5 Milligram
Tablets
C09DA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
BLOPRESS
BLOPRESS
BLOPRESS
BLOPRESS
BLOPRESS
PLUS
Takeda UK
Limited
Takeda UK
Limited
Takeda UK
Limited
Takeda UK
Limited
Interchangeable
List Code:
IC0029-035-002
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Cutaneous
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Page 68 of 608
Trade Name
BLOPRESS
PLUS
BLOPRESS
PLUS
BLOPRESS
PLUS
BLUGRAL
BLUGRAL
BLUGRAL
BONAPENYA
BONAPENYA
BONAPENYA
ONCE A WEEK
BONASOL
ONCE WEEKLY
BONDRONAT
Licence Holder Licence
Number
Takeda UK
Limited
Takeda UK
Limited
Takeda UK
Limited
Niche Generics
Limited
Niche Generics
Limited
Niche Generics
Limited
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Xeolas
Pharmaceuticals
Limited
Roche
Registration
Limited
Strength
Dosage Form ATC
PA1547/002/004
32/25 Milligram
Tablets
C09DA06
Interchangeable
List Code:
IC0029-034-002
PA1547/002/001
8/12.5 Milligram
Tablets
C09DA06
Interchangeable
List Code:
IC0029-058-002
PA1547/002/002
16/12.5 Milligram
Tablets
C09CA01
Interchangeable
List Code:
IC0029-036-002
PA1063/048/001
25 Milligram
Film Coated
Tablet
G04BE03
Interchangeable
List Code:
IC0063-022-014
PA1063/048/002
50 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0063-023-013
PA1063/048/003
100 Milligram
Interchangeable
List Code:
IC0063-024-013
PA0281/158/001
Active
Ingredients
Article 10b Fixed
Combination
Article 10(1) Generic
Application
-Per Oral
G04BE03
-SILDENAFIL
CITRATE
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
G04BE03
-SILDENAFIL
CITRATE
Article 10(1) Generic
Application
-Per Oral
5 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
-Per Oral
Interchangeable
List Code:
IC0068-001-003
PA0281/158/002
Article 10(1) Generic
Application
30 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
-Per Oral
Interchangeable
List Code:
IC0068-033-003
PA0281/158/003
Article 10(1) Generic
Application
35 Milligram
Film Coated
Tablet
M05BA07
-RISEDRONATE
SODIUM
-Per Oral
Interchangeable
List Code:
IC0068-124-003
PA1572/001/001
Article 10(1) Generic
Application
70 Milligram
Oral Solution
M05BA04
-ALENDRONIC
ACID
Article 10(3) Hybrid
Application
-Per Oral
EU/1/96/012/001
1 Micromol
Concentrate for
Soln for Inf
M05BA06
-IBANDRONIC
ACID
MONOSODIUM
MONOHYDRATE
-IBANDRONIC
ACID
MONOSODIUM
MONOHYDRATE
-IBANDRONIC
ACID
-Intra-venous
-Intra-venous
Roche
Registration
Limited
EU/1/96/012/004
2 Mg/Ml
Concentrate for
Soln for Inf
M05BA06
BONDRONAT
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Actavis Group
PTC ehf
EU/1/96/012/010
mg mg/tablet
Film Coated
Tablet
M05BA06
EU/1/96/012/01113
6 Mg/Ml
Concentrate for
Soln for Inf
M05BA06
-IBANDRONIC
ACID
EU/1/96/012/009
50 Milligram
Tablets
M05BA06
-IBANDRONIC
ACID
PA1380/169/001
40 Microgram/ML
Eye Drops
Solution
S01EE04
-TRAVOPROST
BONEFOS
Bayer Limited
PA1410/002/001
800 Milligram
Film Coated
Tablet
M05BA02
BONEFURBIT
Rowa
Pharmaceuticals
Limited
PA0074/064/001
150 Base
Milligrams
Film Coated
Tablet
M05BA06
-CLODRONATE
DISODIUM
TETRAHYDRAT
E
-IBANDRONATE
SODIUM
MONOHYDRATE
BONDRONAT
FILM-COATED
BONDULC
Routes of
Administration
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-SILDENAFIL
CITRATE
BONDRONAT
BONDRONAT
Legal Basis
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
Article 10(3) Hybrid
Application
-Ocular
Article 10(1) Generic
Application
-Per Oral
Page 69 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
BONJELA
Reckitt Benckiser
Ireland Ltd
PA0979/001/001
0 %w/w
Oromucosal Gel
N02BA03
BONJELA
TEETHING GEL
Reckitt Benckiser
Ireland Ltd
PA0979/001/003
8.714 / 0.010
%w/w
Oromucosal Gel
N02BA03
BONVIVA
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
GlaxoSmithKline
(Ireland) Limited
EU/1/03/265/3-4
150 Milligram
Coated Tablets
M05BA06
EU/1/03/265/5-6
3 Mg/Ml
Solution for
Injection
M05BA06
-IBANDRONIC
ACID
EU/1/03/265/01-2
2.5 mg Milligram
Tablets
M05BA06
-IBANDRONIC
ACID
PA1077/020/001
N/A
Suspension for
Injection
J07AJ52
BOOTS BITE
AND STING
ANTIHISTAMINE
BOOTS
PHARMACEUTI
CAL
DECONGESTA
NT
BOOTS
PHARMACEUTI
CALS CHESTY
COUGH &
CONGESTION
RELIEF
BOOTS
PHARMACEUTI
CALS DAY
COLD & FLU
The Boots
Company Plc
PA0004/065/001
2 %w/w
Cream
D04AA02
-DIPHTHERIA
TOXOID
ADSORBED
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-MEPYRAMINE
MALEATE
The Boots
Company Plc
PA0004/064/001
60 Milligram
Tablets
R01BA02
The Boots
Company Plc
PA0004/054/001
100mg/30mg
MG/5ml
Oral Solution
R01BA52
The Boots
Company Plc
PA0004/061/002
1000 mg/30ml
Oral Solution
N02BE51
BOOTS
PHARMACEUTI
CALS DAY
COLD & FLU
RELIEF
The Boots
Company Plc
PA0004/061/001
500/5/30
Milligram
Capsules Hard
N02BE51
BOOTS
PHARMACEUTI
CALS
DIARRHOEA
RELIEF
BOOTS
PHARMACEUTI
CALS DRY
COUGH &
CONGESTION
RELIEF
The Boots
Company Plc
PA0004/059/001
2 Milligram
Capsules Hard
A07DA03
The Boots
Company Plc
PA0004/053/001
10 / 30 MG/5ml
Oral Solution
R05DA20
BONVIVA
BONVIVA 2.5MG
FILM-COATED
TABLETS
BOOSTRIX
Human Medicines Authorised/Transfer Pending Products
-CHOLINE
SALICYLATE
-CETALKONIUM
CHLORIDE
-CHOLINE
SALICYLATE
-CETALKONIUM
CHLORIDE
-IBANDRONIC
ACID
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-GUAIFENESIN
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-PARACETAMOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-PHOLCODINE
-PARACETAMOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-PHOLCODINE
-LOPERAMIDE
HYDROCHLORI
DE
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
DEXTROMETH
ORPHAN
HYDROBROMID
E
Legal Basis
Article 10c Informed Consen
Routes of
Administration
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
Page 70 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
BOOTS
PHARMACEUTI
CALS SORE
THROAT RELIEF
LEMON
FLAVOUR
BORTEZOMIB
The Boots
Company Plc
PA0004/057/001
Milligram
Lozenges
R02AA20
Aspire Pharma
Limited
PA1619/006/001
1 Milligram
Pdr for Soln for
Injection
L01XX32
BORTEZOMIB
Aspire Pharma
Limited
PA1619/006/002
3.5 Milligram
Pdr for Soln for
Injection
L01XX32
BORTEZOMIB
ACCORD
Accord
Healthcare
Limited
Hospira UK
Limited
EU/1/15/1019/00
1
3.5 Milligram
Pdr for Soln for
Injection
L01XX32
EU/1/16/1114/00
1
3.5 Milligram
Pdr for Soln for
Injection
L01XX32
Koanaa
Healthcare
Limited
Generics (UK)
Limited
PA2041/003/001
3.5 Milligram
Infus/Pdr/Oral
Soln
L01XX32
PA0405/073/001
3.5 Milligram
Pdr for Soln for
Injection
L01XX32
Sun
Phamaceutical
Industries Europe
B.V.
Teva B.V.
EU/1/16/1102/00
1
3.5 Milligram
Pdr for Soln for
Injection
L01XX32
Pdr for Soln for
Injection
L01XX32
BOSULIF
Pfizer Limited
100 Milligram
Pfizer Limited
BOTOX
Allergan
Pharmaceuticals
Ireland
Allergan
Pharmaceuticals
Ireland
Allergan
Pharmaceuticals
Ireland
Generics (UK)
Limited
Film Coated
Tablet
Film Coated
Tablet
Pdr+Solv for Soln
for Inj
L01XE14
BOSULIF
EU/1/13/818/001002
EU/1/13/818/003004
PA0148/060/001
PA0148/060/002
50 Allergan Units
Pdr for Soln for
Injection
M03AX01
-BOTULINUM
TOXIN TYPE A
-Intra-venous
PA0148/060/003
200 Allergan
Units
Pdr for Soln for
Injection
M03AX01
-BOTULINUM
TOXIN TYPE A
-Intra-dermal
-Intra-venous
PA0405/099/001
20 Mg/Ml
Solution for
injection in prefilled syringe
Inhalation
Powder, Capsule
L03AX13
-GLATIRAMER
ACETATE
R03BB04
-TIOTROPIUM
BROMIDE
BORTEZOMIB
HOSPIRA
BORTEZOMIB
KOANAA
BORTEZOMIB
MYLAN
BORTEZOMIB
SUN
BORTEZOMIB
TEVA
BOTOX
BOTOX
BRABIO
PA1986/032/001
3.5
500 Milligram
100 Allergan
Units
L01XE14
M03AX01
AMYLMETACRE
SOL
-BORTEZOMIB
-BORTEZOMIB
(AS MANNITOL
BORONIC
ESTER)
-BOSUTINIB
MONOHYDRATE
-BOSUTINIB
MONOHYDRATE
-BOTULINUM
TOXIN TYPE A
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
-Subcutaneous
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Intra-venous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Per Oral
-Intra-dermal
-Intra-Muscular
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Subcutaneous
BRALTUS
Teva B.V.
PA1986/006/001
10 Microgram
BRAMITOB 300
MG/4 ML
NEBULISER
SOLUTION
BRAVELLE
Chiesi Limited
PA0743/017/001
300/4 Mg/Ml
Nebuliser
Solution
J01GB01
-TOBRAMYCIN
-Inhalation
Ferring Ireland
Ltd
PA1009/019/001
75 International
Unit
Pdr+Solv for Soln
for Inj
G03GA04
-Intra-venous
BREAKYL
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
PA1332/027/001
200 Microgram
Buccal Film
N02AB03
UROFOLLITRO
PIN
-FENTANYL
CITRATE
PA1332/027/005
1200 Microgram
Buccal Film
N02AB03
-FENTANYL
CITRATE
PA1332/027/004
800 Microgram
Buccal Film
N02AB03
-FENTANYL
CITRATE
PA1332/027/003
600 Microgram
Buccal Film
N02AB03
-FENTANYL
CITRATE
PA1332/027/002
400 Microgram
Buccal Film
N02AB03
-FENTANYL
CITRATE
BREAKYL
BREAKYL
BREAKYL
BREAKYL
Human Medicines Authorised/Transfer Pending Products
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Inhalation
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
Page 71 of 608
Trade Name
BREAKYL
START
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Meda Health
Sales Ireland
Limited
Almirall, S.A.
PA1332/027/006
Microgram
Buccal Film
N02AB03
-FENTANYL
CITRATE
EU/1/12/781/001003
322 Microgram
Powder for
Inhalation
R03BB05
Baxter
Healthcare
Limited
Baxter
Healthcare
Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
AstraZeneca UK
Limited
PA0167/099/003
10 Mg/Ml
Solution for
Injection
C07AB09
PA0167/099/004
10 Mg/Ml
Solution for
Infusion
C07AB09
PA0678/111/001
40 mg/g
Cream
D10AE01
-MICRONIZED
ACLIDINIUM
BROMIDE
-ESMOLOL
HYDROCHLORI
DE
-ESMOLOL
HYDROCHLORI
DE
-BENZOYL
PEROXIDE
PA0970/036/002
500
Microgram/ML
Solution for
Injection
R03CC03
-TERBUTALINE
SULFATE
AstraZeneca UK
Limited
Imbat Limited
PA0970/036/008
Powder for
Inhalation
Powder for
Inhalation
Solution for
Injection
R03CC03
PPA1151/175/00
1
EU/1/08/466/1-2
500
Mcg/Acutuation
500
Mcg/Acutuation
100 Micromol
V03AB35
-TERBUTALINE
SULFATE
-TERBUTALINE
SULFATE
-SUGAMMADEX
Actavis Group
PTC ehf
PA1380/175/001
25 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/002
50 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/003
75 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/004
100 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/005
150 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/006
200 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/007
225 Milligram
Capsules Hard
N03A
-PREGABALIN
BRIEKA
Actavis Group
PTC ehf
PA1380/175/008
300 Milligram
Capsules Hard
N03A
-PREGABALIN
BRILIQUE
AstraZeneca AB
60 Milligram
-TICAGRELOR
AstraZeneca AB
B01AC24
-TICAGRELOR
BRIMICA
GENUAIR
AstraZeneca AB
Film Coated
Tablet
Film Coated
Tablet
Powder for
Inhalation
B01AC24
BRILIQUE
EU/1/10/655/007011
EU/1/10/655/001006
EU/1/14/963/001002
R03AL05
BRINAVESS
Cardiome UK
Limited
EU/1/10/645/001002
20 Mg/Ml
Concentrate for
Soln for Inf
C01BG11
BRINTELLIX
H. Lundbeck A/S
EU/1/13/891/001007
5 Milligram
Film Coated
Tablet
N06AX26
BRINTELLIX
H. Lundbeck A/S
EU/1/13/891/008017
10 Milligram
Film Coated
Tablet
N06AX26
BRINTELLIX
H. Lundbeck A/S
EU/1/13/891/018026
15 Milligram
Film Coated
Tablet
N06AX26
-MICRONIZED
FORMOTEROL
FUMARATE
DIHYDRATE
-MICRONIZED
ACLIDINIUM
BROMIDE
-VERNAKALANT
HYDROCHLORI
DE
-VORTIOXETINE
HYDROBROMID
E
-VORTIOXETINE
HYDROBROMID
E
-VORTIOXETINE
HYDROBROMID
E
BRETARIS
GENUAIR
BREVIBLOC
PREMIXED
BREVIBLOC
PREMIXED
BREVOXYL
BRICANYL 500
MICROGRAMS/
ML SOLUTION
FOR INJECTION
BRICANYL
TURBOHALER
BRICANYL
TURBOHALER
BRIDION 100
MG/ML
SOLUTION FOR
INJECTION
BRIEKA
Merck Sharp and
Dohme Limited
Human Medicines Authorised/Transfer Pending Products
90 Milligram
340/12
Microgram
R03AC03
Legal Basis
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
Routes of
Administration
-Oromucosal
-Inhalation
-Intra-venous
-Intra-venous
PPA
Article 8(3) - Full
new Application
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Inhalation
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Page 72 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
BRINTELLIX
H. Lundbeck A/S
EU/1/13/891/027035
20 Milligram
Film Coated
Tablet
N06AX26
BRINTELLIX
H. Lundbeck A/S
EU/1/13/891/036
20 Mg/Ml
Oral Drops
Solution
N06AX26
BRINZOLAMIDE
Actavis Group
PTC ehf
PA1380/150/001
10 Mg/Ml
Eye Drops
Suspension
S01EC04
-VORTIOXETINE
HYDROBROMID
E
VORTIOXETINEDL-LACTATE
-BRINZOLAMIDE
BRINZOLAMIDE
SANDOZ
Rowex Ltd
PA0711/226/001
10 Mg/Ml
Eye Drops
Suspension
S01EC04
-BRINZOLAMIDE
BRIVIACT
UCB Pharma
S.A.
UCB Pharma
S.A.
UCB Pharma
S.A.
UCB Pharma
S.A.
UCB Pharma
S.A.
UCB Pharma
S.A.
UCB Pharma
S.A.
Imbat Limited
EU/1/15/1073/00
1-004
EU/1/15/1073/00
5-008
EU/1/15/1073/00
9-012
EU/1/15/1073/01
3-016
EU/1/15/1073/01
7-020
EU/1/15/1073/02
1
EU/1/15/1073/02
2
PPA1151/176/00
1
PA0540/094/001
10 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Oral Solution
N03AX23
Solution for
Injection
Eye Drops
Solution
Eye Drops
Solution
N03AX23
BRIVARACETAM
BRIVARACETAM
BRIVARACETAM
BRIVARACETAM
BRIVARACETAM
BRIVARACETAM
BRIVARACETAM
-PROPAMIDINE
ISETIONATE
-PROPAMIDINE
ISETIONATE
PA0540/094/002
0.15 %w/w
Eye Ointment
S01AX14
EU/1/12/760/001002
40 Milligram
Infus/Pdr/Oral
Soln
R05CB16
BRIVIACT
BRIVIACT
BRIVIACT
BRIVIACT
BRIVIACT
BRIVIACT
BROLENE
BROLENE
BROLENE
BRONCHITOL
BRONCHOFOR
CE CHESTY
COUGH
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Pharmaxis
Pharmaceuticals
Ltd
Bioforce (UK) Ltd
TR0725/010/001
Human Medicines Authorised/Transfer Pending Products
25 Milligram
50 Milligram
75 Milligram
100 Milligram
10 Mg/Ml
10 Mg/Ml
0.1 %w/v
0.1 %w/v
Oral Drops
Solution
N03AX23
N03AX23
N03AX23
N03AX23
N03AX23
S01AX15
S01AX15
DIBROMPROPA
MIDINE
ISETIONATE
-MANNITOL
-TINCTURE
FROM FRESH
IVY HERB
(HEDERA HELIX
L.) (1:5.7-6.0)
EXTRACTION
SOLVENT:
ETHANOL 51%
V/V.
-TINCTURE
FROM FRESH
AERIAL PARTS
OF THYME
(THYMUS
VULGARIS L.)
(1:8.0-8.2)
EXTRACTION
SOLVENT:
ETHANOL 51%
V/V
-TINCTURE
FROM
LIQUORICE
ROOT
(GLYCYRRHIZA
GLABRA L.)
(1:10-11)
EXTRACTION
SOLVENT:
ETHANOL 51%
V/V.
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
PPA
-Ocular
-Ocular
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Inhalation
-Per Oral
Page 73 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Syrup
Active
Ingredients
BRONCHOSAN
DRY, TICKLY
COUGH SYRUP
Bioforce (UK) Ltd
TR0725/008/001
BRUFEN
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Rowex Ltd
PA2010/002/004
400 Milligram
Granules
Effervescent
M01AE01
-EXTRACT (AS
SOFT EXTRACT)
FROM PICEA
ABIES (L.)
KARSTEN
(SPRUCE)
SHOOTS (0.91.2:1).
EXTRACTION
SOLVENT:
WATER
-IBUPROFEN
PA2010/002/003
200 Milligram
Granules
Effervescent
M01AE01
PA2010/002/005
600 Milligram
Granules
Effervescent
PA2010/002/002
600 Milligram
PA2010/002/001
Legal Basis
Routes of
Administration
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-IBUPROFEN
Article 8(3) - Full
new Application
-Per Oral
M01AE01
-IBUPROFEN
Article 10(3) Hybrid
Application
-Per Oral
Film Coated
Tablet
M01AE01
-IBUPROFEN
-Per Oral
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
-Per Oral
PA2010/002/006
100 MG/5ml
Oral Suspension
M01AE01
-IBUPROFEN
PA2010/002/007
800 Milligram
Tablet Prolonged
Release
M01AE01
-IBUPROFEN
PA0711/225/002
200 Milligram
Capsules, Soft
M01AE01
-IBUPROFEN
Rowa
Pharmaceuticals
Limited
Rowex Ltd
PA0074/067/001
200 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA0711/225/001
100mg/5 Millilitre
Oral Suspension
M01AE01
-IBUPROFEN
Rowa
Pharmaceuticals
Limited
Rowex Ltd
PA0074/067/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA0711/225/003
400 Milligram
Capsules, Soft
M01AE01
-IBUPROFEN
Rowa
Pharmaceuticals
Limited
A. Nelson &
Company Limited
Weleda (UK)
Limited
ViroPharma
SPRL
ViroPharma
SPRL
ViroPharma
SPRL
ViroPharma
SPRL
PA0074/067/003
600 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
HOR1149/007/0
01
HOR0407/026/0
01
EU/1/11/709/001
6C-MM
EU/1/11/709/003
7.5 Milligram
EU/1/11/709/004
10 Milligram
EU/1/11/709/002
5 Mg/Ml
PA0573/002/003
9 Milligram
PA0573/002/002
2 Mg/Dose
PA0573/002/001
3mg Milligram
BUDESONIDE
TEVA PHARMA
Dr. Falk Pharma
GmbH
Dr. Falk Pharma
GmbH
Dr. Falk Pharma
GmbH
Teva Pharma
B.V.
PA0749/207/001
0.25 mg/2ml
BUDESONIDE
TEVA PHARMA
Teva Pharma
B.V.
PA0749/207/002
0.5 mg/2ml
BRUFEN
BRUFEN
BRUFEN
BRUFEN
BRUFEN
PAEDIATRIC
BRUFEN
RETARD
BRUPRO
BRUPRO
BRUPRO FOR
CHILDREN
BRUPRO MAX
BRUPRO MAX
BRUPRO RX
BRYONIA
BRYONIA
BUCCOLAM
BUCCOLAM
BUCCOLAM
BUCCOLAM
BUDENOFALK
BUDENOFALK
BUDENOFALK
Human Medicines Authorised/Transfer Pending Products
6C & 30C
Milligram
2.5 Milligram
Tablets
-Per Oral
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10c Informed Consen
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-BRYONIA
CRETICA
-BRYONIA
-Per Oral
-Per Oral
Oromucosal
Solution
Oromucosal
Solution
Oromucosal
Solution
Oromucosal
Solution
N05CD08
-MIDAZOLAM
-Oromucosal
N05CD08
-MIDAZOLAM
-Oromucosal
N05CD08
-MIDAZOLAM
-Oromucosal
N05CD08
-MIDAZOLAM
Granules GastroResistant
Rectal Foam
A07EA06
-BUDESONIDE
-Per Oral
A07EA06
-BUDESONIDE
-Rectal
Capsules GastroResistant
Nebuliser
Suspension
A07EA06
-BUDESONIDE
-Per Oral
R03BA02
-BUDESONIDE
Nebuliser
Suspension
R03BA02
-BUDESONIDE
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Oromucosal
-Inhalation
-Inhalation
Page 74 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
BUDESONIDE
TEVA PHARMA
Teva Pharma
B.V.
PA0749/207/003
1 mg/2ml
Nebuliser
Suspension
R03BA02
-BUDESONIDE
BUFAR
EASYHALER
Orion Corporatio
PA1327/018/001
80/4.5 Microgram
Powder for
Inhalation
R03AK07
BUFOMIX
EASYHALER
Orion Corporatio
PA1327/015/004
80/4.5 Microgram
Powder for
Inhalation
R03AK07
BUFOMIX
EASYHALER
Orion Corporatio
PA1327/015/002
160/4.5
Microgram
Powder for
Inhalation
R03AK07
BUFOMIX
EASYHALER
Orion Corporatio
PA1327/015/003
320/9 Microgram
Powder for
Inhalation
R03AK07
BUPIVACAINE
Claris
Lifesciences (UK)
Limited
Claris
Lifesciences (UK)
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Actavis Group
PTC ehf
PA1389/007/001
2.5 Mg/Ml
Solution for
Injection
N01BB10
PA1389/007/002
5.0 Mg/Ml
Solution for
Injection
N01BB10
PA1390/132/001
2.5 Mg/Ml
Solution for
Injection
N01BB01
PA1390/132/002
5 Mg/Ml
Solution for
Injection
N01BB01
PA0073/091/001
0.0025 %w/v
Solution for
Injection
N01BB01
PA0073/091/002
0.005 %w/v
Solution for
Injection
N01BB01
PA1380/087/001
200 Milligram
Film Coated
Tablet
M01AE01
-BUDESONIDE
-FORMOTEROL
FUMARATE
DIHYDRATE
-BUDESONIDE
-FORMOTEROL
FUMARATE
DIHYDRATE
-BUDESONIDE
-FORMOTEROL
FUMARATE
DIHYDRATE
-BUDESONIDE
-FORMOTEROL
FUMARATE
DIHYDRATE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-IBUPROFEN
BUPLEX
Actavis Group
PTC ehf
PA1380/087/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
BUPLEX JUNIO
Actavis Group
PTC ehf
PA1380/087/003
100 MG/5ml
Oral Suspension
M01AE01
-IBUPROFEN
BUPLEX RX
Actavis Group
PTC ehf
PA1380/088/001
200 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
BUPLEX RX
Actavis Group
PTC ehf
PA1380/088/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
BUPLEX RX
Actavis Group
PTC ehf
PA1380/088/003
600 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
BUPRENORPHI
NE
Activase
Pharmaceuticals
Ltd
PA1567/001/001
0.4 Milligram
Tablet Sublingual
N07BC01
BUPRENORPHI
NE
Activase
Pharmaceuticals
Ltd
PA1567/001/002
2 Milligram
Tablet Sublingual
N07BC01
BUPRENORPHI
NE
Activase
Pharmaceuticals
Ltd
PA1567/001/003
8 Milligram
Tablet Sublingual
N07BC01
BUPRENORPHI
NE
Morningside
Healthcare
Limited
PA1333/003/002
2 Milligram
Tablet Sublingual
N02AE01
BUPRENORPHI
NE
HYDROCHLORI
DE
BUPRENORPHI
NE
HYDROCHLORI
DE
BUPRENORPHI
NE
HYDROCHLORI
DE
BUPRENORPHI
NE
HYDROCHLORI
DE
BUPIVACAINE
BUPIVACAINE
BUPIVACAINE
BUPIVACAINE
HYDROCHLORI
DE
BUPIVACAINE
HYDROCHLORI
DE
BUPLEX
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Epidural
-Inhalation
-Epidural
-Epidural
-Intra-articular
-Perineural
-Epidural
-Intra-articular
-Perineural
-Intra-venous
-Intra-venous
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10a Bibliographical
App
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Sublingual
Article 10(1) Generic
Application
-Sublingual
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Sublingual
Page 75 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
BUPRENORPHI
NE
Morningside
Healthcare
Limited
PA1333/003/003
8 Milligram
Tablet Sublingual
N02AE01
BURINEX
PA0046/016/002
1 Milligram
Tablets
C03CA02
PA0046/016/003
5.0 Milligram
Tablets
C03CA02
-BUMETANIDE
PA00257/070/00
1
PA0007/016/001
1 %w/w
Cutaneous Spray
Solution
Coated Tablets
D04AB04
-BENZOCAINE
A03BB01
PA0007/016/002
20 Mg/Ml
A03BB01
PA0007/067/001
10 Milligram
Solution for
Injection
Coated Tablets
BUSIETE
Leo Laboratories
Limited
Leo Laboratories
Limited
GR Lane Health
Products Ltd
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
Teva B.V.
BUPRENORPHI
NE
HYDROCHLORI
DE
-BUMETANIDE
PA1986/026/001
5 Microgram per
hour
Transdermal
Patch
N02AE01
BUSIETE
Teva B.V.
PA1986/026/002
10 Microgram per
hour
Transdermal
Patch
N02AE01
BUSIETE
Teva B.V.
PA1986/026/003
20 Microgram per
hour
Transdermal
Patch
N02AE01
BUSILVEX
Pierre Fabre
Medicament
Fresenius Kabi
Oncology Plc
EU/1/03/254/002
6 Mg/Ml
L01AB01
EU/1/14/951/001
6 Mg/Ml
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
-HYOSCINE
BUTYLBROMIDE
-HYOSCINE
BUTYLBROMIDE
-HYOSCINE
BUTYLBROMIDE
BUPRENORPHI
NE
BUPRENORPHI
NE
BUPRENORPHI
NE
-BUSULFAN
L01AB01
-BUSULFAN
Imbat Limited
PPA1151/194/00
1
5 Microgram per
hour
Transdermal
Patch
N02AE01
BUTRANS
Imbat Limited
PPA1151/194/00
2
10 Microgram per
hour
Transdermal
Patch
N02AE01
BUTRANS
Imbat Limited
PPA1151/194/00
3
20 Microgram per
hour
Transdermal
Patch
N02AE01
BUTRANS
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
PA1688/002/004
15 Microgram per
hour
Transdermal
Patch
N02AE01
PA1688/002/002
10 Milligram
Transdermal
Patch
N02AE01
BUPRENORPHI
NE
BUPRENORPHI
NE
BUPRENORPHI
NE
BUPRENORPHI
NE
BUPRENORPHI
NE
Mundipharma
Pharmaceuticals
Limited
PA1688/002/003
20 Milligram
Transdermal
Patch
N02AE01
BUPRENORPHI
NE
Mundipharma
Pharmaceuticals
Limited
PA1688/002/001
5 Milligram
Transdermal
Patch
N02AE01
BUPRENORPHI
NE
Kwizda Pharma
GmbH
TR2006/001/001
59.5 N/A
Syrup
R05CA10
-THYME HERB
EXTRACT DER
7-13:1,
EXTRACTION
MEDIUM:
WATER, NATIVE
MARSHMALLOW
LIQUID
EXTRACT DER
1:12-14,
EXTRACTION
MEDIUM:
WATER, NATIVE
BURINEX
BURNEZE
SPRAY
BUSCOPAN
BUSCOPAN
AMPOULES
BUSCOPAN RX
BUSULFAN
FRESENIUS
KABI
BUTRANS
BUTRANS 10
MICROGRAMS/
HOUR
TRANSDERMAL
PATCH.
BUTRANS 20
MICROGRAMS/
HOUR
TRANSDERMAL
PATCH.
BUTRANS 5
MICROGRAMS/
HOUR
TRANSDERMAL
PATCH.
BUTTERCUP
BRONCHOSTOP
COUGH
Human Medicines Authorised/Transfer Pending Products
10 Milligram
A03BB01
Legal Basis
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
Article 10c Informed Consen
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Per Oral
Article 10(1) Generic
Application
-Intra-venous
Article 10(3) Hybrid
Application
-Transdermal
-Transdermal
-Transdermal
-Transdermal
-Per Oral
Page 76 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
BUTTERCUP
BRONCHOSTOP
COUGH
Kwizda Pharma
GmbH
TR2006/001/002
Milligram
Pastilles
R05CA10
BYDUREON
AstraZeneca AB
2 Milligram
AstraZeneca AB
A10BX04
-EXENATIDE
BYETTA
AstraZeneca AB
EU/1/06/362/3-4
10 Microgram
A10BX04
-EXENATIDE
BY-MADOL SR
Ethypharm
PA0549/016/001
50 Milligram
N02AX02
-TRAMADOL
HYDROCHLORI
DE
-Per Oral
Ethypharm
Interchangeable
List Code:
IC0074-023-030
PA0549/016/002
Pdr+Solv for
Susp for Inj
Solution for
Injection
Solution for
Injection
Prolonged
Release
Capsules
A10BX04
BYETTA
EU/1/11/696/001004
EU/1/06/362/1-2
-THYME HERB
DRY EXTRACT
7-13:1, NATIVE
EXTRACTION
SOLVENT:
WATER
-EXENATIDE
100 Milligram
N02AX02
-TRAMADOL
HYDROCHLORI
DE
-Per Oral
Ethypharm
Interchangeable
List Code:
IC0074-024-030
PA0549/016/003
Prolonged
Release
Capsules
150 Milligram
N02AX02
-TRAMADOL
HYDROCHLORI
DE
-Per Oral
Ethypharm
Interchangeable
List Code:
IC0074-062-030
PA0549/016/004
Prolonged
Release
Capsules
200 Milligram
N02AX02
-TRAMADOL
HYDROCHLORI
DE
-Per Oral
BY-MYCIN
Fannin Limited
Interchangeable
List Code:
IC0074-067-030
PA1457/010/001
Prolonged
Release
Capsules
50 Milligram
Capsules Hard
J01AA02
BY-MYCIN
Fannin Limited
PA1457/010/002
100 Milligram
Capsules Hard
J01AA02
BY-VERTIN
Fannin Limited
PA1457/011/001
8 Milligram
Tablets
N07CA01
Fannin Limited
Interchangeable
List Code:
IC0084-009-002
PA1457/011/002
-DOXYCYCLINE
HYCLATE
-DOXYCYCLINE
HYCLATE
-BETAHISTINE
DIHYDROCHLO
RIDE
16 Milligram
Tablets
N07CA01
-Per Oral
Interchangeable
List Code:
IC0084-038-002
PA0822/114/001
-BETAHISTINE
DIHYDROCHLO
RIDE
1 Milligram
Tablets
N04BC06
-CABERGOLINE
-Per Oral
PA0822/114/002
2 Milligram
Tablets
N04BC06
-CABERGOLINE
-Per Oral
EU/1/16/1136/00
1-002
EU/1/16/1136/00
3-004
EU/1/16/1136/00
5-006
PA2102/002/001
20 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Orodispersible
Tablet
L01XE26
-CABOZANTINIB
L01XE26
-CABOZANTINIB
L01XE26
-CABOZANTINIB
A12AX
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
-ZINC OXIDE
-CALAMINE
-CALAMINE
-ZINC OXIDE
-CALCIUM
CARBONICUM
HAHNEMANNI
(CONCHAE)
BY-MADOL SR
BY-MADOL SR
BY-MADOL SR
BY-VERTIN
CABASER
5 Microgram
CABOMETYX
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Ipsen Pharma
CABOMETYX
Ipsen Pharma
CABOMETYX
Ipsen Pharma
CADELIUS
Italfarmaco S.A.
CAELYX
Janssen-Cilag
International NV
EU/1/96/011/001
2 Mg/Ml
Concentrate for
Susp for Inf
L01DB01
CAELYX
Janssen-Cilag
International NV
EU/1/96/011/002
2.0 Mg/Ml
Concentrate for
Susp for Inf
L01DB01
CALAMINE
Pinewood
Laboratories Ltd,
Ovelle Limited
PA0281/051/001
5, 15 %w/v
D02AB
PA0206/016/002
15/5 %w/v
A. Nelson &
Company Limited
HOR1149/008/0
01
8X-MM
Cutaneous
Suspension
Cutaneous
Suspension
Pillules
CABASER
CALAMINE
LOTION
CALC CARB
Human Medicines Authorised/Transfer Pending Products
40 Milligram
60 Milligram
600mg/1000
Base Milligrams
D02AB
-Per Oral
-Subcutaneous
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 10a Bibliographical
App
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Per Oral
Page 77 of 608
Trade Name
CALC. FLUOR.
Licence Holder Licence
Number
Strength
Dosage Form ATC
HOR1149/009/0
01
PPA0465/156/00
1
PA1547/007/001
8X - MM
Pillules
500 Milligram
DPR1633/017/0
01
500mg/400
International Unit
Tablets
Chewable
Tablets
Chewable
Chewable/Disper
sible tablet
A12AA04
CALCICHEW
500MG
CALCICHEW D3
FORTE
A. Nelson &
Company Limited
PCO
Manufacturing
Takeda UK
Limited
Primecrown 2010
Ltd
CALCICHEW D3
FORTE
PCO
Manufacturing
DPR0465/001/0
01
500mg/400I
Tablets
Chewable
A12AX
CALCICHEW D3
FORTE
CHEWABLE
TABLETS
IMED Healthcare
Ltd.
DPR1463/044/0
01
500mg/400IU
Tablets
Chewable
A12AX
CALCICHEW D3
FORTE
CHEWABLE
TABLETS
LTT Pharma
Limited
PPA1562/100/00
1
500mg/400I
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE
Takeda UK
Limited
PA1547/007/002
500mg/400IU
%v/v
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE
PCO
Manufacturing
DPR0465/046/0
01
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE
Primecrown 2010
Ltd
DPR1633/002/0
01
500/400 %v/v
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE
Imbat Limited
PPA1151/155/00
1
500mg/400I
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE
PCO
Manufacturing
PPA0465/156/00
2
500/400 N/A
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE
Eurodrug Ltd
DPR1392/074/0
01
500/400 mg/IU
Tablets
Chewable
A12AX
CALCICHEW-D3
FORTE 500 MG/
400 IU
Takeda UK
Limited
PA1547/007/003
500/10
Film Coated
Tablet
A12AX
CALCICHEW-D3
FORTE DOUBLE
STRENGTH
Takeda UK
Limited
PA1547/007/004
1000/80
International Unit
Tablets
Chewable
A12AX
CALCICHEW
Human Medicines Authorised/Transfer Pending Products
500 Milligram
A12AA04
A12AX
Active
Ingredients
-CALCIUM
FLUORATUM
-CALCIUM
CARBONATE
-CALCIUM
CARBONATE
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
CHOLECALCIF
EROL (02) 400
INTERNATION
UNIT
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
CHOLECALCIF
EROL (02)
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
CHOLECALCIF
EROL
CONCENTRATE
(POWDER
FORM)
-CALCIUM
CARBONATE
CHOLECALCIF
EROL
CONCENTRATE
(POWDER
FORM)
Legal Basis
Routes of
Administration
-Per Oral
PPA
-Per Oral
-Per Oral
PPA
PPA
-Per Oral
-Per Oral
Page 78 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
CALCICHEW-D3
LEMON
Takeda UK
Limited
PA1547/007/005
500/1000 mg/IU
Tablets
Chewable
A12AX
CALCIPOTRIOL/
BETAMETHASO
NE ROWEX
Rowex Ltd
PA0711/254/001
50 + 0.5
Ointment
D05AX52
CALCIUM
ACETATE
CALCIUM
CARBONICUM
HAHNEMANII
(CALC CARB)
CALCIUM
CHLORIDE
INJECTION
MINIJET
CALCIUM
FLUORATUM
(CALC. FLUOR.)
CALCIUM
PHOSPHORICU
M (CALC.
PHOS.)(6C &
30C)
CALCIUM
RESONIUM
Pinewood
Laboratories Ltd,
Weleda (UK)
Limited
PA0281/063/001
500 Milligram
Tablets
A12AA12
HOR0407/012/0
01
6C & 30C
Tablets
International
Medication
Systems (UK) Ltd
PA0255/007/001
10 %w/v
Solution for
Injection
Weleda (UK)
Limited
HOR0407/046/0
01
6C & 30C
Tablets
-CALCIUM
FLUORATUM
-Per Oral
Weleda (UK)
Limited
HOR0407/021/0
01
6C & 30C
Tablets
-CALCIUM
PHOSPHORICU
M
-Per Oral
Sanofi-Aventis
Ireland Limited
T/A SANOFI
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0540/141/001
99.934 %w/w
Powder for Oral
Suspension
V03AE01
PA0678/127/001
15ml 3.27g 2.18g
Grams
Syrup
A12AA06
PA0678/128/001
600 mg + 400 IU
Base Milligrams
Tablets
Effervescent
A12AX
CALCIUP
Rowex Ltd
PA0711/217/002
500mg/440I
Milligram
Tablets
Chewable
A12AX
CALCIUP D3
FORTE
Rowex Ltd
PA0711/217/001
1000/880
Tablets
Chewable
A12AX
CALDEASE
MEDICATED
Clonmel
Healthcare Ltd
PA0126/153/001
15 %w/w
Ointment
D02AB
CALCIUM
SANDOZ
CALCIUM-DSANDOZ
Human Medicines Authorised/Transfer Pending Products
A12AA07
-CALCIUM
CARBONATE
CHOLECALCIF
EROL
CONCENTRATE
(POWDER
FORM)
COLECALCIFE
ROL
-ALL-RAC
ALPHATOCOPHEROL
-MEDIUM CHAIN
TRIGLYCERIDE
S
-MODIFIED
MAIZE STARCH
-SUCROSE
-SODIUM
ASCORBATE
-SILICA
COLLOIDAL
ANHYDROUS
-CALCIPOTRIOL
BETAMETHASO
NE
-CALCIUM
ACETATE
-CALCIUM
CARBONICUM
HAHNEMANNI
(CONCHAE)
-CALCIUM
CHLORIDE
DIHYDRATE
Legal Basis
-CALCIUM
POLYSTYRENE
SULFONATE
-CALCIUM
GLUBIONATE
-CALCIUM
LACTOBIONATE
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
CHOLECALCIF
EROL
CONCENTRATE
-CALCIUM
CARBONATE
CHOLECALCIF
EROL
CONCENTRATE
(POWDER
FORM 100,000
IU/G)
-ZINC OXIDE
Article 8(3) - Full
new Application
-Per Oral
Article 10(3) Hybrid
Application
-Cutaneous
-Per Oral
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Page 79 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
CALDESENE 10
% W/W
MEDICATED
POWDER
CALDESENE
ADULT
Clonmel
Healthcare Ltd
PA0126/152/001
10 %w/w
Cutaneous
Powder
D01AE54
-CALCIUM
UNDECYLEN
Clonmel
Healthcare Ltd
PA0126/247/001
10 %w/w
Unknown
D01AE04
CALENDOLON
Weleda (UK)
Limited
Weleda (UK)
Limited
PA0407/005/001
20 %v/w
Ointment
D03
PA0407/025/001
13.3 %w/v
D03
CALFOVIT D3
Menarini
International
Operations
Luxembourg S.A.
PA0865/006/001
%v/v
Cutaneous
Solution
Concentrate
Powder for Oral
Suspension
-CALCIUM
UNDECYLENAT
E
-CALENDULA
OFFICINALIS
-CALENDULA
OFFICINALIS
CALMURID
Galderma (UK)
Ltd
Galderma (UK)
Ltd
PA0590/008/001
%w/w
Cream
D02AE01
PA0590/009/001
10/1/5 %w/w
Cream
D07XA01
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
PA0823/010/005
120 mg/ 5 ml
MG/5ml
Oral Suspension
PA0823/010/002
120 MG/5ml
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
Pfizer Healthcare
Ireland
PA0823/010/008
CALVEPEN
CALENDULA
LOTION
Article 10c Informed Consen
Routes of
Administration
-Topical
N02BE01
-CALCIUM
PHOSPHATE
COLECALCIFE
ROL
-UREA
-LACTIC ACID
-UREA
HYDROCORTIS
ONE
-LACTIC ACID
-PARACETAMOL
-Per Oral
Oral Suspension
N02BE01
-PARACETAMOL
-Per Oral
250 Milligram
Orodispersible
Tablet
N02BE01
-PARACETAMOL
-Per Oral
PA0823/010/003
250 MG/5ml
Oral Suspension
N02BE01
-PARACETAMOL
-Per Oral
PA0823/010/004
250 MG/5ml
Oral Suspension
N02BE01
-PARACETAMOL
-Per Oral
PA0822/173/001
600/400
Film Coated
Tablet
A12AX
Clonmel
Healthcare Ltd
PA0126/137/001
333 Milligram
Film Coated
Tablet
J01CE02
CALVEPEN
Clonmel
Healthcare Ltd
PA0126/137/002
666 Milligram
Film Coated
Tablet
J01CE02
CALVEPEN 250
MG/5 ML
POWDER FOR
ORAL
SUSPENSION
CALVIDIN
Clonmel
Healthcare Ltd
PA0126/137/003
250 Milligram
Powder for Oral
Suspension
J01CE02
-CALCIUM
CARBONATE
CHOLECALCIF
EROL
CONCENTRATE
PHENOXYMET
HYLPENICILLIN
CALCIUM
PHENOXYMET
HYLPENICILLIN
CALCIUM
PHENOXYMET
HYLPENICILLIN
CALCIUM
Meda Health
Sales Ireland
Limited
PA1332/051/001
600/400IU Base
Milligrams
Tablets
Chewable
A12AX
CAMCOLIT
Essential Pharma
Ltd
Essential Pharma
Ltd
Merck Sante
s.a.s.
PA1994/001/001
250 mg Milligram
N05AN01
PA1994/001/002
400 mg Milligram
PA0738/001/001
333.0 Milligram
Film Coated
Tablet
Film Coated
Tablet
Tablets GastroResistant
LTT Pharma
Limited
PPA1562/178/00
1
333 Milligram
Tablets GastroResistant
N07BB03
CALMURID HC
10%/5%/1%
CALPOL
CALPOL 120
MG/5ML INFANT
ORAL
SUSPENSION.
CALPOL
FASTMELTS
CALPOL SIX
PLUS
CALPOL SIX
PLUS
CALTRATE
CAMCOLIT
CAMPRAL EC
CAMPRAL EC
Human Medicines Authorised/Transfer Pending Products
A12AX
Legal Basis
N05AN01
N07BB03
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-LITHIUM
CARBONATE
-LITHIUM
CARBONATE
ACAMPROSATE
CALCIUM
ACAMPROSATE
CALCIUM
Article 10a Bibliographical
App
-Per Oral
-Per Oral
Page 80 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
CAMPTO
Pfizer Limited
PA0019/053/003
20 Mg/Ml
Concentrate for
Soln for Inf
L01XX19
CANCIDAS
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Clonmel
Healthcare Ltd
EU/1/01/196/001
50mg Milligram
EU/1/01/196/003
70 Milligram
PA0126/251/001
16/12.5 Milligram
Pdr/Conc/Soln for
Infus
Pdr/Conc/Soln for
Infus
Tablets
Interchangeable
List Code:
IC0029-036-002
PA1380/092/001
4 Milligram
Tablets
C09CA06
Interchangeable
List Code:
IC0009-008-002
PA1380/092/002
8 Milligram
Tablets
Interchangeable
List Code:
IC0009-009-002
PA1380/092/003
16 Milligram
Interchangeable
List Code:
IC0009-038-002
PA1380/126/001
CANCIDAS
CANDESARTAN
/
HYDROCHLOR
OTHIAZIDE
CLONMEL
CANDESARTAN
ACTAVIS
CANDESARTAN
ACTAVIS
CANDESARTAN
ACTAVIS
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
CANDESARTAN
HYDROCHLOR
OTHIAZIDE
ACTAVIS
Actavis Group
PTC ehf
CANDESARTAN
HYDROCHLOR
OTHIAZIDE
ACTAVIS
Actavis Group
PTC ehf
CANDESARTAN
HYDROCHLOR
OTHIAZIDE
KRKA
Krka d.d., Novo
mesto
CANDESARTAN
HYDROCHLOR
OTHIAZIDE
KRKA
Krka d.d., Novo
mesto
CANDESARTAN
HYDROCHLOR
OTHIAZIDE
KRKA
Krka d.d., Novo
mesto
CANDESARTAN
HYDROCHLOR
OTHIAZIDE
KRKA
Krka d.d., Novo
mesto
CANDESARTAN
KRKA
Krka d.d., Novo
mesto
CANDESARTAN
KRKA
CANDESARTAN
KRKA
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Active
Ingredients
Legal Basis
Routes of
Administration
J02AX04
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
-CASPOFUNGIN
-Intra-venous
J02AX04
-CASPOFUNGIN
-Intra-venous
C09DA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
C09CA06
-CANDESARTAN
CILEXETIL
Article 10(1) Generic
Application
-Per Oral
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
Article 10(1) Generic
Application
-Per Oral
8/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-058-002
PA1380/126/002
16/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-036-002
PA1347/011/001
8/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-058-002
PA1347/011/002
16/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-036-002
PA1347/011/003
32/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-035-002
PA1347/011/004
32/25 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-034-002
PA1347/026/001
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-008-002
PA1347/026/002
Article 10(1) Generic
Application
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-009-002
PA1347/026/003
Article 10(1) Generic
Application
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0009-038-002
Human Medicines Authorised/Transfer Pending Products
Page 81 of 608
Trade Name
CANDESARTAN
KRKA
CANDESARTAN
MYLAN
CANDESARTAN
MYLAN
CANDESARTAN
MYLAN
CANDESARTAN
TEVA
CANDESARTAN
TEVA
CANDESARTAN
TEVA
Licence Holder Licence
Number
Krka d.d., Novo
mesto
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
CANDESARTAN
/HYDROCHLOR
OTHIAZIDE
TEVA
Teva Pharma
B.V.
CANDIST
Clonmel
Healthcare Ltd
CANDIST
CANDIST
CANDIST PLUS
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1347/026/004
32 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-037-002
PA0577/120/001
Article 10(1) Generic
Application
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-008-002
PA0577/120/002
Article 10(1) Generic
Application
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-009-002
PA0577/120/003
Article 10(1) Generic
Application
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-038-002
PA0749/124/002
Article 10(1) Generic
Application
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-008-002
PA0749/124/003
Article 10(1) Generic
Application
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-009-002
PA0749/124/004
Article 10(1) Generic
Application
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-038-002
PA0749/192/001
Article 10(1) Generic
Application
16/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0029-036-002
PA0126/206/001
4 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-008-002
PA0126/206/002
Article 10(1) Generic
Application
8 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-009-002
PA0126/206/003
Article 10(1) Generic
Application
16 Milligram
Tablets
C09CA06
-CANDESARTAN
CILEXETIL
-Per Oral
Interchangeable
List Code:
IC0009-038-002
PA0126/207/002
Article 10(1) Generic
Application
16/12.5 Milligram
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
150 Milligram
Capsule
J02AC01
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-FLUCONAZOLE
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
CANECLEAR
Phoenix Labs
Interchangeable
List Code:
IC0029-036-002
PA1113/013/001
CANESTEN
PPA1562/191/00
1
PA1410/039/007
1 Per Cent
Cream
D01AC01
CANESTEN
LTT Pharma
Limited
Bayer Limited
100 Milligram
Pessary
G01AF02
CANESTEN
Bayer Limited
PA1410/039/009
500 Milligram
Pessary
G01AF02
CANESTEN
Bayer Limited
PA1410/039/008
200 Milligram
Pessary
G01AF02
CANESTEN
Bayer Limited
PA1410/039/002
1 %w/w
Cream
D01AC01
CANESTEN
Bayer Limited
PA1410/039/010
500 Milligram
Vaginal Capsule
G01AF02
Human Medicines Authorised/Transfer Pending Products
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
Page 82 of 608
Trade Name
CANESTEN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
PCO
Manufacturing
PCO
Manufacturing
Bayer Limited
PPA0465/048/00
1
PPA0465/048/00
2
PA1410/039/013
10 mg/g
Cream
D01AC01
500 Milligram
Pessary
G01AF02
1 %w/w
Cream
D01AC01
Bayer Limited
PA1410/039/001
500mg/2 %w/w
Pessaries and
Cream
G01AF02
CANESTEN
COMBI
PESSARY &
CREAM
CANESTEN
CREAM COMBI
PCO
Manufacturing
PPA0465/048/00
3
500/20 Milligram
Pessaries and
Cream
G01AF02
Bayer Limited
PA1410/039/003
2 Unknown
Vaginal Cream
G01AF02
CANESTEN
DUOPACK
Bayer Limited
PA1410/039/005
100mg/1 %w/w
Pessaries and
Cream
G01AF02
CANESTEN HC
Bayer Limited
PA1410/040/001
1/1 %w/w
Cream
D01AC20
CANESTEN HC
PCO
Manufacturing
PPA0465/246/00
1
1/1 %w/w
Cream
D01AC01
CANESTEN HC
IMED Healthcare
Ltd.
PPA1463/049/00
1
1.0 / 1.0 %w/w
Cream
D01AC01
CANESTEN
INTERNAL
CREAM
CANESTEN
SOFT VAGINAL
CAPSULE
COMBI
CANESTEN
THRUSH
CANESTEN
THRUSH
CANESTEN
THRUSH
CANESTEN
THRUSH
VAGINAL
CREAM
CANORAL
CANTHARIS
Bayer Limited
PA1410/039/006
10 %w/w
Vaginal Cream
G01AF02
Bayer Limited
PA1410/039/014
500mg/2%w/w
Milligram
Capsules, Soft
G01AF02
PCO
Manufacturing
Bayer Limited
PPA0465/048/00
4
PA1410/039/012
20 mg/g
Vaginal Cream
G01AF02
2 %w/w
Vaginal Cream
G01AF02
LTT Pharma
Limited
Imbat Limited
DPR1562/003/0
02
PPA1151/201/00
4
2 %w/w
Cream
D01AC01
2 %w/w
Vaginal Cream
G01AF02
Bayer Limited
Weleda (UK)
Limited
Dermal
Laboratories Ltd
PA1410/041/001
HOR0407/048/0
01
PA0278/016/001
150 Milligram
6C-200C
Capsules Hard
Tablets
J02AC01
0.5/1/1 %w/w
Shampoo
D05AA
Accord
Healthcare
Limited
EU/1/12/762/001006
150 Milligram
Film Coated
Tablet
L01BC06
-FLUCONAZOLE
-LYTTA
VESICATORIA
-SALICYLIC
ACID
-COCONUT OIL
-COAL TAR
-CAPECITABINE
300 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
CANESTEN
CANESTEN
ATHLETE'S
FOOT CREAM
CANESTEN
COMBI
CAPASAL
THERAPEUTIC
SHAMPOO
CAPECITABINE
CAPECITABINE
Accord
Healthcare
Limited
Interchangeable
List Code:
IC0079-062-003
EU/1/12/762/007012
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
HYDROCORTIS
ONE
CLOTRIMAZOLE
HYDROCORTIS
ONE
CLOTRIMAZOLE
HYDROCORTIS
ONE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
Legal Basis
Routes of
Administration
PPA
PPA
Article 10c Informed Consen
-Topical
PPA
-Cutaneous
PPA
-Topical
PPA
Article 8(3) - Full
new Application
-Cutaneous
-Vaginal
PPA
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0079-029-003
Human Medicines Authorised/Transfer Pending Products
Page 83 of 608
Trade Name
CAPECITABINE
CAPECITABINE
CAPECITABINE
CAPECITABINE
ACTAVIS
CAPECITABINE
ACTAVIS
CAPECITABINE
MEDAC
CAPECITABINE
MEDAC
CAPECITABINE
MEDAC
CAPECITABINE
SANDOZ
CAPECITABINE
SANDOZ
CAPECITABINE
TEVA
CAPECITABINE
TEVA
CAPOTEN
CAPOTEN
CAPOZIDE
Licence Holder Licence
Number
Accord
Healthcare
Limited
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
500 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0079-117-003
PA1422/011/001
150 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABIINE
-Per Oral
Interchangeable
List Code:
IC0079-062-003
PA1422/011/002
Article 10(1) Generic
Application
500 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
-Per Oral
Interchangeable
List Code:
IC0079-117-003
PA1380/115/001
Article 10(1) Generic
Application
150 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
-Per Oral
Interchangeable
List Code:
IC0079-062-003
PA1380/115/002
Article 10(1) Generic
Application
500 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
Article 10(1) Generic
Application
-Per Oral
150 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
Article 10(1) Generic
Application
-Per Oral
300 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
Article 10(3) Hybrid
Application
-Per Oral
500 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0079-117-003
PA0711/206/001
150 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0079-062-003
PA0711/206/002
Article 10(1) Generic
Application
500 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABINE
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0079-117-003
EU/1/12/761/001
Article 10(1) Generic
Application
150 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABIINE
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0079-062-003
EU/1/12/761/002
Article 10(1) Generic
Application
500 Milligram
Film Coated
Tablet
L01BC06
-CAPECITABIINE
-Per Oral
Interchangeable
List Code:
IC0079-117-003
PA0002/039/001
Article 10(1) Generic
Application
25 Milligram
Tablets
C09AA01
-CAPTOPRIL
-Per Oral
PA0002/039/002
50 Milligram
Tablets
C09AA01
-CAPTOPRIL
-Per Oral
PA0002/053/002
50/25 Milligram
Tablets
C09BA01
-CAPTOPRIL
HYDROCHLOR
OTHIAZIDE
Fresenius Kabi
Oncology Plc
Fresenius Kabi
Oncology Plc
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
EU/1/12/762/013018
Strength
Interchangeable
List Code:
IC0079-117-003
EU/1/12/802/001014
Interchangeable
List Code:
IC0079-062-003
EU/1/12/802/015028
Interchangeable
List Code:
IC0079-029-003
EU/1/12/802/029042
Human Medicines Authorised/Transfer Pending Products
Page 84 of 608
Trade Name
CAPRELSA
Licence Holder Licence
Number
Strength
Genzyme Europe
B.V.
Genzyme Europe
B.V.
Pinewood
Laboratories Ltd,
EU/1/11/749/001
100 Milligram
EU/1/11/749/002
300 Milligram
PA0281/130/001
75 Milligram
CAPTOR
CAPTOR
CAPTOR
CAPTOR-HCT 25
MG/12.5 MG
TABLETS
Rowex Ltd
Rowex Ltd
Rowex Ltd
Rowex Ltd
PA0711/002/001
PA0711/002/002
PA0711/002/003
PA0711/025/001
CAPTOR-HCT 50
MG/25 MG
TABLETS
Rowex Ltd
CARBAGLU
DISPERSIBLE
CARBAMAZEPI
NE ESSENTIAL
PHARMA
CARBAMAZEPI
NE ESSENTIAL
PHARMA
CARBIDOPA/LE
VODOPA FAIRMED
CARBIDOPA/LE
VODOPA FAIRMED
CARBIDOPA/LE
VODOPA FAIRMED
CARBIDOPA/LE
VODOPA FAIRMED
CARBO VEG
CAPRELSA
CAPRIN
CARBO
VEGETABILIS
(CARBO. VEG.)
CARBOCISTEIN
E
CARBOMIX
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATINTEVA
CARBOSAN
CARBOSYLANE
CARDICOR
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Film Coated
Tablet
Film Coated
Tablet
Tablets GastroResistant
L01XE12
-VANDETANIB
-Per Oral
L01XE12
-VANDETANIB
-Per Oral
N02BA01
-Per Oral
12.5 Milligram
25 Milligram
50 Milligram
25/12.5 mg
Milligram
Tablets
Tablets
Tablets
Tablets
C09AA01
C09AA01
C09AA01
C09BA01
PA0711/025/003
50/25mg
Milligram
Tablets
C09BA01
Orphan Europe
EU/1/02/246/1-2
200 Milligram
Tablets
A16AA05
Essential Pharma
Ltd
PA1994/003/001
125 Milligram
Suppositories
N03AF01
Essential Pharma
Ltd
PA1994/003/002
250 Milligram
Suppositories
N03AF01
Fair-Med
Healthcare
GmbH
Fair-Med
Healthcare
GmbH
Fair-Med
Healthcare
GmbH
Fair-Med
Healthcare
GmbH
A. Nelson &
Company Limited
Weleda (UK)
Limited
PA1789/007/001
12.5/50 Milligram
Tablets
N04BA02
ACETYLSALICY
LIC ACID
-CAPTOPRIL
-CAPTOPRIL
-CAPTOPRIL
-CAPTOPRIL
HYDROCHLOR
OTHIAZIDE
-CAPTOPRIL
HYDROCHLOR
OTHIAZIDE
-CARGLUMIC
ACID
CARBAMAZEPI
NE
CARBAMAZEPI
NE
-CARBIDOPA
-LEVODOPA
PA1789/007/002
10/100 Milligram
Tablets
N04BA02
-CARBIDOPA
-LEVODOPA
PA1789/007/003
25/100 Milligram
Tablets
N04BA02
-CARBIDOPA
-LEVODOPA
PA1789/007/004
25/250 Milligram
Tablets
N04BA02
-CARBIDOPA
-LEVODOPA
HOR1149/010/0
01
HOR0407/003/0
01
4X-MM %v/v
Pillules
6C & 30C
Tablets
Chanelle Medical
PA0688/045/001
375 Milligram
Capsules Hard
R05CB03
Beacon
Pharmaceuticals
Ltd
Accord
Healthcare
Limited
Hospira UK
Limited
Fresenius Kabi
Oncology Plc
PA1312/002/001
81.3 %w/w
Granules for Oral
Suspension
A07BA01
PA1390/006/001
10 Mg/Ml
Concentrate for
Soln for Inf
PA0437/017/002
10 Mg/Ml
PA1422/008/001
10 Mg/Ml
Teva Pharma
B.V.
Rowa
Pharmaceuticals
Limited
Laboratoires
Grimberg
PA0749/004/001
10 Mg/Ml
PA0074/011/001
Merck Serono
Limited
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Rectal
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-CARBO
VEGETABILIS
-CARBO
VEGETABILIS
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
CARBOCISTEIN
E
-CHARCOAL,
ACTIVATED
Article 10(1) Generic
Application
-Per Oral
L01XX02
-CARBOPLATIN
Article 10(1) Generic
Application
-Intra-venous
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
L01XA02
-CARBOPLATIN
L01XA02
-CARBOPLATIN
Article 10(1) Generic
Application
-Intra-venous
L01XA02
-CARBOPLATIN
2 %w/w
Concentrate for
Soln for Inf
Gel
A02BX01
PA0345/001/001
140 Milligram
Capsule
A03AX13
PA0654/007/001
1.25 Milligram
Film Coated
Tablet
C07AB07
CARBENOXOL
ONE SODIUM
-CHARCOAL,
ACTIVATED
-DIMETICONE,
ACTIVATED
-DIMETICONE,
ACTIVATED
-CHARCOAL,
ACTIVATED
-BISOPROLOL
HEMIFUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-044-014
Human Medicines Authorised/Transfer Pending Products
Page 85 of 608
Trade Name
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
Licence Holder Licence
Number
Merck Serono
Limited
Merck Serono
Limited
Merck Serono
Limited
Merck Serono
Limited
Merck Serono
Limited
Imbat Limited
Imbat Limited
Imbat Limited
Imbat Limited
Active
Ingredients
Legal Basis
Routes of
Administration
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-018-014
PA0654/007/003
3.75 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-108-014
PA0654/007/004
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA0654/007/005
7.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-041-003
PA0654/007/006
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
7.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
3.75 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
1.25 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
1.25 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
PPA
-Per Oral
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
PPA
-Per Oral
Interchangeable
List Code:
IC0065-002-014
PPA1151/048/00
4
Interchangeable
List Code:
IC0065-001-014
PPA1151/048/00
5
Interchangeable
List Code:
IC0065-041-003
PPA1151/048/00
6
Interchangeable
List Code:
IC0065-002-014
PPA1151/048/00
3
PCO
Manufacturing
PCO
Manufacturing
Interchangeable
List Code:
IC0065-044-014
PPA0465/204/00
2
Imbat Limited
Dosage Form ATC
PA0654/007/002
Interchangeable
List Code:
IC0065-108-014
PPA0465/204/00
1
Imbat Limited
Strength
Interchangeable
List Code:
IC0065-018-014
PPA1151/048/00
1
Interchangeable
List Code:
IC0065-044-014
PPA1151/048/00
2
Interchangeable
List Code:
IC0065-018-014
Human Medicines Authorised/Transfer Pending Products
Page 86 of 608
Trade Name
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDICOR
CARDIOPLAST
CARDIOPLAST
CARDIOPLAST
CARDURA
CARDURA
CARDURA XL
CARDURA XL
CARDURA XL
CARDURA XL
Licence Holder Licence
Number
LTT Pharma
Limited
PPA1562/142/00
1
LTT Pharma
Limited
Interchangeable
List Code:
IC0065-044-014
PPA1562/142/00
2
LTT Pharma
Limited
Interchangeable
List Code:
IC0065-018-014
PPA1562/142/00
3
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0065-041-003
PPA1463/085/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0065-044-014
PPA1463/085/00
2
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Pfizer Limited
Pfizer Limited
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Imbat Limited
Imbat Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
1.25 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
7.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
HEMIFUMARATE
-Per Oral
1.25 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
2.5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
NITROGLYCERI
N (GLYCERYL
TRINITRATE)
NITROGLYCERI
N (GLYCERYL
TRINITRATE)
NITROGLYCERI
N (GLYCERYL
TRINITRATE)
-DOXAZOSIN
MESILATE
Interchangeable
List Code:
IC0065-018-014
PA0577/174/001
0.2
Transdermal
Patch
C01DA02
PA0577/174/002
0.4
Transdermal
Patch
C01DA02
PA0577/174/003
0.6
Transdermal
Patch
C01DA02
Article 10(1) Generic
Application
-Transdermal
Article 10(1) Generic
Application
-Transdermal
Article 10(1) Generic
Application
-Transdermal
PA0019/043/001
1 Milligram
Tablets
C02CA04
Interchangeable
List Code:
IC0021-039-002
PA0019/043/002
2 Milligram
Tablets
C02CA04
-DOXAZOSIN
-Per Oral
Interchangeable
List Code:
IC0021-006-002
PA0822/004/001
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
-Per Oral
Interchangeable
List Code:
IC0021-008-024
PA0822/004/002
8 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
-Per Oral
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
PPA
-Per Oral
8 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
PPA
-Per Oral
Interchangeable
List Code:
IC0021-009-024
PPA1151/022/00
1
Interchangeable
List Code:
IC0021-008-024
PPA1151/022/00
2
-Per Oral
Interchangeable
List Code:
IC0021-009-024
Human Medicines Authorised/Transfer Pending Products
Page 87 of 608
Trade Name
CARDURA XL
CARDURA XL
CARDURA XL
CARDURA XL
CARISTENOL
CARISTENOL
Licence Holder Licence
Number
LTT Pharma
Limited
PPA1562/003/00
3
LTT Pharma
Limited
Interchangeable
List Code:
IC0021-009-024
PPA1562/003/00
1
Clear Pharmacy
Clear Pharmacy
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
8 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
PPA
-Per Oral
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
PPA
-Per Oral
8 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
PPA
-Per Oral
Interchangeable
List Code:
IC0021-009-024
PA1390/109/001
2 Milligram
G04BD07
-TOLTERODINE
TARTRATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0025-006-032
PA1390/109/002
Prolonged
Release
Capsules
4 Milligram
G04BD07
-TOLTERODINE
TARTRATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0025-008-032
PA0126/254/001
Prolonged
Release
Capsules
0.03/3 Milligram
Film Coated
Tablet
G03AA12
DROSPIRENON
E
-ETHINYL
ESTRADIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
-SALICYLIC
ACID
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0021-008-024
PPA1596/024/00
1
Interchangeable
List Code:
IC0021-008-024
PPA1596/024/00
2
-Per Oral
CARMEN
Clonmel
Healthcare Ltd
CARMENELLE
Clonmel
Healthcare Ltd
PA0126/253/001
0.02/3 Milligram
Film Coated
Tablet
G03AA12
CARNATION
CALLOUS CAPS
40% W/W
MEDICATED
PLASTERS
CARNATION
CORN CAPS 40
% W/W
MEDICATED
PLASTERS
CARNATION
VERICAP
VERRUCA
TREATMENT
CARSEM XL
Cuxson Gerrard
& Company Ltd
PA0229/003/002
40 %w/w
Impregnated
Dressing
D11AF
Cuxson Gerrard
& Company Ltd
PA0229/003/001
40 %w/w
Impregnated
Dressing
D11AF
-SALICYLIC
ACID
Cuxson Gerrard
& Company Ltd
PA0229/003/003
10 %w/w
Medicated
Plaster
D11AF
-SALICYLIC
ACID
Teva Pharma
B.V.
PA0749/072/001
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
Interchangeable
List Code:
IC0021-008-024
PA1347/037/001
3.125 Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
PA1347/037/002
6.25 Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
PA1347/037/003
12.5 Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
PA1347/037/004
25 Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
CARVEDILOL
KRKA
CARVEDILOL
KRKA
CARVEDILOL
KRKA
CARVEDILOL
KRKA
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Human Medicines Authorised/Transfer Pending Products
Page 88 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
CASACOL
EXPECTORANT
SYRUP
Phoenix Labs
PA1113/007/001
20/100/200
MG/5ml
Infus/Pdr/Oral
Soln
R05CA10
CASODEX
Clear Pharmacy
50 Milligram
CASODEX
PCO
Manufacturing
IMED Healthcare
Ltd.
LTT Pharma
Limited
Imbat Limited
PPA1596/049/00
1
PPA0465/144/00
1
PPA1463/107/00
1
PPA1562/192/00
1
PPA1151/104/00
1
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
AstraZeneca UK
Limited
PA0970/004/001
50mg Milligram
Clonmel
Healthcare Ltd
PA0126/174/001
CASPOFUNGIN
Demo S.A.
CASPOFUNGIN
Active
Ingredients
Legal Basis
Routes of
Administration
L02BB03
METHOXYPHE
NAMINE
HYDROCHLORI
DE
-GUAIFENESIN
-SODIUM
CITRATE
-BICALUTAMIDE
PPA
-Per Oral
L02BB03
-BICALUTAMIDE
PPA
-Per Oral
L02BB03
-BICALUTAMIDE
-Per Oral
L02BB03
-BICALUTAMIDE
-Per Oral
L02BB03
-BICALUTAMIDE
Tablets
L02BB03
-BICALUTAMIDE
50 Milligram
Film Coated
Tablet
L02BB03
-BICALUTAMIDE
PA1989/001/001
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
Demo S.A.
PA1989/001/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
Flynn Pharma Ltd
PA1226/013/001
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
Flynn Pharma Ltd
PA1226/013/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
Wockhardt UK
Limited
PA1339/070/001
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
Wockhardt UK
Limited
PA1339/070/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
PA0274/002/001
50.00 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
PA0274/002/002
70.00 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
EU/1/15/1081/00
1
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
ACETATE
EU/1/15/1081/00
2
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
ACETATE
CASPOFUNGIN
ACTAVIS
McCarthys
Laboratories
Limited
McCarthys
Laboratories
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Actavis Group
PTC ehf
PA1380/193/001
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
ACTAVIS
Actavis Group
PTC ehf
PA1380/193/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/287/001
50 Milligram
Concentrate for
Soln for Inf
J02AX04
-CASPOFUNGIN
ACETATE
CASPOFUNGIN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/287/002
70 Milligram
Concentrate for
Soln for Inf
J02AX04
-CASPOFUNGIN
ACETATE
CASPOFUNGIN
PFIZER
Pfizer Healthcare
Ireland
PA0822/185/001
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
PFIZER
Pfizer Healthcare
Ireland
PA0822/185/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASODEX
CASODEX
CASODEX 50
MG FILMCOATED
TABLETS
CASODEX 50MG
FILM-COATED
TABLETS
CASOMIDE
CASPOFUNGIN
CASPOFUNGIN
ACCORD
CASPOFUNGIN
ACCORD
Human Medicines Authorised/Transfer Pending Products
50 Milligram
50 Milligram
50 Milligram
50 Milligram
PPA
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Page 89 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
CASPOFUNGIN
ROWEX
Rowex Ltd
PA0711/249/001
50 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
ROWEX
Rowex Ltd
PA0711/249/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
CASPOFUNGIN
TEVA
CASPOFUNGIN
TEVA
CASPOFUNGIN
XELLIA
Teva B.V.
PA1986/009/001
50 Milligram
J02AX04
Teva B.V.
PA1986/009/002
70 Milligram
Xellia
Pharmaceuticals
ApS
Xellia
Pharmaceuticals
ApS
Moorfields Eye
Hospital NHS
Foundation Trust
Novartis
Pharmaceuticals
UK Ltd
PA1982/004/001
50 Milligram
Pdr/Conc/Soln for
Infus
Pdr/Conc/Soln for
Infus
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
ACETATE
-CASPOFUNGIN
ACETATE
-CASPOFUNGIN
PA1982/004/002
70 Milligram
Pdr/Conc/Soln for
Infus
J02AX04
-CASPOFUNGIN
PA1464/001/001
2 %w/v
Eye Drops
Solution
S01GX01
PA0013/088/002
50 Milligram
Coated Tablets
M01AB05
-SODIUM
CROMOGLICAT
E
-DICLOFENAC
POTASSIUM
Interchangeable
List Code:
IC0057-023-040
PA0007/014/003
0.15 Micromol
Solution for
Injection
C02AC01
CASPOFUNGIN
XELLIA
CATACROM
CATAFLAM
J02AX04
CATAPRES
Boehringer
Ingelheim Limited
CATAPRES
TABLETS 100
MICROGRAMS.
CATASART
Boehringer
Ingelheim Limited
PA0007/014/001
0.1 Milligram
Tablets
C02AC01
Rowex Ltd
PA0711/134/001
4 Milligram
Tablets
C09CA06
Rowex Ltd
Interchangeable
List Code:
IC0009-008-002
PA0711/134/002
8 Milligram
Tablets
C09CA06
Rowex Ltd
Interchangeable
List Code:
IC0009-009-002
PA0711/134/003
16 Milligram
Tablets
Rowex Ltd
Interchangeable
List Code:
IC0009-038-002
PA0711/164/001
16/12.5 Milligram
Interchangeable
List Code:
IC0029-036-002
PA1748/003/001
-CLONIDINE
HYDROCHLORI
DE
-CLONIDINE
HYDROCHLORI
DE
-CANDESARTAN
CILEXETIL
Legal Basis
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Intra-venous
-Intra-venous
-Ocular
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-CANDESARTAN
CILEXETIL
Article 10(1) Generic
Application
-Per Oral
C09CA06
-CANDESARTAN
CILEXETIL
Article 10(1) Generic
Application
-Per Oral
Tablets
C09DA06
Article 10(1) Generic
Application
-Per Oral
10 Per Cent
Ointment
D06BB12
-CANDESARTAN
CILEXETIL
HYDROCHLOR
OTHIAZIDE
-GREEN TEA
DRY EXTRACT
HOR0407/022/0
01
6C & 30C
Tablets
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Gilead Sciences
International
PA0822/115/003
20 Microgram
PA0822/115/001
5 Microgram
PA0822/115/002
10 Microgram
EU/1/09/543/001
75 Milligram
CEFACLOR
Chanelle Medical
PA0688/013/001
250 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Powder and
solvent for
nebuliser solution
Capsules Hard
CEFACLOR
Chanelle Medical
PA0688/013/002
500 Milligram
CEFIXIME
Orchid Europe
Limited
PA1335/002/001
200 Milligram
CATASART
CATASART
CATASART
PLUS
CATEPHEN
CAUSTICUM
(CAUST.)(6C &
30C)
CAVERJECT
CAVERJECT
CAVERJECT
CAYSTON
Kora Corporation
Ltd t/a Kora
Healthcare
Weleda (UK)
Limited
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
-CAUSTICUM
HAHNEMANNI
-Per Oral
G04BE01
-ALPROSTADIL
-Intra Cavernous
G04BE01
-ALPROSTADIL
-Intra-Tracheal
G04BE01
-ALPROSTADIL
-Intra Cavernous
J01DF01
-Inhalation
J01DC04
-AZTREONAM
(AS LYSINE
SALT)
-CEFACLOR
Capsules Hard
J01DC04
-CEFACLOR
Film Coated
Tablet
J01DD08
-CEFIXIME
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 90 of 608
Trade Name
CEFOTAXIME
Licence Holder Licence
Number
Strength
PA1339/002/001
500 Milligram
PA1339/002/002
1 Grams
PA1339/002/003
2 Grams
CEFTAL
Wockhardt UK
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
Rowex Ltd
PA0711/101/002
CEFTAL
Rowex Ltd
CEFTAZIDIME
Dosage Form ATC
Active
Ingredients
Routes of
Administration
J01DD01
250 Milligram
Pdr for Soln
Inj/Inf
Pdr for Soln
Inj/Inf
Pdr for Soln
Inj/Inf
Coated Tablets
PA0711/101/003
500 Milligram
Coated Tablets
J01DC02
Wockhardt UK
Limited
PA1339/003/001
1 Grams
Pdr for Soln
Inj/Inf
J01DD02
CEFTAZIDIME
Wockhardt UK
Limited
PA1339/003/002
2 Grams
Pdr for Soln
Inj/Inf
J01DD02
CEFTAZIDIME
Hospira UK
Limited
PA0437/074/001
500 Milligram
Pdr for Soln for
Injection
J01D
CEFTAZIDIME
Hospira UK
Limited
PA0437/074/002
1 Grams
Pdr for Soln
Inj/Inf
J01D
CEFTAZIDIME
Hospira UK
Limited
PA0437/074/003
2 Grams
Pdr for Soln
Inj/Inf
J01D
CEFTAZIDIME
PA1217/012/001
500 Milligram
Pdr for Soln for
Injection
J01DD02
PA1217/012/002
1 Grams
Pdr for Soln
Inj/Inf
J01DD02
PA1217/012/003
2 Grams
Pdr for Soln
Inj/Inf
J01DD02
PA1339/004/001
1 Grams
PA1339/004/002
2 Grams
PA0437/070/001
1 Grams
PA1947/002/001
250 Milligram
Pdr for Soln for
Injection
Pdr for Soln
Inj/Inf
Pdr for Soln for
Injection
Pdr for Soln for
Injection
J01DD04
CEFTRIAXONE
HOSPIRA
CEFUROXIME
Hikma
Farmaceutica
(Portugal) SA
Hikma
Farmaceutica
(Portugal) SA
Hikma
Farmaceutica
(Portugal) SA
Wockhardt UK
Limited
Wockhardt UK
Limited
Hospira UK
Limited
Stravencon Ltd
CEFUROXIME
Stravencon Ltd
PA1947/002/002
750 Milligram
Pdr for Soln for
Injection
J01DC02
-CEFUROXIME
SODIUM
CEFUROXIME
Stravencon Ltd
PA1947/002/003
1500 Milligram
Pdr for Soln for
Injection
J01DC02
-CEFUROXIME
SODIUM
CEFUROXIME
Fresenius Kabi
Limited
PA0566/054/001
750 Milligram
Pdr for Soln
Inj/Inf
J01DC02
-CEFUROXIME
SODIUM
CEFUROXIME
Fresenius Kabi
Limited
PA0566/054/002
1.5 Grams
Pdr for Soln
Inj/Inf
J01DC02
-CEFUROXIME
SODIUM
CEFUROXIME
Flynn Pharma Ltd
PA1226/009/001
750 Milligram
J01DC02
-CEFUROXIME
SODIUM
-Intra-Muscular
-Intra-venous
CEFUROXIME
Flynn Pharma Ltd
PA1226/009/002
1.5 Grams
J01DC02
Actavis Group
PTC ehf
PA1380/055/001
250 Base
Milligrams
-CEFUROXIME
SODIUM
-CEFUROXIME
AXETIL
-Intra-venous
CEFUROXIME
ACTAVIS
Powder for
suspension for
injection
Pdr for Soln for
Injection
Film Coated
Tablet
CEFUROXIME
ACTAVIS
Actavis Group
PTC ehf
PA1380/055/002
500 Base
Milligrams
Film Coated
Tablet
J01DC02
-CEFUROXIME
AXETIL
CEFUROXIME
MILPHARM
Milpharm Limited
PA1050/021/004
250 Milligram
Film Coated
Tablet
J01DA
CEFUROXIME
MILPHARM
Milpharm Limited
PA1050/021/005
500 Milligram
Film Coated
Tablet
J01DA
CELEBREX
Pfizer Healthcare
Ireland
PA0822/116/001
100 Milligram
Capsules Hard
M01AH01
-CEFUROXIME
AXETIL
(AMORPHOUS)
-CEFUROXIME
AXETIL
(AMORPHOUS)
-CELECOXIB
CEFOTAXIME
CEFOTAXIME
CEFTAZIDIME
CEFTAZIDIME
CEFTRIAXONE
CEFTRIAXONE
Human Medicines Authorised/Transfer Pending Products
J01DD01
J01DD01
J01DC02
J01DD04
J01DD04
J01DC02
J01DC02
-CEFOTAXIME
SODIUM
-CEFOTAXIME
SODIUM
-CEFOTAXIME
SODIUM
-CEFUROXIME
AXETIL
-CEFUROXIME
AXETIL
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTRIAXONE
SODIUM
-CEFTRIAXONE
SODIUM
-CEFTRIAXONE
SODIUM
-CEFUROXIME
SODIUM
Legal Basis
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 91 of 608
Trade Name
CELEBREX
CELEBREX
Licence Holder Licence
Number
Pfizer Healthcare
Ireland
Imbat Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0822/116/002
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
-Per Oral
PPA1151/070/00
1
PPA0465/118/00
1
200 Milligram
Capsule
M01AH01
-CELECOXIB
PPA
-Per Oral
100 Milligram
Capsules Hard
M01AH01
-CELECOXIB
PPA
-Per Oral
Clear Pharmacy
PPA1596/034/00
1
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
PPA
-Per Oral
PCO
Manufacturing
PPA0465/118/00
2
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
PPA
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
CELEBREX
100MG HARD
CAPSULES
CELEBREX 200
MG CAPSULE,
HARD
CELEBREX
200MG HARD
CAPSULES
CELECOXIB
ACTAVIS
PCO
Manufacturing
Actavis Group
PTC ehf
PA1380/139/001
100 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
ACTAVIS
Actavis Group
PTC ehf
PA1380/139/002
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
KRKA
Krka d.d., Novo
mesto
PA1347/033/001
100 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
KRKA
Krka d.d., Novo
mesto
PA1347/033/002
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
PFIZER
Pfizer Healthcare
Ireland
PA0822/083/001
100 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
PFIZER
Pfizer Healthcare
Ireland
PA0822/083/002
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
ROWEX
Rowex Ltd
PA0711/241/001
100 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELECOXIB
ROWEX
Rowex Ltd
PA0711/241/002
200 Milligram
Capsules Hard
M01AH01
-CELECOXIB
CELEVAC
500MG
TABLETS
CELLCEPT
Amdipharm
Limited
PA1142/010/001
500 Milligram
Tablets
A06AC06
Roche Products
Limited
EU/1/96/005/001
250 mg Milligram
Capsule
L04AA06
CELLCEPT
Roche Products
Limited
EU/1/96/005/002
500 Milligram
Tablets
L04AA06
CELLCEPT
Roche
Registration
Limited
Roche Products
Limited
EU/1/96/005/006
1g/5ml
Powder for Oral
Suspension
L04AA06
EU/1/96/005/003
250 Milligram
Capsule
L04AA06
CELLCEPT
Roche Products
Limited
EU/1/96/005/004
500 Milligram
Tablets
L04AA06
CELLCEPT IV
Roche
Registration
Limited
Allergan
Pharmaceuticals
Ireland
Allergan
Pharmaceuticals
Ireland
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
PCO
Manufacturing
LTT Pharma
Limited
Primecrown 2010
Ltd
EU/1/96/005/005
500 mg Mg/Ml
Pdr for Soln for
Infusion
L04AA06
PA0148/059/001
1 %w/v
Eye Drops
Solution
S01XA20
METHYLCELLU
LOSE
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
-CARMELLOSE
SODIUM
PA0148/059/002
0.5 %w/v
Eye Drops
Solution
S01XA20
-CARMELLOSE
SODIUM
-Ocular
DPR1463/039/0
01
DPR1463/039/0
02
PPA0465/259/00
1
PPA1562/028/00
2
DPR1633/014/0
01
0.5 %w/v
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
Ear Drops
Solution
S01XA20
-CARMELLOSE
SODIUM
-CARMELLOSE
SODIUM
-CARMELLOSE
SODIUM
-CARMELLOSE
SODIUM
-CARMELLOSE
SODIUM
-Ocular
CELLCEPT
CELLUVISC
CELLUVISC
CELLUVISC
CELLUVISC
CELLUVISC
CELLUVISC
CELLUVISC
Human Medicines Authorised/Transfer Pending Products
1 %w/v
1 %w/v
1 %w/v
1 %w/v
S01XA20
S01XA20
S01XA20
S01XA20
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Ocular
PPA
PPA
Page 92 of 608
Trade Name
Licence Holder Licence
Number
CELLUVISC
Imbat Limited
CELSENTRI
ViiV Healthcare
UK Ltd
ViiV Healthcare
UK Ltd
Institut Georges
Lopez - IGL
CELSENTRI
CELSIOR
CENTRAX
Strength
PPA1151/102/00
1
EU/1/07/418/1-5
1 %w/v
EU/1/07/418/6-10
300 Milligram
150 Milligram
PA1996/001/001
Dosage Form ATC
Eye Drops
Solution
Film Coated
Tablet
Film Coated
Tablet
Solution for
Organ
Preservation
S01XA20
Active
Ingredients
J05AX09
-CARMELLOSE
SODIUM
-MARAVIROC
J05AX09
-MARAVIROC
V07AB
-GLUTATHIONE
-MANNITOL
-LACTOBIONIC
ACID
-GLUTAMIC
ACID
-SODIUM
HYDROXIDE
-CALCIUM
CHLORIDE 2
H2O
-POTASSIUM
CHLORIDE
-MAGNESIUM
CHLORIDE 6
H2O
-HISTIDINE
-PRAZEPAM
Legal Basis
Routes of
Administration
PPA
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Subcutaneous
-Per Oral
Pfizer Healthcare
Ireland
Leo Laboratories
Limited
PA0822/010/001
10 Milligram
Tablets
N05BA11
PA0046/019/001
2.5/573 Milligram
Modified-release
Tablets
C03AB01
CEPLENE 0.5
MG/0.5 ML
SOLUTION FOR
INJECTION
CEPROTIN
EpiCept GmbH
EU/1/08/477/1
0.5/0.5 Mg/Ml
Solution for
Injection
L03AX14
Baxter AG
EU/1/01/190/002
-PROTEIN C
-Intra-venous
Baxter AG
EU/1/01/190/001
B01AD12
-PROTEIN C
-Intra-venous
CERAZETTE
Imbat Limited
G03AC09
-DESOGESTREL
-Per Oral
CERAZETTE
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
IMED Healthcare
Ltd.
PCO
Manufacturing
Genzyme Europe
B.V.
GE Healthcare
Limited
Genzyme Europe
B.V.
Genzyme Europe
B.V.
Genzyme Europe
B.V.
Genzyme Europe
B.V.
Genzyme Europe
B.V.
PPA1151/222/00
1
PA1286/048/001
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Film Coated
Tablet
Film Coated
Tablet
B01AX12
CEPROTIN
1000
International Unit
500 International
Unit
75 Microgram
G03AC09
-DESOGESTREL
-Per Oral
Film Coated
Tablet
Film Coated
Tablet
Capsules Hard
G03AC09
-DESOGESTREL
G03AC09
-DESOGESTREL
A16AX10
Pdr for Soln for
Injection
Pdr for Soln for
Infusion
Pdr for Soln for
Infusion
Pdr for Soln for
Infusion
Pdr for Soln for
Infusion
Pdr for Soln for
Infusion
V09AA01
-ELIGLUSTAT
(AS TARTRATE)
-EXAMETAZIME
A16AB02
-IMIGLUCERASE
A16AB02
-IMIGLUCERASE
A16AB02
-IMIGLUCERASE
-Intra-venous
A16AB02
-IMIGLUCERASE
-Intra-venous
A16AB02
-IMIGLUCERASE
-Intra-venous
CENTYL K
CERAZETTE
CERAZETTE
CERDELGA
CERETEC
FREEZE DRIED
CEREZYME
CEREZYME
CEREZYME
CEREZYME
CEREZYME
75 Microgram
PPA1463/071/00
1
PPA0465/307/00
1
EU/1/14/974/001002
PA0240/004/001
75 Microgram
EU/1/97/053/002
200 %v/v
EU/1/97/053/001
%v/v
75 Microgram
84 Milligram
0.5mg Milligram
EU/1/97/053/005
%v/v
EU/1/97/053/004
%v/v
EU/1/97/053/003
%v/v
Human Medicines Authorised/Transfer Pending Products
BENDROFLUM
ETHIAZIDE
-POTASSIUM
CHLORIDE
-HISTAMINE
DIHYDROCHLO
RIDE
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Page 93 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
CERNEVIT
Baxter
Healthcare
Limited
PA0167/097/001
%v/v
Pdr for Soln
Inj/Inf
A11BA
CERTICAN
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Thornton & Ross
Limited
PA0013/124/001
0.25 Milligram
Tablets
L04AA18
PA0013/124/002
0.5 Milligram
Tablets
L04AA18
PA0013/124/003
0.75 Milligram
Tablets
L04AA18
PA0013/124/004
1 Milligram
Tablets
L04AA18
PA0013/124/005
0.1 Milligram
Dispersable
Tablet
L04AA18
PA0013/124/006
0.25 Milligram
Dispersable
Tablet
L04AA18
PA0540/096/001
20 Milligram
Pdr/Conc/Soln for
Infus
L01DB02
PA0610/018/001
%v/v
Ear Drops
Solution
S02DC
CERVARIX
GlaxoSmithKline
Biologicals S.A.
EU/1/07/419/1-12
20 Microgram
Suspension for
Injection
J07BM02
CETIRELIEF
ALLERGY 10 MG
FILM-COATED
TABLETS
CETRINE
Phoenix Labs
PA1113/014/001
10 Milligram
Film Coated
Tablet
R06AE07
Rowex Ltd
PA0711/075/001
10 Milligram
Film Coated
Tablet
R06AE07
-Per Oral
CETRINE
ALLERGY
Rowex Ltd
Interchangeable
List Code:
IC0088-002-003
PA0711/075/002
-CETIRIZINE
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
R06AE07
-Per Oral
CETRIZ
Actavis Group
PTC ehf
PA1380/054/001
10 Milligram
Film Coated
Tablet
R06AE07
CETROTIDE
Ares-Serono
(Europe) Limited
EU/1/99/100/001
0.25 Milligram
Pdr+Solv for Soln
for Inj
H01CC02
-CETIRIZINE
HYDROCHLORI
DE
-CETIRIZINE
HYDROCHLORI
DE
-CETRORELIX
ACETATE
CERTICAN
CERTICAN
CERTICAN
CERTICAN
CERTICAN
CERUBIDIN
CERUMOL
Human Medicines Authorised/Transfer Pending Products
-RETINOL
PALMITATE
COLECALCIFE
ROL
-DL-ALFATOCOFEROL
-ASCORBIC
ACID
-PYRIDOXINE
HYDROCHLORI
DE
CYANOCOBALA
MIN
-FOLIC ACID
DEXPANTHENO
L
-BIOTIN
-NICOTINAMIDE
COCARBOXYLA
SE
TETRAHYDRAT
E
-RIBOFLAVIN
SODIUM
PHOSPHATE
-EVEROLIMUS
(STABILISED
WITH BHT)
-EVEROLIMUS
(STABILISED
WITH BHT)
-EVEROLIMUS
(STABILISED
WITH BHT)
-EVEROLIMUS
(STABILISED
WITH BHT)
-EVEROLIMUS
(STABILISED
WITH BHT)
-EVEROLIMUS
(STABILISED
WITH BHT)
DAUNORUBICIN
Legal Basis
CHLOROBUTA
NOL
-ARACHIS OIL
-HPV 16 L1
PROTEIN
-HPV 18 L1
PROTEIN
-CETIRIZINE
HYDROCHLORI
DE
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Intra-Muscular
-Per Oral
-Per Oral
-Subcutaneous
Page 94 of 608
Trade Name
CETROTIDE
Licence Holder Licence
Number
Strength
EU/1/99/100/002
0.25 Milligram
EU/1/99/100/003
3 Milligram
CHAMOMILLA TABLETS
CHAMPIX
Ares-Serono
(Europe) Limited
Ares-Serono
(Europe) Limited
Weleda (UK)
Limited
Pfizer Limited
HOR0407/018/0
01
EU/1/06/360/01
6C & 30C
Milligram
0.5 Milligram
CHAMPIX
Pfizer Limited
EU/1/06/360/02
CHENODEOXY
CHOLIC ACID
CHIROCAINE
Sigma-tau
Arzneimittel
GmbH
AbbVie Limited
CHIROCAINE
Dosage Form ATC
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Tablets
H01CC02
Tablets
N07BA03
1.0 Milligram
Tablets
N07BA03
EU/1/16/1110/00
1
250 Milligram
Capsules Hard
A05AA01
PA1824/003/004
0.625 Mg/Ml
Solution for
Infusion
N01BB10
AbbVie Limited
PA1824/003/005
1.25 Mg/Ml
Solution for
Infusion
N01BB10
CHIROCAINE
AbbVie Limited
PA1824/003/001
2.5 Mg/Ml
Solution injection
or concentrate for
solution infusion
N01BB10
CHIROCAINE
AbbVie Limited
PA1824/003/002
5.0 Micromol
Solution injection
or concentrate for
solution infusion
N01BB10
CHIROCAINE
AbbVie Limited
PA1824/003/003
7.5 Micromol
Solution injection
or concentrate for
solution infusion
N01BB10
CHLORAMPHE
NICOL EYE
DROPS BP
CHLORAMPHE
NICOL EYE
OINTMENT BP
CHLORAPREP
Martindale
Pharmaceuticals
Ltd
Martindale
Pharmaceuticals
Ltd
Carefusion U.K.
244 Limited
PA0361/013/001
0.5 %w/v
Eye Drops
Solution
S01AA01
PA0361/013/002
1 %w/v
Ointment
S01AA01
PA1435/001/002
20/0.70
Cutaneous
Solution
D08AC52
CHLORAPREP
WITH TINT
Carefusion U.K.
244 Limited
PA1435/001/001
2/70 Per Cent
Cutaneous
Solution
D08AC52
CHLORHEXIDIN
E ACETATE BP
Baxter
Healthcare
Limited
Baxter
Healthcare
Limited
PA0167/010/012
0.05 %w/v
Solution for
Irrigation
B05CA02
PA0167/032/025
.015/.15 %w/v
Infus/Pdr/Oral
Soln
D08AC52
Ecolab Limited
PA1110/011/001
0.2 %w/v
Oromucosal
Solution
A01AB03
Ecolab Limited
PA1110/011/002
0.2 %w/v
Oromucosal
Solution
A01AB03
CETROTIDE
CHLORHEXIDIN
E
ACETATE/CETR
IMIDE
CHLORHEXIDIN
E GLUCONATE
ANTISEPTIC
MOUTHWASH
ORIGINAL
FLAVOUR
CHLORHEXIDIN
E GLUCONATE
ANTISEPTIC
MOUTHWASH
PEPPERMINT
FLAVOUR
Human Medicines Authorised/Transfer Pending Products
H01CC02
Active
Ingredients
-CETRORELIX
ACETATE
-CETRORELIX
ACETATE
-MATRICARIA
RECUTITA
-VARENICLINE
TARTRATE
-VARENICLINE
TARTRATE
CHENODEOXY
CHOLIC ACID
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
CHLORAMPHE
NICOL
CHLORAMPHE
NICOL
CHLORHEXIDIN
E GLUCONATE
-ISOPROPANOL
CHLORHEXIDIN
E GLUCONATE
-ISOPROPANOL
CHLORHEXIDIN
E DIACETATE
CHLORHEXIDIN
E DIACETATE
-CETRIMONIUM
BROMIDE
CHLORHEXIDIN
E GLUCONATE
Legal Basis
Routes of
Administration
-Subcutaneous
-Subcutaneous
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
-Epidural
-Epidural
-Ocular
-Topical
-Ocular
-Topical
Article 8(3) - Full
new Application
-Cutaneous
Article 8(3) - Full
new Application
-Cutaneous
CHLORHEXIDIN
E GLUCONATE
Page 95 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
CHLORHEXIDIN
E ORIGINAL
0.2%
MOUTHWASH
CHLORHEXIDIN
E PEPPERMINT
0.2%
MOUTHWASH
CHLOROMYCE
TIN 0.5% W/V
REDIDROPS
EYE DROPS,
SOLUTION
CHLOROMYCE
TIN 1% W/W
OPHTHALMIC
OINTMENT
CHLORPHENA
MINE
Eurodrug Ltd
DPR1392/075/0
01
0.2 %w/v
Oromucosal
Solution
A01AB03
CHLORHEXIDIN
E GLUCONATE
Eurodrug Ltd
DPR1392/075/0
02
0.2 %w/v
Oromucosal
Solution
A01AB03
CHLORHEXIDIN
E GLUCONATE
Mercury
Pharmaceuticals
Ltd
PA0899/028/002
0.5 %w/v
Eye Drops
Solution
S01AA01
CHLORAMPHE
NICOL
Mercury
Pharmaceuticals
Ltd
PA0899/028/001
1 %w/w
Eye Ointment
S01AA01
CHLORAMPHE
NICOL
Kyowa Kirin Ltd
PA1049/012/001
10 Mg/Ml
Solution for
Injection
R06AB04
CHLORPROMA
ZINE ELIXIR BP
Pinewood
Laboratories Ltd,
PA0281/124/001
25 MG/5ml
Oral Solution
N05AA01
CHOLEDIAM KIT
FOR
RADIOPHARMA
CEUTICAL
PREPARATION
CHOLESTAGEL
625 MG FILMCOATED
TABLETS
CHOLIB
MEDiAM
PA1229/001/001
N/A
Pdr for Soln for
Injection
V09DA04
CHLORPHENA
MINE MALEATE
CHLORPROMA
ZINE
HYDROCHLORI
DE
-MEBROFENIN
Genzyme Europe
B.V.
EU/1/03/268/1-3
625 mg Milligram
Tablets
C10AC04
Mylan Products
Limited
EU/1/13/866/001002
145/20 Milligram
Film Coated
Tablet
C10BA04
CHOLIB
Mylan Products
Limited
EU/1/13/866/003004
145/40 Milligram
Film Coated
Tablet
C10BA04
CHONDROMEL
IBSA
Farmaceutici
Italia S.r.l
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
PA1104/003/001
400 Milligram
Capsule
M01AX25
EU/1/02/237/006
2.5 Milligram
G04BE08
-TADALAFIL
-Per Oral
EU/1/02/237/7-8
5 Milligram
G04BE08
-TADALAFIL
-Per Oral
EU/1/02/237/1-5
10, 20mg
Milligram
100 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Pdr+Solv for
conc/solv for inf
G04BE08
-TADALAFIL
-Per Oral
L01BA04
-PEMETREXED
DISODIUM
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
CIALIS
CIALIS
CIALIS
CIAMBRA
CIAMBRA
CIBACEN 10 MG
FILM COATED
TABLET
CIBACEN 5 MG
FILM COATED
TABLET
EU/1/15/1055/00
1
-MICRONIZED
FENOFIBRATE
-SIMVASTATIN
WITH 0.2%
BUTYLATED
HYDROXYANIS
OLE (BHA),
(E320)
-MICRONIZED
FENOFIBRATE
-SIMVASTATIN
WITH 0.2%
BUTYLATED
HYDROXYANIS
OLE (BHA),
(E320)
-CHONDROITIN
SULFATE
EU/1/15/1055/00
2
500 Milligram
Pdr+Solv for
conc/solv for inf
L01BA04
-PEMETREXED
DISODIUM
PA1332/001/002
10 Milligram
Film Coated
Tablet
C09AA07
PA1332/001/001
5 Milligram
Film Coated
Tablet
C09AA07
-BENAZEPRIL
HYDROCHLORI
DE
-BENAZEPRIL
HYDROCHLORI
DE
Human Medicines Authorised/Transfer Pending Products
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 96 of 608
Trade Name
CIDOMYCIN
PAEDIATRIC
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Sanofi-Aventis
Ireland Limited
T/A SANOFI
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0540/036/004
20 mg/2ml
Solution for
Injection
S01AA11
-GENTAMICIN
SULFATE
PA0577/069/001
250 Milligram
Film Coated
Tablet
J01MA02
CIFLOXAGER
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/069/002
500 Milligram
Film Coated
Tablet
J01MA02
CIFOX
Rowex Ltd
PA0711/122/001
250 Milligram
Film Coated
Tablet
J01MA02
CIFOX
Rowex Ltd
PA0711/122/002
500 Milligram
Film Coated
Tablet
J01MA02
CIFOX
Rowex Ltd
PA0711/122/003
750 Milligram
Film Coated
Tablet
J01MA02
CILEST
Janssen-Cilag
Ltd
PA0748/029/001
250/35
Microgram
Tablets
G03FB05
CILIQUE
Consilient Health
Limited
PA1876/003/001
250 / 35
Microgram
Tablets
G03AA11
CILOSTAZOL
Focus
Pharmaceuticals
Ltd
Novartis
Pharmaceuticals
UK Ltd
PA1338/014/001
100 Milligram
Tablets
B01AC23
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
NORGESTIMAT
E
ETHINYLESTRA
DIOL
NORGESTIMAT
E
ETHINYLESTRA
DIOL
-CILOSTAZOL
PA0013/128/001
3 Mg/Ml
Ear Drops
Solution
S02AA15
Clonmel
Healthcare Ltd
UCB Pharma
S.A.
PA0126/077/002
400 Milligram
Tablets
A02BA01
EU/1/09/544/1-2
200 Milligram
Solution for
Injection
L04AB05
PA1390/129/001
30 Milligram
Film Coated
Tablet
H05BX01
PA1390/129/002
60 Milligram
Film Coated
Tablet
H05BX01
-CINACALCET
PA1390/129/003
90 Milligram
Film Coated
Tablet
H05BX01
-CINACALCET
CINACALCET
APOTEX
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Apotex Europe
B.V.
CERTOLIZUMAB
PEGOL
-CINACALCET
PA1513/009/001
30 Milligram
Film Coated
Tablet
H05BX01
CINACALCET
APOTEX
Apotex Europe
B.V.
PA1513/009/002
60 Milligram
Film Coated
Tablet
H05BX01
CINACALCET
APOTEX
Apotex Europe
B.V.
PA1513/009/003
90 Milligram
Film Coated
Tablet
H05BX01
CINACALCET
MYLAN
Mylan S.A.S.
EU/1/15/1054/00
1-004
30 Milligram
Film Coated
Tablet
H05BX01
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
CIFLOXAGER
CILOXAN
CIMELDINE
CIMZIA
CINACALCET
ACCORD
CINACALCET
ACCORD
CINACALCET
ACCORD
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
CIPROFLOXACI
N
HYDROCHLORI
DE
-CIMETIDINE
-Per Oral
Article 8(3) - Full
new Application
-Subcutaneous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 97 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
CINACALCET
MYLAN
Mylan S.A.S.
EU/1/15/1054/00
5-007
60 Milligram
Film Coated
Tablet
H05BX01
CINACALCET
MYLAN
Mylan S.A.S.
EU/1/15/1054/00
8-010
90 Milligram
Film Coated
Tablet
H05BX01
CINACALCET
TEVA
Teva B.V.
PA1986/007/001
30 Milligram
Film Coated
Tablet
H05B
CINACALCET
TEVA
Teva B.V.
PA1986/007/002
60 Milligram
Film Coated
Tablet
H05B
CINACALCET
TEVA
Teva B.V.
PA1986/007/003
90 Milligram
Film Coated
Tablet
H05B
CINQAERO
Teva
Pharmaceuticals
Limited
ViroPharma
SPRL
Actavis Group
PTC ehf
EU/1/16/1125/00
1
10 Mg/Ml
Concentrate for
Soln for Inf
EU/1/11/688/001
500 N/A
B06AC01
-C1 INHIBITOR
-Intra-venous
PA1380/049/002
250 Base
Milligrams
Pdr+Solv for Soln
for Inj
Film Coated
Tablet
J01MA02
-Per Oral
CIPLOX
Actavis Group
PTC ehf
PA1380/049/003
500 Base
Milligrams
Film Coated
Tablet
J01MA02
CIPLOX
Actavis Group
PTC ehf
PA1380/049/004
750 Base
Milligrams
Film Coated
Tablet
J01MA02
CIPRAGER
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/047/003
40 Milligram
Film Coated
Tablet
N06AB04
Interchangeable
List Code:
IC0073-004-003
PA0577/047/001
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
-CITALOPRAM
HYDROBROMID
E
10 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-002-003
PA0577/047/002
-CITALOPRAM
HYDROBROMID
E
20 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E
-Per Oral
20 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
Interchangeable
List Code:
IC0073-003-003
PA0776/001/001
10 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-002-003
PA0776/001/002
-CITALOPRAM
HYDROBROMID
E
20 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-003-003
PA0776/001/004
-CITALOPRAM
HYDROBROMID
E
40 Mg/Ml
Oral Drops
Solution
N06AB04
-CITALOPRAM
HYDROCHLORI
DE
-Per Oral
CINRYZE
CIPLOX
CIPRAGER
CIPRAGER
CIPRAMIL
CIPRAMIL
CIPRAMIL
CIPRAMIL
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PCO
Manufacturing
Lundbeck (
Ireland ) Limited
Lundbeck (
Ireland ) Limited
Lundbeck (
Ireland ) Limited
Interchangeable
List Code:
IC0073-003-003
PPA0465/068/00
2
Interchangeable
List Code:
IC0073-132-049
Human Medicines Authorised/Transfer Pending Products
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
-CINACALCET
HYDROCHLORI
DE
Legal Basis
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
Page 98 of 608
Trade Name
CIPRAMIL
CIPRAMIL
CIPROFLOXACI
N
Licence Holder Licence
Number
Imbat Limited
Imbat Limited
PPA1151/049/00
1
Strength
Dosage Form ATC
Active
Ingredients
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E
PPA
-Per Oral
Interchangeable
List Code:
IC0073-002-003
PA1389/002/001
2 Mg/Ml
Solution for
Infusion
J01MA02
PA0437/057/002
2 Mg/Ml
Solution for
Infusion
J01MA02
CIPROFLOXACI
N LACTATE
CIPROFLOXACI
N LACTATE
CIPROFLOXACI
N LACTATE
CIPROFLOXACI
N
Interchangeable
List Code:
IC0073-003-003
PPA1151/049/00
2
CIPROFLOXACI
N
CIPROFLOXACI
N
Hospira UK
Limited
PA0437/057/001
2 Mg/Ml
Solution for
Infusion
J01MA02
CIPROFLOXACI
N 2 MG/ML
SOLUTION FOR
INFUSION
CIPROFLOXACI
N KRKA
Noridem
Enterprises Ltd
PA1122/005/001
2 Mg/Ml
Solution for
Infusion
J01MA02
Krka d.d., Novo
mesto
PA1347/035/001
250 Milligram
Film Coated
Tablet
J01MA02
CIPROFLOXACI
N KRKA
Krka d.d., Novo
mesto
PA1347/035/002
500 Milligram
Film Coated
Tablet
J01MA02
CIPROFLOXACI
N KRKA
Krka d.d., Novo
mesto
PA1347/035/003
750 Milligram
Film Coated
Tablet
J01MA02
CIPROFLOXACI
N MYLAN
Generics (UK)
Limited
PA0405/058/001
2 Mg/Ml
Solution for
Injection
J01MA02
CIPROFLOXACI
N TEVA
Teva Pharma
B.V.
PA0749/031/002
250 Milligram
Film Coated
Tablet
J01MA02
CIPROFLOXACI
N TEVA
Teva Pharma
B.V.
PA0749/031/003
500 Milligram
Film Coated
Tablet
J01MA02
CIPROTAN
Clonmel
Healthcare Ltd
PA0126/131/001
10 Milligram
Film Coated
Tablet
N06AB04
Interchangeable
List Code:
IC0073-002-003
PA0126/131/002
20 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E’
2 Mg/Ml
Solution for
Infusion
J01MA02
CIPROFLOXACI
N LACTATE
CIPROFLOXACI
N LACTATE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
Clonmel
Healthcare Ltd
Routes of
Administration
20 Milligram
Claris
Lifesciences (UK)
Limited
Hospira UK
Limited
CIPROTAN
Legal Basis
CIPROXIN
Bayer Limited
Interchangeable
List Code:
IC0073-003-003
PA1410/028/005
CIPROXIN
Bayer Limited
PA1410/028/006
2 Mg/Ml
Solution for
Infusion
J01MA02
CIPROXIN
Bayer Limited
PA1410/028/002
250 Milligram
Film Coated
Tablet
J01MA02
CIPROXIN
Bayer Limited
PA1410/028/003
500 Milligram
Film Coated
Tablet
J01MA02
Human Medicines Authorised/Transfer Pending Products
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N
CIPROFLOXACI
N
CIPROFLOXACI
N
-CITALOPRAM
HYDROBROMID
E’
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 99 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
CIPROXIN
Bayer Limited
PA1410/028/004
750 Milligram
Film Coated
Tablet
J01MA02
CIPROXIN
Bayer Limited
PA1410/028/007
2 Mg/Ml
Solution for
Infusion
J01MA02
CIPROXIN IV
FLEXIBAG
Bayer Limited
PA1410/028/010
2 Mg/Ml
Solution for
Infusion
J01MA02
CIRCADIN
Neurim
Pharmaceuticals
EEC Ltd
Noridem
Enterprises Ltd
EU/1/07/392/001
2 Milligram
Tablet Prolonged
Release
N05CH01
PA1122/017/001
2 Mg/Ml
Solution for Inj/Inf
M03AC11
Accord
Healthcare
Limited
Caduceus
Pharma Ltd
PA1390/025/001
1 Mg/Ml
Concentrate for
Soln for Inf
L01XA01
CISATRACURIU
M
-CISPLATIN
PA1399/005/001
1 Mg/Ml
Concentrate for
Soln for Inf
L01XA01
-CISPLATIN
CISPLATIN
Fresenius Kabi
Oncology Plc
PA1422/015/001
1 Mg/Ml
Concentrate for
Soln for Inf
L01XA01
-CISPLATIN
CISPLATIN
PA0437/004/007
1 Mg/Ml
-CISPLATIN
PA0749/119/002
1 Mg/Ml
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
L01XA01
CISPLATIN
TEVA
Hospira UK
Limited
Teva Pharma
B.V.
L01XA01
-CISPLATIN
CITALOPRAM
Chanelle Medical
PA0688/008/001
10 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0073-002-003
PA0688/008/002
-CITALOPRAM
HYDROBROMID
E
20 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Chanelle Medical
Interchangeable
List Code:
IC0073-003-003
PA0688/008/003
-CITALOPRAM
HYDROBROMID
E
40 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-004-003
PA1338/003/001
-CITALOPRAM
HYDROBROMID
E
40 Mg/Ml
Oral Drops
Solution
N06AB04
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0073-132-049
PA0312/012/001
-CITALOPRAM
HYDROCHLORI
DE
40 Mg/Ml
Oral Drops
Solution
N06AB04
-CITALOPRAM
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E
-Per Oral
Interchangeable
List Code:
IC0073-003-003
PA1390/136/001
10 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-002-003
PA1390/136/002
-CITALOPRAM
HYDROBROMID
E
20 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E
-Per Oral
CISATRACURIU
M
CISPLATIN
CISPLATIN
CITALOPRAM
CITALOPRAM
CITALOPRAM
CITALOPRAM
CITALOPRAM
CITALOPRAM
ACTAVIS
CITALOPRAM
ACTAVIS
Focus
Pharmaceuticals
Ltd
Rosemont
Pharmaceuticals
Ltd
WPR Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Interchangeable
List Code:
IC0073-132-049
PPA0565/062/00
1
Interchangeable
List Code:
IC0073-003-003
Human Medicines Authorised/Transfer Pending Products
CIPROFLOXACI
N
HYDROCHLORI
DE
CIPROFLOXACI
N LACTATE
CIPROFLOXACI
N LACTATE
-MELATONIN
Routes of
Administration
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Page 100 of 608
Trade Name
CITALOPRAM
BLUEFISH
CITALOPRAM
BLUEFISH
CITALOPRAM
BLUEFISH
CITALOPRAM
TEVA
CITALOPRAM
TEVA
CITALOPRAM
TEVA
Licence Holder Licence
Number
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1436/018/001
10 Milligram
Film Coated
Tablet
N06AB04
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0073-002-003
PA1436/018/002
-CITALOPRAM
HYDROBROMID
E
20 Milligram
Film Coated
Tablet
N06AB04
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0073-003-003
PA1436/018/003
-CITALOPRAM
HYDROBROMID
E
40 Milligram
Film Coated
Tablet
N06AB04
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0073-004-003
PA0749/019/001
-CITALOPRAM
HYDROBROMID
E
10 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-002-003
PA0749/019/002
-CITALOPRAM
HYDROBROMID
E
20 Milligram
Film Coated
Tablet
N06AB04
-Per Oral
Interchangeable
List Code:
IC0073-003-003
PA0749/019/003
-CITALOPRAM
HYDROBROMID
E
40 Milligram
Film Coated
Tablet
N06AB04
-CITALOPRAM
HYDROBROMID
E
-Per Oral
3% w/v, 0.54
Microgr N/A
Solution for
Injection
N01BB54
-PRILOCAINE
HYDROCHLORI
DE
-FELYPRESSIN
-SODIUM
PICOSULFATE
-MAGNESIUM
OXIDUM LEVE
-CITRIC ACID
-CITALOPRAM
HYDROBROMID
E
Interchangeable
List Code:
IC0073-004-003
PA1045/001/001
CITANEST WITH
OCTAPRESSIN
DENTAL
Dentsply Limited
CITRAFLEET
Casen-Recordati
S.L.
PA2028/002/001
0.01,3.5,10.97/1
5.08 Grams
Powder for Oral
Solution
A06AB58
CITROL
Rowex Ltd
PA0711/064/001
10 Milligram
Film Coated
Tablet
N06AB04
Rowex Ltd
Interchangeable
List Code:
IC0073-002-003
PA0711/064/002
20 Milligram
Film Coated
Tablet
N06AB04
CITROL
Rowex Ltd
Interchangeable
List Code:
IC0073-003-003
PA0711/064/003
-CITALOPRAM
HYDROBROMID
E
30 Milligram
Film Coated
Tablet
N06AB04
CLAFORAN
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Phoenix Labs
PA0540/037/002
500 Milligram
Pdr for Soln for
Injection
J01DD01
-CITALOPRAM
HYDROBROMID
E
-CEFOTAXIME
SODIUM
PA0540/037/003
1 Grams
Pdr for Soln for
Injection
J01DD01
-CEFOTAXIME
SODIUM
PA1113/015/001
10 Milligram
Tablets
R06AX13
-LORATADINE
PIERRE FABRE
DERMATOLOGI
E
Ranbaxy Ireland
Limited
PA1230/001/001
0.05% %w/w
Cutaneous Foam
D07AD01
-CLOBETASOL
PROPIONATE
PA0408/063/001
250 Milligram
Film Coated
Tablet
J01FA09
-Per Oral
Interchangeable
List Code:
IC0072-130-003
PA0408/063/002
CLARITHROMY
CIN
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
-Per Oral
CITROL
CLAFORAN
CLAREEZE
ALLERGY 10 MG
TABLETS
CLARELUX
CLARITHROMY
CIN
CLARITHROMY
CIN
Ranbaxy Ireland
Limited
Interchangeable
List Code:
IC0072-117-003
Human Medicines Authorised/Transfer Pending Products
Article 10a Bibliographical
App
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 101 of 608
Trade Name
CLARITHROMY
CIN
CLARITHROMY
CIN
CLARITHROMY
CIN
CLARITHROMY
CIN ACTAVIS
CLARITHROMY
CIN ACTAVIS
Licence Holder Licence
Number
Mercury
Pharmaceuticals
Ltd
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Strength
Dosage Form ATC
PA0899/035/001
500 Milligram
Pdr/Conc/Soln for
Infus
J01FA09
PA1390/124/001
250 Milligram
Film Coated
Tablet
J01FA09
PA1390/124/002
500 Milligram
Film Coated
Tablet
J01FA09
PA1380/109/001
250 Milligram
Film Coated
Tablet
J01FA09
Interchangeable
List Code:
IC0072-130-003
PA1380/109/002
500 Milligram
Film Coated
Tablet
250 Milligram
Active
Ingredients
Legal Basis
Routes of
Administration
CLARITHROMY
CIN
CLARITHROMY
CIN
CLARITHROMY
CIN
CLARITHROMY
CIN
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
J01FA09
CLARITHROMY
CIN
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
CLARITHROMY
CIN
AUROBINDO
Milpharm Limited
Interchangeable
List Code:
IC0072-117-003
PA1050/023/001
CLARITHROMY
CIN
AUROBINDO
Milpharm Limited
Interchangeable
List Code:
IC0072-130-003
PA1050/023/002
500 Milligram
Film Coated
Tablet
J01FA09
Article 10(1) Generic
Application
-Per Oral
CLARITHROMY
CIN KRKA
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0072-117-003
PA1347/068/001
CLARITHROMY
CIN
250 Milligram
Film Coated
Tablet
J01FA09
Krka d.d., Novo
mesto
PA1347/068/002
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
MARTINDALE
PHARMA
CLARITHROMY
CIN TEVA
Martindale
Pharmaceuticals
Ltd
PA0361/025/001
500 Milligram
Pdr/Conc/Soln for
Infus
J01FA09
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
CLARITHROMY
CIN KRKA
CLARITHROMY
CIN
CLARITHROMY
CIN
CLARITHROMY
CIN
Teva Pharma
B.V.
PA0749/148/001
250 Milligram
Film Coated
Tablet
J01FA09
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0072-130-003
PA0749/148/002
CLARITHROMY
CIN
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Tablets
R06AX13
-LORATADINE
-Per Oral
10 Milligram
5 MG/5ml
10 Milligram
Tablets
Syrup
Oral Lyophilisate
R06AX13
R06AX13
R06AX13
-LORATADINE
-LORATADINE
-LORATADINE
-Per Oral
500 /125
Milligram
Film Coated
Tablet
J01CR02
-CLAVULANATE
POTASSIUM
-AMOXICILLIN
TRIHYDRATE
50 Microgram
Pressurised
Inhalation Soln
R03BA01
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
BECLOMETASO
NE
DIPROPIONATE
CLARITHROMY
CIN TEVA
CLARITYN
CLARITYN
CLARITYN
CLARITYN
RAPIDE
ALLERGY
CLAVAMEL
FORTE
Teva Pharma
B.V.
PCO
Manufacturing
Bayer Limited
Bayer Limited
Bayer Limited
Clonmel
Healthcare Ltd
Interchangeable
List Code:
IC0072-117-003
PPA0465/336/00
1
PA1410/075/001
PA1410/075/002
PA1410/075/003
PA0126/243/001
CLENIL
MODULITE
Chiesi Limited
Interchangeable
List Code:
IC0037-073-014
PA0743/014/001
CLENIL
MODULITE
Chiesi Limited
PA0743/014/002
100 Microgram
Pressurised
Inhalation Soln
R03BA01
CLENIL
MODULITE
Chiesi Limited
PA0743/014/003
200 Microgram
Pressurised
Inhalation Soln
R03BA01
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 102 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
CLENIL
MODULITE
Chiesi Limited
PA0743/014/004
250 Microgram
Pressurised
Inhalation Soln
R03BA01
CLEONITA
Actavis Group
PTC ehf
PA1380/132/001
0.02/3 Milligram
Film Coated
Tablet
G03AA12
CLEOSENSA
Actavis Group
PTC ehf
PA1380/132/002
0.03/3 Milligram
Film Coated
Tablet
G03AA12
CLEXANE
PCO
Manufacturing
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PPA0465/251/00
1
PA0540/097/002
100 Mg/Ml
Solution for
Injection
Solution for
Injection
B01AB05
PA0540/097/001
100 Mg/Ml
Solution for
Injection
B01AB05
-ENOXAPARIN
SODIUM
Bayer Limited
PA1410/015/001
50 Milligram
G03CA03
CLIMARA
FORTE
CLINDAMYCIN
Bayer Limited
PA1410/015/002
100 Milligram
Fresenius Kabi
Limited
PA0566/045/001
150 Mg/Ml
Transdermal
Patch
Transdermal
Patch
Solution for
Injection
-ESTRADIOL
HEMIHYDRATE
-ESTRADIOL
HEMIHYDRATE
-CLINDAMYCIN
PHOSPHATE
CLINDAMYCIN
PA1338/004/001
150 Mg/Ml
Solution for Inj/Inf
J01FF01
-CLINDAMYCIN
CLINDAMYCIN
Focus
Pharmaceuticals
Ltd
Fannin (UK) Ltd
PA1585/001/001
150 Mg/Ml
Solution for Inj/Inf
J01FF01
-CLINDAMYCIN
CLINDAMYCIN
Imbat Limited
150 Base mg/ml
Solution for Inj/Inf
J01FF01
CLINDAMYCIN
Actavis Group
PTC ehf
PPA1151/156/00
1
PA1380/188/001
150 Milligram
Capsules Hard
J01FF01
CLINDAMYCIN
Chanelle Medical
PA0688/044/001
150 Milligram
Capsules Hard
D10AF01
CLINDAMYCIN
Chanelle Medical
PA0688/044/001
150 Milligram
Capsules Hard
G01AA10
CLINDAMYCIN
Chanelle Medical
PA0688/044/001
150 Milligram
Capsules Hard
J01F
CLINDAMYCIN
Chanelle Medical
PA0688/044/002
300 Milligram
Capsule
D10AF01
CLINDAMYCIN
Chanelle Medical
PA0688/044/002
300 Milligram
Capsule
G01AA10
CLINDAMYCIN
Chanelle Medical
PA0688/044/002
300 Milligram
Capsule
J01F
-CLINDAMYCIN
PHOSPHATE
-CLINDAMYCIN
(AS
HYDROCHLORI
DE)
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
CLEXANE
FORTE
SYRINGES
CLEXANE
SYRINGES100
MG/ML
SOLUTION FOR
INJECTION
CLIMARA
Human Medicines Authorised/Transfer Pending Products
150 Mg/Ml
B01AB05
G03CA03
J01FF01
BECLOMETASO
NE
DIPROPIONATE
DROSPIRENON
E
-ETHINYL
ESTRADIOL
DROSPIRENON
E
-ETHINYL
ESTRADIOL
-ENOXAPARIN
SODIUM
-ENOXAPARIN
SODIUM
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
PPA
-Subcutaneous
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
PPA
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-venous
-Intra-Muscular
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 103 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
CLINIMIX
N14G30E
Baxter
Healthcare
Limited
PA0167/098/004
8.5/30 %v/v
Solution for
Infusion
B05BA01
CLOBADERM
Auden Mckenzie
(Pharma Division)
Ltd
Auden Mckenzie
(Pharma Division)
Ltd
SYRI Limited, t/a
Thame
Laboratories
SYRI Limited, t/a
Thame
Laboratories
Rowex Ltd
PA1352/017/001
0.05 %w/w
Cream
D07AD01
PA1352/017/002
0.05 %w/w
Ointment
D07AD01
-CLOBETASOL
PROPIONATE
PA1861/012/001
5 MG/5ml
Oral Suspension
N05BA09
-CLOBAZAM
PA1861/012/002
10 MG/5ml
Oral Suspension
N05BA09
-CLOBAZAM
PA0711/166/001
75 Milligram
Film Coated
Tablet
B01AC04
Interchangeable
List Code:
IC0005-028-003
PA0540/020/001
-CLOPIDOGREL
HYDROCHLORI
DE
50 Milligram
Tablets
G03GB02
-CLOMIFENE
CITRATE
PA0126/026/001
50 Milligram
Film Coated
Tablet
N05AA01
CLOBADERM
CLOBAZAM
THAME
CLOBAZAM
THAME
CLODEL
CLOMID
CLONACTIL
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Clonmel
Healthcare Ltd
-LEUCINE
PHENYLALANIN
E
-L-METHIONINE
-L-LYSINE
-ISOLEUCINE
-VALINE
-HISTIDINE
-THREONINE
-TRYPTOPHAN,
L-ALANINE
-ARGININE
-AMINOACETIC
ACID
-PROLINE
-SERINE
-TYROSINE
-SODIUM
ACETATE
TRIHYDRATE
-POTASSIUM
PHOSPHATE
DIBASIC
-SODIUM
CHLORIDE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-GLUCOSE
-CALCIUM
CHLORIDE
DIHYDRATE
-CLOBETASOL
PROPIONATE
CLONACTIL
Clonmel
Healthcare Ltd
PA0126/026/002
100 Milligram
Film Coated
Tablet
N05AA01
CLONACTIL
Clonmel
Healthcare Ltd
PA0126/026/003
25 Milligram
Film Coated
Tablet
N05AA01
CLONAZEPAM
Rosemont
Pharmaceuticals
Ltd
Rosemont
Pharmaceuticals
Ltd
PA0312/022/001
0.5 MG/5ml
Oral Solution
N03AE01
CHLORPROMA
ZINE
HYDROCHLORI
DE
CHLORPROMA
ZINE
HYDROCHLORI
DE
CHLORPROMA
ZINE
HYDROCHLORI
DE
-CLONAZEPAM
PA0312/022/002
2 MG/5ml
Oral Solution
N03AE01
-CLONAZEPAM
CLONAZEPAM
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Cutaneous
-Cutaneous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Page 104 of 608
Trade Name
CLONFOLIC
CLONIDINE
HYDROCHLORI
DE
CLONOCID
CLONOCID
CLOPIDOGREL
CLOPIDOGREL
CLOPIDOGREL
ZENTIVA
CLOPIDOGREL
ACTAVIS
CLOPIDOGREL
APOTEX
CLOPIDOGREL
BGR
Licence Holder Licence
Number
Clonmel
Healthcare Ltd
Auden Mckenzie
(Pharma Division)
Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Accord
Healthcare
Limited
Sanofi Pharma
Bristol-Myers
Squibb SNC
Actavis Group
PTC ehf
Apotex Europe
B.V.
Laboratoires
BIOGARAN
CLOPIDOGREL
CLONMEL
Clonmel
Healthcare Ltd
CLOPIDOGREL
HCS
HCS bvba
CLOPIDOGREL
KRKA
CLOPIDOGREL
KRKA D.D.
CLOPIDOGREL
MYLAN
Krka d.d., Novo
mesto
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0126/095/001
0.4 Milligram
Tablets
B03BB01
-FOLIC ACID
PA1352/004/001
25 Microgram
Tablets
N02CX02
PA0126/136/001
250 Milligram
Film Coated
Tablet
J01FA09
Interchangeable
List Code:
IC0072-130-003
PA0126/136/002
-CLONIDINE
HYDROCHLORI
DE
CLARITHROMY
CIN
500 Milligram
Film Coated
Tablet
J01FA09
Interchangeable
List Code:
IC0072-117-003
PA0577/157/001
CLARITHROMY
CIN
75 Milligram
Film Coated
Tablet
B01AC04
Interchangeable
List Code:
IC0005-028-003
PA1390/092/001
-CLOPIDOGREL
HYDROBROMID
E
MONOHYDRATE
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROGEN
SULPHATE
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROGENSU
LFATE
Article 10c Informed Consen
-Per Oral
Interchangeable
List Code:
IC0005-028-003
PA1380/057/001
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
BESILATE
-Per Oral
Interchangeable
List Code:
IC0005-028-003
EU/1/09/568/1-18
Article 10(1) Generic
Application
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
BESYLATE
-Per Oral
Interchangeable
List Code:
IC0005-028-003
EU/1/09/558/1-10
Article 10(1) Generic
Application
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROGEN
SULPHATE
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
B01AC04
Film Coated
Tablet
B01AC04
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
75 Milligram
-CLOPIDOGREL
(HYDROGEN
SULFATE)
-CLOPIDOGREL
HYDROCHLORI
DE
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0005-028-003
EU/1/08/465/114,18-19
Interchangeable
List Code:
IC0005-028-003
PA0126/279/001
EU/1/10/651/001015
Interchangeable
List Code:
IC0005-028-003
EU/1/09/556/1-9
Krka, d.d., Novo
mesto
Interchangeable
List Code:
IC0005-028-003
EU/1/09/562/0019
Mylan S.A.S.
Interchangeable
List Code:
IC0005-028-003
EU/1/09/559/1-9
Interchangeable
List Code:
IC0005-028-003
Human Medicines Authorised/Transfer Pending Products
75
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 105 of 608
Trade Name
CLOPIDOGREL
RATIOPHARM
Licence Holder Licence
Number
Teva B.V.
CLOPIDOGREL
RATIOPHARM
GMBH
Archie Samuel
s.r.o.
CLOPIDOGREL
TAD
TAD Pharma
GmbH
CLOPIDOGREL
TEVA
CLOPIDOGREL
TEVA PHARMA
CLOPIDOGREL
ZENTIVA
CLOPIDOGRELSPLENDRIS
CLOPIDROGEL
IWA
EU/1/14/975/001017
Strength
Dosage Form ATC
Teva B.V.
Sanofi Pharma
Bristol-Myers
Squibb SNC
Splendris
Pharmaceuticals
GmbH
IWA Consulting
ApS
B01AC04
-CLOPIDOGREL
HYDROGEN
SULPHATE
Article 10(1) Generic
Application
-Per Oral
75 Milligram
Film Coated
Tablet
B01AC04
Article 10(1) Generic
Application
-Per Oral
EU/1/09/555/1-9
75 Milligram
Film Coated
Tablet
B01AC04
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0005-028-003
EU/1/09/540/1-16
-CLOPIDOGREL
BESILATE
-MACROGOL
6000
-CARBON
DIOXIDE
-CLOPIDOGREL
HYDROCHLORI
DE
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROGEN
SULPHATE
Article 10(1) Generic
Application
-Per Oral
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
300 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
Interchangeable
List Code:
IC0005-029-003
PA1772/001/001
75 Milligram
Film Coated
Tablet
B01AC04
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0005-028-003
PA1367/003/001
-CLOPIDOGREL
HYDROGEN
SULPHATE
75 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
BESILATE
Article 10(1) Generic
Application
-Per Oral
200 Mg/Ml
Solution for
Injection
N05AF05
ZUCLOPENTHI
XOL
DECANOATE
ZUCLOPENTHI
XOL
DIHYDROCHLO
RIDE
ZUCLOPENTHI
XOL
DECANOATE
CLARITHROMY
CIN
Interchangeable
List Code:
IC0005-028-003
EU/1/09/541/1-8
Interchangeable
List Code:
IC0005-028-003
EU/1/09/561/0019
Interchangeable
List Code:
IC0005-028-003
EU/1/08/465/1517
CLOPIXOL
Lundbeck Limited
CLOPIXOL
Lundbeck Limited
PA0115/005/003
10 Milligram
Film Coated
Tablet
N05AF05
CLOPIXOL
CONC.
Lundbeck Limited
PA0115/005/007
500 Mg/Ml
Solution for
Injection
N05AF05
CLOROM
Rowex Ltd
PA0711/061/001
250 Milligram
Film Coated
Tablet
J01FA09
Rowex Ltd
Interchangeable
List Code:
IC0072-130-003
PA0711/061/002
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
CLOROM
Imbat Limited
Routes of
Administration
Film Coated
Tablet
Interchangeable
List Code:
IC0005-028-003
PA0115/005/001
CLOROM
Legal Basis
75 Milligram
Interchangeable
List Code:
IC0005-028-003
Teva B.V.
Active
Ingredients
Interchangeable
List Code:
IC0072-117-003
PPA1151/119/00
1
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
Interchangeable
List Code:
IC0072-117-003
Human Medicines Authorised/Transfer Pending Products
Page 106 of 608
Trade Name
CLOROM XL
Licence Holder Licence
Number
Morningside
Healthcare
Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1333/010/001
500 Milligram
Tablet Prolonged
Release
J01FA09
CLARITHROMY
CIN
Article 10(1) Generic
Application
-Per Oral
25 Milligram
Tablets
N05AH02
-CLOZAPINE
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
-Per Oral
CLOZALUX
Rowex Ltd
Interchangeable
List Code:
IC0072-117-050
PA0711/125/001
CLOZALUX
Rowex Ltd
PA0711/125/002
50 Milligram
Tablets
N05AH02
-CLOZAPINE
CLOZALUX
Rowex Ltd
PA0711/125/003
100 Milligram
Tablets
N05AH02
-CLOZAPINE
CLOZARIL
PA2136/001/001
25 Milligram
Tablets
N05AH02
-CLOZAPINE
-Per Oral
PA2136/001/002
100 Milligram
Tablets
N05AH02
-CLOZAPINE
-Per Oral
EU/1/16/1087/00
1
250 IU
Pdr+Solv for Soln
for Inj
B02BD13
EU/1/16/1087/00
2
500 IU
Pdr+Solv for Soln
for Inj
B02BD13
CO-AMOXICLAV
Mylan Products
Limited
Mylan Products
Limited
Bio Products
Laboratory
Limited
Bio Products
Laboratory
Limited
Fannin Limited
PA1457/001/001
500/100 Milligram
Pdr for Soln
Inj/Inf
J01CR02
CO-AMOXICLAV
Fannin Limited
PA1457/001/002
1000/200
Milligram
Pdr for Soln
Inj/Inf
J01CR02
CO-AMOXICLAV
Wockhardt UK
Limited
PA1339/005/001
500/100 Milligram
Pdr for Soln
Inj/Inf
J01CR02
CO-AMOXICLAV
Wockhardt UK
Limited
PA1339/005/002
1000/200
Milligram
Pdr for Soln
Inj/Inf
J01CR02
CO-AMOXICLAV
Hikma
Farmaceutica
(Portugal) SA
PA1217/007/001
250/125 Milligram
Film Coated
Tablet
J01CR02
Brown & Burk UK
Ltd
PA1648/004/001
250/125 Milligram
Film Coated
Tablet
J01CR02
-HUMAN
COAGULATION
FACTOR X
-HUMAN
COAGULATION
FACTOR X
-AMOXICILLIN
SODIUM
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
SODIUM
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
SODIUM
-CLAVULANATE
POTASSIUM
-AMOXICILLIN
SODIUM
-CLAVULANATE
POTASSIUM
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
(IN THE FORM
OF
AMOXICILLIN
TRIHYDRATE)
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED WITH
MICROCRYSTA
LLINE
CELLULOSE
(1:1))
CLOZARIL
COAGADEX
COAGADEX
CO-AMOXICLAV
Interchangeable
List Code:
IC0037-074-014
Interchangeable
List Code:
IC0037-074-014
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 107 of 608
Trade Name
CO-AMOXICLAV
Licence Holder Licence
Number
Brown & Burk UK
Ltd
PA1648/004/002
Strength
Dosage Form ATC
500/125 Milligram
Film Coated
Tablet
J01CR02
500/125 Milligram
Film Coated
Tablet
J01CR02
875/125 Milligram
Film Coated
Tablet
J01CR02
Interchangeable
List Code:
IC0037-073-014
CO-AMOXICLAV
Actavis Group
PTC ehf
PA1380/141/001
Interchangeable
List Code:
IC0037-073-014
CO-AMOXICLAV
Actavis Group
PTC ehf
PA1380/141/002
Interchangeable
List Code:
IC0037-072-003
CO-AMOXICLAV
Fresenius Kabi
Limited
PA0566/064/001
1000/200
Milligram
Pdr for Soln
Inj/Inf
J01CR02
CO-AMOXICLAV
Brown & Burk UK
Ltd
PA1648/004/003
875/125 Milligram
Film Coated
Tablet
J01CA04
500/125 Milligram
Film Coated
Tablet
J01CR02
875/125 Milligram
Film Coated
Tablet
J01CR02
875/125 Milligram
Film Coated
Tablet
J01CR02
Interchangeable
List Code:
IC0037-072-003
CO-AMOXICLAV
AUROBINDO
Aurobindo
Pharma Limited
PA1311/016/001
Interchangeable
List Code:
IC0037-073-014
CO-AMOXICLAV
AUROBINDO
Aurobindo
Pharma Limited
PA1311/016/002
Interchangeable
List Code:
IC0037-072-003
CO-AMOXICLAV
BLUEFISH
Bluefish
Pharmaceuticals
AB
PA1436/002/003
Interchangeable
List Code:
IC0037-072-003
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-AMOXICILLIN
(IN THE FORM
OF
AMOXICILLIN
TRIHYDRATE)
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED WITH
MICROCRYSTA
LLINE
CELLULOSE
(1:1))
-AMOXICILLINE
TRIHYDRATE
-POTASSIUM
CLAVULANATE
& AVICEL (1:1)
PH. EUR.
EQUIVALENT
TO CLAVULANIC
ACID
-AMOXICILLINE
TRIHYDRATE
-POTASSIUM
CLAVULANATE
& AVICEL (1:1)
PH. EUR.
EQUIVALENT
TO CLAVULANIC
ACID
-AMOXICILLIN
SODIUM
-CLAVULANIC
ACID (IN THE
FORM OF
POTASSIUM
CLAVULANATE)
-AMOXICILLIN
(AS
AMOXICILLIN
TRIHYDRATE)
-CLAVULANIC
ACID (AS
POTASSIUM
CLAVULANATE,
DILUTED WITH
MICROCRYSTA
LLINE
CELLULOSE
(1:1))
-AMOXICILLIN
TRIHYDRATE
-POTASSIUM
CLAVULANATE,
DILUTED (WITH
MICROCRYSTA
LLINE
CELLULOSE IN
A RATIO OF 1:1)
-AMOXICILLIN
TRIHYDRATE
-POTASSIUM
CLAVULANATE,
DILUTED (WITH
MICROCRYSTA
LLINE
CELLULOSE IN
A RATIO OF 1:1)
-AMOXICILLIN
-CLAVULANIC
ACID
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 108 of 608
Trade Name
CO-AMOXICLAV
BLUEFISH
Licence Holder Licence
Number
Bluefish
Pharmaceuticals
AB
CO-AMOXICLAV
SUGAR FREE
Brown & Burk UK
Ltd
CO-AMOXICLAV
SUGAR FREE
Brown & Burk UK
Ltd
Strength
Dosage Form ATC
Legal Basis
Routes of
Administration
PA1436/002/002
500/125 Milligram
Film Coated
Tablet
J01CR02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0037-073-014
PA1648/005/003
-AMOXICILLIN
-CLAVULANIC
ACID
200/28.5 MG/5ml
Powder for Oral
Suspension
J01CR02
Article 10(1) Generic
Application
-Per Oral
PA1648/005/004
400/57 MG/5ml
Powder for Oral
Suspension
J01CR02
-AMOXICILLIN
TRIHYDRATE
-POTASSIUM
CLAVULANATE,
DILUTED (WITH
MICROCRYSTA
LLINE
CELLULOSE IN
A RATIO OF 1:1)
-AMOXICILLIN
TRIHYDRATE
-POTASSIUM
CLAVULANATE,
DILUTED (WITH
MICROCRYSTA
LLINE
CELLULOSE IN
A RATIO OF 1:1)
-AMOXICILLIN
SODIUM
-CLAVULANATE
POTASSIUM
-AMOXICILLIN
SODIUM
-CLAVULANATE
POTASSIUM
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-ANAMIRTA
COCCULUS
FRUCT.SIC.
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-COAL TAR
SOLUTION
-SULFUR
-SALICYLIC
ACID
-CODEINE
PHOSPHATE
HEMIHYDRATE
-DANTRON
-POLOXALCOL
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0037-076-034
CO-AMOXICLAV
TEVA
Teva Pharma
B.V.
PA0749/011/001
500/100 Milligram
Pdr for Soln
Inj/Inf
J01CR02
CO-AMOXICLAV
TEVA
Teva Pharma
B.V.
PA0749/011/002
1000/200
Milligram
Pdr for Soln for
Injection
J01CR02
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/86/23-28
300/25 Milligram
Tablets
C09DA04
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/086/001
150/12.5
Milligram
Tablets
C09DA04
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/086/004
300/12.5
Milligram
Tablets
C09DA04
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/086/002
150 Milligram
Tablets
C09DA04
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/086/003
150 Milligram
Tablets
C09DA04
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/086/005
300 Milligram
Tablets
C09DA04
COAPROVEL
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/98/086/007
300 Milligram
Tablets
C09DA04
COCCULUS
Weleda (UK)
Limited
HOR0407/050/0
01
6C - 200C
Tablets
CO-CODAMOL
Mercury
Pharmaceuticals
Ltd
PA0899/034/001
30/500 Milligram
Tablets
Effervescent
N02AA59
COCOIS
RPH
Pharmaceuticals
AB
PA1638/005/001
%v/v
Ointment
D11AC08
CODANT
Mercury
Pharmaceuticals
(Ireland) Ltd
Pinewood
Laboratories Ltd,
PA0073/029/001
30 Milligram
Tablets
R05DA04
PA0281/080/001
25/200 mg/mg
per 5ml
Oral Suspension
A06AB53
CODANTHRAMER
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Page 109 of 608
Trade Name
CODANTHRAMER
CODINEX
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
CO-DIOVAN
Licence Holder Licence
Number
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
PA0281/080/002
Strength
Dosage Form ATC
Oral Suspension
A06AB53
PA0281/005/001
75/1000 mg/mg
per 5ml
3 Micromol
Oral Solution
R05DA04
PA0013/091/001
80/12.5 mg/mg
Film Coated
Tablet
C09DA03
Interchangeable
List Code:
IC0040-081-003
PA0013/091/003
160/25 mg/mg
Film Coated
Tablet
Interchangeable
List Code:
IC0040-078-003
PA0013/091/002
160/12.5 mg/mg
Interchangeable
List Code:
IC0040-077-003
PA0013/091/004
Interchangeable
List Code:
IC0040-079-003
PA0013/091/005
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0040-080-003
PPA1463/043/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0040-081-003
PPA1463/043/00
2
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0040-077-003
PPA1463/043/00
3
PCO
Manufacturing
Interchangeable
List Code:
IC0040-078-003
PPA0465/226/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0040-081-003
PPA0465/226/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0040-077-003
PPA0465/226/00
3
PCO
Manufacturing
Interchangeable
List Code:
IC0040-078-003
PPA0465/226/00
4
Interchangeable
List Code:
IC0040-080-003
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-DANTRON
-POLOXALCOL
-CODEINE
PHOSPHATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
320/12.5 mg/mg
Film Coated
Tablet
C09DA03
Article 8(3) - Full
new Application
-Per Oral
320/25 mg/mg
Film Coated
Tablet
C09DA03
Article 8(3) - Full
new Application
-Per Oral
80/12.5 mg/mg
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE,
MICRONIZED
-VALSARTAN
HYDROCHLOR
OTHIAZIDE,
MICRONIZED
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
160/12.5 mg/mg
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
160/25 mg/mg
Film Coated
Tablet
C09CA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
80/12.5 mg/mg
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
160/12.5 mg/mg
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
160/25 mg/mg
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
320/25 mg/mg
Film Coated
Tablet
C09DA03
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
PPA
-Per Oral
-Per Oral
Page 110 of 608
Trade Name
CO-DIOVAN
Licence Holder Licence
Number
PCO
Manufacturing
PPA0465/226/00
5
Strength
Dosage Form ATC
320/12.5 mg/mg
Film Coated
Tablet
C09DA03
Interchangeable
List Code:
IC0040-079-003
PA0899/033/002
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
15/500 Milligram
Capsules Hard
N02BE51
N02BE51
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-GELSEMIUM
SEMPERVIRENS
(GHP)
CHOLECALCIF
EROL
CONCENTRATE
(2,000,000IU/G
IN ARACHIS OIL)
-TRICLOSAN
-SODIUM
FLUORIDE
-SODIUM
FLUORIDE
-TRICLOSAN
CODIPAR
Mercury
Pharmaceuticals
Ltd
CODIPAR
Mercury
Pharmaceuticals
Ltd
PA0899/033/001
15/500 Milligram
Tablets
Effervescent
COLDENZA
A. Nelson &
Company Limited
HOA1149/005/0
01
6C
Tablets
COLECALCIFE
ROL
SYRI Limited, t/a
Thame
Laboratories
PA1861/005/001
3000 IU/ML
Oral Solution
A11CC05
COLGATE
TOTAL PRO
GUM HEALTH
COLGATE
TOTAL PRO
GUM HEALTH
TARTAR
CONTROL
TOOTHP
COLIFOAM 10%
W/W RECTAL
FOAM
COLOBREATHE
ColgatePalmolive (U.K.)
Ltd
ColgatePalmolive (U.K.)
Ltd
PA0320/005/001
0.30 . 0.32 %w/w
Toothpaste
A01AA01
PA0320/005/003
0.30 . 0.32 %w/w
Toothpaste
A01AA01
Meda Health
Sales Ireland
Limited
Teva B.V.
PA1332/002/001
10 %w/w
Rectal Foam
D07AA02
EU/1/11/747/001
125 Milligram
Inhalation
Powder, Capsule
R07A
COLOFAC
Imbat Limited
PPA1151/122/00
1
135 Milligram
Coated Tablets
A03AA04
COLOFAC
BGP Products
Ltd
PA2007/002/001
135 Milligram
Tablets
A03AA04
COLOMYCIN
IMED Healthcare
Ltd.
DPR1463/043/0
01
1 000 000
International Unit
Pdr for Soln
Inj/Inf
J01XB01
COLOMYCIN
Forest
Laboratories UK
Ltd
Forest
Laboratories UK
Ltd
PCO
Manufacturing
PA0100/001/009
2 000 000
International Unit
Pdr for Soln
Inj/Inf
J01XB01
PA0100/001/008
1 International
Unit
Pdr for Soln
Inj/Inf
J01XB01
DPR0465/041/0
01
1 000 000
International Unit
Pdr for Soln
Inj/Inf
J01XB01
McNeil
Healthcare
(Ireland) Ltd
Imbat Limited
PA0823/045/001
0.2 Millilitre
Capsule
A03AX
PPA1151/087/00
1
PA0148/064/001
0.2 Millilitre
Capsules GastroResistant
Eye Drops
Solution
A02D
COLOMYCIN
COLOMYCIN
INJECTION
COLPERMIN
COLPERMIN
Active
Ingredients
COMBIGAN
Allergan
Pharmaceuticals
Ireland
COMBIGAN
Eurodrug Ltd
DPR1392/059/0
01
2/5 Mg/Ml
Eye Drops
Solution
S01ED51
COMBIPRASAL
Pharma Stulln
GmbH
PA1815/001/001
0.5/2.5 mg/mg
Nebuliser
Solution
R03AK04
Human Medicines Authorised/Transfer Pending Products
2/5 Mg/Ml
S01ED51
HYDROCORTIS
ONE ACETATE
COLISTIMETHA
TE SODIUM (R
INN)
-MEBEVERINE
HYDROCHLORI
DE
-MEBEVERINE
HYDROCHLORI
DE
-COLISTIN
MESILATE
SODIUM
-COLISTIN
MESILATE
SODIUM
-COLISTIN
MESILATE
SODIUM
-COLISTIN
MESILATE
SODIUM
-PEPPERMINT
OIL
-PEPPERMINT
OIL
-BRIMONIDINE
TARTRATE
-TIMOLOL
MALEATE
-BRIMONIDINE
TARTRATE
-TIMOLOL
-IPRATROPIUM
BROMIDE
-SALBUTAMOL
SULFATE
Legal Basis
Routes of
Administration
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Per Oral
--Unknown--
-Inhalation
PPA
-Per Oral
-Per Oral
PPA
-Per Oral
Article 10(3) Hybrid
Application
-Inhalation
Page 111 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
COMBIVENT
UDVS
Boehringer
Ingelheim Limited
PA0007/052/002
0.5/2.5 mg/mg
Nebuliser
Solution
R03AL02
COMBIVIR
ViiV Healthcare
UK Ltd
ViiV Healthcare
UK Ltd
IMED Healthcare
Ltd.
EU/1/98/058/001
150/300 Milligram
Tablets
J05AR01
EU/1/98/058/002
150/300 Milligram
Tablets
J05AR01
PPA1463/068/00
1
0.5/0.4 Milligram
Capsules Hard
G04CA52
0.5/0.4 Milligram
Capsules Hard
G04CA52
-DUTASTERIDE
-TAMSULOSIN
HYDROCHLORI
DE
-Per Oral
0.5/0.4 Milligram
Capsules Hard
G04CA52
-DUTASTERIDE
-TAMSULOSIN
HYDROCHLORI
DE
-Per Oral
0.5/0.4 Milligram
Capsules Hard
G04CA52
-DUTASTERIDE
-TAMSULOSIN
HYDROCHLORI
DE
PPA
-Per Oral
20 Milligram
Capsules Hard
L01XE26
Capsules Hard
L01XE26
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
20 + 80 Milligram
15/500 Milligram
Tablets
A10BD05
-CABOZANTINIB
(S)-MALATE
-CABOZANTINIB
(S)-MALATE
-METFORMIN
HYDROCHLORI
DE
-PIOGLITAZONE
-METFORMIN
HYDROCHLORI
DE
-PIOGLITAZONE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-SODIUM
LACTATE
SOLUTION 50%
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
LACTATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-SODIUM
LACTATE
SOLUTION
-CALCIUM
CHLORIDE
DIHYDRATE
-ENTACAPONE
COMBIVIR
COMBODART
COMBODART
COMBODART
COMBODART
PCO
Manufacturing
GlaxoSmithKline
(Ireland) Limited
Imbat Limited
Interchangeable
List Code:
IC0036-065-001
PPA0465/334/00
1
Interchangeable
List Code:
IC0036-065-001
PA1077/118/001
Interchangeable
List Code:
IC0036-065-001
PPA1151/171/00
1
Interchangeable
List Code:
IC0036-065-001
EU/1/13/890/001
COMETRIQ
Ipsen Pharma
COMETRIQ
Ipsen Pharma
COMPETACT
Takeda Pharma
A/S
EU/1/13/890/002003
EU/1/06/354/001009
COMPETACT
Takeda Pharma
A/S
EU/1/06/354/1012
15/850 Milligram
Film Coated
Tablet
A10BD05
COMPOUND
SODIUM
LACTATE
INTRAVENOUS
INFUSION
B. Braun Medical
Limited
PA0179/004/008
Per Cent
Solution for
Infusion
B05BB01
COMPOUND
SODIUM
LACTATE
INTRAVENOUS
INFUSION B.P.
Baxter
Healthcare
Limited
PA0167/055/007
%v/v
Solution for
Infusion
B05BB01
COMPOUND
SODIUM
LACTATE
INTRAVENOUS
INFUSION BP
B. Braun Medical
Limited
PA0179/004/003
6/6.24/0.40/0.27
%v/v
Solution for
Infusion
B05BB01
COMTAN
Novartis
Europharm
Limited
EU/1/98/081/002
200 Milligram
Tablets
N04BX02
Human Medicines Authorised/Transfer Pending Products
-IPRATROPIUM
BROMIDE
MONOHYDRATE
-SALBUTAMOL
SULFATE
-ZIDOVUDINE
-LAMIVUDINE
-ZIDOVUDINE
-LAMIVUDINE
-DUTASTERIDE
-TAMSULOSIN
HYDROCHLORI
DE
Legal Basis
-Inhalation
PPA
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
Page 112 of 608
Trade Name
COMTAN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis &
Bristol-Myers
Squibb
Orion Corporatio
Orion Corporatio
Orion Corporatio
Orion Corporatio
Pfizer Limited
EU/1/98/081/003
200 Milligram
Tablets
N04BX02
-ENTACAPONE
EU/1/98/081/004
200 Milligram
Tablets
N04BX02
-ENTACAPONE
EU/1/98/081/001
200 Milligram
Tablets
N04BX02
-ENTACAPONE
EU/1/98/082/001
EU/1/98/082/002
EU/1/98/082/003
EU/1/98/082/004
EU/1/09/511/1-4
200 Milligram
200 Milligram
200 Milligram
200 Milligram
20 Milligram
N04BX02
N04BX02
N04BX02
N04BX02
G03XC02
CONCERTA XL
Janssen-Cilag
Ltd
PA0748/049/004
27 Milligram
Tablets
Tablets
Tablets
Tablets
Film Coated
Tablet
Tablet Prolonged
Release
CONCERTA XL
Janssen-Cilag
Ltd
PA0748/049/001
18 Milligram
Tablet Prolonged
Release
N06BA04
CONCERTA XL
Janssen-Cilag
Ltd
PA0748/049/002
36 Milligram
Tablet Prolonged
Release
N06BA04
CONCERTA XL
Janssen-Cilag
Ltd
PA0748/049/003
54 Milligram
Tablet Prolonged
Release
N06BA04
CONCERTA XL
Imbat Limited
PPA1151/243/00
1
18 Milligram
Tablet Prolonged
Release
N06BA04
CONCERTA XL
Imbat Limited
PPA1151/243/00
3
36 Milligram
Tablet Prolonged
Release
N06BA04
CONCERTA XL
Imbat Limited
PPA1151/243/00
2
27 Milligram
Tablet Prolonged
Release
N06BA04
CONDYLINE 0.5
% W/V
CUTANEOUS
SOLUTION
CONSTELLA
Takeda UK
Limited
PA1547/010/001
0.5% %w/v
Cutaneous
Solution
D06BB04
-ENTACAPONE
-ENTACAPONE
-ENTACAPONE
-ENTACAPONE
BAZEDOXIFENE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
PODOPHYLLOT
OXIN
Allergan
Pharmaceuticals
International
Limited
Takeda GmbH
EU/1/12/801/001004
290 Microgram
Capsules Hard
A06AX04
-LINACLOTIDE
Article 8(3) - Full
new Application
-Per Oral
EU/1/09/515/001
20 Milligram
Tablets GastroResistant
A02BC02
Article 10(3) Hybrid
Application
-Per Oral
Takeda GmbH
EU/1/09/515/002
20 Milligram
Tablets GastroResistant
A02BC02
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
Article 10(3) Hybrid
Application
-Per Oral
COMTAN
COMTAN
COMTESS
COMTESS
COMTESS
COMTESS
CONBRIZA
CONTROLOC
CONTROL
CONTROLOC
CONTROL
Human Medicines Authorised/Transfer Pending Products
N06BA04
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Topical
Page 113 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
CONTROLOC
CONTROL
Takeda GmbH
EU/1/09/515/003
20 Milligram
Tablets GastroResistant
A02BC02
CONTROLOC
CONTROL
Takeda GmbH
EU/1/09/515/004
20 Milligram
Tablets GastroResistant
A02BC02
COPALIA
Novartis
Europharm
Limited
EU/1/06/372/001008
5/80
Film Coated
Tablet
C09DB01
5/160
Film Coated
Tablet
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
10/160
Film Coated
Tablet
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
5/160/12.5
Film Coated
Tablet
C09DX01
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-GLATIRAMER
ACETATE
-Per Oral
COPALIA
COPALIA
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Interchangeable
List Code:
IC0042-087-003
EU/1/06/372/009016
Interchangeable
List Code:
IC0042-086-003
EU/1/06/372/017024
Interchangeable
List Code:
IC0042-084-003
EU/1/09/575/1-12
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
-AMLODIPINE
BESYLATE
-VALSARTAN
Legal Basis
Article 10(3) Hybrid
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
COPALIA HCT
Novartis
Europharm
Limited
COPALIA HCT
Novartis
Europharm
Limited
EU/1/09/575/1324
10/160/12.5
Film Coated
Tablet
C09DX01
COPALIA HCT
Novartis
Europharm
Limited
EU/1/09/575/2536
5/160/25
Film Coated
Tablet
C09DX01
COPALIA HCT
Novartis
Europharm
Limited
EU/1/09/575/3748
10/160/25
Film Coated
Tablet
C09DX01
COPALIA HCT
Novartis
Europharm
Limited
EU/1/09/575/4960
10/320/25
Film Coated
Tablet
C09DX01
COPAXONE
Teva
Pharmaceuticals
Limited
Teva
Pharmaceuticals
Limited
Roche Products
Limited
PA1014/001/004
40 Mg/Ml
Solution for
Injection
L03AX13
PA1014/001/002
20 Mg/Ml
Solution for
Injection
L03AX13
-GLATIRAMER
ACETATE
PA0050/153/001
200 Milligram
Film Coated
Tablet
J05AB04
-RIBAVIRIN
-Per Oral
Roche Products
Limited
PA0050/153/002
400 Milligram
Film Coated
Tablet
J05AB04
-RIBAVIRIN
-Per Oral
PCO
Manufacturing
PPA0465/119/00
1
200 Milligram
Tablets
C01BD01
-AMIODARONE
HYDROCHLORI
DE
COPAXONE
PRE-FILLED
SYRINGE
COPEGUS 200
MG FILMCOATED
TABLETS
COPEGUS 400
MG FILMCOATED
TABLET
CORDARONE X
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
PPA
-Subcutaneous
-Per Oral
Page 114 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
CORDARONE X
Imbat Limited
PPA1151/084/00
1
100 Milligram
Tablets
C01BD01
CORDARONE X
Imbat Limited
PPA1151/084/00
2
200 Milligram
Tablets
C01BD01
CORDARONE X
IMED Healthcare
Ltd.
PPA1463/094/00
1
100 Milligram
Tablets
C01BD04
CORDARONE X
IMED Healthcare
Ltd.
PPA1463/094/00
2
200 Milligram
Tablets
C01BD04
CORDARONE X
PCO
Manufacturing
PPA0465/119/00
2
100 Milligram
Tablets
C01BD01
CORDARONE X
LTT Pharma
Limited
PPA1562/176/00
1
200 Milligram
Tablets
C01BD01
CORDARONE X
100MG
TABLETS
CORDARONE X
200MG
TABLETS
CORDARONE X
INTRAVENOUS
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Les Laboratoires
Servier
Les Laboratoires
Servier
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0540/142/001
100 Milligram
Tablets
C01BD04
PA0540/142/002
200 Milligram
Tablets
C01BD01
PA0540/142/003
150mg/3ml N/A
Solution for
Infusion
C01BD04
EU/1/05/317/1-7
5 Milligram
Tablets
C01EB17
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-AMIODARONE
HYDROCHLORI
DE
-IVABRADINE
EU/1/05/317/8-14
7.5 Milligram
Tablets
C01EB17
-IVABRADINE
PA0678/002/001
1 %w/w
Dental Gel
A01AB03
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0678/002/004
0.2 %w/v
Mouth Wash
A01AB03
CHLORHEXIDIN
E
DIGLUCONATE
(AS
CHLORHEXIDIN
E
DIGLUCONATE
SOLUTION (20%
W/V) PH.EUR.
CHLORHEXIDIN
E GLUCONATE
PA0678/002/005
0.2 %w/v
Mouth Wash
A01AB03
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Ferring Ireland
Ltd
PA0678/002/002
0.2 %w/v
Mouth Wash
A01AB03
PA1009/026/001
9 Milligram
Tablet Prolonged
Release
A07EA06
-BUDESONIDE
CORTOPIN
Pinewood
Laboratories Ltd,
PA0281/071/002
1 %w/w
Cream
D07AA02
-Topical
COSARTAL
Actavis Group
PTC ehf
PA1380/046/004
100 Milligram
Film Coated
Tablet
C09CA01
HYDROCORTIS
ONE
-LOSARTAN
POTASSIUM
Interchangeable
List Code:
IC0003-024-003
PA1380/046/003
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
CORLENTOR
CORLENTOR
CORSODYL
CORSODYL
ANISEED
CORSODYL
FRESHMINT
CORSODYL
MINT
CORTIMENT
COSARTAL
Actavis Group
PTC ehf
PPA
-Per Oral
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
CHLORHEXIDIN
E
DIGLUCONATE
(AS
CHLORHEXIDIN
E
DIGLUCONATE
SOLUTION (20%
W/V) PH.EUR.
CHLORHEXIDIN
E GLUCONATE
-Oromucosal
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0003-023-003
Human Medicines Authorised/Transfer Pending Products
Page 115 of 608
Trade Name
COSARTAL
PLUS
COSARTAL
PLUS
COSARTAL
PLUS
COSENTYX
COSENTYX
COSENTYX
COSIMPREL
Licence Holder Licence
Number
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Les Laboratoires
Servier
Strength
Dosage Form ATC
PA1380/098/001
50/12.5 Milligram
Film Coated
Tablet
C09DA01
Interchangeable
List Code:
IC0031-025-003
PA1380/098/002
100/25 Milligram
Film Coated
Tablet
C09DA01
100/12.5
Milligram
Film Coated
Tablet
C09DA01
150 Milligram
Pdr for Soln for
Injection
EU/1/14/980/002003
150 Milligram
EU/1/14/980/004005
150 Milligram
PA0568/029/001
5/5 Milligram
Interchangeable
List Code:
IC0031-027-003
PA1380/098/003
Interchangeable
List Code:
IC0031-026-003
EU/1/14/980/001
-Per Oral
Article 10(1) Generic
Application
-Per Oral
L04AC10
Article 8(3) - Full
new Application
-Subcutaneous
Solution for
injection in prefilled syringe
Solution for
injection in prefilled pen
Film Coated
Tablet
L04AC10
-SECUKINUMAB
Article 8(3) - Full
new Application
-Subcutaneous
L04AC10
-SECUKINUMAB
Article 8(3) - Full
new Application
-Subcutaneous
C09BX02
-BISOPROLOL
FUMARATE
-PERINDOPRIL
ARGININE
-BISOPROLOL
FUMARATE
-PERINDOPRIL
ARGININE
-BISOPROLOL
FUMARATE
-PERINDOPRIL
ARGININE
-BISOPROLOL
FUMARATE
-PERINDOPRIL
ARGININE
-IRON
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
PA0568/029/002
5/10 Milligram
Film Coated
Tablet
C09BX02
COSIMPREL
Les Laboratoires
Servier
PA0568/029/003
10/5 Milligram
Film Coated
Tablet
C09BX02
COSIMPREL
Les Laboratoires
Servier
PA0568/029/004
10/10 Milligram
Film Coated
Tablet
C09BX02
COSMOFER
Pharmacosmos
A/S
Santen OY
PA0982/001/001
50 Milligram
Solution for Inj/Inf
B03AC
PA0879/005/001
20/5 Milligram
S01ED51
COSOPT
LTT Pharma
Limited
PPA1562/043/00
3
20 + 5 Mg/Ml
Eye Drops
Solution
Eye Drops
Solution
COSOPT
PCO
Manufacturing
PPA0465/296/00
1
20/5 Milligram
Eye Drops
Solution
S01ED51
COSOPT
Clear Pharmacy
20 + 5 Mg/Ml
Imbat Limited
Eye Drops
Solution
Ear Drops
Solution
S01ED51
COSOPT
PPA1596/060/00
1
PPA1151/159/00
1
COSOPT
IMED Healthcare
Ltd.
PPA1463/060/00
1
20/5 Milligram
Eye Drops
Solution
S01ED51
COSOPT
Eurodrug Ltd
20/5 Mg/Ml
IMED Healthcare
Ltd.
Santen OY
Eye Drops
Solution
Eye Drops
Solution
Eye Drops
Solution
S01ED51
COSOPT
DPR1392/072/0
01
DPR1463/046/0
01
PA0879/005/002
COSOPT
PRESERVATIV
E-FREE
Human Medicines Authorised/Transfer Pending Products
20/5 Milligram
20/5 Mg/Ml
Routes of
Administration
Article 10(1) Generic
Application
Les Laboratoires
Servier
20 + 5 Base
mg/ml
Legal Basis
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-SECUKINUMAB
COSIMPREL
COSOPT
Active
Ingredients
S01ED51
S01ED51
S01ED51
S01ED51
-DORZOLAMIDE
-TIMOLOL
-DORZOLAMIDE
HYDROCHLORI
DE
-TIMOLOL
MALEATE
-DORZOLAMIDE
HYDROCHLORI
DE
-TIMOLOL
MALEATE
-DORZOLAMIDE
-TIMOLOL
-DORZOLAMIDE
HYDROCHLORI
DE
-TIMOLOL
MALEATE
-DORZOLAMIDE
HYDROCHLORI
DE
-TIMOLOL
MALEATE
-DORZOLAMIDE
-TIMOLOL
-DORZOLAMIDE
-TIMOLOL
-DORZOLAMIDE
-TIMOLOL
-Per Oral
PPA
PPA
PPA
PPA
-Ocular
Page 116 of 608
Trade Name
COTELLIC
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Roche
Registration
Limited
Carysfort
Healthcare
Limited
EU/1/15/1048/00
1
20 Milligram
Film Coated
Tablet
L01XE38
-COBIMETINIB
HEMIFUMARATE
Article 8(3) - Full
new Application
-Per Oral
PA1684/003/001
500/30 Milligram
Capsules Hard
N02AA59
Article 10a Bibliographical
App
-Per Oral
CO-TIPOL
Carysfort
Healthcare
Limited
PA1684/003/002
500/30 Milligram
Suppositories
N02AA59
Article 10a Bibliographical
App
-Per Oral
CO-TIPOL MAX
Carysfort
Healthcare
Limited
PA1684/003/003
1000/60 Milligram
Suppositories
N02AA59
Article 10a Bibliographical
App
-Rectal
CO-VATAN
Rowex Ltd
PA0711/182/001
80/12.5 mg/tablet
Film Coated
Tablet
C09CA03
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0040-081-003
PA0711/182/002
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
160/12.5
mg/tablet
Film Coated
Tablet
C09CA03
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0040-077-003
PA0711/182/003
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
160/25 mg/tablet
Film Coated
Tablet
C09CA03
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0040-078-003
PA0711/182/004
-VALSARTAN
HYDROCHOLO
THIAZIDE
320/12.5
mg/tablet
Film Coated
Tablet
C09CA03
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0040-079-003
PA0711/182/005
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
320/25 mg/tablet
Film Coated
Tablet
C09CA03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0040-080-003
PA0568/024/002
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
5/1.25/5 Milligram
Film Coated
Tablet
C09BX01
-PERINDOPRIL
ARGININE
-INDAPAMIDE
-AMLODIPINE
BESILATE
-PERINDOPRIL
ARGININE
-INDAPAMIDE
-AMLODIPINE
BESILATE
-PERINDOPRIL
ARGININE
-INDAPAMIDE
-AMLODIPINE
BESILATE
-PERINDOPRIL
ARGININE
-INDAPAMIDE
-AMLODIPINE
BESILATE
-PERINDOPRIL
TERTBUTYLAMINE
SALT
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
--Unknown--
-Per Oral
CO-TIPOL
CO-VATAN
CO-VATAN
CO-VATAN
CO-VATAN
COVERDINE
Les Laboratoires
Servier
COVERDINE
Les Laboratoires
Servier
PA0568/024/003
5/1.25/10
Milligram
Film Coated
Tablet
C09BX01
COVERDINE
Les Laboratoires
Servier
PA0568/024/004
10/2.5/5 Milligram
Film Coated
Tablet
C09BX01
COVERDINE
Les Laboratoires
Servier
PA0568/024/005
10/2.5/10
Milligram
Film Coated
Tablet
C09BX01
COVERSYL
Les Laboratoires
Servier
PA0568/002/001
2 Milligram
Tablets
C09AA04
Interchangeable
List Code:
IC0002-006-002
PA0568/002/002
4 Milligram
Tablets
C09AA04
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0002-008-002
PA0568/002/003
-PERINDOPRIL
TERTBUTYLAMINE
SALT
8 Milligram
Tablets
C09AA09
-PERINDOPRIL
TERTBUTYLAMINE
SALT
--Unknown--
-Per Oral
COVERSYL
COVERSYL
Les Laboratoires
Servier
Les Laboratoires
Servier
Interchangeable
List Code:
IC0002-009-002
Human Medicines Authorised/Transfer Pending Products
Page 117 of 608
Trade Name
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE
COVERSYL
ARGININE PLUS
COVERSYL
ARGININE PLUS
COVERSYL
ARGININE PLUS
COVERSYL
ARGININE PLUS
Licence Holder Licence
Number
Les Laboratoires
Servier
Les Laboratoires
Servier
Les Laboratoires
Servier
Les Laboratoires
Servier
Les Laboratoires
Servier
PCO
Manufacturing
PA0568/002/004
2.5 Milligram
PA0568/002/006
10 Milligram
Interchangeable
List Code:
IC0002-002-015
PA0568/002/005
C09AA04
5 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0002-001-015
PA0568/002/008
5 Milligram
PA0568/002/009
10 Milligram
PPA0465/067/00
4
5 Milligram
PCO
Manufacturing
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0002-002-015
PPA1463/024/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0002-001-015
PPA1463/024/00
2
Clear Pharmacy
Clear Pharmacy
B & S Healthcare
Dosage Form ATC
Film Coated
Tablet
Film Coated
Tablet
Interchangeable
List Code:
IC0002-001-015
PPA0465/067/00
5
Clear Pharmacy
Strength
Interchangeable
List Code:
IC0002-002-015
PPA1596/007/00
1
Interchangeable
List Code:
IC0002-001-015
PPA1596/007/00
2
Interchangeable
List Code:
IC0002-002-015
PPA1596/031/00
1
Interchangeable
List Code:
IC0039-020-003
PPA1328/122/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0039-020-003
PPA0465/067/00
7
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0039-015-003
PPA1463/039/00
2
Active
Ingredients
Legal Basis
Routes of
Administration
-PERINDOPRIL
ARGININE
-PERINDOPRIL
ARGININE
--Unknown--
-Per Oral
--Unknown--
-Per Oral
C09AA04
-PERINDOPRIL
ARGININE
--Unknown--
-Per Oral
Orodispersible
Tablet
Orodispersible
Tablet
Film Coated
Tablet
C09AA04
-PERINDOPRIL
ARGININE
-PERINDOPRIL
ARGININE
-PERINDOPRIL
ARGININE
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C09AA04
-PERINDOPRIL
ARGININE
PPA
-Per Oral
5 Milligram
Film Coated
Tablet
C09AA04
-PERINDOPRIL
ARGININE
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C09AA04
-PERINDOPRIL
ARGININE
PPA
-Per Oral
5 Milligram
Film Coated
Tablet
C09AA04
-PERINDOPRIL
ARGININE
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C09AA04
-PERINDOPRIL
ARGININE
PPA
-Per Oral
5/1.25 mg/mg
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
PPA
-Per Oral
5/1.25 Milligram
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
PPA
-Per Oral
10/2.5
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
PPA
-Per Oral
10/2.5
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
PPA
-Per Oral
C09AA04
C09AA04
C09AA04
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0039-015-003
Human Medicines Authorised/Transfer Pending Products
Page 118 of 608
Trade Name
COVERSYL
ARGININE PLUS
COVERSYL
ARGININE PLUS
COVERSYL
ARGININE PLUS
COVERSYL
ARGININE PLUS
Licence Holder Licence
Number
Les Laboratoires
Servier
PCO
Manufacturing
Les Laboratoires
Servier
Les Laboratoires
Servier
COVERSYL
ARGININE PLUS
LTT Pharma
Limited
COVERSYL
PLUS
Les Laboratoires
Servier
COZAAR
COZAAR
COZAAR
COZAAR
COZAAR
COZAAR
COZAAR
COZAAR
PCO
Manufacturing
Imbat Limited
PCO
Manufacturing
Imbat Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Clear Pharmacy
Clear Pharmacy
PA0568/022/002
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
10/2.5 mg/mg
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
Article 10b Fixed
Combination
-Per Oral
5/1.25
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
PPA
-Per Oral
Interchangeable
List Code:
IC0039-020-003
PA0568/008/003
2.5/0.625
Film Coated
Tablet
C09BA04
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0039-019-003
PA0568/016/002
-PERINDOPRIL
ARGININE
-INDAPAMIDE
5/1.25
Film Coated
Tablet
C09BA04
-PERINDOPRIL
ARGININE
-INDAPAMIDE
Article 8(3) - Full
new Application
-Per Oral
10/2.5 Milligram
Film Coated
Tablet
C09BA04
4/1.25 mg/mg
Tablets
C09BA04
50 Milligram
Film Coated
Tablet
C09CA01
-PERINDOPRIL
ARGININE
-INDAPAMIDE
-PERINDOPRIL
TERTBUTYLAMINE
SALT
-INDAPAMIDE
-LOSARTAN
POTASSIUM
50 Milligram
Film Coated
Tablet
C09CA01
100 Milligram
Film Coated
Tablet
100 Milligram
Interchangeable
List Code:
IC0003-024-003
PA1286/004/004
PA1286/004/001
Interchangeable
List Code:
IC0039-015-003
PPA0465/067/00
6
Interchangeable
List Code:
IC0039-020-003
PPA1562/063/00
2
PA0568/016/001
Interchangeable
List Code:
IC0039-011-002
PPA0465/106/00
1
Interchangeable
List Code:
IC0003-023-003
PPA1151/005/00
1
Interchangeable
List Code:
IC0003-023-003
PPA0465/106/00
2
Interchangeable
List Code:
IC0003-024-003
PPA1151/005/00
2
Interchangeable
List Code:
IC0003-021-003
PPA1596/003/00
1
Interchangeable
List Code:
IC0003-023-003
PPA1596/003/00
2
-Per Oral
--Unknown--
-Per Oral
PPA
-Per Oral
-LOSARTAN
POTASSIUM
PPA
-Per Oral
C09CA01
-LOSARTAN
POTASSIUM
PPA
-Per Oral
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
PPA
-Per Oral
2.5 Mg/Ml
Powder for Oral
Suspension
C09CA01
-LOSARTAN
POTASSIUM
Article 8(3) - Full
new Application
-Per Oral
12.5 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
PPA
-Per Oral
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
PPA
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0003-024-003
Human Medicines Authorised/Transfer Pending Products
Page 119 of 608
Trade Name
COZAAR
COZAAR
COZAAR
COZAAR
COZAAR COMP
COZAAR COMP
COZAAR COMP
COZAAR COMP
COZAAR COMP
COZATAN
COZATAN
COZATAN
COMP
COZATAN
COMP
CRAMPEX
TABLETS
Licence Holder Licence
Number
IMED Healthcare
Ltd.
PPA1463/029/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0003-023-003
PPA1463/029/00
2
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Clonmel
Healthcare Ltd
Thornton & Ross
Limited
Routes of
Administration
-LOSARTAN
POTASSIUM
PPA
-Per Oral
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
PPA
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA1286/004/002
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA1286/004/003
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA1286/001/002
50/12.5 Milligram
Film Coated
Tablet
C09DA01
-Per Oral
Interchangeable
List Code:
IC0031-025-003
PA1286/001/003
100/25 Milligram
Film Coated
Tablet
C09DA01
100/25 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
50/12.5 Milligram
Film Coated
Tablet
C09DA01
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
100/12.5
Milligram
Film Coated
Tablet
C09DA01
-Per Oral
Interchangeable
List Code:
IC0031-026-003
PA0126/167/001
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
Interchangeable
List Code:
IC0003-023-003
PA0126/167/002
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA0126/184/001
50/12.5 Milligram
Film Coated
Tablet
C09DA01
Interchangeable
List Code:
IC0031-025-003
PA0126/184/002
100/25 Milligram
Film Coated
Tablet
C09DA01
Interchangeable
List Code:
IC0031-027-003
PA0610/006/001
%v/v
Tablets
A12AX
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
-NICOTINIC
ACID
PCO
Manufacturing
Clonmel
Healthcare Ltd
Legal Basis
C09CA01
Interchangeable
List Code:
IC0031-027-003
PPA0465/109/00
1
Clonmel
Healthcare Ltd
Active
Ingredients
Film Coated
Tablet
PCO
Manufacturing
Clonmel
Healthcare Ltd
Dosage Form ATC
50 Milligram
Interchangeable
List Code:
IC0031-027-003
PPA0465/109/00
2
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Strength
Interchangeable
List Code:
IC0031-025-003
PA1286/001/001
Human Medicines Authorised/Transfer Pending Products
-Per Oral
PPA
-Per Oral
PPA
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 120 of 608
Trade Name
Licence Holder Licence
Number
CREON
Imbat Limited
CREON
McDowell
Pharmaceuticals
Imbat Limited
CREON
CREON
CREON 10000
CREON 10000
CREON 10000
CREON 10000
CREON 10000
CREON 25000
CREON 25000
CREON 25000
CREON 25000
CREON 25000
300 MG
GASTRORESISTANT
CAPSULES
CREON 40000
CREON FOR
CHILDREN 5000
CRESEMBA
CRESEMBA
CRESTOR
CRESTOR
CRESTOR
CRESTOR
CRESTOR
LTT Pharma
Limited
BGP Products
Ltd
McDowell
Pharmaceuticals
IMED Healthcare
Ltd.
B & S Healthcare
PCO
Manufacturing
PCO
Manufacturing
BGP Products
Ltd
LTT Pharma
Limited
IMED Healthcare
Ltd.
Chemilines
Healthcare
(Ireland) Limited
BGP Products
Ltd
BGP Products
Ltd
Basilea Medical
Ltd (c/o Cox
Costello & Horne
Limited)
Basilea Medical
Ltd (c/o Cox
Costello & Horne
Limited)
Imbat Limited
Imbat Limited
Clear Pharmacy
Imbat Limited
Clear Pharmacy
Strength
Dosage Form ATC
PPA1151/065/00
1
PPA1473/018/00
1
PPA1151/065/00
2
PPA1562/143/00
2
PA2007/003/001
150 Milligram
PPA1473/018/00
2
PPA1463/033/00
1
PPA1328/065/00
1
PPA0465/125/00
1
PPA0465/125/00
2
PA2007/003/002
150 Milligram
PPA1562/143/00
1
PPA1463/033/00
2
PPA1915/007/00
1
300 Milligram
PA2007/003/003
400 Milligram
PA2007/003/004
60.12 Milligram
EU/1/15/1036/00
2
200 Milligram
EU/1/15/1036/00
1
PPA1151/044/00
3
Interchangeable
List Code:
IC0006-001-003
PPA1151/044/00
4
Interchangeable
List Code:
IC0006-004-003
PPA1596/025/00
1
Interchangeable
List Code:
IC0006-003-003
PPA1151/044/00
2
Interchangeable
List Code:
IC0006-002-003
PPA1596/025/00
2
300 Milligram
25000
10000 N/A
150 Milligram
150 Milligram
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsule
A09AA02
Active
Ingredients
Legal Basis
Routes of
Administration
A09AA02
-PANCREAS
POWDER
-PANCREATIN
A09AA02
-PANCREATIN
-Per Oral
A09AA02
-PANCREATIN
-Per Oral
A09AA02
-PANCREAS
POWDER
A09AA02
PPA
PPA
PPA
A09AA02
-PANCREATIN
PPA
A09AA02
-PANCREATIN
PPA
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
Capsules GastroResistant
A09AA04
-PANCREATIN
PPA
-Per Oral
A09AA04
-PANCREATIN
PPA
-Per Oral
A09AA02
-PANCREAS
POWDER
-PANCREAS
POWDER
-PANCREAS
POWDER
-PANCREATIN
PPA
Capsules GastroResistant
Granules GastroResistant
Pdr/Conc/Soln for
Infus
A09AA02
100 Milligram
Capsules Hard
J02AC05
ISAVUCONAZO
NIUM SULFATE
5 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
(AS CALCIUM)
-Per Oral
40 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
(AS CALCIUM)
-Per Oral
20 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
(AS CALCIUM)
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
PPA
-Per Oral
150 Milligram
150 Milligram
300 Milligram
300 Milligram
300 Milligram
300 Milligram
A09AA02
A09AA02
A09AA02
A09AA02
J02AC05
-PANCREAS
POWDER
-PANCREAS
POWDER
ISAVUCONAZO
NIUM SULFATE
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Interchangeable
List Code:
IC0006-002-003
Human Medicines Authorised/Transfer Pending Products
Page 121 of 608
Trade Name
CRESTOR
CRESTOR
CRESTOR
CRESTOR
CRESTOR
Licence Holder Licence
Number
AstraZeneca UK
Limited
Imbat Limited
AstraZeneca UK
Limited
AstraZeneca UK
Limited
AstraZeneca UK
Limited
PA0970/057/004
Strength
Dosage Form ATC
Active
Ingredients
Film Coated
Tablet
C10AA07
ROSUVASTATIN
CALCIUM
20 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
Interchangeable
List Code:
IC0006-003-003
PA0970/057/001
10 Milligram
Film Coated
Tablet
C10AA07
-Per Oral
Interchangeable
List Code:
IC0006-002-003
PA0970/057/002
ROSUVASTATIN
CALCIUM
20 Milligram
Film Coated
Tablet
C10AA07
-Per Oral
Interchangeable
List Code:
IC0006-003-003
PA0970/057/003
ROSUVASTATIN
CALCIUM
40 Milligram
Film Coated
Tablet
C10AA07
ROSUVASTATIN
CALCIUM
-Per Oral
8 %w/w
Vaginal Gel
G03DA04
PROGESTERO
NE
PROGESTERO
NE
PROGESTERO
NE
PROGESTERO
NE
PROGESTERO
NE
-INDINAVIR
SULFATE
-INDINAVIR
Interchangeable
List Code:
IC0006-001-003
PPA1151/044/00
1
Interchangeable
List Code:
IC0006-004-003
PPA0465/301/00
1
PCO
Manufacturing
CRINONE
Merck Serono
Limited
PA0654/021/001
8 %w/w
Vaginal Gel
G03DA04
CRINONE
Imbat Limited
PPA1151/235/00
1
8 Per Cent
Vaginal Gel
G03DA04
CRINONE
LTT Pharma
Limited
PPA1562/146/00
1
8 %w/w
Vaginal Gel
G03DA04
CRINONE
IMED Healthcare
Ltd.
PPA1463/112/00
1
8 %w/w
Vaginal Gel
G03DA04
CRIXIVAN
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Genus
Pharmaceuticals
Limited
EU/1/96/024/008
400 Milligram
Capsule
J05AE02
EU/1/96/024/010
Capsule
J05AE02
EU/1/96/024/001
100 Base
Milligrams
200 Milligram
Capsule
J05AE02
EU/1/96/024/004
400 Milligram
Capsule
J05AE02
EU/1/96/024/002
200 Milligram
Capsule
J05AE02
EU/1/96/024/003
200 Milligram
Capsule
J05AE02
EU/1/96/024/005
400 Milligram
Capsule
J05AE02
EU/1/96/024/007
333 Milligram
Capsule
J05AE02
PA1496/001/001
600 Milligram
Pdr for Soln
Inj/Inf
J01CE01
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Weleda (UK)
Limited
EU/1/05/328/001
350 Milligram
J01XX09
-DAPTOMYCIN
EU/1/05/328/002
500 Milligram
J01XX09
-DAPTOMYCIN
HOR0407/023/0
01
6C & 30C
Unknown
Pdr for Soln
Inj/Inf
Pdr for Soln
Inj/Inf
Tablets
Sparkle S.r.l.
EU/1/12/784/001
V
Galderma (UK)
Ltd
PA0590/027/001
Radio-Pharm
Precursor
Medicated Nail
Lacquer
CRIXIVAN
CRIXIVAN
CRIXIVAN
CRIXIVAN
CRIXIVAN
CRIXIVAN
CRYSTAPEN
600MG
POWDER FOR
SOLUTION FOR
INJECTION
CUBICIN
CUBICIN
CUPRUM
METALLICUM
(CUPRUM. MET.)
(6C & 30C)
CUPRYMINA
CURANAIL
Routes of
Administration
5 Milligram
CRINONE
CRIXIVAN
Legal Basis
Human Medicines Authorised/Transfer Pending Products
5 %w/v
-Per Oral
PPA
-INDINAVIR
SULFATE
-INDINAVIR
SULFATE
-INDINAVIR
SULFATE
-INDINAVIR
SULFATE
-INDINAVIR
SULFATE
-INDINAVIR
SULFATE
BENZYLPENICI
LLIN SODIUM
-Per Oral
-Per Oral
-CUPRUM
METALLICUM
D01AE16
-COPPER (64
CU) CHLORIDE
-AMOROLFINE
HYDROCHLORI
DE
Article 10c Informed Consen
-Cutaneous
Page 122 of 608
Trade Name
Licence Holder Licence
Number
Strength
CUROSURF
Chiesi Limited
PA0743/013/001
120 Milligram
CUROSURF
Chiesi Limited
PA0743/013/002
Milligram
CUVITRU
Baxalta
Innovations
GmbH
PA2004/008/001
200 Mg/Ml
CYANOKIT
SERB S.A.,
EU/1/07/420/001
CYANOKIT
SERB S.A.,
CYCLIMORPH
10
Dosage Form ATC
Endotrachpulm
Inst, Susp
Endotrachpulm
Inst, Susp
Solution for
Injection
R07AA02
2.5 Grams
Unknown
V03AB33
EU/1/07/420/002
5 Grams
Pdr for Soln for
Infusion
V03AB33
Amdipharm
Limited
PA1142/003/001
10/50mg/ml
Milligram
Solution for
Injection
N02AA51
CYCLIMORPH
15
Amdipharm
Limited
PA1142/003/002
15/50mg/ml
Milligram
Solution for
Injection
N02AA51
CYKLOKAPRON
Meda Health
Sales Ireland
Limited
Pfizer Healthcare
Ireland
Actavis Group
PTC ehf
PA1332/003/001
500 Milligram
Film Coated
Tablet
B02AA02
PA0822/117/001
Solution for
Injection
Granules for oral
solution
B02AA02
PA1380/051/001
500mg/5ml
MG/5ml
N/A
Eli Lilly
Nederland B.V.
EU/1/04/296/1-4
30 Milligram
Capsules GastroResistant
N06AX21
60 Milligram
Capsules GastroResistant
500 mg Milligram
CYKLOKAPRON
CYMALON
CYMBALTA
CYMBALTA
CYMEVENE
CYMEX
CYRAMZA
Eli Lilly
Nederland B.V.
Roche Products
Limited
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0091-033-006
EU/1/04/296/002005
Interchangeable
List Code:
IC0091-127-006
PA0050/125/002
PA1380/012/001
R07AA02
J06BA01
Routes of
Administration
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
-Per Oral
-Intra-venous
N06AX21
-DULOXETINE
-Per Oral
Pdr/Conc/Soln for
Infus
Cream
J05AB06
-Intra-venous
Concentrate for
Soln for Inf
Oral Powder
L01XC
-GANCICLOVIR
SODIUM
-UREA
-CETRIMONIUM
BROMIDE
CHLOROCRES
OL
-DIMETICONE
-RAMUCIRUMAB
G04B
D08AJ04
10 Mg/Ml
CYSTADANE
EU/1/14/957/001003
EU/1/06/379/001
CYSTADROPS
Orphan Europe
EU/1/15/1049/00
1
3.8 Mg/Ml
Eye Drops
Solution
S01XA21
CYSTAGON
Orphan Europe
Sarl
EU/1/97/039/001
50 Milligram
Capsule
A16AA04
CYSTAGON
Orphan Europe
Sarl
EU/1/97/039/003
150 Milligram
Capsule
A16AA04
CYSTAGON
Orphan Europe
Sarl
EU/1/97/039/002
50 Milligram
Capsule
A16AA04
CYSTAGON
Orphan Europe
Sarl
EU/1/97/039/004
150 Milligram
Capsule
A16AA04
Human Medicines Authorised/Transfer Pending Products
-PORCINE LUNG
SURFACTANT
-PORCINE LUNG
SURFACTANT
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
HYDROXOCOB
ALAMIN
HYDROXOCOB
ALAMIN
-MORPHINE
TARTRATE
-CYCLIZINE
-MORPHINE
TARTRATE
-CYCLIZINE
-TRANEXAMIC
ACID
Legal Basis
-TRANEXAMIC
ACID
-CITRIC ACID
-SODIUM
BICARBONATE
-SODIUM
CITRATE
DIHYDRATE
-SODIUM
CARBONATE
ANHYDROUS
-DULOXETINE
HYDROCHLORI
DE
Eli Lilly
Nederland B.V.
Orphan Europe
1 Grams
Active
Ingredients
A16AA06
-BETAINE
ANHYDROUS
MERCAPTAMIN
E
HYDROCHLORI
DE
MERCAPTAMIN
E BITARTRATE
MERCAPTAMIN
E BITARTRATE
MERCAPTAMIN
E BITARTRATE
MERCAPTAMIN
E BITARTRATE
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Ocular
Page 123 of 608
Trade Name
Licence Holder Licence
Number
Strength
CYSTOPURIN
Bayer Limited
PA1410/042/001
3 Grams
CYSTOPURIN
PCO
Manufacturing
Imbat Limited
PPA0465/280/00
1
PPA1151/144/00
1
PA0540/143/001
3 Grams
CYSTOPURIN
CYSTRIN
CYSTRIN
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
TEVA
CYTOTEC
DACARBAZINE
LIPOMED
DACARBAZINE
MEDAC
DACARBAZINE
MEDAC
DACARBAZINE
MEDAC
DACEPTON
DACOGEN
DAFIRO
DAFIRO
DAFIRO
DAFIRO HCT
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
A12BA02
3 Milligram
Granules for oral
solution
Granules for oral
solution
Granules for oral
solution
Tablets
PA0540/143/002
5 Milligram
Tablets
G04BD04
PA0437/006/003
20 Micromol
Solution for Inj/Inf
L01BC01
-POTASSIUM
CITRATE
-POTASSIUM
CITRATE
-POTASSIUM
CITRATE
-OXYBUTYNIN
HYDROCHLORI
DE
-OXYBUTYNIN
HYDROCHLORI
DE
-CYTARABINE
PA0437/006/009
100 Mg/Ml
L01BC01
-CYTARABINE
PA1422/009/001
100 Mg/Ml
Solution for
Injection
Solution for Inj/Inf
L01BC01
-CYTARABINE
PA1390/091/001
100 Mg/Ml
Solution for Inj/Inf
L01BC01
-CYTARABINE
PA1986/041/001
100 Milligram
Infus/Pdr/Oral
Soln
L01BC01
-CYTARABINE
Pfizer Healthcare
Ireland
Lipomed GmbH
PA0822/118/001
200 Microgram
Tablets
A02BB01
-MISOPROSTOL
PA1760/001/001
200 Milligram
Pdr for Soln
Inj/Inf
L01AX04
-DACARBAZINE
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
EVER Neuro
Pharma GmbH
PA0623/003/002
200 Milligram
Pdr for Soln
Inj/Inf
L01AX04
-DACARBAZINE
CITRATE
PA0623/003/003
500 Milligram
Pdr for Soln for
Infusion
L01AX04
-DACARBAZINE
CITRATE
PA0623/003/004
1000 Milligram
Pdr for Soln for
Infusion
L01AX04
-DACARBAZINE
CITRATE
PA1774/001/002
5 Mg/Ml
Solution for
Infusion
N04BC07
Janssen-Cilag
International NV
Novartis
Europharm
Limited
EU/1/12/792/001
Pdr/Conc/Soln for
Infus
Film Coated
Tablet
L01BC08
-APOMORPHINE
HYDROCHLORI
DE
HEMIHYDRATE
-DECITABINE
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
5/160
Film Coated
Tablet
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
10/160
Film Coated
Tablet
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
5/160/12.5
Milligram
Film Coated
Tablet
C09DX01
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Hospira UK
Limited
Hospira UK
Limited
Fresenius Kabi
Oncology Plc
Accord
Healthcare
Limited
Teva B.V.
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
EU/1/06/371/001008
Interchangeable
List Code:
IC0042-087-003
EU/1/06/371/009016
Interchangeable
List Code:
IC0042-086-003
EU/1/06/371/017024
Interchangeable
List Code:
IC0042-084-003
EU/1/09/574/1-12
Human Medicines Authorised/Transfer Pending Products
3 Grams
50
5/80
A12BA02
A12BA02
G04BD04
PPA
PPA
-Per Oral
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Subcutaneous
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
Article 10b Fixed
Combination
-Per Oral
Page 124 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
DAFIRO HCT
Novartis
Europharm
Limited
EU/1/09/574/1324
10/160/12.
Milligram
Film Coated
Tablet
C09DX01
DAFIRO HCT
Novartis
Europharm
Limited
EU/1/09/574/2536
5/160/25
Milligram
Film Coated
Tablet
C09DX01
DAFIRO HCT
Novartis
Europharm
Limited
EU/1/09/574/3748
10/160/25
Milligram
Film Coated
Tablet
C09DX01
DAFIRO HCT
Novartis
Europharm
Limited
EU/1/09/574/4960
10/320/25
Milligram
Film Coated
Tablet
C09DX01
DAKLINZA
Bristol-Myers
Squibb Pharma
EEIG
Bristol-Myers
Squibb Pharma
EEIG
Bristol-Myers
Squibb Pharma
EEIG
EU/1/14/939/001002
30 Milligram
Film Coated
Tablet
J05AX14
EU/1/14/939/003004
60 Milligram
Film Coated
Tablet
J05AX14
EU/1/14/939/005006
90 Milligram
Film Coated
Tablet
J05AX14
DAKTACORT 2%
/ 1% W/W
CREAM
Janssen-Cilag
Ltd
PA0748/026/001
2% / 1% %w/w
Cream
D07CA01
DAKTARIN
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
Pfizer Healthcare
Ireland
LTT Pharma
Limited
PCO
Manufacturing
Imbat Limited
PA0823/059/001
2.0 %w/w
Cream
A01AB09
PA0823/059/002
2.0 %w/w
Cutaneous
Powder
A01AB09
-MICONAZOLE
NITRATE
PA0823/059/003
20mg/g MG/5ml
Oral Gel
A01AB09
-MICONAZOLE
PA0822/119/002
2 Base %w/w
Vaginal Cream
J01FF01
PPA1562/162/00
1
PPA0465/416/00
1
PPA1151/223/00
1
2 Per Cent
Vaginal Cream
J01FF01
2 Per Cent
Vaginal Cream
J01FF01
150 Milligram
Capsules Hard
J01FF01
DALACIN C
Primecrown 2010
Ltd
PPA1633/028/00
1
150 Milligram
Capsules Hard
J01FF01
DALACIN C
Pfizer Healthcare
Ireland
PA0822/120/001
150 Base
Milligrams
Capsules Hard
J01FF01
DALACIN C
PCO
Manufacturing
Pfizer Healthcare
Ireland
PPA0465/205/00
1
PA0822/120/002
150 Base
Milligrams
150 Micromol
Capsules Hard
J01FF01
-CLINDAMYCIN
PHOSPHATE
-CLINDAMYCIN
PHOSPHATE
-CLINDAMYCIN
PHOSPHATE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
HYDROCHLORI
DE
-CLINDAMYCIN
Concentrate for
Soln for Inf
J01FF01
-CLINDAMYCIN
PHOSPHATE
Pfizer Healthcare
Ireland
PA0822/120/003
150 Micromol
Concentrate for
Soln for Inf
J01FF01
-CLINDAMYCIN
PHOSPHATE
Pfizer Healthcare
Ireland
PA0822/121/001
10 Base mg/ml
Cutaneous
Emulsion
D10AF01
-CLINDAMYCIN
PHOSPHATE
DAKLINZA
DAKLINZA
DAKTARIN
DAKTARIN
ORAL
DALACIN
DALACIN
DALACIN
DALACIN C
DALACIN C
PHOSPHATE
2ML
DALACIN C
PHOSPHATE
4ML
DALACIN T
TOPICAL
LOTION
Human Medicines Authorised/Transfer Pending Products
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-DACLATASVIR
DIHYDROCHLO
RIDE
-DACLATASVIR
DIHYDROCHLO
RIDE
-DECLATASVIR
DIHYDROCHLO
RIDE (BMS790052-05)
-MICONAZOLE
NITRATE
HYDROCORTIS
ONE
-MICONAZOLE
NITRATE
Legal Basis
Routes of
Administration
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Topical
-Topical
-Topical
-Per Oral
PPA
Page 125 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
DALACIN T
TOPICAL
SOLUTION
DALACIN
VAGINAL
OVULE
DALIRESP
Pfizer Healthcare
Ireland
PA0822/121/002
10 Base mg/ml
Cutaneous
Solution
D10AF01
-CLINDAMYCIN
PHOSPHATE
Pfizer Healthcare
Ireland
PA0822/119/001
100 Milligram
Pessary
G01AA10
-CLINDAMYCIN
PHOSPHATE
AstraZeneca AB
500 Milligram
-ROFLUMILAST
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Pinewood
Laboratories Ltd,
15 MG
Film Coated
Tablet
Capsules Hard
R03DX07
DALMANE
EU/1/11/668/001003
PA1332/031/001
N05CD01
PA1332/031/002
30 MG
Capsules Hard
N05CD01
PA0281/073/001
15 MG
Capsules Hard
N05CD01
DALMAPAM
Pinewood
Laboratories Ltd,
PA0281/073/002
30 MG
Capsules Hard
N05CD01
DANCEX SR
Rowex Ltd
PA0711/143/001
5 Milligram
Tablet Prolonged
Release
N02AA05
DANCEX SR
Rowex Ltd
PA0711/143/002
10 Milligram
Tablet Prolonged
Release
N02AA05
DANCEX SR
Rowex Ltd
PA0711/143/003
20 Milligram
Tablet Prolonged
Release
N02AA05
DANCEX SR
Rowex Ltd
PA0711/143/004
40 Milligram
Tablet Prolonged
Release
N02AA05
DANCEX SR
Rowex Ltd
PA0711/143/005
60 Milligram
Tablet Prolonged
Release
N02AA05
DANCEX SR
Rowex Ltd
PA0711/143/006
80 Milligram
Tablet Prolonged
Release
N02AA05
DANCEX SR
PLUS
Rowex Ltd
PA0711/250/001
5/2.5 Milligram
Tablet Prolonged
Release
N02AA55
DANCEX SR
PLUS
Rowex Ltd
PA0711/250/004
40/20 Milligram
Tablet Prolonged
Release
N02AA55
DANCEX SR
PLUS
Rowex Ltd
PA0711/250/003
20/10 Milligram
Tablet Prolonged
Release
N02AA55
DANCEX SR
PLUS
Rowex Ltd
PA0711/250/002
10/5 Milligram
Tablet Prolonged
Release
N02AA55
DANTRIUM
Norgine B.V.
PA1336/004/002
100 Milligram
Capsule
M03CA01
DANTRIUM
Norgine B.V.
PA1336/004/001
25 Milligram
Capsule
M03CA01
DANTRIUM
INTRAVENOUS
DAPTOMYCIN
HOSPIRA
Norgine B.V.
PA1336/004/003
20 Milligram
M03CA01
Hospira UK
Limited
EU/1/17/1175/00
1-002
350 Milligram
Pdr for Soln for
Injection
Pdr for Soln
Inj/Inf
J01XX09
-FLURAZEPAM
HYDROCHLORI
DE
-FLURAZEPAM
HYDROCHLORI
DE
-FLURAZEPAM
HYDROCHLORI
DE
-FLURAZEPAM
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-DANTROLENE
SODIUM
-DANTROLENE
SODIUM
-DANTROLENE
SODIUM
-DAPTOMYCIN
DAPTOMYCIN
HOSPIRA
Hospira UK
Limited
EU/1/17/1175/00
3-004
500 Milligram
Pdr for Soln
Inj/Inf
J01XX09
-DAPTOMYCIN
DALMANE
DALMAPAM
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Vaginal
Article 10c Informed Consen
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
Page 126 of 608
Trade Name
Licence Holder Licence
Number
Strength
DARUNAVIR
Teva B.V.
PA1986/015/001
400 Milligram
DARUNAVIR
Teva B.V.
PA1986/015/002
600 Milligram
DARUNAVIR
CLONMEL
Clonmel
Healthcare Ltd
PA0126/299/002
600 Milligram
DARUNAVIR
CLONMEL
Clonmel
Healthcare Ltd
PA0126/299/003
DARUNAVIR
CLONMEL
Clonmel
Healthcare Ltd
DARUNAVIR
MYLAN
Dosage Form ATC
Film Coated
Tablet
Film Coated
Tablet
Active
Ingredients
Legal Basis
Routes of
Administration
J05AE10
-DARUNAVIR
Film Coated
Tablet
J05AE10
-DARUNAVIR
800 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
PA0126/299/001
400 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
Generics (UK)
Limited
EU/1/16/1140/00
1-005
75 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
MYLAN
Generics (UK)
Limited
EU/1/16/1140/00
6-011
150 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
MYLAN
Generics (UK)
Limited
EU/1/16/1140/01
2-021
300 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
MYLAN
Generics (UK)
Limited
EU/1/16/1140/02
2-029
400 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
MYLAN
Generics (UK)
Limited
EU/1/16/1140/03
9-045
800 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
MYLAN
Generics (UK)
Limited
EU/1/16/1140/03
0-038
600 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
ROWEX
Rowex Ltd
PA0711/269/001
75 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
ROWEX
Rowex Ltd
PA0711/269/002
400 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
ROWEX
Rowex Ltd
PA0711/269/004
800 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARUNAVIR
ROWEX
Rowex Ltd
PA0711/269/003
600 Milligram
Film Coated
Tablet
J05AE10
-DARUNAVIR
DARZALEX
(PREVIOUSLY
KNOWN AS
DARATUMUMAB
JANSSENCILAG)
DASSELTA
Janssen-Cilag
International NV
EU/1/16/1101/00
1-002
20 Mg/Ml
Concentrate for
Soln for Inf
L01XC24
DARATUMUMAB
Krka d.d., Novo
mesto
EU/1/11/739/001008
5 Milligram
Film Coated
Tablet
R06AX27
DATSCAN
GE Healthcare
Limited
AstraZeneca AB
EU/1/00/135/001
2.5 Millilitre
V09AB03
EU/1/10/636/0013
PA0678/100/001
500 Microgram
Solution for
Injection
Film Coated
Tablet
Capsules Hard
DESLORATIDIN
E
-IOFLUPANE
R03DX07
-ROFLUMILAST
-Per Oral
N02BE51
-PARACETAMOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-PHOLCODINE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-Per Oral
DAXAS
DAY NURSE
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
DAZONAY
Rowex Ltd
PA0711/252/001
50/12.5/200
Milligram
Film Coated
Tablet
N04BA03
DAZONAY
Rowex Ltd
PA0711/252/002
75/18.75/200
Milligram
Film Coated
Tablet
N04BA03
DAZONAY
Rowex Ltd
PA0711/252/003
100/25/200
Milligram
Film Coated
Tablet
N04BA03
Human Medicines Authorised/Transfer Pending Products
500/30/5
Milligram
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 127 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
DAZONAY
Rowex Ltd
PA0711/252/004
125/31.25/200
Milligram
Film Coated
Tablet
N04BA03
DAZONAY
Rowex Ltd
PA0711/252/005
150/37.5/200
Milligram
Film Coated
Tablet
N04BA03
DAZONAY
Rowex Ltd
PA0711/252/006
175/43.75/200
Milligram
Film Coated
Tablet
N04BA03
DAZONAY
Rowex Ltd
PA0711/252/007
200/50/200
Milligram
Film Coated
Tablet
N04BA03
DDAVP
DEMOPRESSIN
Ferring Ireland
Ltd
PA1009/001/003
0.1 Milligram
Tablets
H01BA02
DDAVP
DESMOPRESSI
N
DDAVP
DESMOPRESSI
N
DECAPEPTYL 3MONTH
DECAPEPTYL 3MONTH, 11.25
MG
DECAPEPTYL 6MONTH
Ferring Ireland
Ltd
PA1009/001/001
100
Microgram/ML
Nasal Drops Soln
H01BA02
Ferring Ireland
Ltd
PA1009/001/002
4 Microgram/ML
Solution for
Injection
H01BA02
PCO
Manufacturing
Ipsen
Pharmaceuticals
Limited
Ipsen
Pharmaceuticals
Limited
Ipsen
Pharmaceuticals
Limited
The Mentholatum
Company Ltd.
Gentium S.p.A.
PPA0465/261/00
1
PA0869/003/002
11.25 Milligram
Pdr+Solv for
Susp for Inj
Pdr+Solv for
Susp for Inj
L02AE04
L02AE04
-TRIPTORELIN
PAMOATE
-Intra-Muscular
PA0869/003/003
22.5 Milligram
Pdr+Solv for
Susp for Inj
L02AE04
-TRIPTORELIN
PAMOATE
-Intra-Muscular
PA0869/003/001
3 Milligram
Pdr+Solv for
Susp for Inj
L02AE04
-TRIPTORELIN
ACETATE
PA0076/005/001
2 %w/w
Gel
M02AX10
EU/01/13/878/00
1
PA1380/195/001
200 Milligram
Solution for
Infusion
Tablet Prolonged
Release
B01AX01
RACEMENTHOL
-DEFIBROTIDE
DECAPEPTYL
SR
DEEP FREEZE
COLD
DEFITELIO
11.25 Milligram
DELMOSART PR
Actavis Group
PTC ehf
DELMOSART PR
Actavis Group
PTC ehf
PA1380/195/002
27 Milligram
Tablet Prolonged
Release
N06BA04
DELMOSART PR
Actavis Group
PTC ehf
PA1380/195/004
54 Milligram
Tablet Prolonged
Release
N06BA04
DELMOSART PR
Actavis Group
PTC ehf
PA1380/195/003
36 Milligram
Tablet Prolonged
Release
N06BA04
DELTACORTRIL
ENTERIC
DELTACORTRIL
ENTERIC
DELTACORTRIL
ENTERIC
DELTYBA
Imbat Limited
5 Milligram
Phoenix Labs
PA1113/003/002
2.5 Milligram
Otsuka Novel
Products GmbH
Auden Mckenzie
(Pharma Division)
Ltd
D.D.D. Limited
EU/1/13/875/001003
PA1352/021/001
50 Milligram
5 Per Cent
Tablets GastroResistant
Tablets GastroResistant
Tablets GastroResistant
Film Coated
Tablet
Cream
H02AB06
Phoenix Labs
PPA1151/213/00
1
PA1113/003/001
N01BB20
-LIDOCAINE
-PRILOCAINE
PA0302/011/001
6 / 2.7 %w/w
Shampoo
D11AX
-SODIUM
LAURYL
SULFATE
-SODIUM
LAURYL ETHER
SULFO
SUCCINATE
DENELA
DENTINOX
CRADLE CAP
SHAMPOO
Human Medicines Authorised/Transfer Pending Products
18 Milligram
5 Milligram
N06BA04
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
DESMOPRESSI
N ACETATE
DESMOPRESSI
N ACETATE
DESMOPRESSI
N ACETATE
-TRIPTORELIN
Legal Basis
H02AB06
H02AB06
J04AK06
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
PREDNISOLON
PREDNISOLON
PREDNISOLON
-DELAMANID
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
PPA
-Intra-Muscular
-Per Oral
-Per Oral
-Per Oral
-Topical
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
Article 10(3) Hybrid
Application
-Per Oral
-Cutaneous
Page 128 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
DENTINOX
INFANT COLIC
DROPS
DENTOMYCIN
2% W/W
PERIODONTAL
GEL
DENZAPINE
D.D.D. Limited
PA0302/003/001
42 MG/5ml
Oral Suspension
A03AX
-DIMETICONE,
ACTIVATED
Henry Schein UK
Holdings Limited
PA1321/001/001
2 %w/w
Gel
A01AB23
-MINOCYCLINE
HYDROCHLORI
DE DIHYDRATE
Clonmel
Healthcare Ltd
PA0126/235/001
25 Milligram
Tablets
N05AH02
-CLOZAPINE
DENZAPINE
Clonmel
Healthcare Ltd
PA0126/235/002
100 Milligram
Tablets
N05AH02
-CLOZAPINE
DENZAPINE
Clonmel
Healthcare Ltd
PA0126/235/005
50 Mg/Ml
Oral Suspension
N05AH02
-CLOZAPINE
DENZAPINE
Clonmel
Healthcare Ltd
PA0126/235/003
50 Milligram
Tablets
N05AH02
-CLOZAPINE
DENZAPINE
Clonmel
Healthcare Ltd
PA0126/235/004
200 Milligram
Tablets
N05AH02
-CLOZAPINE
DEPIXOL
20MG/ML
SOLUTION FOR
INJECTION
DEPIXOL CONC.
100MG/ML
SOLUTION FOR
INJECTION
DEPOCYTE
Lundbeck Limited
PA0115/001/001
20 Micromol
Solution for
Injection
N05AF01
-FLUPENTIXOL
DECANOATE
Lundbeck Limited
PA0115/001/009
100 Micromol
Solution for
Injection
N05AF01
-FLUPENTIXOL
DECANOATE
SkyePharma PL
EU/1/01/187/001
50 Milligram
L01BC01
-CYTARABINE
DEPOMEDRONE
Pfizer Healthcare
Ireland
PA0822/122/001
40 Mg/Ml
Suspension for
Injection
Suspension for
Injection
H02AB04
DEPOMEDRONE
Pfizer Healthcare
Ireland
PA0822/122/002
40 Mg/Ml
Suspension for
Injection
H02AB04
DEPOMEDRONE
Pfizer Healthcare
Ireland
PA0822/122/003
40 Mg/Ml
Suspension for
Injection
H02AB04
DEPOMEDRONE
40MG/ML WITH
LIDOCAINE
Pfizer Healthcare
Ireland
PA0822/123/002
40/10 Mg/Ml
Suspension for
Injection
H02AB04
DEPOMEDRONE
40MG/ML WITH
LIDOCAINE
10MG/ML
Pfizer Healthcare
Ireland
PA0822/123/001
40 + 10 Mg/Ml
Suspension for
Injection
H02AB04
DEPOPROVERA
Pfizer Healthcare
Ireland
PA0822/124/001
150 Mg/Ml
Suspension for
Injection
L02AB02
DEPREGER
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/067/001
50 Milligram
Film Coated
Tablet
N06AB06
Interchangeable
List Code:
IC0064-023-003
PA0577/067/002
METHYLPREDN
ISOLONE
ACETATE
METHYLPREDN
ISOLONE
ACETATE
METHYLPREDN
ISOLONE
ACETATE
METHYLPREDN
ISOLONE
ACETATE
-LIDOCAINE
HYDROCHLORI
DE
METHYLPREDN
ISOLONE
ACETATE
-LIDOCAINE
HYDROCHLORI
DE
MEDROXYPRO
GESTERONE
ACETATE
-SERTRALINE
HYDROCHLORI
DE
100 Milligram
Film Coated
Tablet
N06AB06
Interchangeable
List Code:
IC0064-024-003
PA0257/059/001
-SERTRALINE
HYDROCHLORI
DE
0.5%w/v %w/v
Cutaneous
Emulsion
P03AX03
-MALATHION
DEPREGER
DERBAC-M
LIQUID
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
GR Lane Health
Products Ltd
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Topical
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 129 of 608
Trade Name
Licence Holder Licence
Number
Strength
DERMATRANS
Rottapharm Ltd
PA0868/006/001
5 mg/24 hours
DERMATRANS
Rottapharm Ltd
PA0868/006/002
10 mg/24 hours
DERMATRANS
Rottapharm Ltd
PA0868/006/003
15 mg/24 hours
DERMESTRIL SEPTEM
DERMESTRILSEPTEM
DERMESTRILSEPTEM
DERMOVATE
Rottapharm Ltd
PA0868/002/005
Rottapharm Ltd
PA0868/002/006
Rottapharm Ltd
PA0868/002/004
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Lexon (UK) Ltd
DERMOVATE
DERMOVATE
Dosage Form ATC
C01DA02
PA1077/005/001
50 mcg/24
Microgram/day
75 mcg/24
Microgram/day
25 mcg/24
Microgram/day
0.05 %w/w
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Cream
PA1077/005/002
0.05 %w/w
Ointment
D07AD01
PPA1097/011/00
1
PA1077/005/003
0.05 %w/w
Ointment
D07AD01
0.05 %w/v
Cutaneous
Solution
D07AD01
LTT Pharma
Limited
PPA1562/093/00
1
0.05 %w/v
Cutaneous
Solution
D07AD01
-CLOBETASOL
PROPIONATE
EMTRICITABINE
-TENOFOVIR
ALAFENAMIDE
EMTRICITABINE
-TENOFOVIR
ALAFENAMIDE
-ZINC
UNDECYLENAT
E
-UNDECYLENIC
ACID
-ZINC
UNDECYLENAT
E
-UNDECYLENIC
ACID
DEFEROXAMIN
E MESILATE
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESMOPRESSI
N ACETATE
DESMOPRESSI
N ACETATE
C01DA02
C01DA02
G03CA03
G03CA03
G03CA03
D07AD01
DERMOVATE
SCALP
APPLICATION
DERMOVATE
SCALP
APPLICATION
DESCOVY
GlaxoSmithKline
(Ireland) Limited
Gilead Sciences
Ltd
EU/1/16/1099/00
1-002
200mg/10mg
Milligram
Film Coated
Tablet
J05AR17
DESCOVY
Gilead Sciences
Ltd
EU/1/16/1099/00
3-004
200mg/25mg
Film Coated
Tablet
J05AR17
DESENEX
OINTMENT
Clonmel
Healthcare Ltd
PA0126/154/001
20 5 %w/w
Ointment
D01AE04
DESENEX
POWDER
Clonmel
Healthcare Ltd
PA0126/154/002
20/2 %w/w
Cutaneous
Powder
D01AE04
DESFERAL
PA0013/065/001
500 Milligram
Pdr/Conc/Soln/In
j/Inf
V03AC01
DESLOR
Novartis
Pharmaceuticals
UK Ltd
Rowex Ltd
PA0711/202/001
5 Milligram
Film Coated
Tablet
R06AX27
DESLOR
Rowex Ltd
PA0711/202/002
0.5 Mg/Ml
Oral Solution
R06AX27
DESLORATADI
NE
Actavis Group
PTC ehf
EU/1/11/745/001009
5 Milligram
Film Coated
Tablet
R06AX27
DESLORATADI
NE
Ratiopharm
GmbH
EU/1/11/746/001012
5 Milligram
Film Coated
Tablet
R06AX27
DESLORATADI
NE
Rosemont
Pharmaceuticals
Ltd
Clonmel
Healthcare Ltd
PA0312/037/001
0.5 Mg/Ml
Oral Solution
R06AX27
PA0126/241/001
0.5 Mg/Ml
Oral Solution
R06AX27
Glenmark
Pharmaceuticals
Europe Limited
Teva B.V.
PA1462/007/001
5 Milligram
Tablets
R06AX26
EU/1/11/732/001013
5 Milligram
Film Coated
Tablet
R06AX27
DESMOSPRAY
Ferring Ireland
Ltd
PA1009/005/001
10 Microgram
Nasal Spray
Solution
H01BA02
DESMOTABS
Ferring Ireland
Ltd
PA1009/007/001
0.2 Milligram
Tablets
H01BA02
DESLORATADI
NE CLONMEL
DESLORATADI
NE GLENMARK
DESLORATADI
NE TEVA
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
-ESTRADIOL
HEMIHYDRATE
-ESTRADIOL
HEMIHYDRATE
-ESTRADIOL
HEMIHYDRATE
-CLOBETASOL
PROPIONATE
-CLOBETASOL
PROPIONATE
-CLOBETASOL
PROPIONATE
-CLOBETASOL
PROPIONATE
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Nasal
-Per Oral
Page 130 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
DESMOTABS
MELT
Ferring Ireland
Ltd
PA1009/007/002
60 Microgram
Oral Lyophilisate
H01BA02
DESMOTABS
MELT
Ferring Ireland
Ltd
PA1009/007/003
120 Microgram
Oral Lyophilisate
H01BA02
DESMOTABS
MELT
Ferring Ireland
Ltd
PA1009/007/004
240 Microgram
Oral Lyophilisate
H01BA02
DESMOTABS
MELT
PCO
Manufacturing
PPA0465/260/00
1
120 Microgram
Oral Lyophilisate
H01BA02
DESOGESTREL
ROWEX
Rowex Ltd
PA0711/243/001
75 Microgram
Film Coated
Tablet
G03AC09
DESUNIN
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
PA1332/044/002
1000
International Unit
Tablets
A11C
PA1332/044/003
2000
International Unit
Tablets
A11C
PA1332/044/004
4000
International Unit
Tablets
A11C
Meda Health
Sales Ireland
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA1332/044/001
800 International
Unit
Tablets
A11CC05
PA0577/144/002
4 Milligram
G04BD07
Interchangeable
List Code:
IC0025-008-032
PA1142/004/001
Prolonged
Release
Capsules
15 Milligram
Coated Tablets
G04BD06
DESUNIN
DESUNIN
DESUNIN
DETERODINE
SR
Active
Ingredients
DESMOPRESSI
N ACETATE
DESMOPRESSI
N ACETATE
DESMOPRESSI
N ACETATE
DESMOPRESSI
N
-DESOGESTREL
MICRONIZED
COLECALCIFE
ROL
COLECALCIFE
ROL
COLECALCIFE
ROL
CONCENTRATE
COLECALCIFE
ROL
-TOLTERODINE
TARTRATE
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
Article 10(1) Generic
Application
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
DETRUNORM
Amdipharm
Limited
DETRUNORM
XL
Amdipharm
Limited
PA1142/004/002
30 Milligram
Capsules
Modified Release
G04BD06
DETRUNORM
XL
Amdipharm
Limited
PA1142/004/003
45 Milligram
Capsules
Modified Release
G04BD06
DETRUSITOL
Pfizer Limited
PA0019/072/003
1 Milligram
Film Coated
Tablet
G04BD07
Pfizer Limited
Interchangeable
List Code:
IC0025-039-003
PA0019/072/004
2 Milligram
Film Coated
Tablet
G04BD07
-TOLTERODINE
L-TARTRATE
1 Milligram
Film Coated
Tablet
G04BD07
-TOLTERODINE
TARTRATE
PPA
-Per Oral
2 Milligram
Film Coated
Tablet
G04BD07
-TOLTERODINE
TARTARE
PPA
-Per Oral
1 Milligram
Film Coated
Tablet
G04BD07
-TOLTERODINE
L-TARTRATE
DETRUSITOL
DETRUSITOL
DETRUSITOL
DETRUSITOL
Imbat Limited
Imbat Limited
LTT Pharma
Limited
Interchangeable
List Code:
IC0025-006-003
PPA1151/158/00
1
Interchangeable
List Code:
IC0025-039-003
PPA1151/158/00
2
Interchangeable
List Code:
IC0025-006-003
PPA1562/060/00
2
-PROPIVERINE
HYDROCHLORI
DE
-PROPIVERINE
HYDROCHLORI
DE
-PROPIVERINE
HYDROCHLORI
DE
-TOLTERODINE
L-TARTRATE
Legal Basis
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0025-039-003
Human Medicines Authorised/Transfer Pending Products
Page 131 of 608
Trade Name
DETRUSITOL
DETRUSITOL
SR
DETRUSITOL
SR
DETRUSITOL
SR
DETRUSITOL
SR
DETRUSITOL
SR
DETRUSITOL
SR
Licence Holder Licence
Number
LTT Pharma
Limited
PPA1562/060/00
3
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0025-006-003
PPA1463/078/00
1
Imbat Limited
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
IMED Healthcare
Ltd.
Clear Pharmacy
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
2 Milligram
Film Coated
Tablet
G04BD07
-TOLTERODINE
L-TARTRATE
-Per Oral
2 Milligram
Prolonged
Release
Capsules
G04BD07
-TOLTERODINE
TARTARE
-Per Oral
4 Milligram
Prolonged
Release
Capsules
G04BD07
-TOLTERODINE
TARTRATE
Interchangeable
List Code:
IC0025-008-032
PA0822/125/001
2 Milligram
G04BD07
-TOLTERODINE
L-TARTRATE
-Per Oral
Interchangeable
List Code:
IC0025-006-032
PA0822/125/002
Prolonged
Release
Capsules
4 Milligram
Prolonged
Release
Capsules
G04BD07
-TOLTERODINE
L-TARTRATE
-Per Oral
4 Milligram
Prolonged
Release
Capsules
G04BD07
-TOLTERODINE
TARTRATE
PPA
-Per Oral
4 Milligram
Prolonged
Release
Capsules
G04BD07
-TOLTERODINE
TARTRATE
PPA
-Per Oral
Interchangeable
List Code:
IC0025-008-032
PA0979/004/002
4.8% %w/v
Cutaneous
Solution
Concentrate
Eye Drops
Solution
D08AE05
CHLOROXYLEN
OL
DEXAMETHAS
ONE
PHOSPHATE
DEXAMETHAS
ONE SODIUM
PHOSPHATE
DEXAMETHAS
ONE
DEXAMETHAS
ONE SODIUM
PHOSPHATE
DEXAMETHAS
ONE SODIUM
PHOSPHATE
DEXAMETHAS
ONE SODIUM
PHOSPHATE
DEXAMETHAS
ONE SODIUM
PHOSPHATE
DEXAMETHAS
ONE
PHOSPHATE
Article 10a Bibliographical
App
-Ocular
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Intra-venous
Article 10(3) Hybrid
Application
-Ocular
Article 10(3) Hybrid
Application
-Ocular
Interchangeable
List Code:
IC0025-006-032
PPA1151/164/00
1
Interchangeable
List Code:
IC0025-008-032
PPA1463/040/00
1
Interchangeable
List Code:
IC0025-008-032
PPA1596/014/00
1
DETTOL
ANTISEPTIC
DISINFECTANT
DEXAFREE
Reckitt Benckiser
Ireland Ltd
Laboratoires
Thea
PA1107/005/001
1 Mg/Ml
DEXAMETHAS
ONE
Rosemont
Pharmaceuticals
Ltd
PA0312/030/001
10 MG/5ml
Oral Solution
H02AB02
DEXAMETHAS
ONE
Aspen Pharma
Trading Limited
PA1691/014/001
2 Milligram
Tablets
H02AB02
DEXAMETHAS
ONE
PHOSPHATE
Wockhardt UK
Limited
PA1339/052/002
4 Mg/Ml
Solution for Inj/Inf
H02AB02
DEXAMETHAS
ONE
PHOSPHATE
Alissa Healthcare
Research Limited
PA1887/001/001
1.0 Mg/Ml
Eye Drops
Solution
S01BA01
DEXAMETHAS
ONE
PHOSPHATE
Hospira UK
Limited
PA0437/014/002
4 Mg/Ml
Solution for
Injection
H02AB02
DEXAMETHAS
ONE SODIUM
PHOSPHATE
Wockhardt UK
Limited
PA1339/052/001
0.1 %w/v
Eye Drops
Solution
S01BA01
Human Medicines Authorised/Transfer Pending Products
S01BA01
PPA
-Per Oral
Page 132 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
DEXDOR
Orion Corporatio
EU/1/11/718/001006
100
Microgram/ML
Concentrate for
Soln for Inf
N05CM18
DEXIMUNE
Dexcel-Pharma
Limited
Dexcel-Pharma
Limited
Dexcel-Pharma
Limited
Rowex Ltd
PA0895/005/003
100 Milligram
Capsules, Soft
PA0895/005/002
50 Milligram
PA0895/005/001
DEXSOL
DIABACT UBT
DIABREZIDE
DEXIMUNE
DEXIMUNE
DEXKETOPROF
EN ROWEX
DIACLIDE MR
DIACLIDE MR
L04AD01
Capsules, Soft
L04AD01
-CICLOSPORIN
-Per Oral
25 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
-Per Oral
PA0711/216/002
25 Milligram
Film Coated
Tablet
M01AE17
Article 10(1) Generic
Application
Rosemont
Pharmaceuticals
Ltd
PA0312/009/001
2 MG/5ml
Oral Solution
H02AB02
Kibion AB
L. Molteni & C.
dei F.lli Alitti
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA1273/001/001
PA0925/001/001
50 Milligram
80 Milligram
Tablets
Tablets
V04CX
A10BB09
DEXKETOPROF
EN
TROMETAMOL
DEXAMETHAS
ONE SODIUM
PHOSPHATE
-13C-UREA
-GLICLAZIDE
PA0577/030/003
60 Milligram
Modified-release
Tablets
A10BB09
-GLICLAZIDE
-Per Oral
Interchangeable
List Code:
IC0086-127-021
PA0577/030/002
Article 10(1) Generic
Application
30 Milligram
Modified-release
Tablets
A10BB09
-GLICLAZIDE
Article 10(1) Generic
Application
-Per Oral
250 Milligram
Capsule
N03AX17
-STIRIPENTOL
500 Milligram
500 Milligram
Capsule
Powder for Oral
Suspension
Powder for Oral
Suspension
Modified-release
Tablets
N03AX17
N03AX17
-STIRIPENTOL
-STIRIPENTOL
N03AX17
-STIRIPENTOL
A10BB09
-GLICLAZIDE
Article 10(1) Generic
Application
-Per Oral
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
DIACOMIT
DIACOMIT
Biocodex
Biocodex
DIACOMIT
Biocodex
DIACRONAL MR
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
DIAFER
Pharmacosmos
A/S
DIAGLYC
Teva Pharma
B.V.
DIAMICRON
Imbat Limited
DIAMICRON MR
Imbat Limited
DIAMICRON MR
Routes of
Administration
-Intra-venous
Biocodex
DIAMICRON MR
Legal Basis
DEXMEDETOMI
DINE
HYDROCHLORI
DE
-CICLOSPORIN
DIACOMIT
DIACRONAL MR
Active
Ingredients
Les Laboratoires
Servier
Les Laboratoires
Servier
Interchangeable
List Code:
IC0086-033-050
EU/1/06/367/0013
EU/1/06/367/4-6
EU/1/06/367/1012
EU/1/06/367/7-9
250 Milligram
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PA1347/024/001
60 Milligram
Interchangeable
List Code:
IC0086-127-021
PA1347/024/002
30 Milligram
Modified-release
Tablets
A10BB09
-GLICLAZIDE
-Per Oral
Interchangeable
List Code:
IC0086-033-050
PA0982/004/001
Article 10(1) Generic
Application
50 Mg/Ml
Solution for
Injection
B03AC
Article 8(3) - Full
new Application
-Intra-venous
PA0749/076/001
30 Milligram
Modified-release
Tablets
A10BB09
-IRON (III)
ISOMALTOSIDE
1000
-GLICLAZIDE
-Per Oral
Interchangeable
List Code:
IC0086-033-050
PPA1151/026/00
2
PPA1151/026/00
1
Article 10(1) Generic
Application
80 Milligram
Tablets
A10BB09
-GLICLAZIDE
PPA
-Per Oral
30 Milligram
Modified-release
Tablets
A10BB09
-GLICLAZIDE
PPA
-Per Oral
Interchangeable
List Code:
IC0086-033-050
PA0568/013/002
60 Milligram
Modified-release
Tablets
A10BB09
-GLICLAZIDE
-Per Oral
Interchangeable
List Code:
IC0086-127-021
PA0568/013/001
30 Milligram
Modified-release
Tablets
A10BB09
-GLICLAZIDE
-Per Oral
Interchangeable
List Code:
IC0086-033-050
Human Medicines Authorised/Transfer Pending Products
Page 133 of 608
Trade Name
DIAMOX
Licence Holder Licence
Number
Strength
Dosage Form ATC
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Baxter
Healthcare
Limited
PA0899/021/003
250 Milligram
Tablets
S01EC01
PA0899/021/002
500 Milligram
Pdr for Soln for
Injection
S01EC01
PA0899/021/001
250 Milligram
Capsules
Modified Release
S01EC01
PA0167/084/021
3.86 %w/v
Solution for
Dialysis
B05DB
DIANEAL PD4
GLUCOSE
Baxter
Healthcare
Limited
PA0167/084/001
13.6 Mg/Ml
Solution for
Dialysis
B05DB
DIANEAL PD4
GLUCOSE
Baxter
Healthcare
Limited
PA0167/084/011
2.27 %w/v
Solution for
Dialysis
B05DB
DIANETTE
PCO
Manufacturing
PPA0465/050/00
1
2 / 0.035
Milligram
Coated Tablets
G03HB01
DIANETTE
Bayer Limited
PA1410/003/001
2.0/0.035
Milligram
Tablets
G03HB01
DIANETTE
IMED Healthcare
Ltd.
PPA1463/050/00
1
2mg/35
Microgram
Coated Tablets
G03HB01
DIANETTE
Clear Pharma
Limited
PPA1823/001/00
1
2/35 mg/mcg
Coated Tablets
G03HB01
DIANETTE
Imbat Limited
PPA1151/181/00
1
2/35 Milligram
Film Coated
Tablet
G03HB01
DIAMOX
DIAMOX SR
DIANEAL PD4
GLUCOSE
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
ACETAZOLAMI
DE
ACETAZOLAMI
DE SODIUM
ACETAZOLAMI
DE
-GLUCOSE
-SODIUM
CHLORIDE
-SODIUM
LACTATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-GLUCOSE
-SODIUM
CHLORIDE
-SODIUM
LACTATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
ANHYDROUS
-GLUCOSE
-SODIUM
CHLORIDE
-SODIUM
LACTATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
CYPROTERONE
ACETATE
ETHINYLESTRA
DIOL
CYPROTERONE
ACETATE
ETHINYLESTRA
DIOL
CYPROTERONE
ACETATE
ETHINYLESTRA
DIOL
CYPROTERONE
ACETATE
ETHINYLESTRA
DIOL
CYPROTERONE
ACETATE
ETHINYLESTRA
DIOL
Legal Basis
Routes of
Administration
PPA
PPA
PPA
PPA
Page 134 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
DIANETTE
LTT Pharma
Limited
PPA1562/154/00
1
2/35 mg/mcg
Coated Tablets
G03HB01
DIAZEMULS
PA1380/032/001
5 Mg/Ml
PA1380/108/001
2 Milligram
Emulsion for
Injection
Tablets
N05BA01
DIAZEPAM
ACTAVIS
Actavis Group
PTC ehf
Actavis Group
PTC ehf
CYPROTERONE
ACETATE
ETHINYLESTRA
DIOL
-DIAZEPAM
N05BA01
-DIAZEPAM
DIAZEPAM
ACTAVIS
Actavis Group
PTC ehf
PA1380/108/002
5 Milligram
Tablets
N05BA01
-DIAZEPAM
DIAZEPAM
ACTAVIS
Actavis Group
PTC ehf
PA1380/108/003
10 Milligram
Tablets
N05BA01
-DIAZEPAM
DICLAC
Rowex Ltd
PA0711/009/009
100 Milligram
Suppositories
M01AB05
-DICLOFENAC
SODIUM
-Rectal
Rowex Ltd
Interchangeable
List Code:
IC0056-024-046
PA0711/009/007
25 Milligram
Tablets GastroResistant
M01AB05
-DICLOFENAC
SODIUM
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0056-022-016
PA0711/009/008
50 Milligram
Tablets GastroResistant
M01AB05
-DICLOFENAC
SODIUM
-Per Oral
DICLAC
Rowex Ltd
Interchangeable
List Code:
IC0056-023-016
PA0711/009/010
25 Micromol
M01AB05
DICLAC
Rowex Ltd
PA0711/009/003
75 Milligram
Solution for
Injection
Tablet Prolonged
Release
-DICLOFENAC
SODIUM
-DICLOFENAC
SODIUM
Rowex Ltd
Interchangeable
List Code:
IC0056-028-024
PA0711/009/002
1 %w/w
Gel
M02AA15
-DICLOFENAC
SODIUM
-Topical
DICLAC RELIEF
Rowex Ltd
Interchangeable
List Code:
IC0056-115-043
PA0711/009/005
1% %w/w
Gel
D11AX18
-Topical
DICLAC
RETARD
Rowex Ltd
PA0711/009/006
100 Milligram
Tablet Prolonged
Release
M01AB05
-DICLOFENAC
SODIUM
-DICLOFENAC
SODIUM
Interchangeable
List Code:
IC0056-024-024
PA0281/106/001
75 Milligram
Tablet Prolonged
Release
M01AB05
-DICLOFENAC
SODIUM
-Per Oral
Interchangeable
List Code:
IC0056-028-024
PA1380/078/002
50 Milligram
Film Coated
Tablet
M01AB05
-DICLOFENAC
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0057-023-040
PA0678/129/001
12.5 Milligram
Film Coated
Tablet
M01AB05
-DICLOFENAC
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0057-021-003
PA1333/014/001
50/0.2 Milligram
Modified-release
Tablets
M01AB55
-DICLOFENAC
SODIUM
-3
MISOPROSTOL
1% HPMC
DISPERSION
-MISOPROSTOL
DICLAC
DICLAC
DICLAC
DICLO
DICLOFENAC
POTASSIUM
Pinewood
Laboratories Ltd,
Actavis Group
PTC ehf
DICLOFENAC
POTASSIUM
NCH
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
DICLOFENAC/M
ISOPROSTOL
Morningside
Healthcare
Limited
Interchangeable
List Code:
IC0058-109-021
Human Medicines Authorised/Transfer Pending Products
M01AB05
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 135 of 608
Trade Name
DICLOFENAC/M
ISOPROSTOL
Licence Holder Licence
Number
Morningside
Healthcare
Limited
DICYCLOVERIN
E
HYDROCHLORI
DE
SYRI Limited, t/a
Thame
Laboratories
DIFENE
Astellas Pharma
Co. Ltd
DIFENE
DIFENE
DIFENE
DIFENE 100 MG
DUAL RELEASE
DIFENE DUAL
RELEASE
DIFENE DUAL
RELEASE
DIFENE SPRAY
GEL
DIFFERIN
DIFFERIN
DIFFERIN
DIFFERIN
CREAM
DIFFERIN GEL
DIFFLAM
Astellas Pharma
Co. Ltd
Astellas Pharma
Co. Ltd
Astellas Pharma
Co. Ltd
Astellas Pharma
Co. Ltd
Astellas Pharma
Co. Ltd
Imbat Limited
Astellas Pharma
Co. Ltd
Galderma (UK)
Ltd
Galderma (UK)
Ltd
Imbat Limited
LTT Pharma
Limited
LTT Pharma
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Imbat Limited
Strength
Dosage Form ATC
Active
Ingredients
75/0.2 Milligram
Modified-release
Tablets
M01BA55
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0058-113-021
PA1861/008/001
-DICLOFENAC
SODIUM
-MISOPROSTOL
10 MG/5ml
Oral Solution
A03AA07
Article 10(1) Generic
Application
-Per Oral
PA1241/012/001
25 Milligram
Capsules GastroResistant
M01AB05
DICYCLOVERIN
E
HYDROCHLORI
DE
-DICLOFENAC
SODIUM
Interchangeable
List Code:
IC0056-022-016
PA1241/012/002
50 Milligram
Capsules GastroResistant
M01AB05
-DICLOFENAC
SODIUM
-Per Oral
Interchangeable
List Code:
IC0056-023-016
PA1241/012/007
100 Milligram
Suppositories
M01AB05
-DICLOFENAC
SODIUM
-Rectal
Interchangeable
List Code:
IC0056-024-046
PA1241/012/005
1 %w/w
Gel
M02AA15
-DICLOFENAC
SODIUM
-Topical
Interchangeable
List Code:
IC0056-115-043
PA1241/012/004
100 Milligram
M01AB05
PA1241/012/003
75 Milligram
Capsules
Modified Release
Capsules
Modified Release
-DICLOFENAC
SODIUM
-DICLOFENAC
SODIUM
75 Milligram
Capsules
Modified Release
M01AB05
-DICLOFENAC
SODIUM
Interchangeable
List Code:
IC0056-028-036
PA1241/012/008
4 %w/w
M02AA15
PA0590/006/003
0.1 %w/w
Cutaneous Spray
Solution
Cream
D10AD03
-DICLOFENAC
SODIUM
-ADAPALENE
PA0590/006/002
0.1 %w/w
Gel
D10AD03
-ADAPALENE
PPA1151/198/00
2
PPA1562/136/00
2
PPA1562/136/00
1
PA1332/017/001
0.1 %w/w
Gel
D10AD03
-ADAPALENE
0.1 %w/w
Cream
D10AD03
-ADAPALENE
0.1 %w/w
Gel
D10AD03
-ADAPALENE
3 %w/w
Cream
M02AA05
PA1332/017/002
0.15 %w/v
Gargle
A01AD02
PA1332/017/003
0.15 %w/v
Oromucosal
Spray
A01AD02
PPA1151/127/00
1
0.15 %w/v
Oromucosal
Spray
A01AD02
Interchangeable
List Code:
IC0056-028-036
PPA1151/073/00
1
M01AB05
DIFFLAM SPRA
PCO
Manufacturing
PPA0465/425/00
1
0.15 %w/v
Oromucosal
Spray
A01AD02
DIFICLIR
Astellas Pharma
Europe BV
Teva Pharma
B.V.
EU/1/11/733/001004
PA0749/127/001
200 Milligram
Film Coated
Tablet
Capsules Hard
A07AA12
J02AC01
-FLUCONAZOLE
DIFFLAM SPRA
DIFFLAM SPRA
DIFLAZOLE
Routes of
Administration
PA1333/014/002
-BENZYDAMINE
HYDROCHLORI
DE
-BENZYDAMINE
HYDROCHLORI
DE
-BENZYDAMINE
HYDROCHLORI
DE
-BENZYDAMINE
HYDROCHLORI
DE
-BENZYDAMINE
HYDROCHLORI
DE
-FIDAXOMICIN
DIFFLAM ORAL
RINSE
Legal Basis
Human Medicines Authorised/Transfer Pending Products
50 Milligram
-Per Oral
-Per Oral
PPA
-Per Oral
-Cutaneous
-Topical
-Cutaneous
-Topical
PPA
-Oromucosal
-Per Oral
-Per Oral
Page 136 of 608
Trade Name
DIFLAZOLE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0749/127/002
150 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
-Per Oral
PA0749/127/003
200 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
-Per Oral
DIFLUCAN
Teva Pharma
B.V.
Teva Pharma
B.V.
Pfizer Limited
PA0019/044/012
2 Mg/Ml
J02AC01
-FLUCONAZOLE
DIFLUCAN
Pfizer Limited
PA0019/044/008
2 Mg/Ml
J02AC01
-FLUCONAZOLE
DIFLUCAN
Pfizer Limited
PA0019/044/011
40 Mg/Ml
J02AC01
-FLUCONAZOLE
DIFLUCAN 10
MG/ML
POWDER FOR
ORAL
SUSPENSION
DIFLUCAN
150MG HARD
CAPSULES
DIFLUCAN 200
MG HARD
CAPSULES
DIFLUCAN 50
MG HARD
CAPSULES
DIGESTISAN
Pfizer Limited
PA0019/044/010
10 Mg/Ml
Solution for
Infusion
Solution for
Infusion
Powder for Oral
Suspension
Powder for Oral
Suspension
J02AC01
-FLUCONAZOLE
Pfizer Limited
PA0019/044/002
150 mg Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
Pfizer Limited
PA0019/044/004
200 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
Pfizer Limited
PA0019/044/001
50 mg Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
-Per Oral
Bioforce (UK) Ltd
TR0725/007/001
-Per Oral
DILACORT
Crescent Pharma
Limited
PA2025/001/001
2.5 Milligram
Tablets GastroResistant
H02AB06
-TINCTURE
FROM CYNARA
SCOLYMUS L.,
FOLIUM REC.
(FRESH
ARTICHOKE
LEAVES) (1:3031)
-TINCTURE
FROM
TARAXACUM
OFFICINALIS
WEB., RADIX
CUM HERBA
REC. (FRESH
DANDELION
ROOT AND
HERB) (1:17-18)
-TINCTURE
FROM PEUMUS
BOLDUS
MOLINA.,
FOLIUM SICC.
(BOLDO
LEAVES) (1:1011)
-TINCTURE
FROM MENTHA
X PIPERITA L.,
HERBA REC.
(FRESH
PEPPERMINT
HERB) (1:18-19)
PREDNISOLONE
DILACORT
Crescent Pharma
Limited
PA2025/001/002
5 Milligram
Tablets GastroResistant
H02AB06
PREDNISOLONE
DILTAM 90 MG
PROLONGED
RELEASE
TABLETS
DILZEM SR
Rowex Ltd
PA0711/004/002
90 Milligram
Tablet Prolonged
Release
C08DB01
-DILTIAZEM
HYDROCHLORI
DE
Cephalon UK
Limited
PA0827/006/001
60 Milligram
C08DB01
DILZEM SR
Cephalon UK
Limited
PA0827/006/002
90 Milligram
DILZEM SR
Cephalon UK
Limited
PA0827/006/003
120 Milligram
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
DIFLAZOLE
Human Medicines Authorised/Transfer Pending Products
Oral Drops
Solution
C08DB01
C08DB01
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 137 of 608
Trade Name
Licence Holder Licence
Number
Strength
DILZEM XL
Cephalon UK
Limited
PA0827/006/006
240 Milligram
DILZEM XL
Cephalon UK
Limited
PA0827/006/004
120 Milligram
DILZEM XL
Cephalon UK
Limited
PA0827/006/005
180 Milligram
DILZEM XL
PROLONGED
RELEASE HARD
CAPSULES
DINUTUXIMAB
BETA APEIRON
(PREVIOUSLY
ISQETTE)
DIODERM 0.1%
W/W CREAM
PCO
Manufacturing
DPR0465/027/0
04
180 Milligram
Apeiron Biologics
AG,
EU/1/17/1191/00
1
Dermal
Laboratories Ltd
DIORALYTE
BLACKCURRAN
T POWDER FOR
ORAL
SOLUTION
Dosage Form ATC
Active
Ingredients
Legal Basis
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Capsule
C08DB01
4.5 Mg/l
Concentrate for
Soln for Inf
L01XC16
-DINUTUXIMAB
BETA
PA0278/003/001
0.1 %w/w
Cream
D07AA02
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/098/001
%v/v
Powder for Oral
Solution
A07CA
DIORALYTE
CITRUS
POWDER FOR
ORAL
SOLUTION
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/098/002
%v/v
Powder for Oral
Solution
A07CA
DIORALYTE
NATURAL,
POWDER FOR
ORAL
SOLUTION
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/099/001
%v/v
Powder for Oral
Solution
A07CA
DIOVAN
Novartis
Pharmaceuticals
UK Ltd
PA0013/079/003
80 Milligram
Film Coated
Tablet
C09CA03
HYDROCORTIS
ONE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-GLUCOSE
-SODIUM
CITRATE ACID
-GLUCOSE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-SODIUM
CITRATE ACID
-GLUCOSE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-SODIUM
CITRATE ACID
-VALSARTAN
Interchangeable
List Code:
IC0038-005-003
PA0013/079/004
160 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
80 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
PPA
-Per Oral
160 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
PPA
-Per Oral
80 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
PPA
-Per Oral
320 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
Article 8(3) - Full
new Application
-Per Oral
DIOVAN
DIOVAN
DIOVAN
DIOVAN
DIOVAN
Novartis
Pharmaceuticals
UK Ltd
Imbat Limited
Imbat Limited
PCO
Manufacturing
Novartis
Pharmaceuticals
UK Ltd
Interchangeable
List Code:
IC0038-082-003
PPA1151/067/00
1
Interchangeable
List Code:
IC0038-005-003
PPA1151/067/00
2
Interchangeable
List Code:
IC0038-082-003
PPA0465/180/00
1
Interchangeable
List Code:
IC0038-005-003
PA0013/079/006
C08DB01
C08DB01
C08DB01
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
-DILTIAZEM
HYDROCHLORI
DE
Routes of
Administration
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0038-083-003
Human Medicines Authorised/Transfer Pending Products
Page 138 of 608
Trade Name
DIOVAN
Licence Holder Licence
Number
Active
Ingredients
Legal Basis
Routes of
Administration
Film Coated
Tablet
C09CA03
-VALSARTAN
160 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
160 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
-Per Oral
80 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
-Per Oral
3 Mg/Ml
Oral Solution
C09CA03
-VALSARTAN
-Per Oral
40 Milligram
Film Coated
Tablet
C09CA03
-VALSARTAN
Interchangeable
List Code:
IC0038-004-003
PA1967/001/001
250 Milligram
Capsule
A07EC03
PA1967/001/002
500 Milligram
Tablets
A07EC03
PA0697/002/001
200 Mg/Ml
Concentrate for
Soln for Inf
B05XB02
-OLSALAZINE
SODIUM
-OLSALAZINE
SODIUM
-L-ALANYL-L
GLUTAMINE
Aspen Pharma
Trading Limited
Bayer Limited
PCO
Manufacturing
IMED Healthcare
Ltd.
Bayer Limited
PA1691/022/001
1 %w/v
Emulsion for
Inj/Inf
Cream
Infus/Pdr/Oral
Soln
Cream
N01AX10
5/95 %w/w
Ointment
D02AC
DIPROSALIC
LTT Pharma
Limited
PPA1562/151/00
1
0.05 + 2 %w/w
Cutaneous
Solution
D07XC01
DIPROSALIC
0.05% W/W +
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
PA1286/029/001
2 %w/w
Cutaneous
Solution
D07XC01
DIPYRIDAMOLE
Pinewood
Laboratories Ltd,
PA0281/149/001
50 MG/5ml
Oral Suspension
B01AC07
-PARAFFIN,
LIQUID
-WHITE SOFT
PARAFFIN
BETAMETHASO
NE
DIPROPIONATE
-SALICYLIC
ACID
BETAMETHASO
NE
DIPROPIONATE
-SALICYLIC
ACID
-DIPYRIDAMOLE
DIPYRIDAMOLE
200MG/5ML
ORAL
DISODIUM
PAMIDRONATE
DISODIUM
PAMIDRONATE
DISODIUM
PAMIDRONATE
SYRI Limited, t/a
Thame
Laboratories
Wockhardt UK
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
PA1861/018/001
200/5 Mg/Ml
Oral Suspension
B01AC07
-DIPYRIADMOLE
PA1339/007/001
15 Mg/Ml
M05BA03
PA1339/007/004
15 Mg/Ml
PA1339/007/003
15 Mg/Ml
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
-PAMIDRONIC
ACID
-PAMIDRONIC
ACID
-PAMIDRONIC
ACID
DIOVAN
DIOVAN
DIOVAN
DIOVAN
DIPENTUM
DIPENTUM
DIPEPTIVEN,
CONCENTRATE
FOR SOLUTION
FOR INFUSION
DIPRIVAN
DIPROBASE
DIPROBASE
DIPROBASE
DIPROBASE
OINTMENT
PA0013/079/005
Dosage Form ATC
40 Milligram
DIOVAN
Novartis
Pharmaceuticals
UK Ltd
Strength
PCO
Manufacturing
Interchangeable
List Code:
IC0038-004-003
PPA0465/180/00
2
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0038-082-003
PPA1463/077/00
2
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0038-082-003
PPA1463/077/00
1
Novartis
Pharmaceuticals
UK Ltd
Imbat Limited
Atnahs Pharma
UK Limited
Atnahs Pharma
UK Limited
Fresenius AG
Interchangeable
List Code:
IC0038-005-003
PA0013/079/007
PPA1151/067/00
3
PA1410/076/002
DPR0465/044/0
01
DPR1463/032/0
01
PA1410/076/001
Human Medicines Authorised/Transfer Pending Products
-Per Oral
PPA
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-PROPOFOL
D02AC
D02AC
D02AC
M05BA03
M05BA03
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
Page 139 of 608
Trade Name
Licence Holder Licence
Number
Strength
DISODIUM
PAMIDRONATE
DISPRIN
DIRECT
Wockhardt UK
Limited
Reckitt Benckiser
Ireland Ltd
PA1339/007/002
15 Mg/Ml
PA0979/007/001
300 Milligram
DISPRIN EXTRA
STRENGTH
Reckitt Benckiser
Ireland Ltd
PA0979/006/002
DISPRIN
ORIGINAL
Reckitt Benckiser
Ireland Ltd
DISTACLOR
DISTACLOR
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Concentrate for
Soln for Inf
Tablets
Chewable
M05BA03
500mg Milligram
Tablets
Effervescent
N02BA01
PA0979/006/001
300mg Milligram
Dispersable
Tablet
N02BA01
Flynn Pharma Ltd
Flynn Pharma Ltd
PA1226/001/001
PA1226/001/002
500 Milligram
125 MG/5ml
J01DC04
J01DC04
DISTACLOR
Flynn Pharma Ltd
PA1226/001/003
250 MG/5ml
J01DC04
-CEFACLOR
-Per Oral
DISTACLOR LA
Flynn Pharma Ltd
PA1226/001/004
375 Milligram
J01DC04
Flynn Pharma Ltd
PA1226/001/005
500 Milligram
AJ Vaccines A/S
PA2160/001/001
Per Cent
DITHROCREAM
Dermal
Laboratories Ltd
Dermal
Laboratories Ltd
Dermal
Laboratories Ltd
Dermal
Laboratories Ltd
Dermal
Laboratories Ltd
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PCO
Manufacturing
PA0278/001/001
0.1 %w/w
Cream
D05AC01
-CEFACLOR
MONOHYDRATE
-CEFACLOR
MONOHYDRATE
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-DITHRANOL
-Per Oral
DISTACLOR LA
FORTE
DITEBOOSTER
Capsules Hard
Granules for Oral
Suspension
Granules for Oral
Suspension
Tablet Prolonged
Release
Tablet Prolonged
Release
Suspension for
Injection
-PAMIDRONIC
ACID
ACETYLSALICY
LIC ACID
ACETYLSALICY
LIC ACID
ACETYLSALICY
LIC ACID
-CEFACLOR
-CEFACLOR
PA0278/001/002
0.25 %w/w
Cream
D05AC01
-DITHRANOL
PA0278/001/003
0.5 %w/w
Cream
D05AC01
-DITHRANOL
PA0278/001/004
1.0 %w/w
Cream
D05AC01
-DITHRANOL
PA0278/001/005
2 %w/w
Cream
D05AC01
-DITHRANOL
PA0540/146/002
2.5 Milligram
Tablets
G04BD04
PA0540/146/003
5 Milligram
Tablets
G04BD04
PPA0465/252/00
1
5 Milligram
Tablets
G04BD04
DITROPAN
LTT Pharma
Limited
PPA1562/180/00
1
5 Milligram
Tablets
G04BD04
DIVIGEL
DIXARIT
Orion Corporatio
Boehringer
Ingelheim Limited
PA1327/002/001
PA0007/032/001
1 Mg/Dose
0.025 Milligram
Gel
Tablets
G03CA03
N02CX02
DOBUTAMINE
Mercury
Pharmaceuticals
(Ireland) Ltd
Claris
Lifesciences (UK)
Limited
Teva B.V.
PA0073/137/001
12.5 Mg/Ml
Concentrate for
Soln for Inf
C01CA07
PA1389/012/001
12.5 Mg/Ml
Concentrate for
Soln for Inf
C01CA07
EU/1/09/611/1-2
40 Mg/Ml
L01CD02
Seacross
Pharmaceuticals
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Actavis Group
PTC ehf
PA1840/003/001
20 Mg/Ml
Concentrate and
solvent for
solution for
infusion
Concentrate for
Soln for Inf
-OXYBUTYNIN
HYDROCHLORI
DE
-OXYBUTYNIN
HYDROCHLORI
DE
-OXYBUTYNIN
HYDROCHLORI
DE
-OXYBUTYNIN
HYDROCHLORI
DE
-ESTRADIOL
-CLONIDINE
HYDROCHLORI
DE
-DOBUTAMINE
HYDROCHLORI
DE
-DOBUTAMINE
HYDROCHLORI
DE
-DOCETAXEL
L01CD02
-DOCETAXEL
ANHYDROUS
EU/1/12/769/002
80/4 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
EU/1/12/769/003
1608 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
EU/1/12/769/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
PA1380/084/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
DITHROCREAM
DITHROCREAM
DITHROCREAM
DITHROCREAM
DITROPAN
DITROPAN
DITROPAN
DOBUTAMINE
DOCETAXEL
DOCETAXEL
DOCETAXEL
ACCORD
DOCETAXEL
ACCORD
DOCETAXEL
ACCORD
DOCETAXEL
ACTAVIS
Human Medicines Authorised/Transfer Pending Products
N02BA01
J01DC04
J07AM51
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-Muscular
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Page 140 of 608
Trade Name
Licence Holder Licence
Number
Strength
DOCETAXEL
HOSPIRA
DOCETAXEL
HOSPIRA
Hospira UK
Limited
Hospira UK
Limited
PA0437/067/001
10 Micromol
EU/1/15/1017/00
1
20 Mg/Ml
DOCETAXEL
KABI
Fresenius Kabi
Oncology Plc
EU/1/12/770/002
DOCETAXEL
KABI
Fresenius Kabi
Oncology Plc
DOCETAXEL
KABI
Dosage Form ATC
Active
Ingredients
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
L01CD02
-DOCETAXEL
TRIHYDRATE
120/6 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
EU/1/12/770/003
160/8 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
Fresenius Kabi
Oncology Plc
EU/1/12/770/004
180/9 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
DOCETAXEL
KABI
Fresenius Kabi
Oncology Plc
EU/1/12/770/001
80/4 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
DOCETAXEL
MYLAN
Mylan S.A.S.
EU/1/11/748/001006
20 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-ANHYDROUS
DOCETAXEL
DOCETAXEL
PFIZER
Pfizer Healthcare
Ireland
PA0822/146/001
10 Mg/Ml
Concentrate for
Soln for Inf
L01CD02
-DOCETAXEL
(ANHYDROUS)
DOCETAXEL
WINTHROP
DOCETAXEL
WINTHROP
DOCETAXEL
WINTHROP
DOCETAXEL
WINTHROP
DOCIN
Aventis Pharma
S.A.
Aventis Pharma
S.A.
Aventis Pharma
S.A.
Aventis Pharma
S.A.
Chanelle Medical
EU/1/07/384/004
80/4 Mg/Ml
L01CD02
EU/1/07/384/003
20 Mg/Ml
EU/1/07/384/001
20 Milligram
EU/1/07/384/002
80 Milligram
PA0688/043/001
100 Milligram
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
Concentrate for
Soln for Inj
Capsule
-DOCETAXEL
TRIHYDRATE
-DOCETAXEL
TRIHYDRATE
-DOCETAXEL
TRIHYDRATE
-DOCETAXEL
TRIHYDRATE
-DOXYCYCLINE
DOLENIO
Blue Bio
Pharmaceuticals
Ltd
PA1516/001/001
1500 Milligram
Film Coated
Tablet
M01AX05
DOLMATIL
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Imbat Limited
PA0540/147/001
200 Milligram
Tablets
PA0540/147/002
400 Milligram
PPA1151/183/00
1
PA1780/001/001
DOLMATIL
DOLMATIL
L01CD02
L01CD02
L01CD02
J01AA02
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 10c Informed Consen
Article 10c Informed Consen
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Per Oral
N05AL01
Film Coated
Tablet
N05AL01
-SULPIRIDE
-Per Oral
200 Milligram
Tablets
N05AL01
-SULPIRIDE
-Per Oral
1500 Milligram
Film Coated
Tablet
M01AX05
-GLUCOSAMINE
SULFATE
SODIUM
CHLORIDE
-DOMPERIDONE
MALEATE
DOMERID
Rowex Ltd
PA0711/046/001
10 Milligram
Tablets
A03FA03
Rowex Ltd
Interchangeable
List Code:
IC0085-002-014
PA0711/046/002
10 Milligram
Tablets
A03FA03
PA1339/050/001
1 Mg/Ml
Oral Suspension
A03FA03
-DOMPERIDONE
MALEATE
-DOMPERIDONE
Interchangeable
List Code:
IC0085-047-027
PA0126/291/001
10 Milligram
Orodispersible
Tablet
A03FA03
-DOMPERIDONE
-GLUCOSAMINE
SULFATE
SODIUM
CHLORIDE
-GLUCOSAMINE
SULFATE
SODIUM
CHLORIDE
DOMPERIDONE
SUBSTIPHARM
Clonmel
Healthcare Ltd
DONA
Meda Health
Sales Ireland
Limited
PA1332/054/002
500 Milligram
Capsules Hard
M01AX05
DONA
PCO
Manufacturing
PPA0465/401/00
1
1500 Milligram
Powder for Oral
Solution
M01AX05
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Per Oral
AHA Medical
Services Ltd
Wockhardt UK
Limited
Routes of
Administration
-GLUCOSAMINE
SULFATE
-GLUCOSAMINE
SULPHATE
SODIUM
CHLORIDE
-SULPIRIDE
DOLORITIS
DOMERID
RELIEF
DOMPERIDONE
Legal Basis
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 141 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
DONA
Imbat Limited
PPA1151/056/00
1
1500 Milligram
Powder for Oral
Solution
M01AX05
DONA 1500 MG
POWDER FOR
ORAL
SOLUTION
DONECEPT
Meda Health
Sales Ireland
Limited
PA1332/054/001
1500 Milligram
Powder for Oral
Solution
M01AX05
Actavis Group
PTC ehf
PA1380/060/001
5 Milligram
Film Coated
Tablet
N06DA02
Interchangeable
List Code:
IC0062-001-015
PA1380/060/002
10 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0062-002-015
PA1390/039/001
5 Milligram
Interchangeable
List Code:
IC0062-001-015
PA1390/039/002
DONECEPT
DONEPEZIL
DONEPEZIL
Actavis Group
PTC ehf
Accord
Healthcare
Limited
Accord
Healthcare
Limited
DONEPEZIL
HYDROCHLORI
DE
Bristol
Laboratories
Limited
DONEPEZIL
HYDROCHLORI
DE
Bristol
Laboratories
Limited
DONEPEZIL
HYDROCHLORI
DE
Wockhardt UK
Limited
DONEPEZIL
HYDROCHLORI
DE
Wockhardt UK
Limited
DONEPEZIL
HYDROCHLORI
DE
DONEPEZIL
HYDROCHLORI
DE BLUEFISH
Rosemont
Pharmaceuticals
Ltd
Bluefish
Pharmaceuticals
AB
DONEPEZIL
HYDROCHLORI
DE BLUEFISH
Bluefish
Pharmaceuticals
AB
DONEPEZIL
KRKA
Krka d.d., Novo
mesto
DONEPEZIL
KRKA
Krka d.d., Novo
mesto
Active
Ingredients
Legal Basis
Routes of
Administration
-GLUCOSAMINE
SULFATE AS
CRYSTALLINE
GLUCOSAMINE
SULFATE
-GLUCOSAMINE
SULFATE
-SODIUM
CHLORIDE
-DONEPEZIL
HYDROCHLORI
DE
PPA
Article 10(1) Generic
Application
-Per Oral
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA1240/006/001
-DONEPEZIL
HYDROCHLORI
DE
5 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA1240/006/002
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA1339/039/001
-DONEPEZIL
HYDROCHLORI
DE
5 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA1339/039/002
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA0312/029/001
-DONEPEZIL
HYDROCHLORI
DE
1 Mg/Ml
Oral Solution
N06DA02
5 Milligram
Film Coated
Tablet
N06DA02
Interchangeable
List Code:
IC0062-001-015
PA1436/015/002
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
-Per Oral
PA1436/015/001
-DONEPEZIL
HYDROCHLORI
DE
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA1347/014/003
-DONEPEZIL
HYDROCHLORI
DE
5 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA1347/014/004
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
Page 142 of 608
Trade Name
DONEPEZIL
TEVA
DONEPEZIL
TEVA
DONESYN
DONESYN
DONESYN
DONESYN
Licence Holder Licence
Number
Teva Pharma
B.V.
Teva Pharma
B.V.
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
PA0749/194/001
5 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA0749/194/002
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA0126/214/001
-DONEPEZIL
HYDROCHLORI
DE
5 Milligram
Orodispersible
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA0126/214/002
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Orodispersible
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA0126/183/001
-DONEPEZIL
HYDROCHLORI
DE
5 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-001-015
PA0126/183/002
-DONEPEZIL
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0062-002-015
PA1848/003/001
-DONEPEZIL
HYDROCHLORI
DE
50%/50 %v/v
Medicinal gas,
compressed
N01AX63
Article 10a Bibliographical
App
40 Mg/Ml
Concentrate for
Soln for Inf
C01CA04
-OXYGEN
-NITROUS
OXIDE
-DOPAMINE
HYDROCHLORI
DE
-TINCTURE OF
VALERIAN
ROOT
(VALERIANA
OFFICINALIS L.)
(1:10-11)
EXTRACTION
SOLVENT:
ETHANOL 58%
V/V
-TINCTURE OF
HOP STROBILE
(HUMULUS
LUPULUS L.)
(1:12-13)
EXTRACTION
SOLVENT:
ETHANOL 65%
V/V
-DORZOLAMIDE
HYDROCHLORI
DE
-DORZOLAMIDE
HYDROCHLORI
DE
-TIMOLOL
MALEATE
-DORZOLAMIDE
HYDROCHLORI
DE
DONOPA
SOL S.p.A.
DOPAMINE
HYDROCHLORI
DE
DORMEASAN
SLEEP
VALERIANHOPS
Hospira UK
Limited
PA0437/003/001
Bioforce (UK) Ltd
TR0725/005/001
DORZOLAMIDE
Blumont Pharma
PA1859/001/001
20 Mg/Ml
Eye Drops
Solution
S01EC03
DORZOLAMIDE
+ TIMOLOL
PHARMASWISS
EYE DROPS
SOLUTION
DORZOLAMIDE
ACTAVIS
20MG/ML EYE
DROPS,
SOLUTION
DORZOLAMIDE
PHARMASWISS
PharmaSwiss
Ceska republika
s.r.o.
PA1696/008/001
20+5 Mg/Ml
Eye Drops
Solution
S01ED51
Actavis Group
PTC ehf
PA1380/082/001
20 Mg/Ml
Eye Drops
Solution
S01EC03
PharmaSwiss
Ceska republika
s.r.o.
Actavis Group
PTC ehf
PA1696/007/001
20 Mg/Ml
Ear/Eye Drops,
solution
S01EC03
-DORZOLAMIDE
PA1380/081/001
2/0.5 Per Cent
Eye Drops
Solution
S01ED51
-DORZOLAMIDE
HYDROCHLORI
DE
-TIMOLOL
MALEATE
DORZOLAMIDE/
TIMOLOL 20
MG/ML + 5
MG/ML EYE
DROPS,
Legal Basis
Human Medicines Authorised/Transfer Pending Products
Oral Drops
Solution
-Per Oral
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Ocular
Article 10(3) Hybrid
Application
-Ocular
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Ocular
-Ocular
-Ocular
Page 143 of 608
Trade Name
DOSTINEX
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0822/126/001
0.5 Milligram
Tablets
G02CB03
-CABERGOLINE
PPA0465/338/00
1
PPA1562/108/00
1
PA1410/082/001
500 Microgram
Tablets
G02CB03
-CABERGOLINE
-Per Oral
500 Microgram
Tablets
G02CB03
-CABERGOLINE
-Per Oral
DOTAGRAF
Pfizer Healthcare
Ireland
PCO
Manufacturing
LTT Pharma
Limited
Bayer Limited
279.32 Mg/Ml
Solution for
Injection
V08CA02
-GADOTERIC
ACID
DOTAGRAF
Bayer Limited
PA1410/082/002
279.32 Mg/Ml
Solution for
Injection
V08CA02
-GADOTERIC
ACID
DOTAREM
GUERBET
PA0686/003/002
279.32 Mg/Ml
V08CA02
DOTAREM
GUERBET
PA0686/003/005
279.32 Mg/Ml
DOTEVATROL
Teva Pharma
B.V.
PA0749/189/001
50 + 0.5
Solution for
Injection
Solution for
Injection
Ointment
DOVOBET
PCO
Manufacturing
PPA0465/213/00
2
50 mcg/g +
Gel
D05AX52
DOVOBET
LTT Pharma
Limited
PPA1562/103/00
1
50 + 0.5
Gel
D05AX52
DOVOBET
Clear Pharmacy
PPA1596/004/00
1
50/0.5
Ointment
D05AX52
DOVOBET
LEO Pharma A/S
PA1025/001/001
50/0.5
Ointment
D05AX52
DOVOBET
Imbat Limited
PPA1151/053/00
1
50 Micrograms/g
Ointment
D05AX03
DOVOBET
LEO Pharma A/S
PA1025/001/002
50mcg/g +
0.5mg/g
Gel
D05AX52
DOVOBET
B & S Healthcare
PPA1328/066/00
1
50 Micrograms/g
Ointment
D05AX52
DOVOBET
OINTMENT
IMED Healthcare
Ltd.
PPA1463/022/00
1
50 Microgram
Ointment
D05AX52
DOVONEX
Cream
D05AX02
50 Micrograms/g
Cream
D05AX02
DOVONEX
B & S Healthcare
50 Micrograms/g
Cream
DOVONEX
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
PPA1463/020/00
1
PPA1596/039/00
1
PPA1328/023/00
2
PA0046/061/001
50 Micrograms/g
DOVONEX
IMED Healthcare
Ltd.
Clear Pharmacy
-GADOTERIC
ACID
-GADOTERIC
ACID
BETAMETHASO
NE
DIPROPIONATE
-CALCIPOTRIOL,
ANHYDROUS
-CALCIPOTRIOL
BETAMETHASO
NE
-CALCIPOTRIOL
BETAMETHASO
NE
-CALCIPOTRIOL
HYDRATE
BETAMETHASO
NE
DIPROPIONATE
-CALCIPOTRIOL
HYDRATE
BETAMETHASO
NE
DIPROPIONATE
-CALCIPOTRIOL
BETAMETHASO
NE
DIPROPIONATE
-CALCIPOTRIOL
BETAMETHASO
NE
-CALCIPOTRIOL
HYDRATE
BETAMETASON
E
DIPROPIONATE
-CALCIPOTRIOL
BETAMETHASO
NE
-CALCIPOTRIOL
50 Micrograms/g
PA0046/061/002
PA0046/064/001
DOSTINEX
DOSTINEX
DOVONEX
DOVONEX
PSORIASIS
Human Medicines Authorised/Transfer Pending Products
V08CA02
D05AX52
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 10(3) Hybrid
Application
-Cutaneous
PPA
-Cutaneous
-Cutaneous
PPA
PPA
Article 10b Fixed
Combination
-Cutaneous
PPA
PPA
PPA
-Topical
-CALCIPOTRIOL
PPA
-Topical
D05AX02
-CALCIPOTRIOL
PPA
Ointment
D05AX02
-CALCIPOTRIOL
-Topical
50 Micrograms/g
Cream
D05AX02
-CALCIPOTRIOL
-Topical
50 Micrograms/g
Ointment
D05AX02
-CALCIPOTRIOL,
ANHYDROUS
Article 10c Informed Consen
-Topical
Page 144 of 608
Trade Name
DOVONEX
SCALP
SOLUTION
DOXACAR
DOXANE XL
DOXAPRAM
HYDROCHLORI
DE
DOXAPRAM
HYDROCHLORI
DE
DOXATAN
DOXATAN
DOXATAN
DOXATAN XL
DOXAZOSIN
AUROBINDO
DOXAZOSIN
AUROBINDO
DOXAZOSIN
AUROBINDO
DOXORUBICIN
DOXORUBICIN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Routes of
Administration
PA0046/061/003
50 Microgram
Cutaneous
Solution
D05AX02
-CALCIPOTRIOL
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/076/001
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
-Per Oral
Interchangeable
List Code:
IC0021-008-024
PA0711/103/001
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
-Per Oral
Interchangeable
List Code:
IC0021-008-024
PA0857/003/001
2/1 Mg/Ml
Solution for
Infusion
R07AB01
-Intra-venous
MercuryPharm
Ltd
PA0857/003/002
20 Mg/Ml
Solution for
Injection
R07AB01
Clonmel
Healthcare Ltd
PA0126/202/001
1 Milligram
Tablets
C02CA04
-DOXAPRAM
HYDROCHLORI
DE
-DOXAPRAM
HYDROCHLORI
DE
-DOXAZOSIN
Interchangeable
List Code:
IC0021-039-002
PA0126/202/002
2 Milligram
Tablets
C02CA04
-DOXAZOSIN
-Per Oral
Interchangeable
List Code:
IC0021-006-002
PA0126/202/003
4 Milligram
Tablets
C02CA04
-DOXAZOSIN
-Per Oral
Interchangeable
List Code:
IC0021-008-002
PA0126/202/004
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
-Per Oral
Interchangeable
List Code:
IC0021-008-024
PA1445/006/001
1 Milligram
Tablets
C02CA04
-DOXAZOSIN
-Per Oral
Interchangeable
List Code:
IC0021-039-002
PA1445/006/002
Article 10(1) Generic
Application
2 Milligram
Tablets
C02CA04
-DOXAZOSIN
-Per Oral
Interchangeable
List Code:
IC0021-006-002
PA1445/006/003
Article 10(1) Generic
Application
4 Milligram
Tablets
C02CA04
-DOXAZOSIN
-Per Oral
Interchangeable
List Code:
IC0021-008-002
PA1390/022/001
Article 10(1) Generic
Application
2 Mg/Ml
Concentrate for
Soln for Inf
L01DB01
Article 10(1) Generic
Application
-Intra Vesical
-Intra-venous
PA1070/003/001
2 Mg/Ml
Solution for
Injection
L01DB01
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
-DOXORUBICIN
HYDROCHLORI
DE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Rowex Ltd
MercuryPharm
Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Aurobindo
Pharma (Malta)
Limited
Aurobindo
Pharma (Malta)
Limited
Aurobindo
Pharma (Malta)
Limited
Accord
Healthcare
Limited
Cell Pharm
GmbH
Actavis Group
PTC ehf
PA1380/111/001
2 Mg/Ml
Concentrate for
Soln for Inf
L01DB01
DOXORUBICIN
Genepharm
(Europe) Trading
Ltd
Seacross
Pharmaceuticals
Limited
Hospira UK
Limited
PA1658/001/001
2 Mg/Ml
Concentrate for
Soln for Inf
L01DB01
PA1840/002/001
2 Mg/Ml
Concentrate for
Soln for Inf
L01DB01
PA0437/026/002
50 Milligram
Pdr for Soln for
Injection
L01DB01
Teva Pharma
B.V.
PA0749/083/001
2 Micromol
Concentrate for
Soln for Inf
L01DB01
DOXORUBICIN
HYDROCHLORI
DE
DOXORUBICIN
TEVA
Legal Basis
Leo Laboratories
Limited
DOXORUBICIN
DOXORUBICIN
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Intra Vesical
-Intra-venous
-Intra Vesical
-Intra-venous
Page 145 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
DOXYCYCLINE
Chanelle Medical
PA0688/042/001
100 Milligram
Capsule
J01AA02
-DOXYCYCLINE
DOXYCYCLINE
TEVA 100MG
HARD
CAPSULES
Norton
Healthcare
Limited T/A IVAX
Pharmaceuticals
UK
Rowex Ltd
PA0282/033/001
100 Milligram
Capsule
J01AA02
-DOXYCYCLINE
HYDROCHLORI
DE
PA0711/141/001
5 Milligram
Film Coated
Tablet
N06DA02
Interchangeable
List Code:
IC0062-001-015
PA0711/141/002
10 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0062-002-015
PA0095/004/001
120 MG/5ml
DOZEPT
DOZEPT
Rowex Ltd
-Per Oral
-DONEPEZIL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
N06DA02
-DONEPEZIL
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Oral Solution
N02BE51
Ricesteele
Manufacturing
Ltd
DRAPOLENE
Ravira Ltd
PA2034/001/001
0.01/0.2 %w/w
Cream
D08AJ01
DRAPOLENE
Ravira Ltd
PA2034/001/001
0.01/0.2 %w/w
Cream
D08AJ04
DRETINE
Teva Pharma
B.V.
PA0749/159/001
0.03 / 3 Milligram
Film Coated
Tablet
G03AA12
DRETINELLE
Teva Pharma
B.V.
PA0749/118/001
0.02 / 3 Milligram
Film Coated
Tablet
G03FA17
DROPODEX
Moorfields Eye
Hospital NHS
Foundation Trust
PA1464/003/001
0.1 %w/v
Eye Drops
Solution
S01BA01
DRYNOL
Menarini
International
Operations
Luxembourg S.A.
PCO
Manufacturing
GE Healthcare
Limited
GlaxoSmithKline
(Ireland) Limited
PA0865/018/001
20 Milligram
Tablets
R06AX29
-PARACETAMOL
DIPHENHYDRA
MINE
HYDROCHLORI
DE
BENZALKONIUM
CHLORIDE
-CETRIMONIUM
BROMIDE
BENZALKONIUM
CHLORIDE
-CETRIMONIUM
BROMIDE
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
DEXAMETHAS
ONE
PHOSPHATE
-BILASTINE
PPA0465/424/00
1
PA0240/021/001
20 Milligram
Tablets
R06AX29
-BILASTINE
Radionuclide
Generator
Gel
V09
PA1077/120/001
2.5-100
Gig.bequerel
10/50 mg/g
DUAKLIR
GENUAIR
AstraZeneca AB
EU/1/14/964/001002
340/12
Microgram
Powder for
Inhalation
R03AL05
DUAVIVE
Pfizer Limited
EU/1/14/960/001
20mg/0.45
Milligram
Modified-release
Tablets
G03CX
-MOLYBDENUM99
-CLINDAMYCIN
PHOSPHATE
-BENZOYL
PEROXIDE
HYDROUS
-MICRONIZED
ACLIDINIUM
BROMIDE
-MICRONIZED
FORMOTEROL
FUMARATE
DIHYDRATE
-CONJUGATED
ESTROGENS
(CE)
BAZEDOXIFENE
ACETATE
DRYTEC
DUAC ONCE
DAILY 10MG/G +
50MG/G GEL
Human Medicines Authorised/Transfer Pending Products
Routes of
Administration
Article 10(1) Generic
Application
DOZOL
DRYNOL
Legal Basis
D10AF51
-Topical
-Topical
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Ocular
-Per Oral
-Per Oral
-Topical
Article 10b Fixed
Combination
-Inhalation
Article 10b Fixed
Combination
-Per Oral
Page 146 of 608
Trade Name
DUKORAL
Licence Holder Licence
Number
Strength
Eurodrug Ltd
DULCOLAX FOR
CHILDREN
DULCOLAX
LIQUID 5 MG/5
ML ORAL
SOLUTION
DULCOLAX
PICO LIQUID
Boehringer
Ingelheim Limited
McDowell
Pharmaceuticals
Boehringer
Ingelheim Limited
PA0007/055/001
5 MG/5ml
Oral Solution
A06AB08
DULCOLAX
PICO PERLES
Boehringer
Ingelheim Limited
PA0007/060/001
2.5 Milligram
Capsules, Soft
A06AB08
DULOXETINE
Wockhardt UK
Limited
PA1339/061/001
20 Milligram
Capsules GastroResistant
N06AX
Interchangeable
List Code:
IC0091-003-006
PA1339/061/004
60 Milligram
Capsules GastroResistant
N06AX
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-127-006
PA1339/061/003
-DULOXETINE
HYDROCHLORI
DE
40 Milligram
Capsules GastroResistant
N06AX
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-004-006
PA1339/061/002
-DULOXETINE
HYDROCHLORI
DE
30 Milligram
Capsules GastroResistant
N06AX
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-033-006
IC0091
PA0126/269/002
-DULOXETINE
HYDROCHLORI
DE
30 Milligram
N06A
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-033-006
PA0126/269/004
-DULOXETINE
HYDROCHLORI
DE
60 Milligram
Capsules GastroResistant
N06A
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-127-006
PA1347/051/002
-DULOXETINE
HYDROCHLORI
DE
30 Milligram
Capsules GastroResistant
N06AX21
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-033-006
PA1347/051/004
-DULOXETINE
HYDROCHLORI
DE
60 Milligram
Capsules GastroResistant
N06AX21
-DULOXETINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Capsules GastroResistant
N06AX21
-DULOXETINE
HYDROCHLORI
DE
Article 10c Informed Consen
-Per Oral
60 Milligram
Capsules GastroResistant
N06AX21
-DULOXETINE
HYDROCHLORI
DE
Article 10c Informed Consen
-Per Oral
DULOXETINE
DULOXETINE
DULOXETINE
DULOXETINE
CLONMEL
DULOXETINE
CLONMEL
DULOXETINE
KRKA
DULOXETINE
KRKA
DULOXETINE
LILLY
DULOXETINE
LILLY
Wockhardt UK
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
IC List
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
5 Milligram
PA0007/054/003
10 Milligram
PPA1151/045/00
1
DPR1392/066/0
01
PA0007/054/002
5 Milligram
A06AB02
-CHOLERA
VACCINE
-BISACODYL
A06AB02
-BISACODYL
A06AB02
-BISACODYL
A06AB02
-BISACODYL
5 Milligram
Tablets GastroResistant
Tablets GastroResistant
Suppositories
A06AB02
-BISACODYL
DPR1473/011/0
01
5 mg/5 ml
Oral Solution
A06AB08
-SODIUM
PICOSULFATE
-Per Oral
-SODIUM
PICOSULPHATE
MONOHYDRATE
-SODIUM
PICOSULPHATE
MONOHYDRATE
-DULOXETINE
HYDROCHLORI
DE
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Eli Lilly
Nederland B.V.
Interchangeable
List Code:
IC0091-127-006
EU/1/14/972/001003
Eli Lilly
Nederland B.V.
Interchangeable
List Code:
IC0091-033-006
EU/1/14/972/005009
5 Milligram
J07AE01
Routes of
Administration
DULCOLAX
DULOXETINE
PA0007/054/001
Infus/Pdr/Oral
Soln
Tablets GastroResistant
Suppositories
Legal Basis
DULCOLAX
DULCOLAX
%v/v
Active
Ingredients
Crucell Sweden
AB
Boehringer
Ingelheim Limited
Boehringer
Ingelheim Limited
Imbat Limited
DULCOLAX
EU/1/03/263/1-3
Dosage Form ATC
Unknown
Capsules GastroResistant
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0091-127-006
Human Medicines Authorised/Transfer Pending Products
Page 147 of 608
Trade Name
DULOXETINE
MYLAN
DULOXETINE
MYLAN
DULOXETINE
ROWEX
DULOXETINE
ROWEX
DULOXETINE
TEVA
DULOXETINE
TEVA
DULOXETINE
ZENTIVA
DULOXETINE
ZENTIVA
Licence Holder Licence
Number
Generics (UK)
Limited
EU/1/15/1010/01010
Generics (UK)
Limited
Interchangeable
List Code:
IC0091-033-006
EU/1/15/1010/01
1-020
Strength
Dosage Form ATC
Legal Basis
Routes of
Administration
30 Milligram
Capsules GastroResistant
N06A
-DULOXETINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
60 Milligram
Capsules GastroResistant
N06A
-DULOXETINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0091-127-006
PA0711/263/001
30 Milligram
Capsules GastroResistant
N06AX21
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0091-033-006
PA0711/263/002
-DULOXETINE
HYDROCHLORI
DE
60 Milligram
Capsules GastroResistant
N06AX21
Article 10(1) Generic
Application
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0091-127-006
PA1986/004/001
-DULOXETINE
HYDROCHLORI
DE
30 Milligram
Capsules GastroResistant
N06A
Article 10(1) Generic
Application
-Per Oral
Teva B.V.
Interchangeable
List Code:
IC0091-033-006
PA1986/004/002
-DULOXETINE
HYDROCHLORI
DE
60 Milligram
Capsules GastroResistant
N06A
-DULOXETINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Capsules GastroResistant
N06A
-DULOXETINE
Article 10(1) Generic
Application
-Per Oral
60 Milligram
Capsules GastroResistant
N06A
-DULOXETINE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0091-127-006
EU/1/10/619/1-7
75/75 mg/mg
Film Coated
Tablet
B01AC30
-CLOPIDOGREL
HYDROGEN
SULPHATE
ACETYLSALICY
LIC ACID
-CLOPIDOGREL
HYDROGEN
SULPHATE
ACETYLSALICY
LIC ACID
-CLOPIDOGREL
HYDROGEN
SULPHATE
ACETYLSALICY
LIC ACID
-LEVODOPA
-CARBIDOPA
-SALICYLIC
ACID
-S)-LACTIC ACID
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-CLOPIDOGREL
HYDROGEN
SULPHATE
ACETYLSALICY
LIC ACID
Article 10b Fixed
Combination
Zentiva k.s.
Zentiva k.s.
Interchangeable
List Code:
IC0091-127-006
EU/1/15/1028/00
1-003
Interchangeable
List Code:
IC0091-033-006
EU/1/15/1028/00
4-007
DUOCOVER
sanofi-aventis
groupe
DUOCOVER
sanofi-aventis
groupe
EU/1/10/623/1-7
75/75
Film Coated
Tablet
B01AC30
DUOCOVER
sanofi-aventis
groupe
EU/1/10/623/8-14
75/100
Film Coated
Tablet
B01AC30
DUODOPA
AbbVie Limited
PA1824/002/001
20/5 Mg/Ml
Gel
N04BA02
DUOFILM
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Sanofi Pharma
Bristol-Myers
Squibb SNC
PA0678/114/001
16.7/15.0 %w/w
Cutaneous
Solution
D11AF
EU/1/10/619/001
75/75 mg/mg
Film Coated
Tablet
B01AC30
DUOPLAVIN
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
-Topical
-Per Oral
Page 148 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
DUOPLAVIN
Sanofi Pharma
Bristol-Myers
Squibb SNC
EU/1/10/619/8-14
75/100 mg/mg
Film Coated
Tablet
B01AC30
DUORESP
SPIROMAX
Teva Pharma
B.V.
EU/1/14/920
/001-003
160/4.5
Microgram
Powder for
Inhalation
R03AK07
DUORESP
SPIROMAX
Teva Pharma
B.V.
EU/1/14/920
/004-006
320/9 Microgram
Powder for
Inhalation
R03AK07
DUORESP
SPIROMAX
TEVA
Teva Pharma
B.V.
EU/1/14/921/001003
160/4.5
Microgram
Powder for
Inhalation
R03AK07
DUORESP
SPIROMAX
TEVA
Teva Pharma
B.V.
EU/1/14/921/004006
320/9 Microgram
Powder for
Inhalation
R03AK07
DUOTRAV
(EXTRAVAN)
Alcon
Laboratories (UK)
Ltd
EU/1/06/338/001003
40/5
Microgram/ML
Eye Drops
Solution
S01ED51
DUPHALAC
BGP Products
Ltd
BGP Products
Ltd
PA2007/004/001
3.335 g/5ml
Oral Solution
A06AD11
PA2007/005/001
10 Milligram
Film Coated
Tablet
G03DB01
ColgatePalmolive (U.K.)
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Imbat Limited
PA0320/008/002
5000 ppm
Toothpaste
A01AA01
PA0748/002/005
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Capsules, Soft
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
PPA1151/252/00
1
PPA1151/252/00
2
PPA1151/252/00
3
PPA1151/252/00
4
PPA0465/314/00
5
PPA0465/314/00
1
PPA0465/314/00
2
PPA0465/314/00
3
PPA0465/314/00
4
PA1963/005/001
12 Microgram per
hour
25 Microgram per
hour
50 Microgram per
hour
75 Microgram per
hour
100 Microgram
per hour
50 Microgram per
hour
75 Microgram per
hour
25 Microgram per
hour
100 Microgram
per hour
12 Microgram per
hour
25 Microgram per
hour
50 Microgram per
hour
75 Microgram per
hour
100 Microgram
per hour
0.5 Milligram
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
N02AB03
-FENTANYL
G04CB02
-DUTASTERIDE
(DMF)
DUPHASTON
DURAPHAT
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUROGESIC
DTRANS
DUTASTERIDE
Imbat Limited
Imbat Limited
Imbat Limited
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
Cipla Europe NV
PA0748/002/001
PA0748/002/002
PA0748/002/003
PA0748/002/004
-CLOPIDOGREL
HYDROGEN
SULPHATE
ACETYLSALICY
LIC ACID
-BUDESONIDE
-FORMOTEROL
FUMATRATE
DIHYDRATE
-BUDESONIDE
-FORMOTEROL
FUMATRATE
DIHYDRATE
-BUDESONIDE
-FORMOTEROL
FUMARATE
DIHYDRATE
-BUDESONIDE
-FORMOTEROL
FUMARATE
DIHYDRATE
-TRAVOPOST
-TIMOLOL
-TIMOLOL
MALEATE
-LACTULOSE
Routes of
Administration
Article 10b Fixed
Combination
-Per Oral
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
-Per Oral
DYDROGESTE
RONE
-SODIUM
FLUORIDE
DUTASTERIDE
Actavis Group
PTC ehf
PA1380/165/001
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
DUTASTERIDE
Generics (UK)
Limited
PA0405/098/001
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
DUTASTERIDE
Teva B.V.
PA1986/027/001
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 149 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
DUTASTERIDE
KRKA
Krka d.d., Novo
mesto
PA1347/069/001
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
DUTASTERIDE
TEVA
Teva Pharma
B.V.
PA0749/167/001
0.5 Milligram
Capsules, Soft
G04CB02
-DUTASTERIDE
DYAZIDE
50MG/25MG
TABLETS.
Mercury
Pharmaceuticals
Ltd
PA0899/009/001
50mg/25mg
Milligram
Tablets
C03EA01
DYMISTA
Meda Health
Sales Ireland
Limited
PA1332/045/001
137/50
Microgram
Nasal Spray
Suspension
R01AD58
DYMISTA
PCO
Manufacturing
PPA0465/422/00
1
137/50
Microgram
Nasal Spray
Suspension
R01AD58.
DYMISTA
IMED Healthcare
Ltd.
PPA1463/114/00
1
137/50
Microgram
Nasal Spray
Suspension
R01AD58
DYNASTAT
Pfizer Limited
EU/1/02/209/001
20 Milligram
M01AH04
DYNASTAT
Pfizer Limited
EU/1/02/209/002
20 Milligram
DYNASTAT
Pfizer Limited
EU/1/02/209/003
20 Milligram
DYNASTAT
Pfizer Limited
EU/1/02/209/004
20 Milligram
DYNASTAT
Pfizer Limited
EU/1/02/209/005
40 Milligram
DYNASTAT
Pfizer Limited
EU/1/02/209/006
40 Milligram
DYNASTAT
Pfizer Limited
EU/1/02/209/007
40 Milligram
DYNASTAT
Pfizer Limited
EU/1/02/209/008
40 Milligram
DYPRACET
Auden Mckenzie
(Pharma Division)
Ltd
PA1352/012/001
20/500 Milligram
Pdr for Soln for
Injection
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr for Soln for
Injection
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Tablets
DYPRACET
Auden Mckenzie
(Pharma Division)
Ltd
PA1352/012/002
30/500 Milligram
Tablets
N02AA58
DYSPORT
Ipsen Biopharm
Limited
PA1609/002/001
500 Units/ml
Pdr for Soln for
Injection
J06AA04
E45 CREAM
Reckitt Benckiser
Ireland Ltd
PA0979/043/001
14.5%/12.6%/1.0
% %w/w
Cream
D02AX
EASOFEN
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
PA0126/060/001
200 Milligram
Coated Tablets
M01AE01
-TRIAMTERENE
HYDROCHLOR
OTHIAZIDE
-AZELASTINE
HYDROCHLORI
DE
-FLUTICASONE
PROPIONATE
-AZELASTINE
HYDROCHLORI
DE
-FLUTICASONE
PROPIONATE
-AZELASTINE
HYDROCHLORI
DE
-FLUTICASONE
PROPIONATE
-WATER,
PURIFIED
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARECOXIB
SODIUM
-PARACETAMOL
DIHYDROCODE
INE
BITARTRATE
-PARACETAMOL
DIHYDROCODE
INE
BITARTRATE
-CLOSTRIDIUM
BOTULINUM
TOXIN TYPE A
HAEMAGGLUTI
NIN COMPLEX
-PARAFFIN
SOFT
-PARAFFIN,
LIQUID
-WOOL FAT
-IBUPROFEN
PA0126/060/004
200 MG/5ml
Oral Suspension
M01AE01
Clonmel
Healthcare Ltd
PA0126/060/003
100 MG/5ml
Oral Suspension
Clonmel
Healthcare Ltd
PA0126/060/002
400 Milligram
Film Coated
Tablet
EASOFEN FOR
CHILDREN SIX
PLUS
STRAWBERRY
EASOFEN FOR
CHILDREN
STRAWBERRY
EASOFEN MAX
STRENGTH
Human Medicines Authorised/Transfer Pending Products
M01AH04
M01AH04
M01AH04
M01AH04
M01AH04
M01AH04
M01AH04
N02AA58
Legal Basis
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Nasal
-Nasal
-Nasal
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-IBUPROFEN
Article 10(1) Generic
Application
-Per Oral
M01AE01
-IBUPROFEN
Article 10(1) Generic
Application
-Per Oral
M01AE01
-IBUPROFEN
-Per Oral
Page 150 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
EBILFUMIN
Actavis Group
PTC ehf
EU/1/14/915/001002
30 Milligram
Capsules Hard
J05AH02
-OSELTAMIVIR
PHOSPHATE
EBILFUMIN
Actavis Group
PTC ehf
EU/1/14/915/003004
45 Milligram
Capsules Hard
J05AH02
-OSELTAMIVIR
PHOSPHATE
EBILFUMIN
Actavis Group
PTC ehf
EU/1/14/915/005006
75 Milligram
Capsules Hard
J05AH02
-OSELTAMIVIR
PHOSPHATE
EBIXA
H. Lundbeck A/S
EU/1/02/219/001003
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
-Per Oral
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-Per Oral
EBIXA
EBIXA
EBIXA
EBYMECT
H. Lundbeck A/S
H. Lundbeck A/S
H. Lundbeck A/S
AstraZeneca AB
Interchangeable
List Code:
IC0022-002-003
EU/1/02/219/005006
Interchangeable
List Code:
IC0022-107-019
EU/1/02/219/022
Interchangeable
List Code:
IC0022-106-003
EU/1/02/219/023035
Interchangeable
List Code:
IC0022-003-003
EU/1/15/1051/00
1-006
5 mg/pump
actuation
-MEMANTINE
HYDROCHLORI
DE
Article 8(3) - Full
new Application
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 8(3) - Full
new Application
-Per Oral
5mg/850
Milligram
Film Coated
Tablet
A10BD15
Article 10c Informed Consen
-Per Oral
5mg/1000
Milligram
Film Coated
Tablet
A10BD15
Article 10c Informed Consen
-Per Oral
Pfizer Limited
EU/1/07/416/002
100 Milligram
Pdr/Conc/Soln for
Infus
J02AX06
ECALTA
Pfizer Limited
EU/1/07/416/001
100 Milligram
Pdr+Solv for soln
for Inf
J02AX06
ECANSYA
Krka d.d., Novo
mesto
EU/1/12/763/001006
150 Milligram
Film Coated
Tablet
L01BC06
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0079-062-003
EU/1/12/763/013018
500 Milligram
Film Coated
Tablet
L01BC06
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0079-117-003
EU/1/12/763/007012
300 Milligram
Film Coated
Tablet
L01BC06
Interchangeable
List Code:
IC0090-142-003
ECANSYA
ECANSYA
-Per Oral
N06DX01
ECALTA
EU/1/15/1051/00
7-012
-Per Oral
Film Coated
Tablet
Interchangeable
List Code:
IC0090-143-003
AstraZeneca AB
-Per Oral
5+10+15+20
Milligram
-METFORMIN
HYDROCHLORI
DE
DAPAGLIFLOZIN
PROPANEDIOL
MONOHYDRATE
-METFORMIN
HYDROCHLORI
DE
DAPAGLIFLOZIN
PROPANEDIOL
MONOHYDRATE
ANIDULAFUNGI
N
ANIDULAFUNGI
N
-CAPECITABINE
EBYMECT
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
-CAPECITABINE
Article 10(3) Hybrid
Application
-Per Oral
-CAPECITABINE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0079-029-003
Human Medicines Authorised/Transfer Pending Products
Page 151 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ECHINACE
Sona Nutrition
Ltd
TR1725/001/001
Film Coated
Tablet
R07AX
ECHINAFORCE
COLD & FLU
Bioforce (UK) Ltd
TR0725/009/003
Tablets
Chewable
L03A
ECHINAFORCE
COLD AND FLU
Bioforce (UK) Ltd
TR0725/009/004
Tablets
L03A
ECHINAFORCE
COLD AND FLU
Bioforce (UK) Ltd
TR0725/009/002
Oral Drops
Solution
L03A
ECHINAFORCE
FORTE COLD
AND FLU
Bioforce (UK) Ltd
TR0725/009/001
Tablets
L03A
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-ECHINACEA
PURPUREA
POWDER
EXTRACT 6-7:1
(EQUIVALENT
TO 762 MG - 889
MG OF
ECHINACEA
PURPUREA
ROOT)
-EXTRACT (AS
DRY EXTRACT)
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH HERB
-EXTRACT (AS
DRY EXTRACT)
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH ROOT
-EXTRACT (AS
DRY EXTRACT)
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH HERB
-EXTRACT (AS
DRY EXTRACT)
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH ROOT
-TINCTURE
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH HERB
(1:12-13)
EXTRACTION
SOLVENT:
ETHANOL
57.3%M/M
-TINCTURE
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH ROOT
(1:11-12).
EXTRACTION
SOLVENT:
ETHANOL
57.3%M/M
-EXTRACT (AS
DRY EXTRACT)
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH HERB
-EXTRACT (AS
DRY EXTRACT)
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH ROOT
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 152 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
ECHINAFORCE
HOT DRINK
COLD AND FLU
ECHINACEA
Bioforce (UK) Ltd
TR0725/009/005
5 Millilitre
Concentrate for
Oral Solution
ECHINAFORCE
SORE THROAT
SPRAY
Bioforce (UK) Ltd
TR0725/013/001
1 N/A
Oromucosal
Spray
R02A
ECZIBET
Generics (UK)
Limited
PA0405/089/001
20 + 1 mg/g
Cream
D07CC01
EDARBI
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
CIS bio
International
EU/1/11/734/001004
EU/1/11/734/005008
EU/1/11/734/009011
PA0677/021/001
20 Milligram
Tablets
C09CA09
40 Milligram
Tablets
C09CA09
80 Milligram
Tablets
C09CA09
2 Milligram
V09CA06
EDISTRIDE
AstraZeneca AB
EU/1/15/1052/00
1-005
5 Milligram
Kit for
radiopharmaceut
ical preparation
Film Coated
Tablet
EDISTRIDE
AstraZeneca AB
EU/1/15/1052/00
6-010
10 Milligram
Film Coated
Tablet
A10BX09
EDLUAR
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Pfizer Healthcare
Ireland
Janssen-Cilag
International NV
PA1332/040/001
5 Milligram
Tablet Sublingual
N05CF02
PA1332/040/002
10 Milligram
Tablet Sublingual
N05CF02
-ZOLPIDEM
TARTRATE
PA0822/127/001
4 Milligram
Tablets
N06AX18
EU/1/11/736/001
25 Milligram
Film Coated
Tablet
J05AG
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Rowex Ltd
PA0577/156/001
600 Milligram
Film Coated
Tablet
J05AG03
-REBOXETINE
MESYLATE
-RILPIVIRINE
(AS
HYDROCHLORI
DE)
-EFAVIRENZ
PA0711/207/001
600 Milligram
Film Coated
Tablet
J05AG03
-EFAVIRENZ
Teva B.V.
EU/1/11/742/001010
600 Milligram
Film Coated
Tablet
J05AG03
-EFAVIRENZ
EDARBI
EDARBI
EDICIS
EDLUAR
EDRONAX 4 MG
TABLETS
EDURANT
EFAVIRENZ
MYLAN
EFAVIRENZ
ROWEX
EFAVIRENZ
TEVA
Human Medicines Authorised/Transfer Pending Products
A10BX09
-TINCTURE
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH HERB
(1:12).
EXTRACTION
SOLVENT:
ETHANOL 65%
V/V
-TINCTURE
FROM FRESH
ECHINACEA
PURPUREA (L.)
MOENCH ROOT
(1:11).
EXTRACTION
SOLVENT: 65
%V/V
-TINCTURE
FROM FRESH
ECHINACEA
PURPUREA (L)
MOENCH HERB
(1:12-13)
EXTRACTION
SOLVENT:ETHA
NOL 65 V/V
-FUSIDIC ACID
BETAMETHASO
NE VALERATE
-AZILSARTAN
MEDOXOMIL
-AZILSARTAN
MEDOXOMIL
-AZILSARTAN
MEDOXOMIL
-N'N'ETHYLENE-(L,L)
-DICYSTEINE
DAPAGLIFLOZIN
PROPANEDIOL
MONOHYDRATE
DAPAGLIFLOZIN
PROPANEDIOL
MONOHYDRATE
-ZOLPIDEM
TARTRATE
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
Article 10(3) Hybrid
Application
-Cutaneous
-Per Oral
-Per Oral
-Per Oral
Article 10a Bibliographical
App
Article 10c Informed Consen
-Intra-venous
Article 10c Informed Consen
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Sublingual
-Per Oral
-Sublingual
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Page 153 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
EFAVIRENZ/EM
TRICITABINE/T
ENOFOVIR
TEVA
Teva B.V.
PA1986/033/001
600mg/200mg/2
45 Milligram
Film Coated
Tablet
J05AR06
EFESTAD
Clonmel
Healthcare Ltd
PA0126/223/001
5 Milligram
Film Coated
Tablet
R06AX27
EFEXOR XL
Pfizer Healthcare
Ireland
PA0822/072/002
75 Milligram
N06AX16
Interchangeable
List Code:
IC0026-028-030
PA0822/072/003
Prolonged
Release
Capsules
150 Milligram
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
-Per Oral
Interchangeable
List Code:
IC0026-062-030
PA0822/072/001
Prolonged
Release
Capsules
37.5 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
-Per Oral
150 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
PPA
-Per Oral
75 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
PPA
-Per Oral
150 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
PPA
-Per Oral
150 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
75 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
PPA
-Per Oral
75 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
PPA
-Per Oral
150 Milligram
Prolonged
Release
Capsules
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
PPA
-Per Oral
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
EFEXOR XL
EFEXOR XL
EFEXOR XL
EFEXOR XL
EFEXOR XL
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Profind
Wholesale Ltd
Imbat Limited
Imbat Limited
Interchangeable
List Code:
IC0026-063-030
PPA1500/058/00
2
Interchangeable
List Code:
IC0026-062-030
PPA1151/076/00
4
Interchangeable
List Code:
IC0026-028-030
PPA1151/076/00
5
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0026-062-030
PPA1463/075/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0026-062-030
PPA1463/075/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0026-028-030
PPA0465/085/00
3
PCO
Manufacturing
Interchangeable
List Code:
IC0026-028-030
PPA0465/085/00
4
EFFENTORA
Teva B.V.
Interchangeable
List Code:
IC0026-062-030
EU/1/08/441/1-2
100 Microgram
Buccal Tablet
N02AB03
EFFENTORA
Teva B.V.
EU/1/08/441/3-4
200 Microgram
Buccal Tablet
N02AB03
EFFENTORA
Teva B.V.
EU/1/08/441/5-6
400 Microgram
Buccal Tablet
N02AB03
EFFENTORA
Teva B.V.
EU/1/08/441/7-8
600 Microgram
Buccal Tablet
N02AB03
EFFENTORA
Teva B.V.
EU/1/08/441/9-10
800 Microgram
Buccal Tablet
N02AB03
EFEXOR XL
EFEXOR XL
EFEXOR XL
EFEXOR XL
Human Medicines Authorised/Transfer Pending Products
-EFAVIRENZ
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
PHOSPHATE
DESLORATIDIN
E
-VENLAFAXINE
HYDROCHLORI
DE
Legal Basis
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 154 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
EFFICIB
Merck Sharp and
Dohme Limited
EU/1/08/457/8-14
50/1000 Milligram
Film Coated
Tablet
A10BD07
EFFICIB
Merck Sharp and
Dohme Limited
EU/1/08/457/1-7
50/850 Milligram
Film Coated
Tablet
A10BD07
EFFICO TONIC
Forest
Laboratories UK
Ltd
PA0100/045/001
0.18/20.20/2.10/
0.31 Milligram
Oral Solution
A11
EFIENT
Daiichi Sankyo
Europe GmbH
EU/1/08/503/1-7
5 Milligram
Film Coated
Tablet
B01AC22
EFIENT
Daiichi Sankyo
Europe GmbH
EU/1/08/503/8-14
10 Milligram
Film Coated
Tablet
B01AC22
EFRACEA 40
MG MODIFIEDRELEASE HARD
CAPSULES
EFUDIX
Galderma (UK)
Ltd
PA0590/025/001
40 Milligram
Capsules
Modified Release
J01AA02
LTT Pharma
Limited
Meda Health
Sales Ireland
Limited
Rowa
Pharmaceuticals
Limited
Almirall, S.A.
PPA1562/119/00
1
PA1332/032/001
5 %w/w
Cream
L01BC02
5 %w/w
Cream
L01BC02
PA0074/066/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
EU/1/12/778/001003
322 Microgram
Powder for
Inhalation
R03BB05
Merus Labs
Luxco II S.à.R.L.
Merus Labs
Luxco II S.à.R.L.
Merus Labs
Luxco II S.à.R.L.
Merus Labs
Luxco II S.à.R.L.
PA2118/002/003
20 Milligram
Tablets
C01DA14
PA2118/002/002
40 Milligram
Tablets
C01DA14
PA2118/002/001
10 Milligram
Tablets
C01DA14
PA2118/002/005
25 Milligram
C01DA14
ELANTAN LA
Imbat Limited
PPA1151/078/00
1
50 Milligram
ELANTAN LA 25
Imbat Limited
PPA1151/078/00
2
ELANTAN LA
HARD
Merus Labs
Luxco II S.à.R.L.
PA2118/002/004
50 Milligram
ELAPRASE
TKT Europe AB
EU/1/06/365/1-3
2 Mg/Ml
ELASTOPLAST
Beiersdorf AG
PA1106/001/001
4.8mg Milligram
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Concentrate for
Soln for Inf
Transdermal
Patch
-MICRONIZED
ACLIDINIUM
BROMIDE
-ISOSORBIDE
MONONITRATE
-ISOSORBIDE
MONONITRATE
-ISOSORBIDE
MONONITRATE
-ISOSORBIDE
MONONITRATE
ELAXIGOL
Chanelle Medical
PA0688/029/001
13.7 Grams
Powder for Oral
Solution
A06AD65
ELDEPRYL
PCO
Manufacturing
PPA0465/304/00
1
5 Milligram
Tablets
N04BD01
EFUDIX
EIRFEM
EKLIRA
GENUAIR
ELANTAN
ELANTAN
ELANTAN
ELANTAN LA
Human Medicines Authorised/Transfer Pending Products
25
-SITAGLIPTIN
PHOSPHATE
-METFORMIN
HYDROCHLORI
DE
-SITAGLIPTIN
PHOSPHATE
-METFORMIN
HYDROCHLORI
DE
-THIAMINE
HYDROCHLORI
DE
-CAFFEINE
-NICOTINAMIDE
-GENTIAN
COMPOUND
INFUSION
-PRASUGREL
HYDROCHLORI
DE
-PRASUGREL
HYDROCHLORI
DE
-DOXYCYCLINE
Legal Basis
Routes of
Administration
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-Per Oral
-Per Oral
-Per Oral
FLUOROURACIL
FLUOROURACIL
-Topical
-Topical
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-Inhalation
C01DA14
-ISOSORBIDE
MONONITRATE
PPA
C01DA14
-ISOSORBIDE
MONOHYDRATE
PPA
C01DA14
-ISOSORBIDE
MONONITRATE
A16AB09
-IDURSULFASE
-Intra-venous
N01BX04
-CAYENNE
PEPPER SOFT
EXTRACT 4-7:1
-MACROGOL
3350
-POTASSIUM
CHLORIDE
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
-SELEGILINE
HYDROCHLORI
DE
-Cutaneous
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Page 155 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
ELDEPRYL
Orion Corporatio
PA1327/003/001
5 Milligram
Tablets
N04BD01
ELIGARD
Astellas Pharma
Co. Ltd
Astellas Pharma
Co. Ltd
PA1241/003/001
7.5 Milligram
L02AE02
PA1241/003/003
45 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Astellas Pharma
Co. Ltd
PA1241/003/002
22.5 Milligram
Pdr+Solv for Soln
for Inj
L02AE02
Bristol-Myers
Squibb
Pharma/Pfizer
EEIG
Bristol-Myers
Squibb
Pharma/Pfizer
EEIG
Laboratoire HRA
Pharma
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
PCO
Manufacturing
PCO
Manufacturing
LTT Pharma
Limited
LTT Pharma
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Swedish Orphan
Biovitrum
International AB
Merck Sharp and
Dohme Limited
EU/1/11/691/006012
5 Milligram
Film Coated
Tablet
B01AF02
-APIXABAN
(BMS-562247-01)
EU/1/11/691/001005, 013
2.5 Milligram
Film Coated
Tablet
B01AF02
-APIXABAN
(BMS-562247-01)
-Per Oral
EU/1/09/522/001
30 Milligram
Tablets
G03AD02
-Per Oral
PA1286/035/003
0.1 %w/v
Cutaneous
Solution
D07AC13
-ULIPRISTAL
(INN)
-MOMETASONE
FUROATE
PA1286/035/001
0.1 %w/w
Cream
D07AC13
-MOMETASONE
FUROATE
PPA0465/268/00
1
PPA0465/268/00
2
PPA1562/145/00
2
PPA1562/145/00
1
PA1286/035/002
0.1 %w/w
Cream
D07AC13
PPA
0.1 %w/w
Ointment
D07AC13
0.1 %w/w
Ointment
D07AC13
0.1 %w/w
Cream
D07AC13
0.1 %w/w
Ointment
D07AC13
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
EU/1/15/1046/00
1
250 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/15/1046/00
2
500 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/15/1046/00
3
750 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/15/1046/00
4
1000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/15/1046/00
5
1500
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/15/1046/00
6
2000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/15/1046/00
7
3000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
Article 8(3) - Full
new Application
-Intra-venous
EU/1/09/609/001
100/0.5
Microgram/ML
Solution for
Injection
G03GA09
ELONVA
Merck Sharp and
Dohme Limited
EU/1/09/609/002
150/0.5
Microgram/ML
Solution for
Injection
G03GA09
ELOXATIN
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Imbat Limited
PA0540/148/001
5 Mg/Ml
Concentrate for
Soln for Inf
L01XA03
EFMOROCTOC
OG ALFA
EFMOROCTOC
OG ALFA
EFMOROCTOC
OG ALFA
EFMOROCTOC
OG ALFA
EFMOROCTOC
OG ALFA
EFMOROCTOC
OG ALFA
EFMOROCTOC
OG ALFA
CORIFOLLITRO
PIN ALFA
CORIFOLLITRO
PIN ALFA
-OXALIPLATIN
PPA1151/064/00
2
50 Microgram
Tablets
H03AA01
LEVOTHYROXI
NE SODIUM
PPA
ELIGARD
ELIGARD® 22.5
MG, POWDER
AND SOLVENT
FOR SOLUTION
ELIQUIS
ELIQUIS
ELLAONE
ELOCON
ELOCON
ELOCON
ELOCON
ELOCON
ELOCON
ELOCON 0.1%
W/W OINTMENT
ELOCTA
ELOCTA
ELOCTA
ELOCTA
ELOCTA
ELOCTA
ELOCTA
ELONVA
ELTROXIN
Human Medicines Authorised/Transfer Pending Products
L02AE02
-SELEGILINE
HYDROCHLORI
DE
-LEUPRORELIN
ACETATE
-LEUPRORELIN
ACETATE
(SYRINGE B)
-LEUPRORELIN
ACETATE
Legal Basis
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Per Oral
PPA
-Subcutaneous
-Subcutaneous
-Intra-venous
Page 156 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
ELTROXIN
Imbat Limited
PPA1151/064/00
3
100 Microgram
Tablets
H03AA01
ELTROXIN
Imbat Limited
PPA1151/064/00
1
25 Microgram
Tablets
H03AA01
ELTROXIN
Mercury Pharma
Group Limited
PA0701/001/001
50 Microgram
Tablets
H03AA01
ELTROXIN
Mercury Pharma
Group Limited
PA0701/001/002
100 Microgram
Tablets
H03AA01
ELTROXIN
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
CIS bio
International
PA0899/020/001
25 Microgram
Tablets
H03AA01
PA0899/020/002
25
Micrograms/5ml
Oral Solution
H03AA01
PA0899/020/003
50
Micrograms/5ml
Oral Solution
H03AA01
PA0899/020/004
100
Micrograms/5ml
Oral Solution
H03AA01
PA0677/010/001
%v/v
Unknown
V09FX01
Gedeon Richter
Plc
PA1330/007/001
0.03/3 Milligram
Film Coated
Tablet
G03AA12
ELVINETTE
Gedeon Richter
Plc
PA1330/008/001
0.02/3 Milligram
Film Coated
Tablet
G03AA12
EMADINE
Alcon
Laboratories (UK)
Ltd
Alcon
Laboratories (UK)
Ltd
Alcon
Laboratories (UK)
Ltd
Alcon
Laboratories (UK)
Ltd
Rowex Ltd
EU/1/98/095/003
0.05 %w/v
Eye Drops
Solution
S01GX06
EU/1/98/095/004
0.05 %w/v
Eye Drops
Solution
S01GX06
-EMEDASTINE
DIFUMARATE
-Ocular
EU/1/98/095/001
0.05 Per Cent
Eye Drops
Solution
S01GX06
-EMEDASTINE
DIFUMARATE
-Ocular
EU/1/98/095/002
0.05 Per Cent
Eye Drops
Solution
S01GX06
-EMEDASTINE
DIFUMARATE
-Ocular
PA0711/158/001
20 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA0711/158/002
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA0654/012/001
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
5 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0065-001-014
PA0654/012/002
10 Milligram
Film Coated
Tablet
C07AB07
-BISOPROLOL
FUMARATE
-Per Oral
80 &125 mg
Milligram
Capsules Hard
A04AD12
-APREPITANT
-Per Oral
ELTROXIN
ELTROXIN
ELTROXIN
ELUMATIC III 220 GBQ
RADIONUCLIDE
GENERATOR
ELVINA
EMADINE
EMADINE EYE
DROPS
EMADINE EYE
DROPS
EMAZOLE
EMAZOLE
EMCOR
EMCOR
EMEND
Rowex Ltd
Merck Serono
Limited
Merck Serono
Limited
Merck Sharp and
Dohme Limited
Interchangeable
List Code:
IC0065-002-014
EU/1/03/262/1-6
Human Medicines Authorised/Transfer Pending Products
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
-SODIUM
PERTECHNETA
TE (99M TC)
PPA
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
-Per Oral
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
-EMEDASTINE
DIFUMARATE
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Ocular
Page 157 of 608
Trade Name
EMEND
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Merck Sharp and
Dohme Limited
Merck Sharp &
Dohme Ltd
Merck Sharp &
Dohme Ltd
PharmaSwiss
Ceska republika
s.r.o.
PharmaSwiss
Ceska republika
s.r.o.
PharmaSwiss
Ceska republika
s.r.o.
Actavis Group
PTC ehf
EU/1/03/262/7-8
40 Milligram
Capsules Hard
A04AD12
-APREPITANT
EU/1/03/262/009010
EU/1/03/262/011
165 Milligram
Capsules Hard
A04AD12
-APREPITANT
125 Milligram
A04AD12
-APREPITANT
PA1696/009/001
150 Microgram
C01CA24
-EPINEPHRINE
BITARTRATE
-Intra-Muscular
PA1696/009/002
300 Microgram
C01CA24
-EPINEPHRINE
BITARTRATE
-Intra-Muscular
PA1696/009/003
500 Microgram
C01CA24
-EPINEPHRINE
BITARTRATE
-Intra-Muscular
PA1380/152/001
4.6 mg/24 hours
Powder for Oral
Solution
Solution for
injection in prefilled pen
Solution for
injection in prefilled pen
Solution for
injection in prefilled pen
Transdermal
Patch
N06DA03
-RIVASTIGMINE
EMERPAND
Actavis Group
PTC ehf
PA1380/152/002
9.5 mg/24 hours
Transdermal
Patch
N06DA03
-RIVASTIGMINE
EMERPAND
Actavis Group
PTC ehf
PA1380/152/003
13.3 mg/24 hours
Transdermal
Patch
N06DA03
-RIVASTIGMINE
EMIZOF
PA0577/083/002
8 Milligram
Film Coated
Tablet
A04AA01
ONDANSETRON
-Intra-venous
PA0577/083/003
4 Milligram
Film Coated
Tablet
A04AA01
ONDANSETRON
-Per Oral
EMIZOF
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Imbat Limited
4 Milligram
-Per Oral
PPA
-Per Oral
EMLA
AstraZeneca UK
Limited
Bristol-Myers
Squibb Pharma
EEIG
Bristol-Myers
Squibb Pharma
EEIG
Merus Labs
Luxco S.à R.L.
EU/1/16/1088/00
1
300 Milligram
Pdr/Conc/Soln for
Infus
L01XC
ONDANSETRON
ONDANSETRON
-LIDOCAINE
-PRILOCAINE
-ELOTUZUMAB
PPA
Imbat Limited
Film Coated
Tablet
Film Coated
Tablet
Cream
A04AA01
EMIZOF
PPA1151/077/00
1
PPA1151/077/00
2
PA0970/038/001
Article 8(3) - Full
new Application
-Intra-venous
EU/1/16/1088/00
2
400 Milligram
Pdr/Conc/Soln for
Infus
L01XC
-ELOTUZUMAB
Article 8(3) - Full
new Application
-Intra-venous
EU/1/04/294/1-12
7.5 Milligram
Tablet Prolonged
Release
G04BD10
-DARIFENACIN
HYDROBROMID
E
-TENOFOVIR
DISOPROXIL
PHOSPHATE
EMTRICITABINE
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
-TENOFOVIR
DISOPROXIL
EMTRICITABINE
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
SUCCINATE
EMEND
EMEND
EMERADE
EMERADE
EMERADE
EMERPAND
EMIZOF
EMPLICITI
EMPLICITI
EMSELEX
8 Milligram
5 %w/w
A04AA01
N01BB20
EMTRICITABINE
- TENOFOVIR
DISOPROXIL
ZENTIVA
Zentiva k.s.
EU/1/16/1148/00
1-002
200/245 Milligram
Film Coated
Tablet
J05AR03
EMTRICITABIN
E/TENOFOVIR
DISOPROXIL
Accord
Healthcare
Limited
PA1390/125/001
200mg/245
Milligram
Film Coated
Tablet
J05AR03
EMTRICITABIN
E/TENOFOVIR
DISOPROXIL
CLONMEL
EMTRICITABIN
E/TENOFOVIR
DISOPROXIL
MYLAN
EMTRICITABIN
E/TENOFOVIR
DISOPROXIL
ROWEX
EMTRICITABIN
E/TENOFOVIR
KRKA
Clonmel
Healthcare Ltd
PA0126/289/001
200/245 mg/mg
Film Coated
Tablet
J05AR03
Mylan S.A.S.
EU/1/16/1133/00
1-006
200/245 Milligram
Film Coated
Tablet
J05AR03
Rowex Ltd
PA0711/271/001
200mg/245
Milligram
Film Coated
Tablet
J05AR03
Krka d.d., Novo
mesto
EU/1/16/1151/00
1-004
200/245 Milligram
Film Coated
Tablet
J05AR03
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Transdermal
-Transdermal
-Transdermal
-Topical
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 158 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
EMTRICITABIN
E/TENOFOVIR
TEVA
Teva B.V.
PA1986/016/001
200/245 Milligram
Film Coated
Tablet
J05AR03
EMTRIVA
Gilead Sciences
International
Dermal
Laboratories Ltd
EU/1/03/261/1-3
200mg Milligram
Capsules Hard
J05AF09
PA0278/008/001
0.5/25/25 %w/w
Cutaneous
Emulsion
D02AX
EMULSIFYING
OINTMENT
Ovelle Limited
PA0206/019/001
30 50 20 %w/w
Ointment
D02AX
ENADOR&PLAC
EBO
Gedeon Richter
Plc
PA1330/008/002
0.02/3 Milligram
Film Coated
Tablet
G03AA12
ENALAPRIL/LE
RCANIDIPINE
KRKA
Krka d.d., Novo
mesto
PA1347/029/001
10/10 Milligram
Film Coated
Tablet
C09BB02
ENALAPRIL/LE
RCANIDIPINE
KRKA
Krka d.d., Novo
mesto
PA1347/029/002
20/10 Milligram
Film Coated
Tablet
C09BB02
ENANTYUM
Laboratorios
Menarini S.A.
PA0901/001/004
12.5 Milligram
Granules for oral
solution
M01AE17
ENANTYUM
Laboratorios
Menarini S.A.
PA0901/001/005
25 Milligram
Granules for oral
solution
M01AE17
ENANTYUM
Laboratorios
Menarini S.A.
PA0901/001/001
12.5 Milligram
Film Coated
Tablet
M01AE17
ENANTYUM
Laboratorios
Menarini S.A.
PA0901/001/002
25 Milligram
Tablets
M01AE17
ENANTYUM
Laboratorios
Menarini S.A.
PA0901/001/003
50 Mg/Ml
Solution for
Injection
M01AE17
ENANTYUM 25
MG ORAL
SOLUTION
ENAP
Laboratorios
Menarini S.A.
PA0901/001/006
25 Milligram
Oral Solution
M01AE17
Rowex Ltd
PA0711/028/001
5 Milligram
Tablets
C09AA02
ENAP
Rowex Ltd
PA0711/028/002
10 Milligram
Tablets
C09AA02
ENAP
Rowex Ltd
PA0711/028/003
20 Milligram
Tablets
C09AA02
ENBREL
Pfizer Limited
25mg Milligram
Pfizer Limited
L04AB01
-ETANERCEPT
ENBREL
Pfizer Limited
L04AB01
-ETANERCEPT
ENBREL
Pfizer Limited
EU/1/99/126/1315
25 Milligram
Pdr+Solv for Soln
for Inj
Pdr for Soln for
Injection
Pdr for Soln for
Injection
Solution for
injection in prefilled syringe
L04AB01
ENBREL
EU/1/99/126/001003
EU/1/99/126/006011
EU/1/99/126/012
EMTRICITABINE
-TENOFOVIR
DISOPROXIL
PHOSPHATE
EMTRICITABINE
BENZALKONIUM
CHLORIDE
-ISOPROPYL
MYRISTATE
-PARAFFIN,
LIQUID
-EMULSIFYING
WAX
-WHITE SOFT
PARAFFIN
-PARAFFIN,
LIQUID
DROSPIRENON
E
ETHINYLESTRA
DIOL
LERCANIDIPINE
HYDROCHLORI
DE
-ENALAPRIL
MALEATE
LERCANIDIPINE
HYDROCHLORI
DE
-ENALAPRIL
MALEATE
DEXKETOPROF
EN
TROMETAMOL
DEXKETOPROF
EN
TROMETAMOL
DEXKETOPROF
EN
TROMETAMOL
DEXKETOPROF
EN
TROMETAMOL
DEXKETOPROF
EN
DEXKETOPROF
EN
-ENALAPRIL
MALEATE
-ENALAPRIL
MALEATE
-ENALAPRIL
MALEATE
-ETANERCEPT
L04AB01
-ETANERCEPT
EMULSIDERM
EMOLLIENT
Human Medicines Authorised/Transfer Pending Products
50 Milligram
25 Milligram
Legal Basis
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Topical
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
--Unknown--
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Subcutaneous
Page 159 of 608
Trade Name
Licence Holder Licence
Number
ENBREL
Pfizer Limited
ENBREL
Pfizer Limited
ENDOFALK
ENDOLUCINBE
TA
Strength
L04AB01
-ETANERCEPT
-Subcutaneous
A06AD65
-Per Oral
40 GBq/ml
Radio-Pharm
Precursor
V10X
PA0167/134/005
50 Milligram
Coated Tablets
L01AA01
Baxter
Healthcare
Limited
Baxter
Healthcare
Limited
GlaxoSmithKline
(Ireland) Limited
PA0167/134/003
500 Milligram
Pdr for Soln for
Injection
L01AA01
PA0167/134/004
1000 Milligram
Pdr for Soln for
Injection
L01AA01
PA1077/023/002
20 Microgram/ML
Suspension for
Injection
J07BC01
-MACROGOL
3350
-POTASSIUM
CHLORIDE
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-LUTETIUM
(177LU)
CHLORIDE
CYCLOPHOSP
HAMIDE
MONOHYDRATE
CYCLOPHOSP
HAMIDE
CYCLOPHOSP
HAMIDE
-HEPATITIS B
SURFACE
ANTIGEN,
RECOMINANT
GlaxoSmithKline
(Ireland) Limited
PA1077/023/001
10 Microgram
Suspension for
Injection
J07BC01
-HEPATITIS B
SURFACE
ANTIGEN,
RECOMINANT
LEO Pharma A/S
PA1025/005/001
50 micrograms/g
+ 0.
Cutaneous Foam
D05AX52
ENTACAPONE
Orion Corporatio
200 Milligram
Niche Generics
Limited
Film Coated
Tablet
Film Coated
Tablet
N04BX02
ENTACAPONE
NICHE
EU/1/11/708/001004
PA1063/055/001
-CALCIPOTRIOL
BETAMETHASO
NE
DIPROPIONATE
-ENTACAPONE
N04BX02
-ENTACAPONE
ENTACAPONE
TEVA
Teva B.V.
EU/1/10/665/001004
200 Milligram
Film Coated
Tablet
N04BX02
-ENTACAPONE
ENTOCORT CR
Tillotts Pharma
GmbH
BOC Gases
Ireland Ltd
PA2018/003/001
3 Milligram
A07EA06
-BUDESONIDE
PA0208/005/001
50/50 %v/v
Capsules GastroResistant
Medicinal gas,
compressed
N01AX13
ENTRESTO
Novartis
Europharm Ltd
EU/1/15/1058/00
1
24/26 Milligram
Film Coated
Tablet
C09DX04
ENTRESTO
Novartis
Europharm Ltd
EU/1/15/1058/00
2-004
49/51 Milligram
Film Coated
Tablet
C09DX04
ENTRESTO
Novartis
Europharm Ltd
EU/1/15/1058/00
5-007
97/103 Milligram
Film Coated
Tablet
C09DX04
ENTYVIO
Takeda Pharma
A/S
Novartis
Europharm Ltd
EU/1/14/923/001
300 Milligram
L04AA33
EU/1/12/789/001006
44 Microgram
Pdr/Conc/Soln for
Infus
Inhalation
Powder, Capsule
-OXYGEN
-NITROUS
OXIDE
SACUBITRIL/VA
LSARTAN
(LCZ696-ABA)
SACUBITRIL/VA
LSARTAN
(LCZ696-ABA)
SACUBITRIL/VA
LSARTAN
(LCZ696-ABA)
-VEDOLIZUMAB
Chiesi
Farmaceutici
S.p.A.
EU/1/14/35/001003
0.75 Milligram
Tablet Prolonged
Release
L04AD02
ENGERIX B
HEPATITIS B
VACCINE
(RDNA) 1.0ML
PFS
ENGERIX B
HEPATITIS B
VACCINE
(RDNA,
ADSORBED)
ENSTILAR
ENTONOX
ENUREV
BREEZHALER
ENVARSUS
PA0573/006/001
AP Grams
ITG Isotope
Technologies
Garching GmbH
Baxter
Healthcare
Limited
EU/1/16/1105/00
1-002
Routes of
Administration
-ETANERCEPT
ENDOXANA
INJECTION
Dr. Falk Pharma
GmbH
Legal Basis
L04AB01
ENDOXANA
INJECTION
50 Milligram
Active
Ingredients
Solution for
Injection
Pdr+Solv for Soln
for Inj
Powder for Oral
Solution
ENDOXANA
EU/1/99/126/1621
EU/1/99/126/022
Dosage Form ATC
Human Medicines Authorised/Transfer Pending Products
10 Milligram
200 Milligram
R03AB06
GLYCOPYRRO
NIUM BROMIDE
-TACROLIMUS
MONOHYDRATE
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Cutaneous
Article 10c Informed Consen
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Intra-venous
Article 10(3) Hybrid
Application
-Per Oral
-Inhalation
Page 160 of 608
Trade Name
ENVARSUS
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Chiesi
Farmaceutici
S.p.A.
Chiesi
Farmaceutici
S.p.A.
Krka d.d., Novo
mesto
EU/1/14/35/004006
1 Milligram
Tablet Prolonged
Release
L04AD02
-TACROLIMUS
MONOHYDRATE
EU/1/14/35/007009
4 Milligram
Tablet Prolonged
Release
L04AD02
-TACROLIMUS
MONOHYDRATE
EU/1/09/580/1-6
0.5 Milligram
Tablets
A10BX02
-REPAGLINIDE
ENYGLID
Krka d.d., Novo
mesto
EU/1/09/580/7-12
1 Milligram
Tablets
A10BX02
-REPAGLINIDE
ENYGLID
Krka d.d., Novo
mesto
EU/1/09/580/1318
2 Milligram
Tablets
A10BX02
-REPAGLINIDE
ENZEPI
Allergan
Pharmaceuticals
International
Limited
Allergan
Pharmaceuticals
International
Limited
Allergan
Pharmaceuticals
International
Limited
Allergan
Pharmaceuticals
International
Limited
Seqirus GmbH
EU/1/16/1113/00
1-004
5,000
International Unit
Capsules GastroResistant
A09AA02
EU/1/16/1113/01
3-016
40,000
International Unit
Capsules GastroResistant
EU/1/16/1113/00
9-012
25,000
International Unit
EU/1/16/1113/00
5-008
EPANUTIN
Martindale
Pharmaceuticals
Ltd
Martindale
Pharmaceuticals
Ltd
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Imbat Limited
EPANUTIN
B & S Healthcare
ENVARSUS
ENYGLID
ENZEPI
ENZEPI
ENZEPI
ENZIRA
EPACLOB
EPACLOB
EPANUTIN
EPANUTIN
EPANUTIN
EPANUTIN
EPANUTIN
EPANUTIN
Legal Basis
Routes of
Administration
-Per Oral
-PANCREAS
POWDER
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
A09AA02
-PANCREAS
POWDER
Article 8(3) - Full
new Application
-Per Oral
Capsules GastroResistant
A09AA02
-PANCREAS
POWDER
Article 8(3) - Full
new Application
-Per Oral
10,000
International Unit
Capsules GastroResistant
A09AA02
-PANCREAS
POWDER
Article 8(3) - Full
new Application
-Per Oral
PA1373/001/001
Per Cent
Suspension for
Injection
J07BB02
Article 8(3) - Full
new Application
-Intra-Muscular
-Subcutaneous
PA0361/035/001
1mg/ml Millilitre
Oral Suspension
N05BA09
A/CALIFORNIA/
7/2009
(H1N1)PDM09LIKE STRAIN
(A/CALIFORNIA/
7/2009, X-181)
-A/HONG
KONG/4801/2014
(H3N2) - LIKE
STRAIN
(A/HONG
KONG/4801/201
4, NYMC X263B)
B/BRISBANE/60
/2008 - LIKE
STRAIN
(B/BRISBANE/6
0/2008)
-CLOBAZAM
-Per Oral
PA0361/035/002
2 Mg/Ml
Oral Suspension
N05BA09
-CLOBAZAM
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
PA0822/011/006
250 MG/5ml
Solution for Inj/Inf
N03AB02
PA0822/011/007
Oral Suspension
N03AB02
PA0822/011/001
30mg/5ml
MG/5ml
25 Milligram
Capsules Hard
N03AB02
PA0822/011/002
50 Milligram
Capsules Hard
N03AB02
PA0822/011/003
100 Milligram
Capsules Hard
N03AB02
PA0822/011/004
300 Milligram
Capsules Hard
N03AB02
PPA1151/165/00
1
DPR1328/031/0
03
100 Milligram
Capsules Hard
N03AB02
300 Milligram
Capsules Hard
N03AB02
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
-PHENYTOIN
SODIUM
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
Page 161 of 608
Trade Name
EPANUTIN
Licence Holder Licence
Number
Strength
Dosage Form ATC
PCO
Manufacturing
Pfizer Healthcare
Ireland
Gilead Sciences
International
PPA0465/244/00
1
PA0822/011/005
100 Milligram
Capsules Hard
N03AB02
50 Milligram
N03AB02
EU/1/16/1116/00
1
400mg/100mg
Milligram
Tablets
Chewable
Film Coated
Tablet
EU/1/13/908/001
30 Milligram
EU/1/13/908/002
EPETHINAN
GlaxoSmithKline
Trading Services
Limited
GlaxoSmithKline
Trading Services
Limited
Acino AG
EPETHINAN
Active
Ingredients
Legal Basis
Routes of
Administration
-PHENYTOIN
SODIUM
-PHENYTOIN
PPA
J05A
-SOFOSBUVIR
-VELPATASVIR
Article 8(3) - Full
new Application
-Per Oral
Pdr+Solv for Soln
for Inj
A10BX13
-ALBIGLUTIDE
Article 8(3) - Full
new Application
-Subcutaneous
50 Milligram
Pdr+Solv for Soln
for Inj
A10BX13
-ALBIGLUTIDE
Article 8(3) - Full
new Application
-Subcutaneous
PA2168/001/001
5/2.5 Milligram
Tablet Prolonged
Release
N02AA55
Article 10(1) Generic
Application
-Per Oral
Acino AG
PA2168/001/002
10/5 Milligram
Tablet Prolonged
Release
N02AA55
Article 10(1) Generic
Application
-Per Oral
EPETHINAN
Acino AG
PA2168/001/003
20/10 Milligram
Tablet Prolonged
Release
N02AA55
Article 10(1) Generic
Application
-Per Oral
EPETHINAN
Acino AG
PA2168/001/004
40/20 Milligram
Tablet Prolonged
Release
N02AA55
Article 10(1) Generic
Application
-Per Oral
EPHEDRINE
HYDROCHLORI
DE
EPIDUO
Martindale
Pharmaceuticals
Ltd
Galderma (UK)
Ltd
PA0361/015/001
30 Mg/Ml
Solution for
Injection
C01CA26
PA0590/030/001
0.1 Per Cent
Gel
EPILIM
CHRONO
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/011
300 Milligram
Tablet Prolonged
Release
N03AG01
EPILIM
CHRONO
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/012
500 Milligram
Tablet Prolonged
Release
N03AG01
EPILIM
CHRONO 200
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/010
200 mg Milligram
Tablet Prolonged
Release
N03AG01
EPILIM
CHRONOSPHE
RE
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/005
100 Milligram
Granules
Prolonged
Release
N03AG01
EPILIM
CHRONOSPHE
RE
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/006
250 Milligram
Granules
Prolonged
Release
N03AG01
EPILIM
CHRONOSPHE
RE
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/007
500 Milligram
Granules
Prolonged
Release
N03AG01
EPILIM
CRUSHABLE
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/150/001
100 Milligram
Tablets
N03AG01
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
-EPHEDRINE
HYDROCHLORI
DE
-ADAPALENE
-BENZOYL
PEROXIDE
-VALPROATE
SODIUM
-VALPROIC
ACID
-VALPROATE
SODIUM
-VALPROIC
ACID
-VALPROATE
SODIUM
-VALPROIC
ACID
-VALPROATE
SODIUM
-VALPROIC
ACID
-VALPROATE
SODIUM
-VALPROIC
ACID
-VALPROATE
SODIUM
-VALPROIC
ACID
-VALPROATE
SODIUM
PA0540/150/002
200 Milligram
Tablets GastroResistant
N03AG01
EPANUTIN
INFATABS
EPCLUSA
(PREVIOUSLYSOFOSBUVIR
VELPATASVIR
GILEAD)
EPERZAN
EPERZAN
EPILIM ENTERI
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Intra-venous
Article 10b Fixed
Combination
-Cutaneous
-Per Oral
-VALPROATE
SODIUM
Page 162 of 608
Trade Name
EPILIM ENTERI
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
PA0540/150/003
500 Milligram
Tablets GastroResistant
N03AG01
-VALPROATE
SODIUM
PA0540/150/013
400 Milligram
Pdr+Solv for soln
for inf/inj
N03AG01
-VALPROATE
SODIUM
PA0540/150/014
200 MG/5ml
Oral Solution
N03AG01
-VALPROATE
SODIUM
PA0540/150/015
200 MG/5ml
Oral Solution
N03AG01
-VALPROATE
SODIUM
EPINITRIL
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Rottapharm Ltd
PA0868/003/001
5 mg/24 hours
C01DA02
EPINITRIL
Rottapharm Ltd
PA0868/003/002
10 mg/24 hours
EPINITRIL
Rottapharm Ltd
PA0868/003/003
15 mg/24 hours
EPIPEN
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Seacross
Pharmaceuticals
Limited
Actavis Group hf
PA1332/050/002
0.30 Mg/Dose
C01CA24
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
-EPINEPHRINE
PA1332/050/001
0.15 Mg/Dose
C01CA24
-EPINEPHRINE
PA1840/001/001
2 Mg/Ml
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Solution for
injection in prefilled pen
Solution for
injection in prefilled pen
Solution for
Injection
L01DB03
PA1366/003/001
2 Mg/Ml
Solution for
Injection
L01DB03
EPIRUBICIN
HYDROCHLORI
DE
EPIRUBICIN
HYDROCHLORI
DE
EPISALVAN
((PREVIOUSLY
OLEOGEL-S10))
Fresenius Kabi
Oncology Plc
PA1422/002/001
2 Micromol
Solution for Inj/Inf
L01DB03
Accord
Healthcare
Limited
Birken AG
PA1390/004/001
2 Mg/Ml
Solution for
Injection
L01DB03
EU/1/15/1069/00
1
10 Per Cent
Ointment
D03
EPIVIR
EU/1/96/015/002
10 Mg/Ml
J05AF05
EU/1/96/015/001
150 Milligram
Infus/Pdr/Oral
Soln
Coated Tablets
J05AF05
-LAMIVUDINE
EU/1/96/015/003
300 Milligram
Coated Tablets
J05AF05
-LAMIVUDINE
PA1390/102/001
25 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
PA1390/102/002
50 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
PA1333/015/001
25 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
PA1333/015/002
50 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
EPLERENONE
ACTAVIS
ViiV Healthcare
UK Ltd
ViiV Healthcare
UK Ltd
ViiV Healthcare
UK Ltd
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Morningside
Healthcare
Limited
Morningside
Healthcare
Limited
Actavis Group
PTC ehf
-EPIRUBICIN
HYDROCHLORI
DE
-EPIRUBICIN
HYDROCHLORI
DE
-EPIRUBICIN
HYDROCHLORI
DE
-EPIRUBICIN
HYDROCHLORI
DE
-DRY EXTRACT
FROM BETULAE
CORTEX (BIRCH
BARK) (5-10:1)
-LAMIVUDINE
PA1380/145/001
25 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
EPLERENONE
ACTAVIS
Actavis Group
PTC ehf
PA1380/145/002
50 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
EPLERENONE
BLUEFISH
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA1436/022/001
25 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
PA1436/022/002
50 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
PA0577/168/001
25 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
EPILIM
INTRAVENOUS
EPILIM LIQUID
EPILIM SYRUP
EPIPEN JUNIOR
EPIRUBICIN
EPIRUBICIN
EPIVIR
EPIVIR 300MG
EPLERENONE
EPLERENONE
EPLERENONE
EPLERENONE
EPLERENONE
BLUEFISH
EPLERENONE
MYLAN
Human Medicines Authorised/Transfer Pending Products
C01DA02
C01DA02
Legal Basis
Routes of
Administration
-Per Oral
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Intra-Muscular
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Intra-Muscular
-Intra-venous
-Intra-venous
-Intra Vesical
-Intra-venous
-Intra Vesical
-Intra-venous
-Cutaneous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 163 of 608
Trade Name
EPLERENONE
MYLAN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Rowex Ltd
PA0577/168/002
50 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
Article 10(1) Generic
Application
-Per Oral
PA0711/235/001
25 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
-Per Oral
EPLERENONE
ROWEX
Rowex Ltd
PA0711/235/002
50 Milligram
Film Coated
Tablet
C03DA04
-EPLERENONE
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/2122
20000/0.5 IU/ML
B03XA01
-EPOETIN ALFA
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/2324
30000/0.75 IU/M
B03XA01
-EPOETIN ALFA
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/2526
40000/1 IU/ML
B03XA01
-EPOETIN ALFA
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/1-2
1000
International Unit
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
Injection
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/3-4
2000
International Unit
Solution for
Injection
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/5-6
3000
International Unit
Solution for
Injection
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/7-8
4000
International Unit
Solution for
Injection
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/9-10
5000
International Unit
Solution for
Injection
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/1112
6000
International Unit
Solution for
Injection
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/1314
8000
International Unit
Solution for
Injection
B03XA01
EPOETIN ALFA
HEXAL
Hexal AG
EU/1/07/411/1516
10,000
International Unit
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/1-2
1000/0.5 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/3-4
2000/0.5 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/5-6
3000/0.5 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/7-8
4000/0.5 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/9-10
5000/0.5 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/1116
10000 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/1722
20000 IU/ML
Solution for
Injection
B03XA01
EPORATIO
Ratiopharm
GmbH
EU/1/09/573/2328
30000 IU/ML
Solution for
Injection
B03XA01
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-RECOMBINANT
HUMAN
ERYTHROPOIE
TIN ALFA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
-XM01 DRUG
SUBSTANCE
EPOETIN THETA
EPLERENONE
ROWEX
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Page 164 of 608
Trade Name
EPREX
Licence Holder Licence
Number
Strength
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
PA0748/025/012
40, 000 IU/ML
PA0748/025/005
2000 Units/ml
PA0748/025/006
4000 Units/ml
PA0748/025/009
10000 IU/ML
Niche Generics
Limited
PA1063/052/001
EPROSARTAN
NICHE
Niche Generics
Limited
EPROSARTAN
NICHE
Dosage Form ATC
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
B03XA01
300 Milligram
PA1063/052/002
Niche Generics
Limited
EPROSARTAN
TEVA
Active
Ingredients
Legal Basis
Routes of
Administration
B03XA01
-EPOETINUM
ALFA
-EPOETIN ALFA
-Subcutaneous
B03XA01
-EPOETIN ALFA
-Intra-venous
B03XA01
-EPOETIN ALFA
-Intra-venous
Film Coated
Tablet
C09CA02
-EPROSARTAN
MESYLATE
400 Milligram
Film Coated
Tablet
C09CA02
-EPROSARTAN
MESYLATE
PA1063/052/003
600 Milligram
Film Coated
Tablet
C09CA02
-EPROSARTAN
MESYLATE
Teva B.V.
PA1986/018/001
300 Milligram
Film Coated
Tablet
C09CA02
-EPROSARTAN
MESYLATE
EPROSARTAN
TEVA
Teva B.V.
PA1986/018/002
400 Milligram
Film Coated
Tablet
C09CA02
-EPROSARTAN
MESYLATE
EPROSARTAN
TEVA
Teva B.V.
PA1986/018/003
600 Milligram
Film Coated
Tablet
C09CA02
-EPROSARTAN
MESYLATE
EPTIFIBATIDE
ACCORD
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Shire
Pharmaceuticals
Ireland Limited
EU/1/15/1065/00
1
0.75 Mg/Ml
Solution for
Infusion
B01AC16
-EPTIFIBATIDE
EU/1/15/1065/00
2
2.0 Mg/Ml
Solution for
Injection
B01AC16
-EPTIFIBATIDE
PA1575/001/004
5 Milligram
Tablets
N06BA04
EQUASYM
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/005
10 Milligram
Tablets
N06BA04
EQUASYM
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/006
20 Milligram
Tablets
N06BA04
EQUASYM XL
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/001
10 Milligram
Capsules
Modified Release
N06BA04
EQUASYM XL
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/002
20 Milligram
Capsules
Modified Release
N06BA04
EQUASYM XL
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/003
30 Milligram
Capsules
Modified Release
N06BA04
EQUASYM XL
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/007
40 Milligram
Capsules
Modified Release
N06BA04
EQUASYM XL
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/008
50 Milligram
Capsules
Modified Release
N06BA04
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
EPREX
EPOETIN ALFA
EPREX
EPOETIN ALFA
EPREX
PREFILLED
SYRINGES
EPROSARTAN
NICHE
EPTIFIBATIDE
ACCORD
EQUASYM
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Page 165 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
EQUASYM XL
Shire
Pharmaceuticals
Ireland Limited
PA1575/001/009
60 Milligram
Capsules
Modified Release
N06BA04
EQUIHES
B. Braun
Melsungen AG
PA0736/024/003
60 Mg/Ml
Solution for
Infusion
B05AA07
EQUIHES
B. Braun
Melsungen AG
PA0736/024/004
100 Mg/Ml
Solution for
Infusion
B05AA07
EQUIHES
B. Braun
Melsungen AG
PA0736/024/001
60 Mg/Ml
Solution for
Infusion
B05AA07
EQUIHES
B. Braun
Melsungen AG
PA0736/024/002
100 Mg/Ml
Solution for
Infusion
B05AA07
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
METHYLPHENI
DATE
HYDROCHLORI
DE
-POLY(O-2HYDROXYETHY
L)STARCH
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-SODIUM
ACETATE
TRIHYDRATE
-MALIC ACID
-POLY(O-2HYDROXYETHY
L)STARCH
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-SODIUM
ACETATE
TRIHYDRATE
-MALIC ACID
-POLY(O-2HYDROXYETHY
L)STARCH
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-SODIUM
ACETATE
TRIHYDRATE
-L-MALIC ACID
DAB
-POLY(O-2HYDROXYETHY
L)STARCH
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-SODIUM
ACETATE
TRIHYDRATE
-MALIC ACID
Legal Basis
Article 10(3) Hybrid
Application
Routes of
Administration
-Per Oral
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Page 166 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ERBITUX
Merck KGaA
EU/1/04/281/2-5
5 Micromol
Solution for
Infusion
L01XC06
ERBITUX
Merck KGaA
EU/1/04/281/001
2 mg/ml Micromol
ERDOTIN
Edmond Pharma
S.r.l.
Roche
Registration
Limited
Actavis Group
PTC ehf
PA1325/001/001
300 Milligram
Solution for
Infusion
Capsule
EU/1/13/848/001
150 Milligram
PA1380/140/001
ERTRACER
SOLUTION FOR
INJECTION
M2i Limited
ERWINASE
Active
Ingredients
Legal Basis
Routes of
Administration
-Intra-venous
L01XC06
-CETUXIMAB,
CHIMERIC
ANTIBODY
-CETUXIMAB
R05CB15
-ERDOSTEINE
-Per Oral
Capsules Hard
L01XX43
-VISMODEGIB
Article 8(3) - Full
new Application
-Per Oral
0.1/0.02 Milligram
Film Coated
Tablet
G03AA07
Article 10(1) Generic
Application
-Per Oral
PA1125/002/001
10-130GBq
Solution for
Injection
V09IX04
Article 10a Bibliographical
App
-Intra-venous
Jazz
Pharmaceuticals
France SAS
Hospira UK
Limited
PA1020/002/001
10000 %v/v
Pdr for Soln for
Injection
L01XX02
LEVONORGEST
REL
ETHINYLESTRA
DIOL
FLUDEOXYGLU
COSE (18F)
INJECTION
CRISTANSPASE
PA0437/048/001
250 Milligram
Capsule
J01FA01
ERYTHROCIN
Amdipharm
Limited
PA1142/008/003
500 Milligram
Film Coated
Tablet
J01FA01
ERYTHROCIN
Amdipharm
Limited
PA1142/008/002
250 Milligram
Film Coated
Tablet
J01FA01
ERYTHROCIN IV
LACTOBIONATE
Amdipharm
Limited
PA1142/008/001
1 Grams
Pdr/Conc/Soln for
Infus
J01FA01
ERYTHROMYCI
N
Amdipharm
Limited
PA1142/007/001
250 Milligram
Tablets GastroResistant
J01FA01
ERYTHROPED
ADULT
Amdipharm
Limited
PA1142/006/004
500 Milligram
Tablets
J01FA01
ERYTHROPED
FORTE SF
Amdipharm
Limited
PA1142/006/003
500 MG/5ml
Granules for Oral
Suspension
J01FA01
ERYTHROPED
PI SF
Amdipharm
Limited
PA1142/006/002
125 MG/5ml
Granules for Oral
Suspension
J01FA01
ERYTHROPED
SF
Amdipharm
Limited
PA1142/006/001
250 MG/5ml
Granules for Oral
Suspension
J01FA01
ESBRIET
EU/1/11/667/001003
267 Milligram
Capsules Hard
L04AX
EU/1/11/667/005008
267 Milligram
Film Coated
Tablet
L04AX05
-PIRFENIDONE
Article 8(3) - Full
new Application
-Per Oral
EU/1/11/667/011
801 Milligram
Film Coated
Tablet
L04AX05
-PIRFENIDONE
Article 8(3) - Full
new Application
-Per Oral
EU/1/11/667/009010
534 Milligram
Film Coated
Tablet
L04AX05
-PIRFENIDONE
Article 8(3) - Full
new Application
-Per Oral
ESCID
CONTROL
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Actavis Group
PTC ehf
ERYTHROMYCI
N
ERYTHROMYCI
N STEARATE
ERYTHROMYCI
N STEARATE
ERYTHROMYCI
N
LACTOBIONATE
ERYTHROMYCI
N
ERYTHROMYCI
N
ETHYLSUCCIN
ATE
ERYTHROMYCI
N
ERYTHROMYCI
N
ERYTHROMYCI
N
-PIRFENIDONE
PA1380/159/001
20 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
ESCIPREX
Rowex Ltd
PA0711/194/001
5 Milligram
Film Coated
Tablet
N06AB10
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
ESCITALOPRAM
OXALATE
Article 10(1) Generic
Application
-Per Oral
ERIVEDGE
ERLIDONA
ERYMAX
ESBRIET
ESBRIET
ESBRIET
Interchangeable
List Code:
IC0071-001-015
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 167 of 608
Trade Name
ESCIPREX
ESCIPREX
ESCIPREX
ESCIPREX
DISTAB
ESCIPREX
DISTAB
ESCIPREX
DISTAB
ESCIPREX
DISTAB
ESCITALOPRAM
ESCITALOPRAM
ESCITALOPRAM
ESCITALOPRAM
ESCITALOPRAM
ESCITALOPRAM
ESCITALOPRAM
ESCITALOPRAM
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Rowex Ltd
PA0711/194/002
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0071-002-015
PA0711/194/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0071-032-015
PA0711/194/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0071-003-015
PA0711/194/005
ESCITALOPRAM
OXALATE
5 Milligram
Orodispersible
Tablet
N06AB10
Article 10(3) Hybrid
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0071-001-015
PA0711/194/006
ESCITALOPRAM
OXALATE
10 Milligram
Orodispersible
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0071-002-015
PA0711/194/007
ESCITALOPRAM
OXALATE
15 Milligram
Orodispersible
Tablet
N06AB10
Article 10(3) Hybrid
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0071-032-015
PA0711/194/008
ESCITALOPRAM
OXALATE
20 Milligram
Orodispersible
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA1240/012/001
ESCITALOPRAM
OXALATE
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA1240/012/002
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1240/012/003
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA1240/012/004
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA1390/037/001
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA1390/037/002
ESCITALOPRAM
OXALATE
ESCITALOPRAM
ESCITALOPRAM
OXALATE
ESCITALOPRAM
ESCITALOPRAM
OXALATE
ESCITALOPRAM
ESCITALOPRAM
OXALATE
ESCITALOPRAM
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1390/037/003
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA0688/041/001
ESCITALOPRAM
OXALATE
20 Mg/Ml
Oral Drops
Solution
N06AB10
ESCITALOPRAM
OXALATE
Article 10(1) Generic
Application
-Per Oral
Bristol
Laboratories
Limited
Bristol
Laboratories
Limited
Bristol
Laboratories
Limited
Bristol
Laboratories
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Chanelle Medical
Human Medicines Authorised/Transfer Pending Products
Page 168 of 608
Trade Name
ESCITALOPRAM
ACTAVIS
ESCITALOPRAM
ACTAVIS
ESCITALOPRAM
ACTAVIS
ESCITALOPRAM
ACTAVIS
ESCITALOPRAM
BIOORGANICS
ESCITALOPRAM
BIOORGANICS
ESCITALOPRAM
BIOORGANICS
ESCITALOPRAM
BLUEFISH
ESCITALOPRAM
BLUEFISH
ESCITALOPRAM
BLUEFISH
ESCITALOPRAM
BLUEFISH
ESCITALOPRAM
GLENMARK
ESCITALOPRAM
GLENMARK
ESCITALOPRAM
GLENMARK
ESCITALOPRAM
GLENMARK
Licence Holder Licence
Number
Actavis Group
PTC ehf
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1380/091/001
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA1380/091/002
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1380/091/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA1380/091/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
BioOrganics BV
Interchangeable
List Code:
IC0071-003-015
PA1082/002/001
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
BioOrganics BV
Interchangeable
List Code:
IC0071-002-015
PA1082/002/002
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
BioOrganics BV
Interchangeable
List Code:
IC0071-032-015
PA1082/002/003
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA1436/023/001
ESCITALOPRAM
OXALATE
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA1436/023/002
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1436/023/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA1436/023/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA1462/010/001
ESCITALOPRAM
OXALATE
5 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA1462/010/002
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1462/010/003
Article 10(1) Generic
Application
15 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA1462/010/004
Article 10(1) Generic
Application
20 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
Article 10(1) Generic
Application
-Per Oral
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Glenmark
Pharmaceuticals
Europe Limited
Glenmark
Pharmaceuticals
Europe Limited
Glenmark
Pharmaceuticals
Europe Limited
Glenmark
Pharmaceuticals
Europe Limited
Interchangeable
List Code:
IC0071-003-015
Human Medicines Authorised/Transfer Pending Products
Page 169 of 608
Trade Name
ESCITALOPRAM
GLENMARK
ESCITALOPRAM
GLENMARK
ESCITALOPRAM
GLENMARK
ESCITALOPRAM
KRKA
ESCITALOPRAM
KRKA
ESCITALOPRAM
KRKA
ESCITALOPRAM
KRKA
ESCITALOPRAM
TEVA
ESCITALOPRAM
TEVA
ESCITALOPRAM
TEVA
ESCITALOPRAM
TEVA
ESCITALPRO
ESCITALPRO
ESCITALPRO
ESCITALPRO
Licence Holder Licence
Number
Glenmark
Pharmaceuticals
s.r.o.
Glenmark
Pharmaceuticals
s.r.o.
Glenmark
Pharmaceuticals
s.r.o.
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1543/001/001
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1543/001/002
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA1543/001/003
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA1347/046/001
ESCITALOPRAM
OXALATE
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA1347/046/002
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA1347/046/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA1347/046/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA0749/111/001
ESCITALOPRAM
OXALATE
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA0749/111/002
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA0749/111/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA0749/111/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA0577/108/001
ESCITALOPRAM
OXALATE
5 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA0577/108/002
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA0577/108/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA0577/108/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
OXALATE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
Human Medicines Authorised/Transfer Pending Products
Page 170 of 608
Trade Name
ESCITOTAB
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Genthon BV
PA0740/011/001
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Genthon BV
Interchangeable
List Code:
IC0071-002-015
PA0740/011/002
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Genthon BV
Interchangeable
List Code:
IC0071-032-015
PA0740/011/003
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Genthon BV
Interchangeable
List Code:
IC0071-003-015
PA0740/012/001
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Genthon BV
Interchangeable
List Code:
IC0071-002-015
PA0740/012/002
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Genthon BV
Interchangeable
List Code:
IC0071-032-015
PA0740/012/003
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
ESMERON
NV Organon
Interchangeable
List Code:
IC0071-003-015
PA0964/001/001
ESCITALOPRAM
OXALATE
10 Mg/Ml
Solution for Inj/Inf
M03AC09
ESMOCARD
Orpha-Devel
Handels und
Vertriebs GmbH
Orpha-Devel
Handels und
Vertriebs GmbH
Gedeon Richter
Plc
Bristol
Laboratories
Limited
PA1353/001/001
100 Milligram
Solution for
Injection
C07AB09
PA1353/001/003
2500 Milligram
Pdr/Conc/Soln for
Infus
C07AB09
EU/1/12/750/001
5 Milligram
Tablets
G03XB
PA1240/011/001
20 Milligram
Tablets GastroResistant
A02BC05
Interchangeable
List Code:
IC0004-003-016
PA1240/011/002
-ROCURONIUM
BROMIDE
-ESMOLOL
HYDROCHLORI
DE
-ESMOLOL
HYDROCHLORI
DE
-ULIPRISTAL
ACETATE
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA1390/097/001
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Pdr for Soln
Inj/Inf
A02BC05
40 Milligram
Pdr for Soln
Inj/Inf
A02BC05
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
PA1380/127/005
PA1380/127/003
20 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA1380/127/004
ESOMEPRAZOL
E SODIUM
ESOMEPRAZOL
E
ESOMEPRAZOL
E SODIUM
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA1380/127/001
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
20 Milligram
Capsules GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
Article 10(3) Hybrid
Application
-Per Oral
ESCITOTAB
ESCITOTAB
ESCIVRIENS
ESCIVRIENS
ESCIVRIENS
ESMOCARD
LYO
ESMYA
ESOMEPRAZOL
E
ESOMEPRAZOL
E
ESOMEPRAZOL
E
Bristol
Laboratories
Limited
ESOMEPRAZOL
E
Accord
Healthcare
Limited
Actavis Group
PTC ehf
ESOMEPRAZOL
E ACTAVIS
Actavis Group
PTC ehf
ESOMEPRAZOL
E ACTAVIS
ESOMEPRAZOL
E ACTAVIS
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0004-003-016
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Intra-venous
Page 171 of 608
Trade Name
ESOMEPRAZOL
E ACTAVIS
ESOMEPRAZOL
E ARISTO
ESOMEPRAZOL
E ARISTO
ESOMEPRAZOL
E KRKA
ESOMEPRAZOL
E KRKA
ESOMEPRAZOL
E MYLAN
ESOMEPRAZOL
E MYLAN
ESOMEPRAZOL
E PENSA
ESOMEPRAZOL
E PENSA
Licence Holder Licence
Number
Actavis Group
PTC ehf
Aristo Pharma
GmbH
Aristo Pharma
GmbH
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Pensa Pharma
AB
Pensa Pharma
AB
ESOMEPRAZOL
E TEVA
PHARMA
Teva Pharma
B.V.
ESOMEPRAZOL
E TEVA
PHARMA
Teva Pharma
B.V.
ESOMEPRAZOL
E TICERIN
Laboratórios
Azevedos Indústria
Farmacêutica S.
3M Deutschland
GmbH
ESPESTESIN
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1380/127/002
40 Milligram
Capsules GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA1983/001/001
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
20 Milligram
Capsules GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA1983/001/002
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Capsules GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA1347/017/001
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
20 Milligram
Capsules GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA1347/017/002
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Capsules GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA0577/123/001
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
20 Milligram
Capsules GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA0577/123/002
ESOMEPRAZOL
E
40 Milligram
Capsules GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA1647/005/001
ESOMEPRAZOL
E
20 Milligram
Tablets GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA1647/005/002
ESOMEPRAZOL
E SODIUM
40 Milligram
Tablets GastroResistant
A02BC05
Article 10(3) Hybrid
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA0749/123/001
ESOMEPRAZOL
E SODIUM
20 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA0749/123/002
ESOMEPRAZOL
E
40 Milligram
Tablets GastroResistant
A02BC05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA1852/002/001
ESOMEPRAZOL
E
40 Milligram
Pdr for Soln
Inj/Inf
A02BC05
ESOMEPRAZOL
E SODIUM
Article 10(1) Generic
Application
-Intra-venous
PA1762/001/001
40/0.010 Mg/Ml
Solution for
Injection
N01BB58
-ARTICAINE
HYDROCHLORI
DE
-EPINEPHRINE
HYDROCHLORI
DE
-ARTICAINE
HYDROCHLORI
DE
-EPINEPHRINE
HYDROCHLORI
DE
-ESTRADIOL
HEMIHYDRATE
ESPESTESIN
3M Deutschland
GmbH
PA1762/001/002
40/0.005 Mg/Ml
Solution for
Injection
N01BB58
ESTRADOT
Novartis
Pharmaceuticals
UK Ltd
PA0013/110/005
25
Microgram/day
Transdermal
Patch
G03CA03
Human Medicines Authorised/Transfer Pending Products
-Intra-Muscular
Page 172 of 608
Trade Name
ESTRADOT
ESTRADOT
ESTRADOT
ESTRADOT
ESTROFEM
ETALOPRO
ETALOPRO
ETALOPRO
ETALOPRO
ETHAMBUTOL
ETHAMBUTOL
ETHAMBUTOL
Licence Holder Licence
Number
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novo Nordisk A/S
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Morningside
Healthcare
Limited
Morningside
Healthcare
Limited
Pfizer Healthcare
Ireland
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0013/110/001
37.5
Microgram/day
Transdermal
Patch
G03CA03
-ESTRADIOL
HEMIHYDRATE
PA0013/110/002
50
Microgram/day
Transdermal
Patch
G03CA03
-ESTRADIOL
HEMIHYDRATE
PA0013/110/003
75
Microgram/day
Transdermal
Patch
G03CA03
-ESTRADIOL
HEMIHYDRATE
PA0013/110/004
100
Microgram/day
Transdermal
Patch
G03CA03
-ESTRADIOL
HEMIHYDRATE
PA0218/050/001
PA0126/212/001
2 Milligram
5 Milligram
Tablets
Film Coated
Tablet
G03CA03
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-001-015
PA0126/212/002
-ESTRADIOL
ESCITALOPRAM
OXALATE
10 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-002-015
PA0126/212/003
ESCITALOPRAM
OXALATE
15 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-032-015
PA0126/212/004
ESCITALOPRAM
OXALATE
20 Milligram
Film Coated
Tablet
N06AB10
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA1333/007/001
ESCITALOPRAM
OXALATE
100 Milligram
Film Coated
Tablet
J04AK02
400 Milligram
Film Coated
Tablet
J04AK02
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
PA1333/007/002
PA0822/180/001
100 Milligram
Film Coated
Tablet
J04AK02
-ETHAMBUTOL
DIHYDROCHLO
RIDE
-ETHAMBUTOL
DIHYDROCHLO
RIDE
-ETHAMBUTOL
DIHYDROCHLO
RIDE
-ETHAMBUTOL
DIHYDROCHLO
RIDE
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
ETHAMBUTOL
Pfizer Healthcare
Ireland
PA0822/180/002
400 Milligram
Film Coated
Tablet
J04AK02
ETHINYLESTRA
DIOL /
DROSPIRENON
E LEON FARMA
Laboratorios
Leon Farma, S.A.
PA1474/004/002
0.03 / 3 Milligram
Film Coated
Tablet
G03AA12
ETHINYLESTRA
DIOL/DROSPIR
ENONE LEON
FARMA
Laboratorios
Leon Farma, S.A.
PA1474/004/001
0.02 / 3 Milligram
Film Coated
Tablet
G03AA12
ETHINYLESTRA
DIOL/DROSPIR
ENONE LEON
FARMA &
PLACEBO
Laboratorios
Leon Farma, S.A.
PA1474/006/001
0.02 / 3 Milligram
Film Coated
Tablet
G03AA12
ETHINYLESTRA
DIOL/DROSPIR
ENONE LEON
FARMA &
PLACEBO
Laboratorios
Leon Farma, S.A.
PA1474/006/002
0.03 / 3 Milligram
Film Coated
Tablet
G03AA12
ETHINYLESTRA
DIOL/DROSPIR
ENONE LEON
FARMA &
PLACEBO
Laboratorios
Leon Farma, S.A.
PA1474/008/001
0.02 / 3 Milligram
Film Coated
Tablet
G03AA12
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Page 173 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
ETHINYLESTRA
DIOL/DROSPIR
ENONE LEON
FARMA &
PLACEBO
Laboratorios
Leon Farma, S.A.
PA1474/008/002
0.03 / 3 Milligram
Film Coated
Tablet
G03AA12
ETHYLEX
AOP Orphan
Pharmaceuticals
AG
Phoenix Labs
PA0934/002/001
50 Milligram
Film Coated
Tablet
N07BB04
PA1113/002/001
5 %w/w
Gel
Accord
Healthcare
Limited
Actavis Group
PTC ehf
PA1390/094/001
20 Mg/Ml
PA1380/168/001
ETOPOSIDE
Fresenius Kabi
Oncology Plc
ETOPOSIDETEVA
ETORICOXIB
Active
Ingredients
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
M02AA06
DROSPIRENON
E
ETHINYLESTRA
DIOL
-NALTREXONE
HYDROCHLORI
DE
-ETOFENAMATE
Concentrate for
Soln for Inf
L01CB01
-ETOPOSIDE
-Intra-venous
20 Mg/Ml
Concentrate for
Soln for Inf
L01CB01
-ETOPOSIDE
PA1422/012/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01CB01
-ETOPOSIDE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Teva Pharma
B.V.
Rowex Ltd
PA0749/002/001
20 Micromol
L01CB01
-ETOPOSIDE
PA0711/232/001
30 Milligram
Concentrate for
Soln for Inf
Film Coated
Tablet
M01AH05
-ETORICOXIB
-Per Oral
ETORICOXIB
Rowex Ltd
PA0711/232/002
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Rowex Ltd
PA0711/232/003
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Rowex Ltd
PA0711/232/004
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Chanelle Medical
PA0688/032/001
30 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Chanelle Medical
PA0688/032/004
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Chanelle Medical
PA0688/032/003
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Chanelle Medical
PA0688/032/002
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Actavis Group
PTC ehf
PA1380/199/001
30 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Actavis Group
PTC ehf
PA1380/199/002
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Actavis Group
PTC ehf
PA1380/199/004
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Actavis Group
PTC ehf
PA1380/199/003
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Generics (UK)
Limited
PA0405/104/001
30 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Generics (UK)
Limited
PA0405/104/002
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Generics (UK)
Limited
PA0405/104/003
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
Generics (UK)
Limited
PA0405/104/004
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
KRKA
Krka d.d., Novo
mesto
PA1347/064/001
30 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
ETOFLAM 5%
W/W GEL
ETOPOSIDE
ETOPOSIDE
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 174 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
ETORICOXIB
KRKA
Krka d.d., Novo
mesto
PA1347/064/002
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
KRKA
Krka d.d., Novo
mesto
PA1347/064/004
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
KRKA
Krka d.d., Novo
mesto
PA1347/064/003
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
TEVA
Teva B.V.
PA1986/002/001
30 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
TEVA
Teva B.V.
PA1986/002/002
60 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
TEVA
Teva B.V.
PA1986/002/003
90 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETORICOXIB
TEVA
Teva B.V.
PA1986/002/004
120 Milligram
Film Coated
Tablet
M01AH05
-ETORICOXIB
ETRIVEX
Galderma (UK)
Ltd
F. Trenka chem.
Pharm. Fabrik
Gesmbh
PA0590/023/001
500
Micrograms/g
Shampoo
D07AD01
-Cutaneous
Tablets
A06AB
Roche Products
Limited
PA0050/142/002
12.5mg Milligram
Tablets
C07AG02
-CLOBETASOL
PROPIONATE
-SENNA FOLIUM
POWDER
-RHUBARB DRY
EXTRACT
-VEGETABLE
CHARCOAL
(CARBO LIGNI)
-CARVEDILOL
Roche Products
Limited
Roche Products
Limited
PA0050/142/003
25mg Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
PA0050/142/004
3.125mg
Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
Roche Products
Limited
Beiersdorf UK
Limited
PA0050/142/001
6.25mg Milligram
Tablets
C07AG02
-CARVEDILOL
-Per Oral
PA1159/001/001
10 %w/w
Cream
D02AX
-UREA
Beiersdorf UK
Limited
PA1159/001/002
10 %w/w
Cutaneous
Emulsion
D02AX
-UREA
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Weleda (UK)
Limited
A. Nelson &
Company Limited
Sigma-Tau
Industrie
Farmaceutiche
Riunite SpA
EU/1/07/425/1618
50/1000 Milligram
Film Coated
Tablet
A10BD08
EU/1/07/425/1-6
50/850 Milligram
Film Coated
Tablet
A10BD08
EU/1/07/425/1315
50/850 Milligram
Film Coated
Tablet
A10BD08
EU/1/07/425/7-12
50/1000 Milligram
Film Coated
Tablet
A10BD08
PA1077/006/001
0.05% %w/w
Cream
D07AB01
PA1077/006/002
0.05 %w/w
Ointment
D07AB01
HOR0407/027/0
01
HOR1149/011/0
01
EU/1/11/716/001004
6C & 30C
Tablets
-VILDAGLIPTIN
-METFORMIN
HCI
-VILDAGLIPTIN
-METFORMIN
HCI
-VILDAGLIPTIN
-METFORMIN
HCI
-VILDAGLIPTIN
-METFORMIN
HCI
-CLOBETASONE
BUTYRATE
-CLOBETASONE
BUTYRATE
-EUPHRASIA
OFFICINALIS
-EUPHRASIA
OFFICINALIS
-PIPERAQUINE
PHOSPHATE
DIHYDROARTE
MISININ
EUCARBON
HERBAL
EUCARDIC
12.5MG
TABLETS
EUCARDIC
25MG TABLETS
EUCARDIC
3.125MG
TABLETS
EUCARDIC 6.25
MG TABLETS
EUCERIN
INTENSIVE 10%
W/W UREA
TREATMENT
CREAM
EUCERIN
INTENSIVE 10%
W/W UREA
TREATMENT
LOTION
EUCREAS
EUCREAS
EUCREAS
EUCREAS
EUMOVATE
EUMOVATE
EUPHRASIA
EUPHRASIA
EURARTESIM
TR1743/001/001
Human Medicines Authorised/Transfer Pending Products
6C-MM N/A
40/320 Milligram
Film Coated
Tablet
P01BF05
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Topical
-Topical
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Page 175 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
EURARTESIM
Sigma-Tau
Industrie
Farmaceutiche
Riunite SpA
EU/1/11/716/005
20/160 Milligram
Film Coated
Tablet
P01BF05
EURAX
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Omrix
Biopharmaceutic
als NV/SA
PA0678/119/002
10 %w/w
Cutaneous
Emulsion
D04AX
-PIPERAQUINE
PHOSPHATE
DIHYDROARTE
MISININ
-CROTAMITON
PA0678/119/001
10 %w/w
Cream
D04AX
-CROTAMITON
EU/1/13/868/001
8.1 Milligram
Sponge
B02BC30
EVICEL
Omrix
Biopharmaceutic
als S.A.
EU/1/08/473/1-3
N/A
Solution for
Sealant
B02BB01
EVIPLERA
Gilead Sciences
International
EU/1/11/737/001002
200/25/300
Milligram
Film Coated
Tablet
J05AR08
EVISTA
Daiichi Sankyo
Europe GmbH
Daiichi Sankyo
Europe GmbH
Daiichi Sankyo
Europe GmbH
Daiichi Sankyo
Europe GmbH
Bioenvision
Limited
EU/1/98/073/002
60 Milligram
Tablets
G03XC01
-HUMAN
FIBRINOGEN
-HUMAN
THROMBIN
-HUMAN
FIBRINOGEN
-HUMAN
THROMBIN
EMTRICITABINE
(FTC)
-RILPIVIRINE
HC1 (RPV)
-TENOFOVIR
DISOPROXIL
FUMARATE
(TDF)
-RALOXIFENE
EU/1/98/073/003
60 Milligram
Tablets
G03XC01
-RALOXIFENE
EU/1/98/073/004
60 Milligram
Tablets
G03XC01
-RALOXIFENE
EU/1/98/073/001
60 Milligram
Tablets
G03XC01
-RALOXIFENE
EU/1/06/334/01
1 Mg/Ml
L01BB06
-CLOFARABINE
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
PA0748/004/004
50
Microgram/day
50/170
Microgram
Conc For
haemodialysis
Soln
Transdermal
Patch
Transdermal
Patch
G03CA03
Bristol-Myers
Squibb Pharma
EEIG
Janssen-Cilag
International NV
EU/1/15/1025/00
1-002
300/150 Milligram
Film Coated
Tablet
J05AR15
-ESTRADIOL
HEMIHYDRATE
NORETHISTER
ONE ACETATE
-ESTRADIOL
HEMIHYDRATE
-ATAZANAVIR
-COBICISTAT
EU/1/02/223/002
%v/v
Transdermal
Patch
G03AA03
EVRA
Janssen-Cilag
International NV
EU/1/02/223/003
%v/v
Transdermal
Patch
G03AA03
EVRA
Janssen-Cilag
International NV
EU/1/02/223/001
%v/v
Transdermal
Patch
G03AA13
EXALIEF
BIAL - Portela &
Cª, S.A.
EU/1/09/520/1-6
400 Milligram
Tablets
N03AF04
EURAX
EVARREST
SEALANT
MATRIX
EVISTA
EVISTA
EVISTA
EVOLTRA
EVOREL
EVOREL CONTI
EVOTAZ
EVRA
PA0748/008/001
Human Medicines Authorised/Transfer Pending Products
G03CA53
NORELGESTR
OMIN
ETHINYLESTRA
DIOL
NORELGESTR
OMIN
ETHINYLESTRA
DIOL
NORELGESTR
OMIN
ETHINYLESTRA
DIOL
ESLICARBAZEP
INE ACETATE
Legal Basis
Article 10b Fixed
Combination
Routes of
Administration
-Per Oral
-Cutaneous
-Cutaneous
Article 8(3) - Full
new Application
-Epilesional
Article 8(3) - Full
new Application
-Per Oral
-Transdermal
Article 10b Fixed
Combination
-Per Oral
-Per Oral
Page 176 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
EXCEDRIN
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0678/122/001
250/250/65
Milligram
Film Coated
Tablet
N02BE51
EXELON
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Accord
Healthcare
Limited
LTT Pharma
Limited
Actavis Group
PTC ehf
EU/1/98/066/1922
4.6 Mg/day
Transdermal
Patch
N06DA03
EU/1/98/066/2326
9.5 Mg/day
Transdermal
Patch
EU/1/98/066/001
1.5 mg Milligram
EU/1/98/066/004
Novartis
Europharm
Limited
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXELON
EXEMESTANE
EXEMESTANE
EXEMESTANE
ACTAVIS
EXFORGE
EXFORGE
Novartis
Europharm
Limited
Active
Ingredients
Legal Basis
Routes of
Administration
ACETYLSALICY
LIC ACID
-PARACETAMOL
-CAFFEINE
-RIVASTIGMINE
BASE
Article 8(3) - Full
new Application
-Transdermal
N06DA03
-RIVASTIGMINE
BASE
Article 8(3) - Full
new Application
-Transdermal
Capsule
N06DA03
3.0 Milligram
Capsule
N06DA03
EU/1/98/066/007
4.5 Milligram
Capsule
N06DA03
EU/1/98/066/010
6.0 Milligram
Capsule
N06DA03
EU/1/98/066/013
2 Mg/Ml
Oral Solution
N06DA03
EU/1/98/066/002
1.5 Milligram
Capsule
N06DA03
EU/1/98/066/003
1.5 Milligram
Capsule
N06DA03
EU/1/98/066/005
3 Milligram
Capsule
N06DA03
EU/1/98/066/006
3 Milligram
Capsule
N06DA03
EU/1/98/066/008
4.5 Milligram
Capsule
N06DA03
EU/1/98/066/009
4.5 Milligram
Capsule
N06DA03
EU/1/98/066/011
6 Milligram
Capsule
N06DA03
EU/1/98/066/012
6 Milligram
Capsule
N06DA03
EU/1/98/066/027030
13.3 mg/24 hours
Transdermal
Patch
N06DA03
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
PA1390/026/001
25 Milligram
Film Coated
Tablet
L02BG06
-EXEMESTANE
PPA1562/184/00
1
PA1380/083/001
25 Milligram
Film Coated
Tablet
Film Coated
Tablet
L02BG06
-EXEMESTANE
L02BG06
-EXEMESTANE
EU/1/06/370/001008
5/80
Tablets
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
5/160
Tablets
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
-Per Oral
Interchangeable
List Code:
IC0042-087-003
EU/1/06/370/009016
25 Milligram
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Transdermal
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0042-086-003
Human Medicines Authorised/Transfer Pending Products
Page 177 of 608
Trade Name
EXFORGE
Licence Holder Licence
Number
Novartis
Europharm
Limited
EU/1/06/370/017024
Interchangeable
List Code:
IC0042-084-003
EU/1/09/569/1-12
Strength
Dosage Form ATC
Active
Ingredients
10/160
Film Coated
Tablet
C09DB01
-AMLODIPINE
BESYLATE
-VALSARTAN
5/160/12.5
Milligram
Film Coated
Tablet
C09DX01
EXFORGE HCT
Novartis
Europharm
Limited
EXFORGE HCT
Novartis
Europharm
Limited
EU/1/09/569/1324
10/160/12.5
Milligram
Film Coated
Tablet
C09DX01
EXFORGE HCT
Novartis
Europharm
Limited
EU/1/09/569/2536
5/160/25
Milligram
Film Coated
Tablet
C09DX01
EXFORGE HCT
Novartis
Europharm
Limited
EU/1/09/569/3748
10/160/25
Milligram
Film Coated
Tablet
C09DX01
EXFORGE HCT
Novartis
Europharm
Limited
EU/1/09/569/4960
10/320/25
Milligram
Film Coated
Tablet
C09DX01
EXJADE
Novartis
Europharm Ltd
Novartis
Europharm Ltd
Novartis
Europharm Ltd
Novartis
Europharm
Limited
Allergan
Pharmaceuticals
Ireland
EU/1/06/356/011013
EU/1/06/356/014016
EU/1/06/356/017019
EU/1/06/356/001009
90 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Tablets
V03AC03
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-AMLODIPINE
BESYLATE
-VALSARTAN
HYDROCHLOR
OTHIAZIDE
-DEFERASIROX
V03AC03
-DEFERASIROX
V03AC03
-DEFERASIROX
V03AC03
-DEFERASIROX
PA0148/049/001
0.3 %w/v
Eye Drops
Solution
S01AE01
-OFLOXACIN
BENZALKONIUM
CHLORIDE
Forest Tosara
Limited
Phoenix Labs
PA0247/002/001
5 %v/w
D05AA
PA1113/010/001
250 MG/5ml
Cutaneous
Emulsion
Oral Solution
-COAL TAR
SOLUTION
CARBOCISTEIN
E
Novartis
Europharm
Limited
Dermal
Laboratories Ltd
EU/1/08/454/1,2,
5
250
Microgram/ML
Pdr+Solv for Soln
for Inj
L03AB08
-INTERFERON
BETA-1B
PA0278/009/001
5 %w/w
Ear Drops
Solution
D02AE01
EXTEROL
Eurodrug Ltd
DPR1392/041/0
01
5 %w/w
Ear Drops
Solution
D02AE01
EXTRANEAL
Baxter
Healthcare
Limited
PA0167/088/001
N/A
Solution for
Dialysis
B05DA
-UREA
HYDROGEN
PEROXIDE
-UREA
HYDROGEN
PEROXIDE
-ICODEXTRIN
-SODIUM
CHLORIDE
-SODIUM
LACTATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
ANHYDROUS
EXJADE
EXJADE
EXJADE
DISPERSIBLE
EXOCIN
(OFLOXACIN)
0.3% W/V EYE
DROPS
SOLUTION
EXOREX
LOTION
EXPUTEX
250MG / 5ML
ORAL
SOLUTION
EXTAVIA
EXTEROL
Human Medicines Authorised/Transfer Pending Products
180 Milligram
360 Milligram
125/250/50
Milligram
R05CB03
Legal Basis
Routes of
Administration
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Topical
Article 10c Informed Consen
-Subcutaneous
Page 178 of 608
Trade Name
Licence Holder Licence
Number
Strength
EXVIERA
AbbVie Ltd
EU/1/14/983/001
250 Milligram
EYLEA
Bayer AG
40 Mg/Ml
EZETIMIB
Actavis Group
PTC ehf
EU/1/12/797/001002
PA1380/197/001
EZETIMIBE
Glenmark
Pharmaceuticals
Europe Limited
Accord
Healthcare
Limited
Generics (UK)
Limited
EZETIMIBE
KRKA
Dosage Form ATC
C10AX09
-EZETIMIBE
Tablets
C10AX09
-EZETIMIBE
10 Milligram
Tablets
C10AX09
-EZETIMIBE
PA0405/063/001
10 Milligram
Tablets
C10AX09
-EZETIMIBE
Krka d.d., Novo
mesto
PA1347/066/001
10 Milligram
Tablets
C10AX09
-EZETIMIBE
EZETIMIBE
TEVA
Teva B.V.
PA1986/012/001
10 Milligram
Tablets
C10AX09
-EZETIMIBE
EZETIMIBE/SIM
VASTATIN
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/180/001
10/20 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
Interchangeable
List Code:
IC0034-051-002
PA0577/180/002
10/40 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
-Per Oral
Interchangeable
List Code:
IC0034-059-002
PA0577/180/003
Article 10(1) Generic
Application
10/80 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
Article 10(1) Generic
Application
-Per Oral
10/20 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
EZETIMIBE/SIM
VASTATIN
EZETIMIBE/SIM
VASTATIN
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
10 Milligram
PA1390/112/001
Routes of
Administration
S01LA05
EZETIMIBE
PA1462/014/001
Legal Basis
-DASABUVIR
SODIUM
-AFLIBERCEPT
EZETIMIBE
J
10 Milligram
Film Coated
Tablet
Solution for
Injection
Tablets
Active
Ingredients
EZETIMIBE/SIM
VASTATIN
Actavis Group hf
Interchangeable
List Code:
IC0034-060-002
PA1366/004/001
EZETIMIBE/SIM
VASTATIN
Actavis Group hf
PA1366/004/002
10/40 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
EZETIMIBE/SIM
VASTATIN
Actavis Group hf
PA1366/004/003
10/80 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
EZETIMIBE/SIM
VASTATIN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/281/001
10mg/10
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/281/002
10mg/20
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/281/004
10mg/80
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/281/003
10mg/40
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN KRKA
Krka d.d., Novo
mesto
PA1347/067/001
10mg/10
Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 179 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
EZETIMIBE/SIM
VASTATIN KRKA
Krka d.d., Novo
mesto
PA1347/067/002
10mg/20
Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
EZETIMIBE/SIM
VASTATIN KRKA
Krka d.d., Novo
mesto
PA1347/067/003
10mg/40
Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
EZETIMIBE/SIM
VASTATIN
ROWEX
Rowex Ltd
PA0711/262/001
10mg/20
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN
ROWEX
Rowex Ltd
PA0711/262/003
10mg/80
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN
ROWEX
Rowex Ltd
PA0711/262/002
10mg/40
Milligram
Tablets
C10BA02
EZETIMIBE/SIM
VASTATIN TEVA
Teva B.V.
PA1986/030/001
10/20
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
CONTAINS
BUTYLHYDROX
YANISOLE
(BHA) 0.01%
-EZETIMIBE
-SIMVASTATIN
EZETIMIBE/SIM
VASTATIN TEVA
Teva B.V.
PA1986/030/002
10/40
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
EZETIMIBE/SIM
VASTATIN TEVA
Teva B.V.
PA1986/030/003
10/80
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
EZETROL
Imbat Limited
10 Milligram
Tablets
C10AX09
-EZETIMIBE
EZETROL
LTT Pharma
Limited
IMED Healthcare
Ltd.
Merck Sharp and
Dohme Limited
Primecrown 2010
Ltd
PCO
Manufacturing
Eurodrug Ltd
PPA1151/256/00
1
PPA1562/138/00
1
DPR1463/042/0
01
PA0035/096/001
10 Milligram
Tablets
C10AX09
-EZETIMIBE
10 Milligram
Tablets
C10AX09
-EZETIMIBE
10mg Milligram
Tablets
C10AX09
-EZETIMIBE
-Per Oral
10 Milligram
Tablets
C10AX09
-EZETIMIBE
-Per Oral
10 Milligram
Tablets
C10AX09
-EZETIMIBE
10 Milligram
Tablets
C10AX09
-EZETIMIBE
-Per Oral
PCO
Manufacturing
McDowell
Pharmaceuticals
Genzyme Europe
B.V.
DPR1633/007/0
01
PPA0465/227/00
1
DPR1392/031/0
01
DPR0465/022/0
01
DPR1473/039/0
01
EU/1/01/188/001002
10 Milligram
Tablets
C10AX09
-EZETIMIBE
-Per Oral
10 Milligram
Tablets
C10AX09
-EZETIMIBE
-Per Oral
35 Milligram
Pdr/Conc/Soln for
Infus
A16AB04
-Intra-venous
FABRAZYME
Genzyme Europe
B.V.
EU/1/01/188/004006
05 Milligram
Pdr/Conc/Soln for
Infus
A16AB04
FABRAZYME
Genzyme Europe
B.V.
EU/1/01/188/003
35 Milligram
Pdr/Conc/Soln for
Infus
A16AB04
FAMCICLOVIR
Teva Pharma
B.V.
PA0749/025/002
250 Milligram
Film Coated
Tablet
J05AB09
-PROTEIN C
AGALSIDASE
BETA
(RECOMBINANT
HUMAN-AGALACTOSIDE
A)
-PROTEIN C
AGALSIDASE
BETA
(RECOMBINANT
HUMAN-AGALACTOSIDE
A)
-PROTEIN C
AGALSIDASE
BETA
(RECOMBINANT
HUMAN-AGALACTOSIDE
A)
-FAMCICLOVIR
EZETROL
EZETROL
EZETROL
EZETROL
EZETROL
EZETROL
EZETROL
FABRAZYME
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-Intra-venous
-Intra-venous
-Per Oral
Page 180 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
FAMCICLOVIR
Fannin (UK) Ltd
PA1585/005/001
125 Milligram
Film Coated
Tablet
J05AB09
-FAMCICLOVIR
FAMCICLOVIR
Fannin (UK) Ltd
PA1585/005/002
250 Milligram
Film Coated
Tablet
J05AB09
-FAMCICLOVIR
FAMCICLOVIR
Medinutrix Ltd
PA2030/001/001
500 Milligram
Film Coated
Tablet
J05AB09
-FAMCICLOVIR
FAMPYRA
Biogen Idec
Limited
EU/1/11/699/001002
10 Milligram
Tablet Prolonged
Release
N07XX07
FAMVIR
PCO
Manufacturing
Novartis
Pharmaceuticals
UK Ltd
PCO
Manufacturing
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Instituto Grifols
S.A.
PPA0465/212/00
2
PA0013/106/006
500 Milligram
Film Coated
Tablet
Film Coated
Tablet
J05AB09
-FAMPRIDINE (4AMINOPYRIDIN
E)
-FAMCICLOVIR
J05AB09
-FAMCICLOVIR
Article 8(3) - Full
new Application
-Per Oral
PPA0465/212/00
1
PA0013/106/001
250 Milligram
J05AB09
-FAMCICLOVIR
PPA
-Per Oral
125 Milligram
Film Coated
Tablet
Coated Tablets
J05AB09
-FAMCICLOVIR
-Per Oral
PA0013/106/002
250 Milligram
Coated Tablets
J05AB09
-FAMCICLOVIR
-Per Oral
PA0849/001/001
250 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
-Intra-venous
FANHDI
Instituto Grifols
S.A.
PA0849/001/002
500 International
Unit
Pdr+Solv for Soln
for Inj
B02BD02
FANHDI
Instituto Grifols
S.A.
PA0849/001/003
1000
International Unit
Pdr+Solv for Soln
for Inj
B02BD02
FARESTON
FARESTON
Orion Corporatio
Orion Corporatio
EU/1/96/004/002
EU/1/96/004/001
60 Milligram
60 Milligram
Tablets
Tablets
L02BA02
L02BA02
FARYDAK
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
AstraZeneca UK
Limited
EU/1/15/1023/00
1-003
10 Milligram
Capsules Hard
L01X
-FACTOR VIII
(ANTIHAEMOPH
ILIC FACTOR)
-FACTOR VIII
(ANTIHAEMOPH
ILIC FACTOR)
-FACTOR VIII
(ANTIHAEMOPH
ILIC FACTOR)
-TOREMIFENE
-TOREMIFENE
CITRATE
PANOBINOSTAT
Article 8(3) - Full
new Application
-Per Oral
EU/1/15/1023/00
4-006
15 Milligram
Capsules Hard
L01X
PANOBINOSTAT
Article 8(3) - Full
new Application
-Per Oral
EU/1/15/1023/00
7-009
20 Milligram
Capsules Hard
L01X
PANOBINOSTAT
Article 8(3) - Full
new Application
-Per Oral
EU/1/03/269/001
250mg/5ml
Milligram
Solution for
Injection
L02BA03
-FULVESTRANT
A. Menarini
Industrie
Farmaceutische
Riunite S.r.l.
LTT Pharma
Limited
PCO
Manufacturing
Sanofi aventis
PA0512/001/001
2.5 %w/w
Gel
M02AA10
-KETOPROFEN
PPA1562/150/00
1
PPA0465/419/00
1
EU/1/00/170/001002
PA2007/006/001
2.5 %w/w
Gel
M02AA10
-KETOPROFEN
2.5 %w/w
Gel
M02AA10
-KETOPROFEN
-Topical
1.5 Mg/Ml
V03AF07
-RASBURICASE
-Intra-venous
N06AB08
PA2007/006/002
100 Milligram
PA0775/007/001
18 Microgram
Pdr/Conc/Soln for
Infus
Film Coated
Tablet
Film Coated
Tablet
Inhalation
Powder, Capsule
-FLUVOXAMINE
MALEATE
-FLUVOXAMINE
MALEATE
-TIOTROPIUM
BROMIDE
MONOHYDRATE
PA1923/002/001
150/0.5 Milligram
Capsules
Modified Release
B03AD03
PA2004/001/001
25 Units/ml
Pdr+Solv for soln
for Inf
B02BD03
FAMVIR
FAMVIR
FAMVIR
FAMVIR
FANHDI
FARYDAK
FARYDAK
FASLODEX 250
MG/5 MLSOLUTION FOR
INJECTION
FASTUM
FASTUM GEL
FASTUM GEL
FASTURTEC
FAVERIN
FAVERIN
FAVYND
FEFOL
SPANSULE
FEIBA
BGP Products
Ltd
BGP Products
Ltd
Boehringer
Ingelheim
International
GmbH
Henley
Laboratories
Limited
Baxalta
Innovations
GmbH
Human Medicines Authorised/Transfer Pending Products
500 Milligram
50 Milligram
N06AB08
R03BB04
-FERROUS
SULFATE
EXSICCATED
-FOLIC ACID
-FEIBA
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Inhalation
-Per Oral
-Intra-venous
Page 181 of 608
Trade Name
FEIBA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Baxalta
Innovations
GmbH
Pfizer Limited
Pfizer Limited
PA2004/001/002
50 Units/ml
Pdr+Solv for soln
for Inf
B02BD03
-FEIBA
-Intra-venous
PA0019/024/008
PA0019/024/002
5.0 mg/g
10 mg Milligram
Gel
Capsule
M02AA07
M01AC01
-PIROXICAM
-PIROXICAM
-Topical
Pfizer Limited
PA0019/024/003
20 mg Milligram
Capsule
M01AC01
-PIROXICAM
Novartis
Pharmaceuticals
UK Ltd
PCO
Manufacturing
BGP Products
Ltd
BGP Products
Ltd
Bayer Limited
PA0013/080/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
-Per Oral
PPA0465/303/00
1
PA2007/007/002
2.5 Milligram
L02BG04
-LETROZOLE
-Per Oral
G03CA03
-ESTRADIOL
-Per Oral
PA2007/007/001
1 Milligram
G03CA03
500 8 100 50
Milligram
FEMOSTON 1/10
BGP Products
Ltd
PA2007/008/001
1 mg, 10 m
Milligram
Film Coated
Tablet
G03FB08
FEMOSTON 2/10
BGP Products
Ltd
PA2007/008/002
2 mg, 10 m
Milligram
Film Coated
Tablet
G03FB08
FEMOSTONCONTI
BGP Products
Ltd
PA2007/008/004
1mg/5mg
Milligram
Film Coated
Tablet
G03FA14
FEMOSTONCONTI
BGP Products
Ltd
PA2007/008/003
0.5/2.5 Milligram
Film Coated
Tablet
G03FA14
FENDRIX
GlaxoSmithKline
Biologicals S.A.
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Pinewood
Laboratories Ltd,
EU/1/04/0299/00
1-003
PA0678/141/001
20mg/0.5ml
Mg/Ml
500 Milligram
Suspension for
Injection
Film Coated
Tablet
J07BC01
J05AB09
-ESTRADIOL
HEMIHYDRATE
-PARACETAMOL
-CAFFEINE
-CODEINE
PHOSPHATE
-HYOSCINE
HYDROBROMID
E
-ESTRADIOL
HEMIHYDRATE
DYDROGESTE
RONE
-ESTRADIOL
HEMIHYDRATE
DYDROGESTE
RONE
-ESTRADIOL
DYDROGESTE
RONE
-ESTRADIOL
DYDROGESTE
RONE
-HEPATITIS B
VACCINE
-FAMCICLOVIR
-Per Oral
PA1410/045/001
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Tablets
PA0281/088/004
100/5 Mg/Ml
Oral Suspension
M01AE01
-IBUPROFEN
FENOPINE 200
MG FILMCOATED
TABLETS
FENOPINE 400
MG FILMCOATED
TABLETS
FENOPINE 600
MG FILMCOATED
TABLETS
FENTADUR
Pinewood
Laboratories Ltd,
PA0281/088/001
200 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
-Per Oral
Pinewood
Laboratories Ltd,
PA0281/088/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
-Per Oral
Pinewood
Laboratories Ltd,
PA0281/088/003
600 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
-Per Oral
Lavipharm S.A.
PA1676/002/001
25 Microgram per
hour
Transdermal
Patch
N02AB03
-FENTANYL
FENTADUR
Lavipharm S.A.
PA1676/002/002
50 Microgram per
hour
Transdermal
Patch
N02AB03
-FENTANYL
FENTADUR
Lavipharm S.A.
PA1676/002/003
75 Microgram per
hour
Transdermal
Patch
N02AB03
-FENTANYL
FELDENE
FELDENE 10 MG
CAPSULES,
HARD
FELDENE 20 MG
CAPSULES,
HARD
FEMARA
FEMARA
FEMATAB
FEMATAB
FEMINAX
TABLETS
FENILABIAL
FENOPINE
Human Medicines Authorised/Transfer Pending Products
2 Milligram
N02BE51
-Per Oral
-Per Oral
-Per Oral
Exceptional
Circumstances
-Per Oral
-Intra-Muscular
Article 10(3) Hybrid
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Transdermal
-Transdermal
-Transdermal
Page 182 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
FENTADUR
Lavipharm S.A.
PA1676/002/004
100 Microgram
per hour
Transdermal
Patch
N02AB03
-FENTANYL
FENTADUR
Lavipharm S.A.
PA1676/002/005
12 Microgram per
hour
Transdermal
Patch
N02AB03
-FENTANYL
FENTAL MATRIX
Rowex Ltd
PA0711/146/001
-FENTANYL
-Transdermal
Rowex Ltd
PA0711/146/002
N02AB03
-FENTANYL
-Transdermal
FENTAL MATRIX
Rowex Ltd
PA0711/146/003
N02AB03
-FENTANYL
-Transdermal
FENTAL MATRIX
Rowex Ltd
PA0711/146/004
N02AB03
-FENTANYL
-Transdermal
FENTANYL 100
MICROGRAMS
IN 2ML
FENTANYL 500
MICROGRAMS
IN 10ML
FEOSPAN
SPANSULE
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Intrapharm
Laboratories
Limited
Iron Therapeutics
(UK) Ltd
Vifor France
PA0073/122/001
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Solution for
Injection
N02AB03
FENTAL MATRIX
25 Microgram per
hour
50 Microgram per
hour
75 Microgram per
hour
100 Microgram
per hour
50 Microgram/ML
N01AH01
-FENTANYL
CITRATE
PA0073/122/002
50 Microgram/ML
Solution for
Injection
N01AH01
-FENTANYL
CITRATE
PA0997/007/001
150 Milligram
Capsules
Modified Release
B03AA07
EU/1/15/1075/00
1
PA0949/004/001
30 Milligram
Capsules Hard
B03AB10
50 Mg/Ml
Solution for Inj/Inf
B03AC01
EU/1/99/108/002003
EU/1/99/108/004006
EU/1/99/108/001
100 Mg/Ml
Unknown
V03AC02
1000 Milligram
-DEFERIPRONE
-Per Oral
500 mg Milligram
Film Coated
Tablet
Tablets
V03AC02
FERRIPROX
FILM-COATED
FERROGRAD
Apotex Europe
Limited
Apotex
Nederland B.V.
Apotex Europe
Limited
Teofarma S.R.L.
-FERROUS
SULFATE
EXSICCATED
-FERRIC
MALTOL
-FERRIC
CARBOXYMALT
OSE
-DEFERIPRONE
V03AC02
-DEFERIPRONE
-Per Oral
PA1235/001/001
325 Milligram
Tablets
B03AA07
FERROGRAD C
Teofarma S.R.L.
PA1235/002/001
%v/v
Tablets
B03AA07
FERROGRAD C
Imbat Limited
PPA1151/141/00
1
325/500 Milligram
Tablet Prolonged
Release
B03AA07
FERROGRAD
FOLIC
Teofarma S.R.L.
PA1235/003/001
%v/v
Tablets
B03AD03
FERRUM FOL
Vifor France
PA0949/002/001
100 Milligram
Tablets
Chewable
B03AD02
FERRUM
HAUSMANN
Vifor France
PA0949/003/002
100 Milligram
Tablets
Chewable
B03AB04
FERRUM
HAUSMANN
SYRUP
Vifor France
PA0949/003/001
50 MG/5ml
Oral Drops
Solution
B03AB04
FERTAVID
Schering Plough
Europe
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
EU/1/09/510/3
50/0.5 IU/ML
G03GA06
EU/1/09/510/6
75/0.5 IU/ML
EU/1/09/510/9
100/0.5 IU/ML
EU/1/09/510/12
150/0.5 IU/ML
EU/1/09/510/1-2
50/0.5 IU/ML
EU/1/09/510/4-5
75/0.5 IU/ML
EU/1/09/510/7-8
100/0.5 IU/ML
EU/1/09/510/1011
150/0.5 IU/ML
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
-FERROUS
SULFATE
-FERROUS
SULFATE
-SODIUM
ASCORBATE
-FERROUS
SULFATE
EXSICCATED
-SODIUM
ASCORBATE
-FERROUS
SULFATE
-FOLIC ACID
-IRON
POLYMALTOSE
-FOLIC ACID
-FERRIC
HYDROXIDE
POLYMALTOSE
COMPLEX
-FERRIC
HYDROXIDE
POLYMALTOSE
COMPLEX
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
FERACCRU
FERINJECT
FERRIPROX
FERRIPROX
FERTAVID
FERTAVID
FERTAVID
FERTAVID
FERTAVID
FERTAVID
FERTAVID
Human Medicines Authorised/Transfer Pending Products
G03GA06
G03GA06
G03GA06
G03GA06
G03GA06
G03GA06
G03GA06
-Transdermal
-Transdermal
-Per Oral
-Per Oral
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
PPA
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
Page 183 of 608
Trade Name
FERTAVID
Licence Holder Licence
Number
Strength
EU/1/09/510/13
200/0.5 IU/ML
EU/1/09/510/14
200/0.5 IU/ML
EU/1/09/510/15
200/0.5 IU/ML
EU/1/09/510/16
150/0.18 IU/ML
EU/1/09/510/17
300/0.36 IU/ML
EU/1/09/510/18
600/0.72 IU/ML
EU/1/09/510/19
900/1.08 IU/ML
FETANEX
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Rowex Ltd
PA0711/137/001
FETANEX
Rowex Ltd
FEXERIC
Dosage Form ATC
Active
Ingredients
G03GA06
12.5 Microgram
per hour
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Transdermal
Patch
N02AB03
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FOLLITROPIN
BETA
-FENTANYL
PA0711/137/003
37.5 Microgram
per hour
Transdermal
Patch
N02AB03
-FENTANYL
Keryx Biopharma
UK Ltd
EU/1/15/1039/00
1
1 Grams
Film Coated
Tablet
V03AE
FEXOFAST
Fannin (UK) Ltd
PA1585/002/001
120 Milligram
Film Coated
Tablet
R06AX26
FEXOFAST
Fannin (UK) Ltd
PA1585/002/002
180 Milligram
Film Coated
Tablet
R06AX26
FEXOFENADINE
HYDROCHLORI
DE
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/170/001
120 Milligram
Film Coated
Tablet
R06AX26
FEXOFENADINE
HYDROCHLORI
DE
Chanelle Medical
PA0688/017/001
120 Milligram
Film Coated
Tablet
R06AX26
FEXOFENADINE
HYDROCHLORI
DE
Chanelle Medical
PA0688/017/002
180 Milligram
Film Coated
Tablet
R06AX26
FIASP
Novo Nordisk A/S
100 Units/ml
STD
Pharmaceutical
Products Ltd
STD
Pharmaceutical
Products Ltd
STD
Pharmaceutical
Products Ltd
STD
Pharmaceutical
Products Ltd
STD
Pharmaceutical
Products Ltd
Hexal AG
Solution for
Injection
Solution for
Injection
A10AB05
FIBRO-VEIN
EU/1/16/1160/00
1-011
PA0246/001/007
PA0246/001/003
0.5 %w/v
Solution for
Injection
C05BB04
PA0246/001/004
1 %w/v
Solution for
Injection
C05BB04
PA0246/001/005
3 %w/v
Solution for
Injection
C05BB04
PA0246/001/006
3 %w/v
Solution for
Injection
C05BB04
EU/1/08/496/1-4
30MU/0.5 Millilitr
Solution for
injection in prefilled syringe
L03AA02
EU/1/08/496/5-8
48MU/0.5 Millilitr
Solution for
injection in prefilled syringe
L03AA02
-FERRIC
CITRATE
COORDINATION
COMPLEX
FEXOFENADINE
HYDROCHLORI
DE
FEXOFENADINE
HYDROCHLORI
DE
FEXOFENADINE
HYDROCHLORI
DE
FEXOFENADINE
HYDROCHLORI
DE
FEXOFENADINE
HYDROCHLORI
DE
-INSULIN
ASPART
-SODIUM
TETRADECYL
SULFATE
-SODIUM
TETRADECYL
SULFATE
-SODIUM
TETRADECYL
SULFATE
-SODIUM
TETRADECYL
SULFATE
-SODIUM
TETRADECYL
SULFATE
-EP2006
(RECOMBINANT
HUMAN
GRANULOCYTECOLONY
STIMULATING
FACTOR)
-EP2006
(RECOMBINANT
HUMAN
GRANULOCYTECOLONY
STIMULATING
FACTOR)
FERTAVID
FERTAVID
FERTAVID
FERTAVID
FERTAVID
FERTAVID
FIBRO-VEIN
FIBRO-VEIN
FIBRO-VEIN
FIBRO-VEIN
FILGRASTIM
HEXAL
FILGRASTIM
HEXAL
Hexal AG
Human Medicines Authorised/Transfer Pending Products
0.2 %w/v
G03GA06
G03GA06
G03GA06
G03GA06
G03GA06
G03GA06
C05BB04
Legal Basis
Routes of
Administration
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Subcutaneous
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
Article 10(4) Similar Biological
App
-Intra-venous
-Subcutaneous
Article 10(4) Similar Biological
App
-Intra-venous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Transdermal
-Transdermal
-Per Oral
Page 184 of 608
Trade Name
FINASTERIDE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Accord
Healthcare
Limited
LTT Pharma
Limited
Rowex Ltd
PA1390/013/002
5 Milligram
Film Coated
Tablet
G04CB01
-FINASTERIDE
PPA1562/185/00
1
PA0711/073/001
5 Milligram
G04CB01
-FINASTERIDE
-Per Oral
G04CB01
-FINASTERIDE
-Per Oral
Aurobindo
Pharma Limited
PA1311/003/001
5 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
G04CB01
-FINASTERIDE
FIRAZYR
Jerini AG
EU/1/08/461/1
30 Milligram
B06AC02
-ICATIBANT
FIRDAPSE
BioMarin Europe
Ltd
EU/1/09/601/001
10 Milligram
Solution for
Injection
Tablets
N07XX05
-Per Oral
FIRMAGON
Ferring
Pharmaceuticals
A/S
Ferring
Pharmaceuticals
A/S
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
EU/1/08/504/002
120 Milligram
Pdr+Solv for Soln
for Inj
L02BX02
-3,4DIAMINOPYRIDI
NE PHOSPHATE
-DEGARELIX
(AS ACETATE)
EU/1/08/504/001
80 Milligram
Pdr+Solv for Soln
for Inj
L02BX02
-DEGARELIX
(AS ACETATE)
-Subcutaneous
PA0540/100/007
200 Milligram
Tablets
J01XD01
-Per Oral
PA0540/100/008
400 Milligram
Film Coated
Tablet
J01XD01
PA0540/100/003
0.5 %w/v
Solution for
Infusion
J01XD01
PA0540/100/001
200 Base mg/5ml
Oral Suspension
J01XD01
METRONIDAZO
LE
METRONIDAZO
LE
METRONIDAZO
LE
METRONIDAZO
LE BENZOATE
Smith & Nephew
Pharmaceuticals
Elpen
Pharmaceutical
Co. Inc.
PA0710/003/001
1.0 %w/w
Cream
D06BA01
PA1879/001/001
50/250
Microgram
Powder for
Inhalation
R03AK06
FLAMERIO
Elpen
Pharmaceutical
Co. Inc.
PA1879/001/002
50/500
Microgram
Powder for
Inhalation
R03AK06
FLAVUSTENOL
XL
Accord
Healthcare
Limited
Instituto Grifols
S.A.
PA1390/043/001
80 Milligram
Tablet Prolonged
Release
C10AA04
Solution for
Infusion
J06BA02
FLEBOGAMMA
DIF
Instituto Grifols
S.A.
EU/1/07/404/006008
100 Mg/Ml
Solution for
Infusion
J06BA02
FLECAINIDE
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Casen-Recordati
S.L.
PA0577/082/001
50 Milligram
Tablets
C01BC04
PA0577/082/002
100 Milligram
Tablets
C01BC04
-FLECAINIDE
ACETATE
-Per Oral
PA0678/138/001
1.293 g Grams
Medicated
Plaster
M02AA15
-DICLOFENAC
EPOLAMINE
-Cutaneous
PA2028/001/001
21.4/9.4 Grams
Rectal Solution
A06AG01
-SODIUM
DIHYDROGEN
PHOSPHATE
DIHYDRATE
-DISODIUM
PHOSPHATE
DODECAHYDR
ATE
FINASTERIDE
FINASTERIDE
ROWEX
FINTRID
FIRMAGON
FLAGYL
FLAGYL
FLAGYL
FLAGYL-S
200MG/5ML
ORAL
SUSPENSION
FLAMAZINE
FLAMERIO
FLEBOGAMMA
FLECAINIDE
FLECTOR
TISSUGEL
FLEET READYTO-USE ENEMA
5 Milligram
EU/1/07/404/1-5
Human Medicines Authorised/Transfer Pending Products
50
-SULFADIAZINE
SILVER
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-FLUVASTATIN
SODIUM
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
-FLECAINIDE
ACETATE
Article 10(1) Generic
Application
Routes of
Administration
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Subcutaneous
-Subcutaneous
-Per Oral
Article 10(3) Hybrid
Application
-Inhalation
Article 10(3) Hybrid
Application
-Inhalation
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-Intra-venous
-Intra-venous
-Per Oral
Page 185 of 608
Trade Name
Licence Holder Licence
Number
Strength
FLERIN
Grünenthal Ltd
PA1189/013/001
700 Milligram
FLEXBUMIN 200
G/L SOLUTION
FOR INFUSION
FLEXOVE
Baxalta
Innovations
GmbH
Laboratoires
Expanscience
Samsung Bioepis
UK Limited
PA2004/002/001
200 g/l
PA1616/001/001
Dosage Form ATC
Active
Ingredients
Medicated
Plaster
Solution for
Infusion
N01BB02
-LIDOCAINE
B05AA01
625 Milligram
Tablets
M01AX05
-HUMAN
PLASMA
PROTEIN
-GLUCOSAMINE
EU/1/16/1106/00
1
100 Milligram
Pdr/Conc/Soln for
Infus
L04AB02
-INFLIXIMAB
PA0678/095/001
50 Microgram
Nasal Spray
Suspension
R01AD08
-FLUTICASONE
PROPIONATE
FLIXOTIDE
DISKUS
FLIXOTIDE
DISKUS
FLIXOTIDE
DISKUS
FLIXOTIDE
DISKUS
FLIXOTIDE
EVOHALER
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
PA1077/044/009
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
FLIXOTIDE
EVOHALER
GlaxoSmithKline
(Ireland) Limited
PA1077/044/015
250 Microgram
FLIXOTIDE
EVOHALER
GlaxoSmithKline
(Ireland) Limited
PA1077/044/013
50 Microgram
FLIXOTIDE
EVOHALER
PCO
Manufacturing
PPA0465/073/00
2
250 Microgram
FLIXOTIDE
EVOHALER
LTT Pharma
Limited
PPA1562/144/00
1
125 Mcg/Dose
FLIXOTIDE
EVOHALER
LTT Pharma
Limited
PPA1562/144/00
2
250 Mcg/Dose
FLIXOTIDE
EVOHALER
Chemilines
Healthcare
(Ireland) Limited
PCO
Manufacturing
PPA1915/003/00
1
125 Microgram
PPA0465/073/00
1
125 Microgram
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
PCO
Manufacturing
PCO
Manufacturing
LTT Pharma
Limited
LTT Pharma
Limited
GlaxoSmithKline
(Ireland) Limited
PA1077/044/016
0.5mg/2ml
Milligram
2mg/2ml
Micromol
0.5 mg/2ml
Powder for
Inhalation
Powder for
Inhalation
Powder for
Inhalation
Powder for
Inhalation
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Pressurised
Inhalation
Suspension
Nebuliser
Suspension
Nebuliser
Suspension
Nebuliser
Suspension
Nebuliser
Suspension
Nebuliser
Suspension
Nebuliser
Suspension
Pdr+Solv for soln
for Inf
R03BA05
PA1077/044/014
50
Mcg/Acutuation
100
Mcg/Acutuation
250
Mcg/Acutuation
500
Mcg/Acutuation
125 Microgram
FLOLAN
GlaxoSmithKline
(Ireland) Limited
PA1077/058/002
0.5 Milligram
Pdr+Solv for soln
for Inf
B01AC09
FLOTROS
Eurodrug Ltd
20 Milligram
Galen Limited
Film Coated
Tablet
Film Coated
Tablet
G04BD09
FLOTROS
DPR1392/064/0
01
PA1329/008/001
FLOXAPEN
Actavis Group
PTC ehf
PA1380/011/007
1000 Milligram
Pdr for Soln
Inj/Inf
J01CF05
FLIXABI ((SB2))
FLIXONASE
ALLERGY
RELIEF
FLIXOTIDE
EVOHALER
EVOHALER
FLIXOTIDE
NEBULES
FLIXOTIDE
NEBULES
FLIXOTIDE
NEBULES
FLIXOTIDE
NEBULES
FLIXOTIDE
NEBULES
FLIXOTIDE
NEBULES
FLOLAN
PA1077/044/010
PA1077/044/011
PA1077/044/012
PA1077/044/017
PPA0465/073/00
3
PPA0465/073/00
4
PPA1562/144/00
3
PPA1562/144/00
4
PA1077/058/001
Human Medicines Authorised/Transfer Pending Products
2 mg/2ml
0.5 mg/2ml
2 mg/2ml
1.5 Milligram
20 Milligram
R03BA05
R03BA05
R03BA05
R03BA05
Legal Basis
Article 10c Informed Consen
Article 10a Bibliographical
App
Routes of
Administration
-Cutaneous
-Intra-venous
-Per Oral
Article 10(4) Similar Biological
App
-Intra-venous
-Inhalation
R03BA05
-FLUTICASONE
PROPIONATE
-Inhalation
R03BA05
-FLUTICASONE
PROPIONATE
-Inhalation
R03BA05
-FLUTICASONE
PROPIONATE
R03BA05
-FLUTICASONE
PROPIONATE
-Inhalation
R03BA05
-FLUTICASONE
PROPIONATE
-Inhalation
R03BA05
-FLUTICASONE
PROPIONATE
R03BA05
-FLUTICASONE
PROPIONATE
R03BA05
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
-FLUTICASONE
PROPIONATE
EPOPROSTEN
OL SODIUM
EPOPROSTEN
OL SODIUM
-TROSPIUM
CHLORIDE
-TROSPIUM
CHLORIDE
R03BA05
R03BA05
R03BA05
R03BA05
R03BA05
B01AC09
G04BD09
FLUCLOXACILL
IN SODIUM
FLUCLOXACILL
IN
PPA
PPA
-Inhalation
-Inhalation
PPA
-Inhalation
PPA
-Inhalation
-Inhalation
-Inhalation
-Per Oral
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Per Oral
-Intra-Muscular
-Intra-venous
Page 186 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
Article 10(3) Hybrid
Application
-Intra-Muscular
-Intra-venous
FLOXAPEN
Actavis Group
PTC ehf
PA1380/011/008
2000 Milligram
Pdr for Soln
Inj/Inf
J01CF05
FLOXAPEN
Actavis Group
PTC ehf
PA1380/011/001
250 Milligram
Capsules Hard
J01CF05
Interchangeable
List Code:
IC0089-130-001
PA1380/011/006
250 MG/5ml
Powder for Oral
Suspension
J01CF05
-Per Oral
Interchangeable
List Code:
IC0089-131-055
PA1380/011/002
FLUCLOXACILL
IN MAGNESIUM
500 Milligram
Capsules Hard
J01CF05
-Per Oral
Interchangeable
List Code:
IC0089-117-001
PA1380/011/003
FLUCLOXACILL
IN SODIUM
250mg Milligram
Pdr for Soln for
Injection
J01CF05
FLUCLOXACILL
IN SODIUM
(STERILE)
FLUCLOXACILL
IN SODIUM
(STERILE)
FLUCLOXACILL
IN MAGNESIUM
FLOXAPEN
FLOXAPEN
Actavis Group
PTC ehf
Actavis Group
PTC ehf
FLOXAPEN
Actavis Group
PTC ehf
FLOXAPEN
Actavis Group
PTC ehf
PA1380/011/004
500mg Milligram
Pdr for Soln for
Injection
J01CF05
FLOXAPEN
SYRUP
Actavis Group
PTC ehf
PA1380/011/005
125 MG/5ml
Powder for Oral
Suspension
J01CF05
Interchangeable
List Code:
IC0089-129-055
PA2032/002/001
0.5 Millilitre
Suspension for
Injection
J07BB02
FLUAD
Seqirus S.r.l.
Human Medicines Authorised/Transfer Pending Products
FLUCLOXACILL
IN SODIUM
FLUCLOXACILL
IN
FLUCLOXACILL
IN SODIUM
Legal Basis
-Per Oral
-Per Oral
A/CALIFORNIA/
7/2009
(H1N1)PDM09LIKE STRAIN
(A/CALIFORNIA/
7/2009, X-181)
-A/HONG
KONG/4801/2014
(H3N2) - LIKE
STRAIN
(A/HONG
KONG/4801/201
4, NYMC X263B)
B/BRISBANE/60
/2008 - LIKE
STRAIN
(B/BRISBANE/6
0/2008)
Page 187 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
FLUARIX
GlaxoSmithKline
(Ireland) Limited
PA1077/025/001
15/15/15mc
Microgram
Suspension for
Injection
J07BB02
FLUCILLIN –
FLUCLOXACILL
IN
Pinewood
Laboratories Ltd,
PA0281/031/004
250 Milligram
Capsules Hard
J01CF05
FLUCILLIN –
FLUCLOXACILL
IN
Pinewood
Laboratories Ltd,
Interchangeable
List Code:
IC0089-130-001
PA0281/031/005
500 Milligram
Capsules Hard
J01CF05
-Per Oral
FLUCLOXACILL
IN
Wockhardt UK
Limited
Interchangeable
List Code:
IC0089-117-001
PA1339/008/001
FLUCLOXACILL
IN SODIUM
250 Milligram
Pdr for Soln
Inj/Inf
J01CF05
-Intra-Muscular
-Intra-venous
FLUCLOXACILL
IN
Wockhardt UK
Limited
PA1339/008/002
500 Milligram
Pdr for Soln
Inj/Inf
J01CF05
FLUCLOXACILL
IN
Wockhardt UK
Limited
PA1339/008/003
1 Grams
Pdr for Soln
Inj/Inf
J01CF05
FLUCLOXACILL
IN
Athlone
Laboratories Ltd
PA0298/017/004
250 MG/5ml
Powder for Oral
Solution
J01CF05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0089-131-055
PA0298/016/001
FLUCLOXACILL
IN SODIUM
MONOHYDRATE
FLUCLOXACILL
IN SODIUM
MONOHYDRATE
FLUCLOXACILL
IN SODIUM
MONOHYDRATE
FLUCLOXACILL
IN
250 Milligram
Capsule
J01CF05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0089-130-001
PA0298/016/002
FLUCLOXACILL
IN
500 Milligram
Capsules Hard
J01CF05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0089-117-001
PA0298/016/003
FLUCLOXACILL
IN SODIUM
125 MG/5ml
Powder for Oral
Solution
J01CF05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0089-129-055
PA0298/017/001
FLUCLOXACILL
IN SODIUM
250 Milligram
Capsule
J01CF05
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0089-130-001
PA0298/017/002
FLUCLOXACILL
IN
500 Milligram
Capsule
J01CF05
FLUCLOXACILL
IN
Article 10(1) Generic
Application
-Per Oral
FLUCLOXACILL
IN
FLUCLOXACILL
IN
FLUCLOXACILL
IN
FLUCLOXACILL
IN
FLUCLOXACILL
IN
Athlone
Laboratories Ltd
Athlone
Laboratories Ltd
Athlone
Laboratories Ltd
Athlone
Laboratories Ltd
Athlone
Laboratories Ltd
Interchangeable
List Code:
IC0089-117-001
Human Medicines Authorised/Transfer Pending Products
A/CALIFORNIA/
7/2009 (H1N1)
PDM09-LIKE
STRAIN USED
NIB-74XP
DERIVED FROM
A/CHRISTCHUR
CH/16/2010
-A/HONG
KONG/4801/2014
(H3N2) - LIKE
STRAIN
(A/HONG
KONG/4801/201
4, NYMC X263B)
B/BRISBANE/60
/2008 - LIKE
STRAIN
(B/BRISBANE/6
0/2008)
FLUCLOXACILL
IN SODIUM
Routes of
Administration
-Per Oral
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
Page 188 of 608
Trade Name
FLUCLOXACILL
IN
Licence Holder Licence
Number
Athlone
Laboratories Ltd
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0298/017/003
125 MG/5ml
Powder for Oral
Solution
J01CF05
FLUCLOXACILL
IN SODIUM
Article 10(1) Generic
Application
-Per Oral
250 Milligram
Pdr for Soln
Inj/Inf
J01CF05
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Intra-Muscular
-Intra-venous
FLUCLOXACILL
IN
Ibigen Srl
Interchangeable
List Code:
IC0089-129-055
PA1862/003/001
FLUCLOXACILL
IN
Ibigen Srl
PA1862/003/002
500 Milligram
Pdr for Soln
Inj/Inf
J01CF05
FLUCLOXACILL
IN
Ibigen Srl
PA1862/003/003
1000 Milligram
Pdr for Soln
Inj/Inf
J01CF05
FLUCLOXACILL
IN
Ibigen Srl
PA1862/003/004
2000 Milligram
Pdr for Soln
Inj/Inf
J01CF05
FLUCOL 150 MG
CAPSULES
FLUCOL 2
MG/ML
SOLUTION FOR
INFUSION
FLUCOL 200 MG
CAPSULES
FLUCOL 50 MG
CAPSULES
FLUCONAZOLE
Rowex Ltd
PA0711/057/003
150mg Milligram
Capsules Hard
J02AC01
FLUCLOXACILL
IN SODIUM
FLUCLOXACILL
IN SODIUM
FLUCLOXACILL
IN SODIUM
FLUCLOXACILL
IN SODIUM
-FLUCONAZOLE
Rowex Ltd
PA0711/057/006
2 Mg/Ml
Solution for
Infusion
J02AC01
-FLUCONAZOLE
-Intra-venous
Rowex Ltd
PA0711/057/004
200mg Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
-Per Oral
Rowex Ltd
PA0711/057/001
50mg Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
-Per Oral
Claris
Lifesciences (UK)
Limited
B. Braun
Melsungen AG
PA1389/001/001
2 Micromol
Solution for
Infusion
J02AC01
-FLUCONAZOLE
PA0736/030/001
2 Mg/Ml
Solution for
Infusion
J02AC01
-FLUCONAZOLE
FLUCONAZOLE
Noridem
Enterprises Ltd
PA1122/006/001
2 Mg/Ml
Solution for
Infusion
J02AC01
-FLUCONAZOLE
FLUCONAZOLE
Claris
Lifesciences (UK)
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Gedeon Richter
Plc
PA1389/001/002
2 Mg/Ml
Solution for
Infusion
J02AC01
-FLUCONAZOLE
PA1390/060/001
50 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
PA1390/060/002
150 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
PA1390/060/003
200 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
PA1330/014/002
150 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
Actavis Group
PTC ehf
PA1380/100/001
50 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
FLUCONAZOLE
ACTAVIS
Actavis Group
PTC ehf
PA1380/100/003
150 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
FLUCONAZOLE
ACTAVIS
Actavis Group
PTC ehf
PA1380/100/004
200 Milligram
Capsules Hard
J02AC01
-FLUCONAZOLE
FLUDARA
PA0611/004/001
50 Milligram
L01BB05
PA0611/004/002
10 Milligram
PA1390/096/001
25 Mg/Ml
Pdr for Soln
Inj/Inf
Film Coated
Tablet
Concentrate for
Soln for Inf
-FLUDARABINE
PHOSPHATE
-FLUDARABINE
PHOSPHATE
-FLUDARABINE
PHOSPHATE
FLUDARABINE
PHOSPHATE
Genzyme Europe
B.V.
Genzyme Europe
B.V.
Accord
Healthcare
Limited
Actavis Group
PTC ehf
PA1380/134/001
25 Mg/Ml
Concentrate for
Soln for Inj
L01BB05
-FLUDARABINE
PHOSPHATE
FLUDARABINE
PHOSPHATE
Fresenius Kabi
Oncology Plc
PA1422/013/001
50 Milligram
Solution for Inj/Inf
L01BB05
-FLUDARABINE
PHOSPHATE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
150 MG
CAPSULES
FLUCONAZOLE
ACTAVIS
FLUDARA ORAL
FLUDARABINE
Human Medicines Authorised/Transfer Pending Products
L01BB05
L01BB05
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
Page 189 of 608
Trade Name
Licence Holder Licence
Number
FLUDROCORTI
SONE ACETATE
Aspen Pharma
Trading Limited
PA1691/018/001
FLUENZ
MedImmune, LL
FLUENZ TETRA
Strength
Tablets
H02AA02
EU/1/10/661/001002
Nasal Spray
Suspension
J07BB03
MedImmune, LL
EU/1/13/887/001
Nasal Spray
Suspension
J07BB03
FLUIMUCIL 200
MG GRANULES
FOR ORAL
SOLUTION
FLUMAZENIL
Zambon S.p.A.
PA1441/001/001
200 Milligram
Granules for oral
solution
R05CB01
Fresenius Kabi
Limited
PA0566/040/001
0.1 Mg/Ml
V03AB25
FLUMAZENIL
TEVA
Teva Pharma
B.V.
PA0749/069/001
0.1 Mg/Ml
FLUOROURACIL
Accord
Healthcare
Limited
Hospira UK
Limited
PA1390/015/001
50 Mg/Ml
Solution for
Injection and
Concentrate for
Infusion
Solution for
Injection and
Concentrate for
Infusion
Solution for Inj/Inf
PA0437/011/001
25 Mg/Ml
Bristol
Laboratories
Limited
PA1240/002/001
FLUOROURACIL
FLUOXETINE
FLUOXETINE
FLUOXETINE
Bristol
Laboratories
Limited
SYRI Limited, t/a
Thame
Laboratories
0.1 Milligram
Dosage Form ATC
Active
Ingredients
FLUDROCORTI
SONE ACETATE
-INFLUENZA
VIRUS, TYPE A,
H1N1
-INFLUENZA
VIRUS, TYPE A,
H3N2
-INFLUENZA
VIRUS, TYPE B
-INFLUENZA
VIRUS, TYPE A,
H1N1
-INFLUENZA
VIRUS, TYPE A,
H3N2
-INFLUENZA
VIRUS, TYPE B
(YAMAGATA
LINEAGE)
-INFLUENZA
VIRUS, TYPE B
(VICTORIA
LINEAGE)
ACETYLCYSTEI
NE
-Nasal
-Nasal
-FLUMAZENIL
Article 10(3) Hybrid
Application
-Intra-venous
V03AB25
-FLUMAZENIL
Article 10(1) Generic
Application
-Intra-venous
L01BC02
FLUOROURACIL
Article 10(1) Generic
Application
-Intra-venous
Solution for Inj/Inf
L01BC02
20 Milligram
Capsules Hard
N06AB03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0075-003-001
PA1240/002/002
FLUOROURACIL
SODIUM
-FLUOXETINE
HYDROCHLORI
DE
60 Milligram
Capsules Hard
N06AB03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0075-127-001
PA1861/020/001
-FLUOXETINE
HYDROCHLORI
DE
20 MG/5ml
N06AB03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0075-055-019
PA0711/257/001
-FLUOXETINE
HYDROCHLORI
DE
8.75 Milligram
Lozenges
R02AX01
FLURBIPROFEN
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Oromucosal
Article 10b Fixed
Combination
-Inhalation
Article 10b Fixed
Combination
-Inhalation
Rowex Ltd
FLUTICASONE
PROPIONATE
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Mundipharma
Pharmaceuticals
Limited
PA0678/118/001
50
Mcg/Acutuation
Nasal Spray
Suspension
R01AD08
-FLUTICASONE
PROPIONATE
(MICRONISED)
PA1688/013/001
50/5 Microgram
Pressurised
Inhalation
Suspension
R03AK07
Mundipharma
Pharmaceuticals
Limited
PA1688/013/002
125/5 Microgram
Pressurised
Inhalation
Suspension
R03AK07
-FLUTICASONE
PROPIONATE
-FORMOTEROL
FUMARATE
FLUTICASEONE
PROPIONATE
-FORMOTEROL
FUMARATE
FLUTIFORM
Routes of
Administration
Article 8(3) - Full
new Application
FLURSIL RELIEF
SUGAR FREE
FLUTIFORM
Legal Basis
Human Medicines Authorised/Transfer Pending Products
-Nasal
Page 190 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
FLUTIFORM
Mundipharma
Pharmaceuticals
Limited
PA1688/013/003
250/10
Microgram
Pressurised
Inhalation
Suspension
R03AK07
FLUZAC
Rowex Ltd
PA0711/110/001
20 Milligram
Capsules Hard
N06AB03
Interchangeable
List Code:
IC0075-003-001
PA0148/007/001
0.1 %w/v
Eye Drops
Suspension
S01BA07
EU/1/07/385/1-4
7.5 Microgram
Suspension for
Injection
J07BB02
FML LIQUIFILM
-FLUTICASONE
PROPIONATE
-FORMOTEROL
FUMARATE
-FLUOXETINE
HYDROCHLORI
DE
FOCLIVIA
Seqirus S.r.l.
EU/1/09/577/1-4
15 Microgram/ML
Suspension for
Injection
J07BB02
FOLIC ACID
Wockhardt UK
Limited
PA1339/022/001
2.5 MG/5ml
Oral Solution
B03BB01
FLUOROMETH
OLONE
A/CALIFORNIA/
7/2009 (H1N1)V
LIKE STRAIN (X179A)
A/VIETNAM/119
4/2004 (H5N1)
VIRUS
SURFACE
INACTIVATED
ANTIGEN
-FOLIC ACID
FOLIC ACID
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Hospira UK
Limited
PA0126/057/001
5 mg Milligram
Tablets
B03BB01
-FOLIC ACID
PA0126/057/002
400 Microgram
Tablets
B03BB01
-FOLIC ACID
PA0437/010/003
7.5 Mg/Ml
Solution for
Injection
V03AF03
-CALCIUM
FOLINATE
Hospira UK
Limited
PA0437/010/005
10 Mg/Ml
Solution for
Injection
V03AF03
-CALCIUM
FOLINATE
Fresenius Kabi
Deutschland
GmbH
Hospira UK
Limited
PA2059/001/001
10 Mg/Ml
Solution for Inj/Inf
V03AF03
-FOLINIC ACID
PA0437/010/001
15 Milligram
Tablets
V03AF03
-CALCIUM
FOLINATE
Actavis Group
PTC ehf
PA1380/120/001
10 Mg/Ml
Solution for Inj/Inf
V03AF03
-FOLINIC ACID
EUSA Pharma
(UK) Limited
InfectoPharm
Arzneimittel und
Consilium GmbH
Novartis
Pharmaceuticals
UK Ltd
AbbVie Limited
Laboratorios
LICONSA, S.A.
Eli Lilly
Nederland B.V.
Plethora
Solutions Ltd
PA2073/001/001
5 Mg/Ml
V03AB34
PA1972/001/001
40 Mg/Ml
Concentrate for
Soln for Inf
Pdr for Soln for
Infusion
-FOMEPIZOLE
SULPHATE
-FOSFOMYCIN
SODIUM
PA0013/089/001
12 Microgram
Capsule
R03AC13
-FORMOTEROL
FUMARATE
PA1824/001/001
PA1239/001/001
99.9w/w %w/w
12 Microgram
N01AB06
R03AC13
-ISOFLURANE
-FORMOTEROL
EU/1/03/247/01-2
H05AA02
-TERIPARATIDE
EU/1/13/381/001
20/80
Microgram/ML
150/50 Mg/Ml
Inhalation Gas
Inhalation
Powder, Capsule
Solution for
Injection
Cutaneous Spray
Solution
N01BB20
-LIDOCAINE
-PRILOCAINE
FORTUM
GlaxoSmithKline
(Ireland) Limited
PA1077/007/001
500 Milligram
Pdr for Soln for
Injection
J01DD02
FORTUM
GlaxoSmithKline
(Ireland) Limited
PA1077/007/002
1 Grams
Pdr+Solv for soln
for inf/inj
J01DD02
FORTUM
GlaxoSmithKline
(Ireland) Limited
PA1077/007/003
2 Grams
Pdr+Solv for soln
for inf/inj
J01DD02
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
-CEFTAZIDIME
PENTAHYDRAT
E
FOCETRIA
FOLIC ACID
FOLINIC ACID
(AS CALCIUM
FOLINATE)
FOLINIC ACID
(AS CALCIUM
FOLINATE)
FOLINIC ACID
(AS CALCIUM
FOLINATE)
FOLINIC ACID
(AS CALCIUM
FOLINATE) 15
MG TABLETS
FOLINIC ACID
(AS CALCIUM
FOLINATE)
ACTAVIS
FOMEPIZOLE
EUSA PHARMA
FOMICYT
FORADIL
FORANE
FORMOTEROL
FORSTEO
FORTACIN
Allergan
Pharmaceuticals
Ireland
GSK Vaccines
S.r.l.
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
J01XX01
Legal Basis
Article 10b Fixed
Combination
Routes of
Administration
-Inhalation
-Per Oral
-Intra-Muscular
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10b Fixed
Combination
-Cutaneous
-Intra-Muscular
-Intra-Muscular
-Subcutaneous
Page 191 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
FORXIGA
Bristol-Myers
Squibb/AstraZen
eca EEIG
EU/1/12/795/001005
5 Milligram
Film Coated
Tablet
A10BX09
FORXIGA
Bristol-Myers
Squibb/AstraZen
eca EEIG
EU/1/12/795/006010
10 Milligram
Film Coated
Tablet
A10BX09
FOSAMAX
ONCE WEEKLY
FOSAMAX
ONCE WEEKLY
Primecrown 2010
Ltd
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
DPR1633/001/0
01
PA1286/008/001
70 Milligram
Tablets
M05BA04
70 Milligram
Tablets
M05BA04
Interchangeable
List Code:
IC0051-101-002
EU/1/05/310/1-4
70/2800 mg/IU
Tablets
M05BB03
Interchangeable
List Code:
IC0052-102-002
EU/1/05/310/6-8
70/5600 mg/IU
Tablets
M05BB03
Interchangeable
List Code:
IC0052-103-002
EU/1/01/197/002
4 Mg/Ml
EU/1/01/197/001
4 Mg/Ml
PA0577/086/002
70 Milligram
Solution for
Injection
Solution for
Injection
Tablets
Interchangeable
List Code:
IC0051-101-002
PA1104/002/001
75 IU/ML
PA1104/002/002
FOSAVANCE
FOSAVANCE
FOSCAN
FOSCAN
FOSTEPOR
ONCE WEEKLY
FOSTIMON
FOSTIMON
FOSTIMON PFS
FOSTIMON PFS
FOSTIMON PFS
FOSTIMON PFS
FOSTOLIN
ONCE WEEKLY
FOZNOL
FOZNOL
FOZNOL
FOZNOL
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
QuantaNova
Limited
QuantaNova
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
IBSA
Farmaceutici
Italia S.r.l
IBSA
Farmaceutici
Italia S.r.l
IBSA
Farmaceutici
Italia S.r.l
IBSA
Farmaceutici
Italia S.r.l
IBSA
Farmaceutici
Italia S.r.l
IBSA
Farmaceutici
Italia S.r.l
Actavis Group
PTC ehf
Shire
Pharmaceutical
Contracts Ltd
Shire
Pharmaceutical
Contracts Ltd
Shire
Pharmaceutical
Contracts Ltd
Shire
Pharmaceutical
Contracts Ltd
Active
Ingredients
DAPAGLIFLOZIN
PROPANEDIOL
MONOHYDRATE
EQUIVALENT
TO 5MG
DAPAGLIFLOZIN
DAPAGLIFLOZIN
PROPANEDIOL
MONOHYDRATE
EQUIVALENT
TO 10MG
DAPAGLIFLOZIN
-ALENDRONATE
SODIUM
-ALENDRONATE
SODIUM
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
L01XD05
-ALENDRONIC
ACID
COLECALCIFE
ROL
-ALENDRONIC
ACID
COLECALCIFE
ROL
-TEMOPORFIN
L01XD05
-TEMOPORFIN
-Intra-venous
M05BA04
-ALENDRONIC
ACID
-Per Oral
Pdr+Solv for Soln
for Inj
G03GA04
150 IU/ML
Pdr+Solv for Soln
for Inj
G03GA04
PA1104/002/004
150 IU/ML
Pdr+Solv for Soln
for Inj
G03GA04
PA1104/002/003
75 IU/ML
Pdr+Solv for Soln
for Inj
G03GA04
PA1104/002/005
225 International
Unit
Pdr+Solv for Soln
for Inj
G03GA04
PA1104/002/006
300 International
Unit
Pdr+Solv for Soln
for Inj
G03GA04
PA1380/044/001
70 Milligram
Tablets
M05BA04
UROFOLLITRO
PIN
UROFOLLITRO
PIN
UROFOLLITRO
PIN
UROFOLLITRO
PIN
UROFOLLITRO
PIN
UROFOLLITRO
PIN
-ALENDRONIC
ACID
Interchangeable
List Code:
IC0051-101-002
PA0689/003/001
250 Milligram
Tablets
Chewable
V03AE03
PA0689/003/002
500 Milligram
Tablets
Chewable
V03AE03
PA0689/003/003
750 Milligram
Tablets
Chewable
V03AE03
PA0689/003/004
1000 Milligram
Tablets
Chewable
V03AE03
Human Medicines Authorised/Transfer Pending Products
-LANTHANUM
CARBONATE
HYDRATE
-LANTHANUM
CARBONATE
HYDRATE
-LANTHANUM
CARBONATE
HYDRATE
-LANTHANUM
CARBONATE
HYDRATE
-Per Oral
-Intra-venous
-Intra-Muscular
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 192 of 608
Trade Name
FOZNOL
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Shire
Pharmaceutical
Contracts Ltd
Shire
Pharmaceutical
Contracts Ltd
Rowex Ltd
PA0689/003/005
750 Milligram
Oral Powder
V03AE03
PA0689/003/006
1000 Milligram
Oral Powder
V03AE03
PA0711/218/001
0.03 / 3 Milligram
Film Coated
Tablet
G03AA12
FREEDO &
PLACEBO
Rowex Ltd
PA0711/219/001
0.03 / 3 Milligram
Film Coated
Tablet
G03AA12
FREEDONEL
Rowex Ltd
PA0711/208/001
0.02 / 3 Milligram
Film Coated
Tablet
G03AA12
FREEDONEL &
PLACEBO
Rowex Ltd
PA0711/210/001
0.02 / 3 Milligram
Film Coated
Tablet
G03AA12
FRESENIUS
PROPOVEN
FRESENIUS
PROPOVEN
FRESENIUS
PROPOVEN
FRISIUM
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Chanelle Medical
PA0566/036/001
1 %w/v
N01AX10
PA0566/036/002
1 %w/v
N01AX10
-PROPOFOL
PA0566/036/003
2 %w/v
N01AX10
-PROPOFOL
PA0540/043/001
10 Milligram
Emulsion for
Inj/Inf
Emulsion for
Inj/Inf
Emulsion for
Inj/Inf
Tablets
-LANTHANUM
CARBONATE
HYDRATE
-LANTHANUM
CARBONATE
HYDRATE
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
DROSPIRENON
E
ETHINYLESTRA
DIOL
-PROPOFOL
N05BA09
-CLOBAZAM
PA0688/027/001
2.5 Milligram
Film Coated
Tablet
N02CC07
FROVEX
PCO
Manufacturing
PPA0465/321/00
1
2.5 Milligram
Film Coated
Tablet
N02CC07
FROVEX
LTT Pharma
Limited
PPA1562/153/00
1
2.5 Milligram
Film Coated
Tablet
N02CC07
FROVEX
Menarini
International
Operations
Luxembourg S.A.
Norton
Healthcare
Limited T/A IVAX
Pharmaceuticals
UK
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0865/009/001
2.5 Milligram
Film Coated
Tablet
N02CC07
PA0282/060/001
40/5 Milligram
Tablets
C03EB01
FROVATRIPTAN
SUCCINATE
MONOHYDRATE
FROVATRIPTAN
SUCCINATE
MONOHYDRATE
FROVATRIPTAN
SUCCINATE
MONOHYDRATE
FROVATRIPTAN
SUCCINATE
MONOHYDRATE
-FUROSEMIDE
-AMILORIDE
HYDROCHLORI
DE
PA0540/101/002
40/5 Milligram
Tablets
C03EB01
FRUMIL LOW
STRENGTH
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/101/001
20/2.5 Milligram
Tablets
C03EB01
FRUSIDE 40MG
Pinewood
Laboratories Ltd,
Leo Laboratories
Limited
PA0281/087/001
40mg Milligram
Tablets
C03CA01
PA0046/040/001
20/1 mg/g
Cream
D07CC01
FOZNOL
FREEDO
FROVATRIPTAN
FRUCO
FRUMIL
FUCIBET
Human Medicines Authorised/Transfer Pending Products
-FUROSEMIDE
-AMILORIDE
HYDROCHLORI
DE
-FUROSEMIDE
-AMILORIDE
HYDROCHLORI
DE
-FUROSEMIDE
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-FUSIDIC ACID
ANHYDROUS
BETAMETHASO
NE
Page 193 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
FUCIBET
Primecrown 2010
Ltd
PPA1633/040/00
1
20 + 1 mg/g
Cream
D07CC01
-FUSIDIC ACID
BETAMETHASO
NE
-FUSIDIC ACID
BETAMETHASO
NE VALERATE
-FUSIDIC ACID
ANHYDROUS
BETAMETHASO
NE VALERATE
-FUSIDIC ACID
BETAMETHASO
NE (AS
BETAMETHASO
NE VALERATE)
-FUSIDIC ACID
BETAMETHASO
NE VALERATE
-FUSIDIC ACID
BETAMETHASO
NE
-FUSIDIC ACID
FUCIBET
IMED Healthcare
Ltd.
PPA1463/082/00
1
20 + 1 mg/g
Cream
D07CC01
FUCIBET
Clear Pharmacy
PPA1596/041/00
1
20/1 mg/g
Cream
D07CC01
FUCIBET
CREAM
PCO
Manufacturing
PPA0465/231/00
1
20 / 1 mg/g
Cream
D07CC01
FUCIBET LIPID
Leo Laboratories
Limited
PA0046/040/002
20/1 mg/g
Cream
D07CC01
FUCIBET LIPID
CREAM
PCO
Manufacturing
PPA0465/231/00
2
20 and 1 mg/g
Cream
D07CC01
FUCIDIN
PPA1463/083/00
1
PA1025/004/001
20 mg/g
Cream
D06AX01
FUCIDIN
IMED Healthcare
Ltd.
LEO Pharma A/S
30 Milligram
Impregnated
Dressing
D09AA02
-FUSIDATE
SODIUM
FUCIDIN
Imbat Limited
20 mg/g
Cream
D06AX01
FUCIDIN
Clear Pharmacy
20 mg/g
Cream
FUCIDIN
PCO
Manufacturing
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
PPA1151/086/00
1
PPA1596/040/00
1
PPA0465/197/00
1
PA0046/004/008
20 mg/g
Legal Basis
Routes of
Administration
PPA
PPA
-Topical
PPA
-Topical
-Cutaneous
-FUSIDIC ACID
Article 10(3) Hybrid
Application
PPA
D06AX01
-FUSIDIC ACID
PPA
Cream
D06AX01
-FUSIDIC ACID
PPA
20 mg/g
Ointment
D06AX01
PA0046/004/010
250mg/5ml Mg/M
Oral Suspension
J01XC01
-FUSIDATE
SODIUM
-FUSIDIC ACID
PA0046/004/012
20 mg/g
Cream
D06AX01
-FUSIDIC ACID
PA0046/004/014
250 Milligram
Tablets
J01XC01
PA0046/005/005
20 + 10 mg/g
Cream
D07CA01
PCO
Manufacturing
Amdipharm
Limited
Amdipharm
Limited
Rowex Ltd
PPA0465/339/00
1
PA1142/016/001
10 mg/g
S01AA13
S01AA13
-FUSIDIC ACID
PA1142/016/002
2mg/0.2 Grams
S01AA13
-FUSIDIC ACID
PA0711/245/001
250 MG/5ml
L02BA03
-FULVESTRANT
FULVESTRANT
TEVA
Teva B.V.
PA1986/011/001
250 Milligram
Eye Drops
Suspension
Eye Drops
Suspension
Eye Drops
Suspension
Solution for
injection in prefilled syringe
Solution for
Injection
-FUSIDATE
SODIUM
-FUSIDIC ACID
ANHYDROUS
HYDROCORTIS
ONE ACETATE
-FUSIDIC ACID
L02BA03
-FULVESTRANT
FUNGASIL
Clonmel
Healthcare Ltd
PA0126/141/001
250 Milligram
Tablets
D01BA02
FUNGASIL
Clonmel
Healthcare Ltd
PA0126/166/001
10 mg/g
Cream
D01AE15
FUNGIZONE
50MG POWDER
FOR STERILE
CONCENTRATE.
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
PA0002/006/001
50 Milligram
Pdr for Soln for
Infusion
J02AA01
-TERBINAFINE
HYDROCHLORI
DE
-TERBINAFINE
HYDROCHLORI
DE
-AMPHOTERICIN
B
FUCIDIN
FUCIDIN
FUCIDIN
FUCIDIN
FUCIDIN H
FUCITHALMIC
FUCITHALMIC
FUCITHALMIC
FULVESTRANT
ROWEX
Human Medicines Authorised/Transfer Pending Products
10 mg/g
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-Muscular
-Per Oral
-Cutaneous
-Intra-venous
Page 194 of 608
Trade Name
FURADANTIN
Licence Holder Licence
Number
Strength
Dosage Form ATC
C03CA01
Tablets
C03CA01
-FUROSEMIDE
-Per Oral
20 Mg/Ml
Unknown
C03CA01
-FUROSEMIDE
PA0073/059/005
50 MG/5ml
Solution for
Injection
C03CA01
-FUROSEMIDE
PA0073/059/006
250/25 Mg/Ml
Solution for Inj/Inf
C03CA01
-FUROSEMIDE
PA0566/041/001
20 mg/2ml
Solution for
Injection
C03CA01
-FUROSEMIDE
PA1389/005/001
10 Mg/Ml
Solution for
Injection
C03CA01
-FUROSEMIDE
PA1861/017/001
4 Mg/Ml
Oral Solution
C03CA01
-FUROSEMIDE
PA1861/017/002
8 Mg/Ml
Oral Solution
C03CA01
-FUROSEMIDE
PA1861/017/003
10 Mg/Ml
Oral Solution
C03CA01
-FUROSEMIDE
PA1240/001/001
20 Milligram
Tablets
C03CA01
-FUROSEMIDE
-Per Oral
PA1240/001/002
40 Milligram
Tablets
C03CA01
-FUROSEMIDE
-Per Oral
PA1390/049/001
10 Mg/Ml
Solution for Inj/Inf
C03CA01
-FUROSEMIDE
-Intra-Muscular
-Intra-venous
PA0255/010/004
10 Mg/Ml
Solution for
Injection
C03CA01
-FUROSEMIDE
EU/1/03/252/1-3
90 Per Cent
Pdr+Solv for Soln
for Inj
J05AX07
-ENFUVIRTIDE
FYBOGEL
CITRUS
FYBOGEL
MEBEVERINE
Claris
Lifesciences (UK)
Limited
SYRI Limited, t/a
Thame
Laboratories
SYRI Limited, t/a
Thame
Laboratories
SYRI Limited, t/a
Thame
Laboratories
Bristol
Laboratories
Limited
Bristol
Laboratories
Limited
Accord
Healthcare
Limited
International
Medication
Systems (UK) Ltd
Roche
Registration
Limited
Reckitt Benckiser
Ireland Ltd
Reckitt Benckiser
Ireland Ltd
PA0979/009/001
3.5 Grams
A06AC01
PA0979/010/001
0.135/3.5 Grams
Granules for Oral
Suspension
Granules
Effervescent
FYBOGEL
ORANGE
FYCOMPA
Reckitt Benckiser
Ireland Ltd
Eisai Ltd.
PA0979/009/002
3.5 Grams
Granules
A06AC01
EU/1/12/776/001
2 Milligram
Film Coated
Tablet
N03AX22
-ISPAGHULA
HUSKS
-MEBEVERINE
HYDROCHLORI
DE
-ISPAGHULA
HUSKS
-ISPAGHULA
HUSKS
-PERAMPANEL
FYCOMPA
Eisai Ltd.
EU/1/12/776/002004
4 Milligram
Film Coated
Tablet
N03AX22
-PERAMPANEL
FYCOMPA
Eisai Ltd.
EU/1/12/776/005007
6 Milligram
Film Coated
Tablet
N03AX22
-PERAMPANEL
FYCOMPA
Eisai Ltd.
EU/1/12/776/008010
8 Milligram
Film Coated
Tablet
N03AX22
-PERAMPANEL
FYCOMPA
Eisai Ltd.
EU/1/12/776/011013
10 Milligram
Film Coated
Tablet
N03AX22
-PERAMPANEL
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
FUROSEMIDE
BRISTOL
FUROSEMIDE
BRISTOL
FUROSEMIDE
INJECTION
FUROSEMIDE
INJECTION BP
MINIJET
FUZEON
50 Milligram
Tablets
J01XE01
PA0899/013/002
100 Milligram
Tablets
J01XE01
PA0126/008/001
20 mg Milligram
Tablets
PA0126/008/002
40 mg Milligram
PA0073/059/004
Routes of
Administration
-Per Oral
FUROSEMIDE
PA0899/013/001
Legal Basis
NITROFURANT
OIN
NITROFURANT
OIN
-FUROSEMIDE
FURADANTIN
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Fresenius Kabi
Limited
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
A06AC51
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 195 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
FYCOMPA
Eisai Ltd.
EU/1/12/776/014016
12 Milligram
Film Coated
Tablet
N03AX22
-PERAMPANEL
FYCOMPA
Eisai Europe Ltd
EU/1/12/776/024
0.5 Mg/Ml
Oral Suspension
N03AX22
-PERAMPANEL
FYDRANE
Laboratoires
Thea
PA1107/012/001
0.2 + 3.1 + 10
Mg/Ml
Solution for
Injection
S01FA56
GABAPENTIN
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Rowex Ltd
Rowex Ltd
Rowex Ltd
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Rosemont
Pharmaceuticals
Ltd
Aurobindo
Pharma Limited
PA1390/057/001
600 Milligram
Film Coated
Tablet
N03AX12
-LIDOCAINE
HYDROCHLORI
DE
PHENYLEPHRI
NE
HYDROCHLORI
DE
-TROPICAMIDE
-GABAPENTIN
PA1390/057/002
800 Milligram
Film Coated
Tablet
N03AX12
-GABAPENTIN
PA0711/132/001
PA0711/132/002
PA0711/132/003
PA0577/097/001
100 Milligram
300 Milligram
400 Milligram
100mg Milligram
Capsule
Capsule
Capsule
Capsule
N03AX12
N03AX12
N03AX12
N03AX12
-GABAPENTIN
-GABAPENTIN
-GABAPENTIN
-GABAPENTIN
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PA0577/097/002
300mg Milligram
Capsule
N03AX12
-GABAPENTIN
-Per Oral
PA0577/097/003
400mg Milligram
Capsule
N03AX12
-GABAPENTIN
-Per Oral
PA1390/057/003
100 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
PA1390/057/004
300 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
PA1390/057/005
400 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
PA0312/025/001
50 Mg/Ml
Oral Solution
N03AX12
-GABAPENTIN
PA1311/006/001
100 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
GABIN
Aurobindo
Pharma Limited
PA1311/006/002
300 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
GABIN
Aurobindo
Pharma Limited
PA1311/006/003
400 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
GABITRIL
PA0749/199/001
5 Milligram
-TIAGABINE
-Per Oral
PA0749/199/002
10 Milligram
N03AG06
-TIAGABINE
-Per Oral
PA0749/199/003
15 Milligram
N03AG06
-TIAGABINE
-Per Oral
PA1410/018/001
1.0 mMol/ml
V08CA09
-GADOBUTROL
GADOVIST
Bayer Limited
PA1410/018/002
1.0 mMol/ml
V08CA09
-GADOBUTROL
GADOVIST
Bayer Limited
PA1410/018/003
1.0 mMol/ml
V08CA09
-GADOBUTROL
GADOVIST
Bayer Limited
PA1410/018/004
1.0 mMol/ml
V08CA09
-GADOBUTROL
GALAFOLD
Amicus
Therapeutics UK
Ltd
Thornton & Ross
Limited
EU/1/15/1082/00
1
123 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Capsules Hard
N03AG06
GADOVIST
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Bayer Limited
L01XC24
PA0610/012/001
305 Milligram
Capsules Hard
B03AA02
-MIGALASTAT
HYDROCHLORI
DE
-FERROUS
FUMARATE
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
ROSEMONT
GABIN
GABITRIL
GABITRIL
GALFER
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
Article 10b Fixed
Combination
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-Intra-ocular
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 196 of 608
Trade Name
GALFER
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Thornton & Ross
Limited
Thornton & Ross
Limited
PA0610/012/002
140 MG/5ml
Oral Suspension
B03AA02
PA0610/013/001
305/0.35
Milligram
Capsules Hard
B03AD02
Mallinckrodt
Medical B.V.
Krka d.d., Novo
mesto
PA0690/003/001
37 MBq/ml
V09HX01
PA1347/015/001
8 Milligram
GALSYA SR
Krka d.d., Novo
mesto
PA1347/015/002
16 Milligram
GALSYA SR
Krka d.d., Novo
mesto
PA1347/015/003
24 Milligram
GALVUS
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Creo Pharma
Limited
EU/1/07/414/1-10
50 Milligram
Solution for
Injection
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Tablets
A10BH02
-GALLIUM (67
GA) CITRATE
-GALANTAMINE
HYDROBROMID
E
-GALANTAMINE
HYDROBROMID
E
-GALANTAMINE
HYDROBROMID
E
-VILDAGLIPTIN
EU/1/07/414/1117
100 Milligram
Tablets
A10BH02
-VILDAGLIPTIN
-Per Oral
PA1884/001/001
70 Milligram
Film Coated
Tablet
N06AA07
-Per Oral
GAMMAGARD
S/D
Baxalta
Innovations
GmbH
PA2004/003/001
0.5 g/30 m
Micromol
Pdr+Solv for soln
for Inf
J06BA02
GAMMANORM
Octapharma
Limited
PA0521/014/002
165 Mg/Ml
Solution for
Injection
J06BA02
GAMUNEX 10%
Grifols
Deutschland
GmbH
PA1405/001/001
100 Mg/Ml
Solution for
Infusion
J06BA02
GANFORT
Allergan
Pharmaceuticals
Ireland
Sanofi Pasteur
MSD
EU/1/06/340/001002
0.3/5 Mg/Ml
Eye Drops
Solution
S01ED51
-LOFEPRAMINE
HYDROCHLORI
DE
-HUMAN
PLASMA
PROTEIN >90%
GAMMA
GLOBULIN
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
IMMUNOGLOB
ULIN HUMAN
NORMAL
-BIMATOPROST
-TIMOLOL
EU/1/06/357/0121
Per Cent
Suspension for
Injection
J07BM01
QUADRIVALENT
HUMAN
PAPILLOMAVIR
US TYPE 11
RECOMBINANT
VACCINE (IN)
QUADRIVALENT
HUMAN
PAPILLOMAVIR
US TYPE 16
RECOMBINANT
VACCINE (IN)
QUADRIVALENT
HUMAN
PAPILLOMAVIR
US TYPE 18
RECOMBINANT
VACCINE (IN)
QUADRIVALENT
HUMAN
PAPILLOMAVIR
US TYPE 6
RECOMBINANT
VACCINE
-Intra-Muscular
GALFER FA 305
MG / 0.35 MG
HARD
CAPSULES
GALLIUM (GA67)
CITRATE
GALSYA SR
GALVUS
GAMANIL
GARDASIL
Human Medicines Authorised/Transfer Pending Products
N06DA04
N06DA04
N06DA04
-FERROUS
FUMARATE
-FERROUS
FUMARATE
-FOLIC ACID
Routes of
Administration
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
Page 197 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
GARDASIL 9
Sanofi Pasteur
MSD
EU/1/15/1007/00
1-003
0.5 Millilitre
Suspension for
Injection
J07B
GASTROGRAFI
N, 660MG/ML +
100MG/ML ORAL
AND RECTAL
Bayer Limited
PA1410/004/001
%v/v
Oral Solution
V08AC08
GASTROLIEF
Clonmel
Healthcare Ltd
PA0126/220/001
20 Milligram
Tablets GastroResistant
A02BC02
GASTROMIRO
612.4MG/ML
ORAL OR
RECTAL
SOLUTION
GAVISCON
ADVANCE
Bracco Imaging
spa
PA1826/005/001
612.4 Mg/Ml
Unknown
V08AB04
Reckitt Benckiser
Ireland Ltd
PA0979/011/008
500/100 Milligram
Tablets
Chewable
A02BX13
GAVISCON
ADVANCE
Reckitt Benckiser
Ireland Ltd
PA0979/011/006
1000/200
Milligram
Oral Suspension
A02BX13
GAVISCON
ADVANCE
Reckitt Benckiser
Ireland Ltd
PA0979/011/001
500mg/100m
MG/5ml
Oral Suspension
A02BX
GAVISCON
ADVANCE PEPPERMINT
FLAVOUR
GAVISCON
EXTRA
Reckitt Benckiser
Ireland Ltd
PA0979/011/007
1000/200
Milligram
Unknown
A02BX13
Reckitt Benckiser
Ireland Ltd
PA0979/015/011
500/213/325
Milligram
Oral Suspension
A02BX13
GAVISCON
EXTRA
Reckitt Benckiser
Ireland Ltd
PA0979/015/012
250/106.5/187.50
Milligram
Tablets
Chewable
A02BX13
GAVISCON
EXTRA LIQUID
SACHETS
PEPPERMINT
FLAVOUR
Reckitt Benckiser
Ireland Ltd
PA0979/015/013
325/10 Mg/Ml
Oral Suspension
A02BX13
GAVISCON
INFANT
Reckitt Benckiser
Ireland Ltd
PA0979/012/001
%v/v
Powder for Oral
Solution
A02BX13
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-HPV TYPE 6 L1
PROTEIN
-HPV TYPE 11
L1 PROTEIN
-HPV 16 L1
PROTEIN
-HPV 18 L1
PROTEIN
-HPV TYPE 31
L1 PROTEIN
-HPV TYPE 33
L1 PROTEIN
-HPV TYPE 45
L1 PROTEIN
-HPV TYPE 52
L1 PROTEIN
-HPV TYPE 58
L1 PROTEIN
-SODIUM
AMIDOTRIZOAT
E
AMIDOTRIZOAT
E MEGLUMINE
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
-IOPAMIDOL
-SODIUM
ALGINATE
-POTASSIUM
BICARBONATE
-SODIUM
ALGINATE
-POTASSIUM
HYDROGEN
CARBONATE
-SODIUM
ALGINATE
-POTASSIUM
HYDROGEN
CARBONATE
-SODIUM
ALGINATE
-POTASSIUM
BICARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-MAGNESIUM
ALGINATE
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Intra-Muscular
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
Article 10a Bibliographical
App
-Per Oral
-Per Oral
Page 198 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
GAVISCON
LIQUID PEPPERMINT
FLAVOUR
Reckitt Benckiser
Ireland Ltd
PA0979/015/002
10 Micromol
Oral Suspension
A02AX13
GAVISCON
LIQUID
SACHETS
Reckitt Benckiser
Ireland Ltd
PA0979/015/010
500 267 160
Milligram
Oral Suspension
A02BX13
GAVISCON
LIQUIDANISEED
FLAVOUR,
ORAL
SUSPENSION
GAVISCON
ORAL
SUSPENSION
Reckitt Benckiser
Ireland Ltd
PA0979/015/003
%v/v
Oral Suspension
A02AX13
Reckitt Benckiser
Ireland Ltd
PA0979/015/001
500/267/160
Milligram
Oral Suspension
A02AX13
GAVISCON
PEPPERMINT
Reckitt Benckiser
Ireland Ltd
PA0979/015/004
250 Milligram
Tablets
Chewable
A02BX13
GAVISCON
STRAWBERRY
Reckitt Benckiser
Ireland Ltd
PA0979/015/005
250/133.5/
Milligram
Tablets
Chewable
A02BX13
GAZYVARO
Roche
Registration
Limited
Gedeon Richter
Plc
EU/1/14/937/001
1000 Milligram
Concentrate for
Soln for Inf
L01XC15
PA1330/006/001
20/150
Microgram
Film Coated
Tablet
G03AA09
GEDAREL
EXTRA
Gedeon Richter
Plc
PA1330/005/001
30/150
Microgram
Film Coated
Tablet
G03AA09
GELASPAN
B. Braun
Melsungen AG
PA0736/034/001
4 Per Cent
Solution for
Infusion
B05AA06
GELOFUSINE
B. Braun
Melsungen AG
PA0736/011/001
40 Mg/Ml
Solution for
Infusion
B05AA06
GEDAREL
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
-SODIUM
ALGINATE
-CALCIUM
CARBONATE
-SODIUM
BICARBONATE
-SODIUM
ALGINATE
-SODIUM
BICARBONATE
-CALCIUM
CARBONATE
OBINUTUZUMAB
ETHINYLESTRA
DIOL
-DESOGESTREL
ETHINYLESTRA
DIOL
-DESOGESTREL
SUCCINYLATED
GELATINE (=
MODIFIED
FLUID
GELATINE)
-SODIUM
CHLORIDE
-SODIUM
ACETATE
TRIHYDRATE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
SUCCINYLATED
GELATINE (=
MODIFIED
FLUID
GELATINE)
-SODIUM
CHLORIDE
-SODIUM
HYDROXIDE
Legal Basis
Routes of
Administration
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10a Bibliographical
App
-Intra-venous
-Intra-venous
Page 199 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
GELOPLASMA
Fresenius Kabi
Limited
PA0566/038/001
3 Grams
Solution for
Infusion
B05AA
GELOPLASMA
Fresenius Kabi
Limited
PA0566/038/002
3 Grams
Solution for
Infusion
B05AA
GELSEMIUM
A. Nelson &
Company Limited
Weleda (UK)
Limited
Bausch & Lomb
UK Limited
Fresenius Kabi
Oncology Plc
HOR1149/012/0
01
HOR0407/024/0
01
PA0555/011/001
6C-MM N/A
GELSEMIUM
Active
Ingredients
-MODIFIED
LIQUID
GELATINE
-SODIUM
CHLORIDE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-POTASSIUM
CHLORIDE
-SODIUM
LACTATE
SOLUTION
-MODIFIED
LIQUID
GELATINE
-SODIUM
CHLORIDE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-POTASSIUM
CHLORIDE
-SODIUM
LACTATE
SOLUTION
-GELSEMIUM
SEMPERVIREN
-GELSEMIUM
SEMPERVIREN
-CARBOMER
6C & 30C
Tablets
0.2 %w/w
Eyegel
S01XA20
PA1422/003/005
38 Mg/Ml
Concentrate for
Soln for Inf
L01BC05
Accord
Healthcare
Limited
Fresenius Kabi
Oncology Plc
PA1390/007/003
2 Grams
Pdr for Soln for
Infusion
L01BC05
PA1422/003/002
1 Grams
Pdr for Soln for
Infusion
L01BC05
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
GEMCITABINE
Fresenius Kabi
Oncology Plc
PA1422/003/003
2 Grams
Pdr for Soln for
Infusion
L01BC05
-GEMCITABINE
GEMCITABINE
Actavis Group
PTC ehf
PA1380/015/004
2 Grams
Pdr for Soln for
Infusion
L01BC05
GEMCITABINE
Fresenius Kabi
Oncology Plc
PA1422/003/001
200 Milligram
Pdr for Soln for
Infusion
L01BC05
GEMCITABINE
Actavis Group
PTC ehf
PA1380/015/003
40 Mg/Ml
Concentrate for
Soln for Inf
L01BC05
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
GEMCITABINE
Hospira UK
Limited
PA0437/063/001
38 Base mg/ml
Concentrate for
Soln for Inf
L01BC05
GEMCITABINE
Fresenius Kabi
Oncology Plc
PA1422/003/004
40 Mg/Ml
Concentrate for
Soln for Inf
L01BC05
GEMCITABINE
Accord
Healthcare
Limited
Actavis Group
PTC ehf
PA1390/007/004
100 Base mg/ml
Concentrate for
Soln for Inf
L01BC05
PA1380/015/001
200 Milligram
Pdr for Soln for
Infusion
L01BC05
GEMCITABINE
Actavis Group
PTC ehf
PA1380/015/002
1 Grams
Pdr for Soln for
Infusion
L01BC05
GEMCITABINE
Accord
Healthcare
Limited
Accord
Healthcare
Limited
PA1390/007/001
200 Milligram
Pdr for Soln for
Injection
L01BC05
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
PA1390/007/002
1 Grams
Pdr for Soln for
Injection
L01BC05
-GEMCITABINE
GELTEARS
GEMCITABINE
GEMCITABINE
GEMCITABINE
GEMCITABINE
GEMCITABINE
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Intra-venous
-Intra-venous
-Per Oral
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Page 200 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
GEMCITABINE
ACTAVIS
Actavis Group
PTC ehf
PA1380/182/001
40 Mg/Ml
Concentrate for
Soln for Inf
L01BC05
GENOTROPIN
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
PA0822/128/002
12 Mg/Ml
H01AC01
PA0822/128/003
0.2 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/004
0.4 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/005
0.6 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/006
0.8 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/007
1 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/001
5.3 Mg/Ml
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
-GEMCITABINE
HYDROCHLORI
DE
-GEMCITABINE
-SOMATROPIN
H01AC01
-SOMATROPIN
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
B. Braun
Melsungen AG
PA0822/128/008
1.2 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/009
1.4 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/010
1.6 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/011
1.8 Mg/Ml
H01AC01
-SOMATROPIN
PA0822/128/012
2.0 Mg/Ml
H01AC01
-SOMATROPIN
PA0736/031/001
1 Mg/Ml
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Solution for
Infusion
J01GB03
GENTAMICIN
B. Braun
Melsungen AG
PA0736/031/002
3 Mg/Ml
Solution for
Infusion
J01GB03
GENTAMICIN
Hospira UK
Limited
Wockhardt UK
Limited
PA0437/016/004
40 Mg/Ml
J01GB03
PA1339/065/001
10 Mg/Ml
Solution for
Injection
Solution for Inj/Inf
GENTAMICIN
Wockhardt UK
Limited
PA1339/065/002
40 Mg/Ml
Solution for Inj/Inf
J01GB03
GENTICIN
Amdipharm
Limited
Amdipharm
Limited
Amdipharm
Limited
PA1142/013/002
0.3 %w/v
S01AX07
PA1142/013/001
80 mg/2ml
PA1142/014/001
0.3 & 1.0 %w/v
Ear/Eye Drops,
solution
Solution for
Injection
Ear Drops
Suspension
GENVOYA
Gilead Sciences
International
EU/1/15/1061/00
1-002
150/150/200/10
Milligram
Film Coated
Tablet
J05AR18
GEODON
Pfizer Limited
PA0019/052/001
20 Milligram
Capsules Hard
N05AE04
GEODON
Pfizer Limited
PA0019/052/002
40 Milligram
Capsules Hard
N05AE04
-GENTAMICIN
(AS
GENTAMICIN
SULPHATE)
-GENTAMICIN
(AS
GENTAMICIN
SULPHATE)
-GENTAMICIN
SULFATE
-GENTAMICIN
(AS
GENTAMICIN
SULPHATE)
-GENTAMICIN
(AS
GENTAMICIN
SULPHATE)
-GENTAMICIN
SULFATE
-GENTAMICIN
SULFATE
-GENTAMICIN
SULFATE
HYDROCORTIS
ONE ACETATE
-ELVITEGRAVIR
-COBICISTAT
EMTRICITABINE
-TENOFOVIR
ALAFENAMIDE
FUMARATE
-ZIPRASIDONE
HYDROCHLORI
DE
MONOHYDRATE
-ZIPRASIDONE
HYDROCHLORI
DE
MONOHYDRATE
GENOTROPIN
GENOTROPIN
GENOTROPIN
GENOTROPIN
GENOTROPIN
GENOTROPIN
5.3 MG
POWDER AND
SOLVENT FOR
SOLUTION
GENOTROPIN
MINIQUICK
GENOTROPIN
MINIQUICK
GENOTROPIN
MINIQUICK
GENOTROPIN
MINIQUICK
GENOTROPIN
MINIQUICK
GENTAMICIN
GENTAMICIN
GENTICIN
GENTISONE HC
Human Medicines Authorised/Transfer Pending Products
J01GB03
S01AX07
S02CA03
Legal Basis
Routes of
Administration
Article 10(3) Hybrid
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
Page 201 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
GEODON
Pfizer Limited
PA0019/052/003
60 Milligram
Capsules Hard
N05AE04
GEODON
Pfizer Limited
PA0019/052/004
80 Milligram
Capsules Hard
N05AE04
GERAMOX
Generics (UK)
Limited
Generics (UK)
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0405/005/001
250 Milligram
Capsules Hard
J01CA04
PA0405/005/002
500 Milligram
Capsules Hard
J01CA04
PA0577/010/001
250 Microgram
Tablets
Interchangeable
List Code:
IC0094-145-002
PA0577/010/002
500 Microgram
Interchangeable
List Code:
IC0094-040-002
PA0577/010/003
GERAMOX
GERAX
GERAX
GERAX
GERIFLOX
GERMENTIN
GERMENTIN
GERMENTIN
GEROQUEL
GEROQUEL
GEROQUEL
GEROQUEL
GEROZAC
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Generics (UK)
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Active
Ingredients
Legal Basis
Routes of
Administration
-Per Oral
N05BA12
-ZIPRASIDONE
HYDROCHLORI
DE
MONOHYDRATE
-ZIPRASIDONE
HYDROCHLORI
DE
MONOHYDRATE
-AMOXICILLIN
TRIHYDRATE
-AMOXICILLIN
TRIHYDRATE
-ALPRAZOLAM
Tablets
N05BA12
-ALPRAZOLAM
-Per Oral
1 Milligram
Tablets
N05BA12
-ALPRAZOLAM
-Per Oral
Interchangeable
List Code:
IC0094-039-002
PA0405/010/002
500 Milligram
Capsule
J01CF05
-Per Oral
Interchangeable
List Code:
IC0089-117-001
PA0577/034/001
FLUCLOXACILL
IN SODIUM
500/125 Milligram
Film Coated
Tablet
J01CR02
-AMOXICILLIN
TRIHYDRATE
-CLAVULANATE
POTASSIUM
-Per Oral
125/31.25
MG/5ml
Powder for Oral
Suspension
J01CR02
-Per Oral
Interchangeable
List Code:
IC0037-071-034
PA0577/034/003
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID
250/125 Milligram
Film Coated
Tablet
J01CR02
-Per Oral
Interchangeable
List Code:
IC0037-074-014
PA0577/090/001
-AMOXICILLIN
TRIHYDRATE
-CLAVULANIC
ACID
25 Milligram
Film Coated
Tablet
N05AH04
-QUETIAPINE
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0019-022-003
PA0577/090/002
Article 10(1) Generic
Application
100 Milligram
Film Coated
Tablet
N05AH04
-QUETIAPINE
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0019-024-003
PA0577/090/003
Article 10(1) Generic
Application
200 Milligram
Film Coated
Tablet
N05AH04
-QUETIAPINE
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0019-067-003
PA0577/090/004
Article 10(1) Generic
Application
300 Milligram
Film Coated
Tablet
N05AH04
-QUETIAPINE
FUMARATE
-Per Oral
Interchangeable
List Code:
IC0019-029-003
PA0577/071/001
Article 10(1) Generic
Application
60 Milligram
Capsules Hard
N06AB03
-FLUOXETINE
HYDROCHLORI
DE
-FLUOXETINE
HYDROCHLORI
DE
Interchangeable
List Code:
IC0037-073-014
PA0577/034/002
Interchangeable
List Code:
IC0075-127-001
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
Page 202 of 608
Trade Name
GEROZAC
GERTAC
GERTAC
GILENYA
GINKGOFORCE
MEMORY &
CIRCULATION
GINKGO
GIOTRIF
Licence Holder Licence
Number
Generics (UK)
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Novartis
Europharm
Limited
Bioforce (UK) Ltd
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0405/036/001
20 Milligram
Capsules Hard
N06AB03
-Per Oral
Interchangeable
List Code:
IC0075-003-001
PA0577/023/001
-FLUOXETINE
HYDROCHLORI
DE
150 Milligram
Film Coated
Tablet
A02BA02
-Per Oral
Interchangeable
List Code:
IC0087-062-051
PA0577/023/002
-RANITIDINE
HYDROCHLORI
DE
300 Milligram
Film Coated
Tablet
A02BA02
-RANITIDINE
HYDROCHLORI
DE
-Per Oral
0.5 Milligram
Capsules Hard
L04AA27
-FINGOLIMOD
-Per Oral
-EXTRACT OF
GINKGO BILOBA
L. FRESH LEAF
(3-5:1).
EXTRACTION
SOLVENT
ETHANOL
60%M/M
-AFATINIBDIMALEATE
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Interchangeable
List Code:
IC0087-029-051
EU/1/11/677/001004
TR0725/016/001
Tablets
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
PharmaSwiss
Ceska republika
s.r.o.
MGI Pharma
Limited
Chanelle Medical
EU/1/13/879/001003
20 Milligram
Film Coated
Tablet
L01XE13
EU/1/13/879/004006
30 Milligram
Film Coated
Tablet
L01XE13
-AFATINIBDIMALEATE
Article 8(3) - Full
new Application
-Per Oral
EU/1/13/879/007009
40 Milligram
Film Coated
Tablet
L01XE13
-AFATINIBDIMALEATE
Article 8(3) - Full
new Application
-Per Oral
EU/1/13/879/010012
50 Milligram
Film Coated
Tablet
L01XE13
-AFATINIBDIMALEATE
Article 8(3) - Full
new Application
-Per Oral
PA1696/003/001
50mcg/ml + 5
Mg/Ml
Eye Drops
Solution
S01ED51
PA1018/001/001
7.7 Milligram
Implant
L01AD01
-LATANOPROST
-TIMOLOL
MALEATE
-CARMUSTINE
PA0688/040/002
5 Milligram
Tablets
A10BB01
GLIBENCLAMID
E
Chanelle Medical
PA0688/040/001
2.5 Milligram
Tablets
A10BB01
GLICLAZIDE MR
Bristol
Laboratories
Limited
PA1240/010/001
30 Milligram
Tablet Prolonged
Release
A10BB09
15 Milligram
Tablets
A10BG03
GIOTRIF
GIOTRIF
GIOTRIF
GLAUCOTIMA
GLIADEL
GLIBENCLAMID
E
GLIBENCLAMID
E
GLIBENCLAMID
E
-GLICLAZIDE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
GLIDIPION
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0086-033-050
EU/1/12/756/001009
GLIDIPION
Actavis Group
PTC ehf
EU/1/12/756/010018
30 Milligram
Tablets
A10BG03
GLIDIPION
Actavis Group
PTC ehf
EU/1/12/756/019027
45 Milligram
Tablets
A10BG03
GLIMEPIRIDE
Accord
Healthcare
Limited
Accord
Healthcare
Limited
PA1390/018/001
1 Milligram
Tablets
A10BB12
-PIOGLITAZONE
HYDROCHLORI
DE
-PIOGLITAZONE
HYDROCHLORI
DE
-PIOGLITAZONE
HYDROCHLORI
DE
-GLIMEPIRIDE
PA1390/018/002
2 Milligram
Tablets
A10BB12
-GLIMEPIRIDE
GLIMEPIRIDE
Human Medicines Authorised/Transfer Pending Products
-Ocular
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 203 of 608
Trade Name
GLIMEPIRIDE
GLIMEPIRIDE
GLIOLAN
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLIVEC
GLUBRAVA
GLUCAGEN
HYPOKIT
GLUCAGEN
HYPOKIT
GLUCOBAY 100
MG TABLETS
GLUCOBAY 50
MG TABLETS
GLUCOPHAGE
GLUCOPHAGE
GLUCOPHAGE
GLUCOSAMINE
PHARMA NORD
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Takeda Pharma
A/S
PA1390/018/003
3 Milligram
Tablets
A10BB12
-GLIMEPIRIDE
PA1390/018/004
4 Milligram
Tablets
A10BB12
-GLIMEPIRIDE
EU/1/07/413/1-3
30 Mg/Ml
Powder for Oral
Solution
L01XD04
EU/1/01/198/007
100 Milligram
Coated Tablets
L01XE01
-5AMINOLEVULIN
IC ACID
HYDROCHLORI
DE
-IMATINIB
MESILATE
EU/1/01/198/009
400 Milligram
Coated Tablets
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/008
100 Milligram
Coated Tablets
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/010
400 Milligram
Coated Tablets
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/002
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/003
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/004
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/005
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/006
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/01/198/001
50 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
-Per Oral
EU/1/07/421/001009
15/850 Milligram
Film Coated
Tablet
A10BD05
Novo Nordisk A/S
PA0218/031/002
1 Milligram
H04AA01
PCO
Manufacturing
Bayer Limited
PPA0465/331/00
1
PA1410/029/002
1 Milligram
H04AA01
-GLUCAGON
100 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Tablets
-PIOGLITAZONE
HYDROCHLORI
DE
-METFORMIN
HYDROCHLORI
DE
-GLUCAGON
A10BF01
-ACARBOSE
Bayer Limited
PA1410/029/001
50 Milligram
Tablets
A10BF01
-ACARBOSE
Merck Serono
Limited
PA0654/019/001
500 Milligram
Film Coated
Tablet
A10BA02
-Per Oral
Interchangeable
List Code:
IC0067-117-003
PA0654/019/002
-METFORMIN
HYDROCHLORI
DE
850 Milligram
Film Coated
Tablet
A10BA02
-Per Oral
Interchangeable
List Code:
IC0067-118-003
PA0654/019/003
-METFORMIN
HYDROCHLORI
DE
1000 Milligram
Film Coated
Tablet
A10BA02
-METFORMIN
HYDROCHLORI
DE
-Per Oral
400 Base
Milligrams
Capsules Hard
M01AX05
-GLUCOSAMINE
HEMISULPHAT
E:POTASSIUM
CHLORIDE
COMPLEX (1:1)
-Per Oral
Merck Serono
Limited
Merck Serono
Limited
Pharma Nord
ApS
Interchangeable
List Code:
IC0067-119-003
PA1242/001/001
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10c Informed Consen
-Per Oral
Page 204 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
FMC Pharma Ltd
PA1521/003/002
750 Milligram
Film Coated
Tablet
M01AX05
GLUCOSAMINE
SULFATE
FMC Pharma Ltd
PA1521/003/003
1500 Milligram
Film Coated
Tablet
M01AX05
GLUCOSE
Baxter
Healthcare
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
B. Braun Medical
Limited
Maco Pharma
(UK) Ltd
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Baxter
Healthcare
Limited
PA0167/009/031
10 %w/v
Solution for
Infusion
B05BA03
PA0566/031/009
5 %w/w
B05CX01
PA0566/031/010
10 %w/w
PA0179/001/039
50 %w/v
PA0931/002/001
5 %w/v
PA0566/031/001
5 %w/v
PA0566/031/002
5 %w/v
PA0566/031/003
5 %w/v
PA0566/031/004
5 %w/v
PA0566/031/005
10 %w/v
PA0566/031/006
10 %w/v
PA0566/031/007
10 %w/v
PA0566/031/008
10 %w/v
PA0167/009/030
5.0 Anhyd %w/v
Solution for
Infusion
Solution for
Infusion
Concentrate for
Soln for Inf
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
Solution for
Infusion
International
Medication
Systems (UK) Ltd
B. Braun Medical
Limited
PA0255/008/003
50 %w/v
Solution for
Injection
V06DC01
-GLUCOSE
PA0179/001/003
A
5 %w/v
Solution for
Infusion
B05CX01
-GLUCOSE
B. Braun Medical
Limited
PA0179/001/028
10 %w/v
Solution for
Infusion
B05BA03
-GLUCOSE
ANHYDROUS
B. Braun
Melsungen AG
PA0736/004/001
5 %w/v
Solution for
Infusion
B05BA03
-GLUCOSE
MONOHYDRATE
-Intra-venous
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
EU/1/00/151/001003
EU/1/00/151/002
Base Milligrams
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
15 Milligram
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
EU/1/00/151/1719,24
EU/1/00/151/004
30 Milligram
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
30 Milligram
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
EU/1/00/151/2022
EU/1/00/151/007
45 Milligram
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
15 mg Milligram
Tablets
A10BG03
-PIOGLITAZONE
-Per Oral
EU/1/00/151/009
45 Milligram
Tablets
A10BG03
Dermal
Laboratories Ltd
Amsterdam
Molecular
Therapeutics
Martindale
Pharmaceuticals
Ltd
Martindale
Pharmaceuticals
Ltd
PA0278/005/001
10 %w/v
D11AF
EU/1/12/791/001
3x10
Cutaneous
Solution
Solution for
Injection
-PIOGLITAZONE
HYDROCHLORI
DE
-GLUTARAL
C10AX10
-ALIPOGENE
TIPRAVOVEC
-Intra-Muscular
PA0361/011/001
70 %w/w
Suppositories
A06AX01
-GLYCEROL
-Rectal
PA0361/011/002
70 %w/w
Suppositories
A06AX01
-GLYCEROL
-Rectal
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE
GLUCOSE 5%
W/V
INTRAVENOUS
INFUSION
GLUCOSE
INJECTION BP
MINIJET
GLUCOSE
INTRAVENOUS
INFUSION BP
GLUCOSE
INTRAVENOUS
INFUSION BP
GLUCOSE
INTRAVENOUS
INFUSION BP
GLUSTIN
GLUSTIN
GLUSTIN
GLUSTIN
GLUSTIN
GLUSTIN
GLUSTIN
GLUTAROL
GLYBERA
GLYCEROL 1G
SUPPOSITORIE
S
GLYCEROL 2G
SUPPOSITORIE
S
Human Medicines Authorised/Transfer Pending Products
B05BA03
B05BA03
B05CX01
B05CX01
B05CX01
B05CX01
B05CX01
B05CX01
B05BA03
B05BA03
B05BA03
B05XX
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Routes of
Administration
GLUCOSAMINE
SULFATE
GLUCOSE
-GLUCOSAMINE
SULFATE 2
NACI
-GLUCOSAMINE
SULPHATE 2
NACI
-GLUCOSE
MONOHYDRATE
Legal Basis
-Per Oral
-Per Oral
-Intra-venous
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
MONOHYDRATE
-GLUCOSE
MONOHYDRATE
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
ANHYDROUS
-GLUCOSE
MONOHYDRATE
Page 205 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
GLYCEROL
SUPPOSITORIE
S BP FOR
ADULTS
GLYCERYL
TRINITRATE
GLYCOPYRRO
NIUM BROMIDE
Martindale
Pharmaceuticals
Ltd
PA0361/011/003
70 %w/v
Unknown
A06AX01
-GLYCEROL
Hospira UK
Limited
MercuryPharm
Ltd
PA0437/012/001
5 Mg/Ml
C01DA02
PA0857/001/001
200
Microgram/ML
Concentrate for
Soln for Inf
Solution for
Injection
GLYCOPYRRO
NIUM BROMIDE
AND
NEOSTIGMINE
METILSULFATE
GLYPRESSIN
MercuryPharm
Ltd
PA0857/002/001
0.5/2.5 Mg/Ml
Solution for
Injection
N07AA51
Ferring Ireland
Ltd
Ferring Ireland
Ltd
Ayrton Saunders
Ltd
PA1009/004/001
1 Milligram
H01BA04
PA1009/004/002
0.12 N/A
PA0501/004/001
0.7%w/w %w/w
Pdr+Solv for Soln
for Inj
Solution for
Injection
Sublingual Spray
-GLYCERYL
TRINITRATE
GLYCOPYRRO
NIUM BROMIDE
GLYCOPYRRO
NIUM BROMIDE
-NEOSTIGMINE
METILSULFATE
-TERLIPRESSIN
ACETATE
-TERLIPRESSIN
ACETATE
-GLYCERYL
TRINITRATE
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Cambridge
Healthcare
Supplies Limited
Cambridge
Healthcare
Supplies Limited
EU/1/16/1146/00
1-009
10/5 Milligram
Film Coated
Tablet
A10BD19
EU/1/16/1146/01
0-018
25/5 Milligram
Film Coated
Tablet
A10BD19
PA0980/004/001
0.1% %w/v
Eye Drops
Solution
S01AX15
PA0980/004/002
0.15 w/w
Eye Ointment
S01AX14
GONAL-F
Serono Limited
EU/1/95/001/025
5 Micrograms/g
G03GA05
GONAL-F
Serono Limited
EU/1/95/001/026
5 Microgram
GONAL-F
EU/1/95/01/027
5 Microgram
GONAL-F
Serono Europe
Limited
Serono Limited
EU/1/95/001/028
10 Microgram
GONAL-F
Serono Limited
EU/1/95/001/027
5 Micrograms/g
GONAL-F
Serono Limited
EU/1/95/001/022
2.5 Micrograms/g
GONAL-F
Serono Limited
EU/1/95/001/021
600 IU/ML
GONAL-F
Serono Limited
EU/1/95/001/009
GONAL-F
Serono Limited
EU/1/95/001/012
GONAL-F
Serono Limited
EU/1/95/1/33-35
150 International
Unit
150 International
Unit
600 IU/ML
GONAL-F AMPOULE
GONAL-F AMPOULE
GONAL-F - VIAL
Serono Limited
EU/1/95/001/001
Serono Limited
EU/1/95/001/004
Serono Limited
EU/1/95/001/005
GONAL-F
AMPOULE
GONAPEPTYL
DEPOT
GRAFALON
Serono Limited
EU/1/95/001/003
Ferring Ireland
Ltd
Neovii Biotech
GmbH
PA1009/018/001
75 International
Unit
75 International
Unit
75 International
Unit
75 International
Unit
3.75 Milligram
PA1015/001/001
20 Mg/Ml
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Solution for
Injection
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for
Susp for Inj
Concentrate for
Soln for Inf
GRANISETRON
MARTINDALE
PHARMA
Martindale
Pharmaceuticals
Ltd
PA0361/029/001
Concentrate for
Soln for Inj
A04AA02
GLYPRESSIN
GLYTRIN 400
MICROGRAM
PER METERED
DOSE
GLYXAMBI
GLYXAMBI
GOLDEN EYE
GOLDEN EYE
Human Medicines Authorised/Transfer Pending Products
1
A03AB02
H01BA04
C01DA02
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
G03GA05
L02AE04
L04AA04
EMPAGLIFLOZI
N
-LINAGLIPTIN
EMPAGLIFLOZI
N
-LINAGLIPTIN
-PROPAMIDINE
ISETIONATE
DIBROMPROPA
MIDINE
ISETIONATE
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-FOLLITROPIN
ALFA
-TRIPTORELIN
-ANTI-HUMAN TLYMPHOCYTE
IMMUNOGLOB
ULIN FROM
RABBITS
-GRANISETRON
HYDROCHLORI
DE
Legal Basis
Routes of
Administration
-Rectal
-Intra-Muscular
-Intra-venous
-Intra-venous
-Intra-venous
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Ocular
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Intra-venous
Page 206 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
GRANISETRON
MARTINDALE
PHARMA
GRANISETRON
TEVA
Martindale
Pharmaceuticals
Ltd
Teva Pharma
B.V.
PA0361/029/002
3/3
Concentrate for
Soln for Inj
A04AA02
PA0749/027/004
1 Mg/Ml
Concentrate for
Soln for Inf
A04AA02
GRANOCYTE 13
Chugai Pharma
UK Ltd
Chugai Pharma
UK Ltd
Accord
Healthcare
Limited
PA0950/002/002
105mcg
Microgram
263mcg
Microgram
20 Milligram
Pdr+Solv for soln
for inf/inj
Pdr+Solv for soln
for inf/inj
Film Coated
Tablet
L03AA10
-GRANISETRON
HYDROCHLORI
DE
-GRANISETRON
HYDROCHLORI
DE
-LENOGRASTIM
L03AA10
-LENOGRASTIM
G04BE03
MICROCRYSTA
LLINE
CELLULOSE
(PH101)
A. Nelson &
Company Limited
Weleda (UK)
Limited
Apotex Europe
B.V.
HOR1149/013/0
01
HOR0407/004/0
01
EU/1/13/877/001002
8X-MM
GRASTOFIL
Apotex Europe
B.V.
GRAZAX 75,000
SQ-T
GREPID
GRANOCYTE 34
GRANPIDAM
((PREVIOUSLY
KNOWN AS
SILDENAFIL
ACCORDPHAR
MA))
GRAPHITES
GRAPHITES
(GRAPH.)
GRASTOFIL
HALCION
HALCION
HALDOL
DECANOATE
HALDOL
DECANOATE
HALF BETA
PROGRANE
HALF SINEMET
CR
Article 10(1) Generic
Application
-Per Oral
-Intra-venous
-GRAPHITES
-Per Oral
-GRAPHITES
-Per Oral
Solution for
Injection
L03AA02
-FILGRASTIM
EU/1/13/877/003004
48MU/0.5 Millilitr
Solution for
Injection
L03AA02
-FILGRASTIM
ALK-Abello A/S
PA1255/004/001
75, 000 Per Cent
Oral Lyophilisate
V01AA02
Pharmathen S.A.
EU/1/09/535/1-16
75 Milligram
Film Coated
Tablet
B01AC04
-GRASS
POLLEN
EXTRACT
(PHLEUM
PRATENSE)
-CLOPIDOGREL
BESYLATE
Interchangeable
List Code:
IC0005-028-003
PA1648/006/001
500 Milligram
Film Coated
Tablet
D01BA01
-GRISEOFULVIN
PA0991/001/001
1 %w/w
D01AA08
-GRISEOFULVIN
PA0748/020/002
1200 Milligram
Cutaneous Spray
Solution
Vaginal Capsule
G01AF04
PA0748/020/001
20 mg/g
Vaginal Cream
G01AF04
PA0748/017/002
150 Milligram
Pessary
G01AF05
PA0812/004/001
200 Milligram
Vaginal Capsule
G01AF12
-MICONAZOLE
NITRATE
-MICONAZOLE
NITRATE
-ECONAZOLE
NITRATE
FENTICONAZO
LE NITRATE
PA0812/004/002
600 Milligram
Vaginal Capsule
G01AF12
FENTICONAZO
LE NITRATE
PA0943/026/001
1 Milligram
Pdr+Solv for Soln
for Inj
H01BA04
-TERLIPRESSIN
ACETATE
EU/1/11/678/001002
PA0822/129/001
0.5 Mg/Ml
L01XX41
N05CD05
-ERIBULIN
MESYLATE
-TRIAZOLAM
-Intra-venous
250 Microgram
Solution for
Injection
Tablets
PA0822/129/002
125 Microgram
Tablets
N05CD05
-TRIAZOLAM
-Per Oral
PA0748/021/001
50 Mg/Ml
N05AD01
100 Mg/Ml
PA0644/001/002
80 Milligram
PA1286/009/001
25/100 Milligram
-HALOPERIDOL
DECANOATE
-HALOPERIDOL
DECANOATE
-PROPRANOLOL
HYDROCHLORI
DE
-LEVODOPA
-CARBIDOPA
-Intra-Muscular
PA0748/021/002
Solution for
Injection
Solution for
Injection
Prolonged
Release
Capsules
Tablet Prolonged
Release
Transdermal
Limited
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Recordati
Industria Chimica
e Farmaceutica
SpA
Recordati
Industria Chimica
e Farmaceutica
SpA
Alliance
Pharmaceuticals
Ltd.
Eisai Ltd.
HALAVEN
-Intra-venous
30MU/0.5 Millilitr
GRISOL
HAEMOPRESSI
N
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Tablets
Brown & Burk UK
Ltd
GYNOXIN
EU/1/16/1137/00
1-005
Routes of
Administration
6C & 30C
GRISEOFULVIN
GYNODAKTARIN
GYNODAKTARIN
GYNO-PEVARYL
1 VAGINAL
GYNOXIN
PA0950/002/001
Legal Basis
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Janssen-Cilag
Ltd
Janssen-Cilag
Ltd
Tillomed
Laboratories
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Human Medicines Authorised/Transfer Pending Products
N05AD01
C07AA05
N04BA02
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Oromucosal
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Vaginal
Article 10(1) Generic
Application
-Intra-venous
-Per Oral
-Intra-Muscular
Page 207 of 608
Trade Name
Licence Holder Licence
Number
Strength
5 Mg/Ml
Dosage Form ATC
HALOPERIDOL
INJECTION BP
5MG/ML
HARPADOL
Mercury
Pharmaceuticals
(Ireland) Ltd
Laboratoires
ARKOPHARMA
PA0073/101/001
HARTMANN'S
Fresenius Kabi
Limited
PA0566/030/001
%v/v
Solution for
Infusion
B05BB01
HARTMANN'S
Fresenius Kabi
Limited
PA0566/030/002
%v/v
Solution for
Infusion
B05BB01
HARTMANN'S
Fresenius Kabi
Limited
PA0566/030/003
%v/v
Solution for
Infusion
B05BB01
HARTMANN'S
Fresenius Kabi
Limited
PA0566/030/004
%v/v
Solution for
Infusion
B05BB01
HARTMANN'S
Fresenius Kabi
Limited
PA0566/030/005
%v/v
Solution for
Infusion
B05BB01
HARTMANN'S
SOLUTION
COMPOUND
SODIUM
LACTATE
INTRAVENOUS
INFUSION BP
Maco Pharma
(UK) Ltd
PA0931/009/001
6/0.27/0.4 Grams
Solution for
Infusion
B05BB01
HARTMANN'S
SOLUTION
COMPOUND
SODIUM
LACTATE
INTRAVENOUS
INFUSION BP
Maco Pharma
(UK) Ltd
PA0931/009/003
Grams
Solution for
Infusion
B05BB01
HARVONI
Gilead Sciences
International
EU/1/14/958/001002
90\400 Milligram
Film Coated
Tablet
J05AX65
TR1450/001/001
Human Medicines Authorised/Transfer Pending Products
Solution for
Injection
N05AD01
Capsule
Active
Ingredients
Legal Basis
Routes of
Administration
-HALOPERIDOL
-DEVILS CLAW
SECONDARY
ROOTS
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
ANHYDROUS
-SODIUM
LACTATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
ANHYDROUS
-SODIUM
LACTATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
ANHYDROUS
-SODIUM
LACTATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
ANHYDROUS
-SODIUM
LACTATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
LACTATE
SOLUTION 50%
-SODIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-POTASSIUM
CHLORIDE
-SODIUM
LACTATE
SOLUTION 60%
-SODIUM
CHLORIDE
-CALCIUM
CHLORIDE
DIHYDRATE
-POTASSIUM
CHLORIDE
-SODIUM
LACTATE
SOLUTION 60%
-LEDIPASVIR
-SOFOSBUVIR
-Per Oral
Article 10a Bibliographical
App
-Intra-venous
Article 10a Bibliographical
App
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
Page 208 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
HAVRIX JUNIOR
MONDOSE
VACCINE
HEPATITIS A
VACCINE
HAVRIX
MONODOSE
VACCINE
GlaxoSmithKline
(Ireland) Limited
PA1077/026/001
720 Elisa Units
Suspension for
Injection
J07BC02
-HEPATIT A
VIRUS ANTIGEN
GlaxoSmithKline
(Ireland) Limited
PA1077/026/002
Elisa Units
Suspension for
Injection
J07BC02
HAY-CROM
Imbat Limited
PPA1151/120/00
1
2 %w/v
Eye Drops
Solution
S01GX01
HBVAXPRO
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Sanofi Pasteur
MSD Ltd
Reckitt Benckiser
Ireland Ltd
EU/1/01/183/004
5 Microgram
J07BC01
EU/1/01/183/005
5 Microgram
EU/1/01/183/008
10 Microgram/ML
EU/1/01/183/011
10 Microgram/ML
EU/1/01/183/013
10 Microgram/ML
EU/1/01/183/007
10 Microgram/ML
EU/1/01/183/015
40 Microgram/ML
EU/1/01/183/018025,30-31
EU/1/01/183/026029,32
EU/1/01/183/001
0.5ml
Microgram/ML
1 ml
Microgram/ML
0.5 Microgram
PA0979/045/001
1 %w/v
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Cream
-HEPATIT A
VIRUS ANTIGEN
-ALUMINIUM
HYDROXIDE
-SODIUM
CROMOGLICAT
E
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
-HEPATITIS B
VACCINE
HYDROCORTIS
ONE ACETATE
Chefaro Ireland
DAC
INFAI Institut fur
biomedizinish
INFAI Institut fur
biomedizinish
Bayer AG
PA1186/009/001
500 Milligram
N02BE01
-PARACETAMOL
EU/1/97/045/001
75 Milligram
V04CX
-13C-UREA
V04CX
-13C-UREA
B02BD02
Bayer AG
EU/1/00/144/003
Bayer AG
EU/1/00/144/001
Bayer AG
EU/1/00/144/004
Bayer AG
EU/1/00/144/005
Pierre Fabre
Dermatologie
EU/1/14/919/001
Film Coated
Tablet
Powder for Oral
Solution
Powder for Oral
Solution
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Oral Solution
Gambro Lundia
AB
PA0785/005/001
solution for
haemodialysis/h
aemofiltration
B05ZB
-FACTOR VIII,
RECOMBINANT
-FACTOR VIII,
RECOMBINANT
-FACTOR VIII,
RECOMBINANT
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-PROPRANOLOL
HYDROCHLORI
DE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-CALCIUM
CHLORIDE
DIHYDRATE
-LACTIC ACID
-SODIUM
HYDROGEN
CARBONATE
-SODIUM
CHLORIDE
HBVAXPRO
HBVAXPRO
HBVAXPRO
HBVAXPRO
HBVAXPRO
HBVAXPRO
HBVAXPRO
HBVAXPRO
HBVAXPRO
HC45
HYDROCORTIS
ONE ACETATE
CREAM
HEDEX
HELIOBACTER
TEST INFAI
HELIOBACTER
TEST INFAI
HELIXATE
NEXGEN
HELIXATE
NEXGEN
HELIXATE
NEXGEN
HELIXATE
NEXGEN
HELIXATE
NEXGEN
HEMANGIOL
HEMOSOL B0
EU/1/97/045/003
EU/1/00/144/002
Human Medicines Authorised/Transfer Pending Products
500 International
Unit
1000
International Unit
250IU
International Unit
2000
International Unit
3000
International Unit
3.75 Mg/Ml
J07BC01
J07BC01
J07BC01
J07BC01
J07BC01
J07BC01
J07BC01
J07BC01
J07BC01
D07AA02
B02BD02
B02BD02
B02BD02
B02BD02
C07AA05
Legal Basis
Routes of
Administration
PPA
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Intra-Muscular
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
Page 209 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
HEMOSOL B0
Gambro Lundia
AB
PA0785/005/002
HEPAR
SULFURIS
CALCAREUM
(HEPAR. SULF.)
HEPAR SULPH
Weleda (UK)
Limited
HOR0407/011/0
01
6C & 30C
Tablets
A. Nelson &
Company Limited
HOR1149/014/0
01
8X-MM
Pillules
HEPARIN
SODIUM 10
I.U./ML
FLUSHING
SOLUTION
HEPARIN
SODIUM BP
1000
Wockhardt UK
Limited
PA1339/010/001
10 IU/ML
B01AB01
Baxter
Healthcare
Limited
PA0167/067/001
1 IU/ML
Flushing solution
maintenance
patency
intravenous
devices
Solution for
Infusion
HEPARIN
SODIUM BP
2000
Baxter
Healthcare
Limited
PA0167/067/003
2 IU/ML
Solution for
Infusion
B01AB01
HEPARIN
SODIUM, 0.2ML
AMPOULES
HEPARIN
SODIUM, 10ML
AMPOULES
HEPARIN
SODIUM, 5 ML
VIALS
HEPARIN
SODIUM, 5 ML
VIALS
HEPARIN
SODIUM, 5ML
AMPOULES
HEPARIN
SODIUM, 5ML
VIALS
HEPATECT CP
Wockhardt UK
Limited
PA1339/009/005
25,000 IU/ML
B01AB01
Wockhardt UK
Limited
PA1339/009/004
1000 IU/ML
Wockhardt UK
Limited
PA1339/009/007
5000 IU/ML
Wockhardt UK
Limited
PA1339/009/008
25000 IU/ML
Wockhardt UK
Limited
PA1339/009/003
1000 IU/ML
Wockhardt UK
Limited
PA1339/009/006
1000 IU/ML
Biotest Pharma
GmbH
PA0592/005/004
50 IU/ML
Solution injection
or concentrate for
solution infusion
Solution injection
or concentrate for
solution infusion
Solution injection
or concentrate for
solution infusion
Solution injection
or concentrate for
solution infusion
Solution injection
or concentrate for
solution infusion
Solution injection
or concentrate for
solution infusion
Solution for
Infusion
HEPATYRIX
GlaxoSmithKline
(Ireland) Limited
PA1077/099/001
%v/v
Suspension for
Injection
J07CA10
HEPSERA
Gilead Sciences
International
Roche
Registration
Limited
Roche
Registration
Limited
EU/1/03/251/001
10mg Milligram
Tablets
J05AF08
EU/1/00/145/002
600 MG/5ml
Solution for
Injection
EU/1/00/145/001
Milligram
Pdr for Soln for
Infusion
HERCEPTIN
HERCEPTIN
150MG
Human Medicines Authorised/Transfer Pending Products
solution for
haemodialysis/h
aemofiltration
B05Z
B01AB01
Active
Ingredients
Legal Basis
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-CALCIUM
CHLORIDE
DIHYDRATE
-LACTIC ACID
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-HEPAR
SULFURIS
CALCAREUM
GHP
-HEPAR
SULPHURIS
CALCAREUM
-HEPARIN
SODIUM
Routes of
Administration
-Per Oral
-Per Oral
-HEPARIN
SODIUM
-SODIUM
CHLORIDE
-SODIUM
PHOSPHATE
-CITRIC ACID
MONOHYDRATE
-HEPARIN
SODIUM
-SODIUM
CHLORIDE
-SODIUM
PHOSPHATE
-HEPARIN
SODIUM
B01AB01
-HEPARIN
SODIUM
B01AB01
-HEPARIN
SODIUM
B01AB01
-HEPARIN
SODIUM
B01AB01
-HEPARIN
SODIUM
B01AB01
-HEPARIN
SODIUM
J06BB04
L01XC03
-HUMAN
PLASMA
PROTEIN >96%
IMMUNOGLOB
ULINS
-HEPATIT A
VIRUS ANTIGEN
-VI
POLYSACCHAR
IDE OF
SALMONELLA
TYPHI
-ADEFOVIR
DIPIVOXIL
-TRASTUZUMAB
L01XC03
-TRASTUZUMAB
Article 8(3) - Full
new Application
-Intra-venous
-Intra-Muscular
-Per Oral
Article 8(3) - Full
new Application
-Subcutaneous
-Intra-venous
Page 210 of 608
Trade Name
HETLIOZ
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Vanda
Pharmaceuticals
Limited
GUERBET
EU/1/15/1008/00
1
20 Milligram
Capsules Hard
N05CH03
-TASIMELTEON
PA0686/006/001
320 Base mg/ml
Solution for
Injection
V08AB11
HEXACIMA
Sanofi Pasteur
SA
EU/1/13/828/001007
0.5 Millilitre
Suspension for
Injection
J07CA09
HEXVIX
Ipsen
Pharmaceuticals
Limited
PA0869/007/001
85 Milligram
Pdr+Solv/Soln/In
travesical Use
V04CX
HEXYON
Sanofi Pasteur
Europe
EU/1/13/829/001007
0.5 Millilitre
Suspension for
Injection
J07CA09
-IODINE
-IOXAGLATE
SODIUM
-IOXAGLATE
MEGLUMINE
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN
-TYPE 1
(MAHONEY)
-TYPE 2 (MEF-1)
-TYPE 3
(SAUKETT)
-HAEMOPHILUS
INFLUENZAE
TYPE B
CAPSULAR
POLYSACCHAR
IDE
(POLYRIBOSYL
RIBITOL
PHOSPHATE)
CONJUGATED
TO TETANOUS
PROTEIN
-HEPATITIS B
SURFACE
ANTIGEN
HEXAMINOLEV
ULINATE
HYDROCHLORI
DE
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN
-TYPE 1
(MAHONEY)
-TYPE 2 (MEF-1)
-TYPE 3
(SAUKETT)
-HEPATITIS B
SURFACE
ANTIGEN
-HAEMOPHILUS
INFLUENZAE
TYPE B
POLYSACCHAR
IDE
(POLYRIBOSYL
RIBITOL
PHOSPHATE)
CONJUGATED
TO TETANOUS
PROTEIN
HEXABRIX
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Intra-Muscular
-Intra Vesical
Article 8(3) - Full
new Application
-Intra-Muscular
Page 211 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
HIBERIX.
HAEMOPHILUS
TYPE B (HIB)
VACCINE
GlaxoSmithKline
(Ireland) Limited
PA1077/027/001
N/A
Pdr+Solv for Soln
for Inj
J07AG51
HIBISCRUB
Regent Medical
Overseas Limited
PA1218/001/001
4.0 %w/v
Cutaneous
Solution
D08AC02
HIDRASEC
Bioproject Europe
Ltd
Bioproject Europe
Ltd
Bioproject Europe
Ltd
Novartis
Europharm
Limited
Novartis
Europharm
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Fannin Limited
PA1714/001/001
100 Milligram
Capsules Hard
A07XA04
PA1714/001/003
30 Milligram
A07XA04
PA1714/001/002
10 Milligram
EU/1/09/594/1-5
150 Microgram
Granules for Oral
Suspension
Granules for Oral
Suspension
Inhalation
Powder, Capsule
EU/1/09/594/6-10
300 Microgram
Inhalation
Powder, Capsule
R03AC18
-INDACATEROL
MALEATE
-Inhalation
PA0577/046/001
10 Milligram
Coated Tablets
R06AX13
-LORATADINE
-Per Oral
PA1457/012/002
10 Milligram
Film Coated
Tablet
R06AE07
-CETIRIZINE
DIHYDROCHLO
RIDE
-Per Oral
10 Milligram
Film Coated
Tablet
R06AE07
-CETIRIZINE
DIHYDROCHLO
RIDE
-Per Oral
200 Mg/Ml
Solution for
Injection
J06BA01
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
-AGNUS
CASTUS
EXTRACT (AS
DRY ROOT)
FROM AGNUS
CASTUS FRUIT
(VITEX AGNUSCASTUS L)
-ST. JOHN'S
WORT DRY
EXTRACT (AS
DRY EXTRACT)
FROM ST.
JOHN'S WORT
AERIAL PART
(HYPERICUM
PERFORATUM
L)
-MILK THISTLE
EXTRACT (AS
DRY ROOT)
-DEVIL'S CLAW
EXTRACT (AS
DRY ROOT)
-ECHINACEA
ROOT EXTRACT
(AS DRY ROOT)
FROM
ECHINACEA
ROOT
(ECHINACEA
PURPUREA L)
-DRY EXTRACT
FROM MELISSA
OFFICINALIS L.
FOLIUM (LEMON
BALM LEAF)
-Subcutaneous
HIDRASEC
CHILDREN
HIDRASEC
INFANTS
HIROBRIZ
BREEZHALER
HIROBRIZ
BREEZHALER
HISTACLAR
HISTEK
HISTEK
ALLERGY 10 MG
FILM-COATED
TABLETS
HIZENTRA
Fannin Limited
Interchangeable
List Code:
IC0088-002-003
PA1457/012/001
CSL Behring
GmbH
EU/1/11/687/00112
HOLLAND &
BARRETT
AGNUS CASTUS
PMS RELIEF
Holland & Barrett
International
Limited
TR1563/007/001
Tablets
HOLLAND &
BARRETT
HYPERICUM
Holland & Barrett
International
Limited
TR1563/002/002
Capsules Hard
HOLLAND &
BARRETT MILK
THISTLE
HOLLAND AND
BARRETT
DEVIL'S CLAW
HOLLAND AND
BARRETT
ECHINACEA
COLD AND FLU
Holland & Barrett
International
Limited
Holland & Barrett
International
Limited
Holland & Barrett
International
Limited
TR1563/027/001
Capsules Hard
TR1563/006/001
Capsules Hard
TR1563/005/001
Capsules Hard
HOLLAND AND
BARRETT
LEMON BALM
Holland & Barrett
International
Limited
TR1563/004/001
Human Medicines Authorised/Transfer Pending Products
245 Milligram
Capsules Hard
A07XA04
R03AC18
-HAEMOPHILUS
INFLUENZAE
TYPE B
POLYSACCHAR
IDE
-TETANUS
TOXOID
CHLORHEXIDIN
E GLUCONATE
RACECADOTRIL
RACECADOTRIL
RACECADOTRIL
-INDACATEROL
MALEATE
Legal Basis
-Intra-Muscular
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Inhalation
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 212 of 608
Trade Name
Licence Holder Licence
Number
HOLLAND AND
BARRETT
VALERIAN
HOLOCLAR
Holland & Barrett
International
Limited
Chiesi
Farmaceutici
S.p.A.
TR1563/001/001
EU/1/14/987/001
HRF
(GONADORELI
N)
HUMALOG
HUMALOG
VIALS
HUMAN
ALBUMIN
BAXALTA
Intrapharm
Laboratories
Limited
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly and
Company Limited
Baxalta
Innovations
GmbH
HUMAN
ALBUMIN
BAXALTA
Strength
Dosage Form ATC
Active
Ingredients
Unknown
N05CM09
-VALERIAN DRY
ROOT EXTRACT
79,000-316,000
Unknown
S01XA19
PA0997/005/001
100 Microgram
Pdr+Solv for Soln
for Inj
H01CA01
-EX VIVO
EXPANDED
AUTOLOGOUS
CORNEAL
EPITHELIAL
CELLS
CONTAINING
STEM CELLS
-GONADORELIN
EU/1/96/007/019
100 Units/ml
A10AB04
EU/1/96/007/039042
EU/1/96/007/004
200 Units/ml
EU/1/96/007/005
100 Units/ml
EU/1/96/007/008
100 Units/ml
EU/1/96/007/006
100 Units/ml
EU/1/96/007/010
100 Units/ml
EU/1/96/007/002
PA2004/004/001
100 International
Unit
50 g/l
Solution for
Injection
Solution for
Injection
Solution for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Solution for
Injection
Solution for
Infusion
Baxalta
Innovations
GmbH
PA2004/004/002
200 g/l
Solution for
Infusion
B05AA01
HUMAN
ALBUMIN
GRIFOLS
HUMAN
ALBUMIN
GRIFOLS
HUMIRA
Instituto Grifols
S.A.
PA0849/002/002
50 g/l
Solution for
Infusion
B05AA01
Instituto Grifols
S.A.
PA0849/002/001
200 g/l
Solution for
Infusion
B05AA01
-HUMAN
ALBUMIN
AbbVie Limited
EU/1/03/256/1-10
40 mg Milligram
L04AB04
-ADALIMUMAB
HUMIRA
AbbVie Limited
EU/1/03/256/020
80 Milligram
L04AB04
-ADALIMUMAB
HUMULIN I
(ISOPHANE)
HUMULIN I
(ISOPHANE)
HUMULIN I
(ISOPHANE)
CARTRIDGE
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
PA0047/059/006
100 IU/ML
A10AC01
PA0047/059/003
100 IU/ML
PA0047/059/008
100 IU/ML
Solution for
Injection
Solution for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
HUMULIN I
(ISOPHANE)
VIAL
Eli Lilly and
Company Limited
PA0047/059/007
100 IU/ML
Suspension for
Injection
A10AC01
HUMULIN I
KWIKPEN
(ISOPHANE)
Eli Lilly and
Company Limited
PA0047/088/002
100 IU/ML
Suspension for
Injection
A10AC01
HUMULIN I
KWIKPEN
(ISOPHANE)
HUMULIN M3
(MIXTURE 3)
HUMULIN M3
(MIXTURE 3)
Eli Lilly and
Company Limited
PA0047/088/001
100 IU/ML
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-INSULIN
HUMAN
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-INSULIN
HUMAN
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
PA0047/069/002
100 IU/ML
A10AD01
PA0047/069/004
100 IU/ML
Suspension for
Injection
Suspension for
Injection
HUMALOG
HUMALOG 3ML
HUMALOG
MIX25
HUMALOG
MIX25
HUMALOG
MIX50
HUMALOG NPL
Human Medicines Authorised/Transfer Pending Products
100 Units/ml
Legal Basis
Routes of
Administration
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
-INSULIN
LISPRO
A10AB04
A10AB04
A10AD04
A10AD04
A10AD04
A10AD04
A10AB04
B05AA01
A10AC01
A10AC01
A10AD01
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-PLASMA
PROTEIN
CONTAINING AT
LEAST 95%
HUMAN
ALBUMIN
-PLASMA
PROTEIN
CONTAINING AT
LEAST 95%
HUMAN
ALBUMIN
-ALBUMIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
Page 213 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
HUMULIN M3
(MIXTURE 3)
CARTRIDGE
Eli Lilly and
Company Limited
PA0047/069/006
100 IU/ML
Suspension for
Injection
A10AD01
HUMULIN M3
(MIXTURE 3)
VIAL
Eli Lilly and
Company Limited
PA0047/069/005
100 IU/ML
Suspension for
Injection
A10AD01
HUMULIN M3
KWIKPEN
(MIXTURE 3)
Eli Lilly and
Company Limited
PA0047/092/002
100 IU/ML
Suspension for
Injection
A10AD01
HUMULIN M3
KWIKPEN
(MIXTURE 3)
HUMULIN S
(SOLUBLE)
Eli Lilly and
Company Limited
PA0047/092/001
100 IU/ML
Suspension for
Injection
A10AD01
Eli Lilly and
Company Limited
PA0047/058/005
100 IU/ML
Solution for
Injection
A10AB01
-INSULIN
HUMAN
HUMULIN S
(SOLUBLE)
HUMULIN S
(SOLUBLE)
CARTRIDGE
Eli Lilly and
Company Limited
Eli Lilly and
Company Limited
PA0047/058/003
100 IU/ML
A10AB01
PA0047/058/007
100 IU/ML
Solution for
Injection
Solution for
Injection
HUMULIN S
(SOLUBLE) VIAL
Eli Lilly and
Company Limited
PA0047/058/006
100 IU/ML
Solution for
Injection
A10AB01
HYALGAN
PREFILLED
SYRINGE
HYALURONIDA
SE
Fidia
Farmaceutici
S.p.A.
Wockhardt UK
Limited
PA0814/001/001
20mg/2ml Mg/Ml
Solution for
Injection
M09AX01
-INSULIN
HUMAN
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-HYALURONATE
SODIUM
PA1339/011/001
1500
International Unit
Pdr for Soln
Inj/Inf
B06AA03
HYCAMTIN
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
EU/1/96/027/006
0.25 Milligram
Capsules Hard
L01XX17
EU/1/96/027/007
1 Milligram
Capsules Hard
L01XX17
EU/1/96/027/001
4 Milligram
Pdr for Soln for
Infusion
L01XX17
EU/1/96/027/003
4 Milligram
Pdr for Soln for
Infusion
L01XX17
EU/1/96/027/004
1mg/1ml
International Unit
Pdr for Soln for
Infusion
L01XX17
HYCAMTIN
Novartis
Europharm
Limited
EU/1/96/027/005
1mg/1ml
International Unit
Pdr for Soln for
Infusion
L01XX17
HYDREA
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Ecolab Limited
PA0002/027/001
500 Milligram
Capsules Hard
L01XX05
PA1110/004/001
4 %w/v
Cutaneous
Solution
D08AC02
CHLORHEXIDIN
E GLUCONATE
PA0943/014/001
%w/w
Unknown
D02AX
-NO ACTIVE
LISTED
HYDROCORTIS
ONE
Alliance
Pharmaceuticals
Ltd.
Amdipharm
Limited
PA1142/019/001
10 Milligram
Tablets
H02AB09
HYDROCORTIS
ONE
Amdipharm
Limited
PA1142/019/002
20 Milligram
Tablets
H02AB09
HYDROCORTIS
ONE
HYDROCORTIS
ONE
HYCAMTIN
HYCAMTIN
HYCAMTIN
HYCAMTIN
HYDREX
SURGICAL
SCRUB 4.0%
W/V
CUTANEOUS
SOLUTION
HYDROBATH
EMOLLIENT
Human Medicines Authorised/Transfer Pending Products
A10AB01
Legal Basis
Routes of
Administration
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-HUMAN
INSULIN
(RECOMBINANT
DNA ORIGIN)
-INSULIN
HUMAN
HYALURONIDA
SE
-TOPOTECAN
HYDROCHLORI
DE
-TOPOTECAN
HYDROCHLORI
DE
-TOPOTECAN
HYDROCHLORI
DE
-TOPOTECAN
HYDROCHLORI
DE
-TOPOTECAN
(AS
HYDROCHLORI
DE)
-TOPOTECAN
(AS
HYDROCHLORI
DE)
HYDROXYCAR
BAMIDE
-Intra-Muscular
-Intra-venous
-Subcutaneous
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Intra-venous
-Intra-venous
-Topical
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
Page 214 of 608
Trade Name
HYDROCORTIS
ONE 1 % W/W
CREAM
HYDROCORTIS
YL SKIN CREAM
1%
HYDROCORTIS
YL SKIN
OINTMENT 1%
HYDROCORTO
NE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Ovelle Limited
PA0206/030/001
1 %w/w
Cream
D07AA02
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Auden Mckenzie
(Pharma Division)
Ltd
Martindale
Pharmaceuticals
Ltd
PA0540/046/001
1.0 %w/w
Cream
D07AA02
PA0540/046/002
1.0 %w/w
Ointment
D07AA02
PA1352/013/001
10 Milligram
Tablets
H02AB09
PA0361/018/001
20 Mg/Ml
Solution for
Injection and
Concentrate for
Infusion
N02AA03
HYDROMORPH
ONE
HYDROCHLORI
DE
Martindale
Pharmaceuticals
Ltd
PA0361/018/002
50 Mg/Ml
Solution for
Injection and
Concentrate for
Infusion
N02AA03
HYOSCINE
PA0361/017/001
400
Microgram/ML
Solution for
Injection
A04AD
PA0361/017/002
600
Microgram/ML
Solution for
Injection
A04AD
HOR1149/015/0
01
HOR0407/030/0
01
PA0407/024/001
6C-MM N/A
HYPERICUM/C
ALENDULA
Martindale
Pharmaceuticals
Ltd
Martindale
Pharmaceuticals
Ltd
A. Nelson &
Company Limited
Weleda (UK)
Limited
Weleda (UK)
Limited
HYPNOVEL
AMPOULES
Roche Products
Limited
HYPNOVEL
AMPOULES
HYPOLOC
HYDROMORPH
ONE
HYDROCHLORI
DE
HYOSCINE
HYPERICUM
HYPERICUM
HYPOLOC PLUS
6C & 30C
Tablets
%v/v
Ointment
PA0050/061/001
10 mg/2ml
Solution for
Injection
N05CD08
Roche Products
Limited
PA0050/061/002
10 MG/5ml
Solution for
Injection
N05CD08
Menarini
International
Operations
Luxembourg S.A.
PA0865/010/001
5 Milligram
Tablets
C07AB12
Interchangeable
List Code:
IC0082-001-002
PA0865/016/001
5/12.5 Milligram
Film Coated
Tablet
C07BB12
PA0865/016/002
5/25 Milligram
Film Coated
Tablet
C07BB12
PA0019/023/001
1 mg Milligram
Tablets
C02CA01
HYPOVASE
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Pfizer Limited
HYPOVASE
Pfizer Limited
PA0019/023/004
0.5 mg Milligram
Tablets
C02CA01
HYQVIA
Baxter
EU/1/13/840/001
100 Mg/Ml
Solution for
Infusion
J06BA02
HYTRIN
PCO
Manufacturing
PPA0465/161/00
1
2 Milligram
Tablets
G04CA03
HYTRIN
PCO
Manufacturing
PPA0465/161/00
2
5 Milligram
Tablets
G04CA03
HYPOLOC PLUS
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
HYDROCORTIS
ONE
HYDROCORTIS
ONE
HYDROCORTIS
ONE
HYDROCORTIS
ONE
HYDROMORPH
ONE
HYDROCHLORI
DE
HYDROMORPH
ONE
HYDROCHLORI
DE
-HYOSCINE
HYDROBROMID
E
-HYOSCINE
HYDROBROMID
E
-HYPERICUM
PERFORATUM
-HYPERICUM
PERFORATUM
-HYPERICUM
PERFORATUM
-CALENDULA
OFFICINALIS
-MIDAZOLAM
HYDROCHLORI
DE
-MIDAZOLAM
HYDROCHLORI
DE
-NEBIVOLOL
-NEBIVOLOL
HYDROCHLOR
OTHIAZIDE
-NEBIVOLOL
HYDROCHLOR
OTHIAZIDE
-PRAZOSIN
HYDROCHLORI
DE
-PRAZOSIN
HYDROCHLORI
DE
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
-RECOMBINANT
HUMAN
HYALURONIDA
SE
-TERAZOSIN
HYDROCHLORI
DE
-TERAZOSIN
HYDROCHLORI
DE
Routes of
Administration
-Topical
-Cutaneous
-Per Oral
-Intra-Muscular
-Intra-venous
-Subcutaneous
-Intra-Muscular
-Intra-venous
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Per Oral
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Subcutaneous
PPA
-Per Oral
PPA
-Per Oral
Page 215 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
HYTRIN
PCO
Manufacturing
PPA0465/161/00
3
10 Milligram
Tablets
G04CA03
HYTRIN
Amdipharm
Limited
PA1142/005/002
2 Milligram
Tablets
G04CA03
HYTRIN
Amdipharm
Limited
PA1142/005/003
5 Milligram
Tablets
G04CA03
HYTRIN
Amdipharm
Limited
PA1142/005/004
10 Milligram
Tablets
G04CA03
HYTRIN
(STARTER
PACK)
Amdipharm
Limited
PA1142/005/001
1 and 2 Milligram
Tablets
G04CA03
IASIBON
Pharmathen S.A.
EU/1/10/659/001002&8-10
50 Milligram
Film Coated
Tablet
M05BA06
IASIBON
Pharmathen S.A.
EU/1/10/659/003
1 Milligram
Concentrate for
Soln for Inf
M05BA06
-IBANDRONIC
ACID
IASIBON
Pharmathen S.A.
EU/1/10/659/004
2 Milligram
Concentrate for
Soln for Inf
M05BA06
-IBANDRONIC
ACID
IASIBON
Pharmathen S.A.
EU/1/10/659/005007
6 Milligram
Concentrate for
Soln for Inf
M05BA06
-IBANDRONIC
ACID
IBANDRONIC
ACID
Noridem
Enterprises Ltd
PA1122/018/001
6 Milligram
Concentrate for
Soln for Inf
M05BA06
IBANDRONIC
ACID ACCORD
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
EU/1/12/798/001
2 Milligram
Concentrate for
Soln for Inf
M05BA06
EU/1/12/798/002004
6 Milligram
Concentrate for
Soln for Inf
M05BA06
EU/1/12/798/005006
3 Milligram
Solution for
Injection
M05BA06
IBANDRONIC
ACID CLONMEL
Clonmel
Healthcare Ltd
PA0126/240/001
150 Milligram
Film Coated
Tablet
M05BA06
IBANDRONIC
ACID LICONSA
Laboratorios
LICONSA, S.A.
PA1239/013/001
150 Base
Milligrams
Film Coated
Tablet
M05BA06
IBANDRONIC
ACID MYLAN
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Roche
Registration
Limited
PA0577/111/001
150 Milligram
Film Coated
Tablet
M05BA06
-IBANDRONATE
SODIUM
MONOHYDRATE
-IBANDRONATE
SODIUM
MONOHYDRATE
-IBANDRONATE
SODIUM
MONOHYDRATE
-IBANDRONATE
SODIUM
MONOHYDRATE
-IBANDRONATE
SODIUM
-IBANDRONIC
ACID
-IBANDRONATE
SODIUM
MONOHYDRATE
-IBANDRONIC
SODIUM
MONOHYDRATE
-IBANDRONIC
SODIUM
MONOHYDRATE
EU/1/03/266/01-2
2.5 mg Milligram
Tablets
M05BA06
-IBANDRONIC
ACID
Sandoz GmbH
EU/1/11/685/001005
50 Milligram
Film Coated
Tablet
M05BA06
-IBANDRONIC
ACID
IBANDRONIC
ACID TEVA
Teva B.V.
EU/1/10/642/001002
50 Milligram
Film Coated
Tablet
M05BA06
-IBANDRONIC
ACID
IBANDRONIC
ACID TEVA
Teva B.V.
EU/1/10/642/003004
150 Milligram
Film Coated
Tablet
M05BA06
-IBANDRONIC
ACID
IBLIAS
Bayer AG
Bayer AG
250 International
Unit
500 International
Unit
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
B02BD02
IBLIAS
EU/1/15/1077/00
1
EU/1/15/1077/00
2
-OCTOCOG
ALFA
-OCTOCOG
ALFA
IBANDRONIC
ACID ACCORD
IBANDRONIC
ACID ACCORD
IBANDRONIC
ACID ROCHE
2.5MG FILMCOATED
TABLETS
IBANDRONIC
ACID SANDOZ
Human Medicines Authorised/Transfer Pending Products
B02BD02
-TERAZOSIN
HYDROCHLORI
DE
-TERAZOSIN
HYDROCHLORI
DE DIHYDRATE
-TERAZOSIN
HYDROCHLORI
DE DIHYDRATE
-TERAZOSIN
HYDROCHLORI
DE DIHYDRATE
-TERAZOSIN
HYDROCHLORI
DE DIHYDRATE
-TERAZOSIN
HYDROCHLORI
DE DIHYDRATE
-IBANDRONIC
ACID
Legal Basis
Routes of
Administration
PPA
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
Page 216 of 608
Trade Name
Licence Holder Licence
Number
IBLIAS
Bayer AG
IBLIAS
Bayer AG
IBLIAS
Bayer AG
IBRANCE
Pfizer Limited
IBRANCE
Pfizer Limited
IBRANCE
Pfizer Limited
IBUGEL
Dermal
Laboratories Ltd
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
The Boots
Company Plc
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
EU/1/15/1077/00
3
EU/1/15/1077/00
4
EU/1/15/1077/00
5
EU/1/16/1147/00
1-002
EU/1/16/1147/00
3-004
EU/1/16/1147/00
5-006
PA0278/020/001
1000
International Unit
2000
International Unit
3000
International Unit
75 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Capsules Hard
B02BD02
L01XE33
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-PALBOCICLIB
100 Milligram
Capsules Hard
L01XE33
-PALBOCICLIB
125 Milligram
Capsules Hard
L01XE33
-PALBOCICLIB
5 %w/w
Gel
M02AA13
-IBUPROFEN
PA1390/104/001
200 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA1390/104/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA1390/104/003
600 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA0004/066/001
200/12.8
Milligram
Film Coated
Tablet
M01AE51
Rowex Ltd
PA0711/205/001
100 MG/5ml
Oral Suspension
M01AE01
-IBUPROFEN
-CODEINE
PHOSPHATE
HEMIHYDRATE
-IBUPROFEN
Galpharm
Healthcare
Limited
Galpharm
Healthcare
Limited
McNeil
Healthcare
(Ireland) Ltd
PA1754/001/001
200 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA1754/001/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
PA0823/067/001
200/30 Milligram
Film Coated
Tablet
R05X
-IBUPROFEN
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Incyte Bioscience
UK Ltd
Incyte Bioscience
UK Ltd
Incyte Bioscience
UK Ltd
Krka d.d., Novo
mesto
EU/1/08/484/1-6
& 13-15
50/850 Milligram
Film Coated
Tablet
A10BD08
-Per Oral
EU/1/08/484/712, 16-18
50/1000 Milligram
Film Coated
Tablet
A10BD08
-Per Oral
EU/1/13/839/006
30 Milligram
L01XE24
-PONATINIB HCI
EU/1/13/839/001002
EU/1/13/839/003004
PA1347/022/001
15 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Tablet Prolonged
Release
L01XE24
-PONATINIB HCI
L01XE24
-PONATINIB HCI
C03BA11
-INDAPAMIDE
ICTASTAN
Actavis Group
PTC ehf
PA1380/191/001
200/245 Milligram
Film Coated
Tablet
J05AR03
IDELVION
CSL Behring
GmbH
CSL Behring
GmbH
CSL Behring
GmbH
CSL Behring
GmbH
Primecrown 2010
Ltd
EU/1/16/1095/00
1
EU/1/16/1095/00
4
EU/1/16/1095/00
3
EU/1/16/1095/00
2
PPA1633/033/00
1
250 International
Unit
2000
International Unit
1000
International Unit
500 International
Unit
500/400IU
Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Tablets
Chewable
B02BD
-TENOFOVIR
DISOPROXIL
EMTRICITABINE
-RIX-FP
B02BD
-RIX-FP
B02BD
-RIX-FP
B02BD
-RIX-FP
A12AX
-CALCIUM
CARBONATE
COLECALCIFE
ROL
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBUPROFEN
AND CODEINE
200 MG/ 12.8 MG
FILM-COATED
IBUPROFEN
FOR CHILDREN
IBUPROFEN
GALPHARM
IBUPROFEN
GALPHARM
MAX
IBUPROFEN/PS
EUDOEPHEDRI
NE
HYDROCHLORI
DE
ICANDRA
ICANDRA
ICLUSIG
ICLUSIG
ICLUSIG
ICORVIDA SR
IDELVION
IDELVION
IDELVION
IDEOS
Human Medicines Authorised/Transfer Pending Products
45 Milligram
1.5 Milligram
B02BD02
B02BD02
-Intra-venous
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
Page 217 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
IDEOS
Imbat Limited
PPA1151/202/00
1
500mg/400 IU
Milligram
Tablets
Chewable
A12AX
IDEOS
LTT Pharma
Limited
PPA1562/078/00
1
500/400IU
Milligram
Tablets
Chewable
A12AX
IDEOS
Laboratoire
Innotech
International
PA1033/001/001
500/400IU
Milligram
Tablets
Chewable
A12AX
IDEOS 500
MG/400 IU
CHEWABLE
TABLETS
PCO
Manufacturing
PPA0465/128/00
1
500 mg/400 IU
Base Milligrams
Tablets
Chewable
A12AX
IDFLU
Sanofi Pasteur
SA
EU/1/08/507/001003
9 Microgram
Suspension for
Injection
J07BB02
IDFLU
Sanofi Pasteur
SA
EU/1/08/507/004006
15 Microgram
Suspension for
Injection
J07BB02
IDROLAX
Ipsen Limited
PA0583/006/001
10 Grams
A06AD15
IELMAG3
Imaging
Equipment
Limited
Krka d.d., Novo
mesto
PA1803/001/001
0.2 Milligram
EU/1/11/673/009016
300mg/12.5mg
Milligram
Powder for Oral
Solution
Kit for
radiopharmaceut
ical preparation
Film Coated
Tablet
IFIRMACOMBI
Krka d.d., Novo
mesto
EU/1/11/673/001008
150/12.5
Milligram
Film Coated
Tablet
C09DA04
IFIRMACOMBI
Krka d.d., Novo
mesto
EU/1/11/673/017024
300/25 Milligram
Film Coated
Tablet
C09DA04
IFIRMASTA
Krka d.d., Novo
mesto
EU/1/08/480/1-6
75 Milligram
Film Coated
Tablet
C09CA04
IFIRMASTA
Krka d.d., Novo
mesto
EU/1/08/480/7-12
150 Milligram
Film Coated
Tablet
C09CA04
IFIRMASTA
Krka d.d., Novo
mesto
EU/1/08/480/1318
300 Milligram
Film Coated
Tablet
C09CA04
IFIRMACOMBI
Human Medicines Authorised/Transfer Pending Products
V09CA03
C09DA04
Active
Ingredients
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-A/NEW
CALEDONIA/20/
99 (H1H1)-LIKE
STRAIN
A/WISCONSIN/6
7/2005 (H3N2)
LIKE STRAIN
B/MALAYSIA/25
06/2004 LIKE
STRAIN
-A/NEW
CALEDONIA/20/
99 (H1H1)-LIKE
STRAIN
A/WISCONSIN/6
7/2005 (H3N2)
LIKE STRAIN
B/MALAYSIA/25
06/2004 LIKE
STRAIN
-MACROGOL
4000
-MERTIATIDE
-IRBESARTAN
HYDROCHLORI
DE
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLORI
DE
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLORI
DE
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLORI
DE
-IRBESARTAN
HYDROCHLORI
DE
-IRBESARTAN
HYDROCHLORI
DE
Legal Basis
Routes of
Administration
-Per Oral
PPA
-Per Oral
-Per Oral
PPA
-Per Oral
-Intra-dermal
-Intra-dermal
-Per Oral
Article 10a Bibliographical
App
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 218 of 608
Trade Name
IGNATIA
Licence Holder Licence
Number
IKERVIS
Weleda (UK)
Limited
A. Nelson &
Company Limited
Santen OY
IKOREL
Imbat Limited
IKOREL
Imbat Limited
IKOREL
PCO
Manufacturing
PCO
Manufacturing
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Rayner
Pharmaceuticals
Limited
Alimera Sciences
Limited
IGNATIA
IKOREL
IKOREL
IKOREL
ILARIS
ILARIS
ILARIS
ILUBE
ILUVIEN
Strength
Dosage Form ATC
Active
Ingredients
HOR0407/029/0
01
HOR1149/016/0
01
EU/1/15/990/001002
PPA1151/160/00
1
PPA1151/160/00
2
PPA0465/103/00
1
PPA0465/103/00
2
PA0540/102/001
6C & 30C
Tablets
6C-MM %v/v
Pillules
1 Mg/Ml
S01XA18
10 Milligram
Eye Drops
Emulsion
Tablets
-STRYCHNOS
IGNATII
-STRYCHNOS
IGNATII
-CICLOSPORIN
C01DX16
20 Milligram
Tablets
10 Milligram
C01DX16
-NICORANDIL
PPA
-Per Oral
Tablets
C01DX16
-NICORANDIL
PPA
-Per Oral
20 Milligram
Tablets
C01DX16
-NICORANDIL
PPA
-Per Oral
10 Milligram
Tablets
C01DX16
-NICORANDIL
-Per Oral
PA0540/102/002
20 Milligram
Tablets
C01DX16
-NICORANDIL
-Per Oral
EU/1/09/564/003
150 Milligram
Pdr+Solv for Soln
for Inj
L04AC08
-CANAKINUMAB
EU/1/09/564/1-2
150 Micromol
Pdr for Soln for
Injection
L04AC08
-CANAKINUMAB
EU/1/09/564/004
150 Mg/Ml
Solution for
Injection
L04AC08
-CANAKINUMAB
PA2161/002/001
5 %w/v
Eye Drops
Solution
S01XA08
PA1953/001/001
190 Microgram
ACETYLCYSTEI
NE
FLUOCINOLONE
ACETONIDE
-PARACETAMOL
-CAFFEINE
BROMPHENIRA
MINE MALEATE
-IMATINIB
MESILATE
S01BA15
325 / 30 / 3
Milligram
Film Coated
Tablet
R06AB51
IMATINIB
Cipla (EU)
Limited
PA1809/017/001
100 Milligram
Capsules Hard
L01X
IMATINIB
Cipla (EU)
Limited
PA1809/017/002
400 Milligram
Capsules Hard
L01X
-IMATINIB
MESILATE
IMATINIB
Wockhardt UK
Limited
PA1339/060/001
100 Milligram
Film Coated
Tablet
L01X
-IMATINIB
IMATINIB
Wockhardt UK
Limited
PA1339/060/002
400 Milligram
Film Coated
Tablet
L01X
-IMATINIB
IMATINIB
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Generics (UK)
Limited
EU/1/13/845/001008
100 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESYLATE
EU/1/13/845/009014
400 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESYLATE
PA0405/095/001
100 Milligram
Film Coated
Tablet
-IMATINIB
MESILATE
IMATINIB
Generics (UK)
Limited
PA0405/095/002
400 Milligram
Film Coated
Tablet
-IMATINIB
MESILATE
IMATINIB
Fresenius Kabi
Deutschland
GmbH
Fresenius Kabi
Deutschland
GmbH
Actavis Group
PTC ehf
PA2059/002/001
100 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESILATE
PA2059/002/002
400 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESILATE
EU/1/13/825/019023
400 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESYLATE
IMATINIB
ACTAVIS
-Per Oral
-NICORANDIL
PA0417/018/001
IMATINIB
-Per Oral
-Ocular
Seven Seas Ltd
IMATINIB
Routes of
Administration
Article 8(3) - Full
new Application
PPA
ILVICO
IMATINIB
Legal Basis
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
-Per Oral
-Subcutaneous
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
-Ocular
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 219 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
IMATINIB
ACTAVIS
Actavis Group
PTC ehf
EU/1/13/825/001002
50 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESYLATE
IMATINIB
ACTAVIS
Actavis Group
PTC ehf
EU/1/13/825/015018
400 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESYLATE
IMATINIB
ACTAVIS
Actavis Group
PTC ehf
EU/1/13/825/008014
100 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESYLATE
IMATINIB
ACTAVIS
Actavis Group
PTC ehf
EU/1/13/825/003007
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESYLATE
IMATINIB
ACTAVIS
GROUP
IMATINIB
ACTAVIS
GROUP
IMATINIB
CLONMEL
Actavis Group
PTC ehf
PA1380/164/001
100 Milligram
Film Coated
Tablet
L01X
-IMATINIB
MESILATE
Actavis Group
PTC ehf
PA1380/164/002
400 Milligram
Film Coated
Tablet
L01X
-IMATINIB
MESYLATE
Clonmel
Healthcare Ltd
PA0126/256/001
100 Milligram
Film Coated
Tablet
L01X
-IMATINIB
MESYLATE
IMATINIB
CLONMEL
Clonmel
Healthcare Ltd
PA0126/256/002
400 Milligram
Film Coated
Tablet
L01X
-IMATINIB
MESYLATE
IMATINIB KRKA
D.D.
IMATINIB KRKA
D.D.
IMATINIB
MEDAC
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Rowex Ltd
PA1347/054/001
100 Milligram
L01XE01
PA1347/054/002
400 Milligram
EU/1/13/876/001
100 Milligram
Film Coated
Tablet
Film Coated
Tablet
Capsules Hard
-IMATINIB
MESILATE
-IMATINIB
MESILATE
-IMATINIB
MESILATE
EU/1/13/876/002
400 Milligram
Capsules Hard
L01XE01
PA0711/248/001
100 Milligram
Film Coated
Tablet
IMATINIB
ROWEX
Rowex Ltd
PA0711/248/002
400 Milligram
IMATINIB TEVA
Teva B.V.
EU/1/12/808/001012
IMATINIB TEVA
Teva B.V.
IMATINIB TEVA
L01XE01
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-IMATINIB
MESILATE
Article 10(1) Generic
Application
-Per Oral
L01XE01
-IMATINIB
MESILATE
-Per Oral
Film Coated
Tablet
L01XE01
-IMATINIB
MESILATE
100 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESILATE
EU/1/12/808/033040
400 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
Teva B.V.
EU/1/12/808/021032
100 Milligram
Capsules Hard
L01XE01
-IMATINIB
MESILATE
IMATINIB TEVA
Teva B.V.
EU/1/12/808/013020
400 Milligram
Film Coated
Tablet
L01XE01
-IMATINIB
MESILATE
IMBRUVICA
Janssen-Cilag
International NV
Imbat Limited
EU/1/14/945/001002
PPA1151/027/00
1
PA0970/041/002
140 Milligram
Capsules Hard
L01XE27
-IBRUTINIB
60 Milligram
Tablet Prolonged
Release
Film Coated
Tablet
C01DA14
-ISOSORBIDE
MONONITRATE
-ISOSORBIDE
MONONITRATE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
PPA
PA1077/008/003
10 Milligram
N02CC01
-SUMATRIPTAN
-Nasal
PA1077/008/004
20 Milligram
N02CC01
-SUMATRIPTAN
-Nasal
PPA1562/188/00
1
PPA1562/188/00
2
PA1077/008/006
50 Milligram
N02CC01
100 Milligram
-SUMATRIPTAN
SUCCINATE
-SUMATRIPTAN
SUCCINATE
-SUMATRIPTAN
SUCCINATE
-SUMATRIPTAN
SUCCINATE
-Per Oral
PA1077/008/007
Nasal Spray
Solution
Nasal Spray
Solution
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
IMATINIB
MEDAC
IMATINIB
ROWEX
IMDUR
IMDUR
PROLONGEDRELEASE
IMIGRAN
IMIGRAN
IMIGRAN
IMIGRAN
IMIGRAN FTAB
IMIGRAN FTAB
AstraZeneca UK
Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
LTT Pharma
Limited
LTT Pharma
Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Human Medicines Authorised/Transfer Pending Products
60 Milligram
100 Milligram
50 Milligram
L01XE01
Routes of
Administration
C01DA14
N02CC01
N02CC01
N02CC01
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 220 of 608
Trade Name
IMIGRAN FTAB
IMIGRAN FTAB
IMIGRAN FTAB
IMIGRAN
MIGRAINE
RELIEF
IMIPENEM/CILA
STATIN
IMLYGIC
Licence Holder Licence
Number
PCO
Manufacturing
Imbat Limited
PCO
Manufacturing
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Hikma
Farmaceutica
(Portugal) SA
Amgen Europe
B.V.
Strength
PPA0465/070/00
3
PPA1151/248/00
1
PPA0465/070/00
4
PA0678/110/001
50 Milligram
PA1217/005/001
Dosage Form ATC
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
N02CC01
-SUMATRIPTAN
N02CC01
-SUMATRIPTAN
SUCCINATE
-SUMATRIPTAN
SUCCINATE
-SUMATRIPTAN
SUCCINATE
500/500 Milligram
Pdr for Soln for
Infusion
J01DH51
-IMIPENEM
-CILASTATIN
EU/1/15/1064/00
1
1 x 10e6 PFU
Millilitre
Solution for
Injection
L01XC19
-TALIMOGENE
LAHERPAREPV
EC
-TALIMOGENE
LAHERPAREPV
EC
-INTERFERON
GAMMA
POMALIDOMIDE
POMALIDOMIDE
POMALIDOMIDE
POMALIDOMIDE
-LOPERAMIDE
HYDROCHLORI
DE
-DIMETICONE,
ACTIVATED
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-LOPERAMIDE
HYDROCHLORI
DE
-DIMETICONE,
ACTIVATED
-LOPERAMIDE
HYDROCHLORI
DE
-DIMETICONE,
ACTIVATED
ETONOGESTR
EL
ETONOGESTR
EL
ETONOGESTR
EL
ETONOGESTR
EL
100 Milligram
100 Milligram
50 Milligram
N02CC01
N02CC01
IMLYGIC
Amgen Europe
B.V.
EU/1/15/1064/00
2
1 x 10e8 PFU
Millilitre
Solution for
Injection
L01XC19
IMMUKIN 2 X
106 IU (0.1 MG)
IMNOVID
Boehringer
Ingelheim Limited
Celgene Europe
Ltd
Celgene Europe
Ltd
Celgene Europe
Ltd
Celgene Europe
Ltd
Rowex Ltd
PA0007/049/001
International Unit
L03AB03
EU/1/13/850/001
1 Milligram
Solution for
Injection
Capsules Hard
EU/1/13/850/002
2 Milligram
Capsules Hard
L04AX06
EU/1/13/850/003
3 Milligram
Capsules Hard
L04AX06
EU/1/13/850/004
4 Milligram
Capsules Hard
L04AX06
PA0711/238/001
2/125 Milligram
Tablets
A07DA53
McNeil
Healthcare
(Ireland) Ltd
Imbat Limited
PA0823/056/003
2mg Milligram
Capsule
A07DA03
PPA1151/060/00
1
2 Milligram
Capsules Hard
A07DA03
McNeil
Healthcare
(Ireland) Ltd
Imbat Limited
PA0823/056/002
2mg Milligram
Tablets
A07DA03
PPA1151/060/00
2
2 Milligram
Orodispersible
Tablet
A07DA03
IMODIUM
INSTANTS
PCO
Manufacturing
PPA0465/001/00
2
2 Milligram
Orodispersible
Tablet
A07DA03
IMODIUM
LIQUIRELIEF
McNeil
Healthcare
(Ireland) Ltd
Imbat Limited
PA0823/056/005
2 Milligram
Capsules, Soft
A07DA03
PPA1151/112/00
1
2/125 Milligram
Tablets
A07DA53
IMODIUM PLUS
McNeil
Healthcare
(Ireland) Ltd
PA0823/060/002
2/125 Milligram
Tablets
A07DA03
IMPLANON NXT
Imbat Limited
PPA1151/094/00
1
68 Milligram
Implant
G03AC08
IMPLANON NXT
PCO
Manufacturing
PPA0465/250/00
1
68 Milligram
Implant
G03AC08
IMPLANON NXT
LTT Pharma
Limited
PPA1562/125/00
1
68 Milligram
Implant
G03AC08
IMPLANON NXT
Lexon (UK) Ltd
PPA1097/005/00
1
68 Milligram
Implant
G03AC08
IMNOVID
IMNOVID
IMNOVID
IMODEX PLUS
IMODIUM
IMODIUM
IMODIUM
INSTANTS
IMODIUM
INSTANTS
IMODIUM PLUS
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
L04AX06
Legal Basis
PPA
Routes of
Administration
-Per Oral
-Per Oral
PPA
Article 10c Informed Consen
-Per Oral
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intralesional
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 10(3) Hybrid
Application
-Per Oral
-Intralesional
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
PPA
PPA
Page 221 of 608
Trade Name
IMPLANON NXT
IMPLANT FOR
SUBDERMAL
USE
IMPLANON NXT
IMPLANT FOR
SUBDERMAL
USE
IMUGER
IMUGER
IMUNOVIR
IMURAN
IMURAN
IMURAN
IMURAN
IMURAN
IMURAN
IMURAN
IMURAN
IMURAN 25
MILLIGRAM
FILM-COATED
TABLETS
IMURAN FILMCOATED
TABLETS 50MG
IMVANEX
INACTIVATED
INFLUENZA
VACCINE (SPLIT
VIRION) BP,
INCIVO
INCRELEX
INCRESYNC
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
IMED Healthcare
Ltd.
PPA1463/108/00
1
68 Milligram
Implant
G03AC08
ETONOGESTR
EL
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Kora Corporation
Ltd t/a Kora
Healthcare
B & S Healthcare
PA1286/050/001
68 Milligram
Implant
G03AC08
ETONOGESTR
EL
PA0577/032/001
25 Milligram
Film Coated
Tablet
L04AX01
-AZATHIOPRINE
-Per Oral
PA0577/032/002
50 Milligram
Film Coated
Tablet
L04AX01
-AZATHIOPRINE
-Per Oral
PA1748/001/001
500 Milligram
Tablets
J05AX05
-Per Oral
PPA1328/170/00
1
PA1691/003/001
50 Milligram
L04AX01
PA1691/003/003
50 Milligram
PA1691/003/002
25 Milligram
50 Milligram
McDowell
Pharmaceuticals
PCO
Manufacturing
PPA1823/010/00
1
PPA0465/077/00
2
PPA1151/039/00
1
PPA1473/007/00
2
PPA0465/077/00
1
Film Coated
Tablet
Pdr for Soln
Inj/Inf
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Tablets
-INOSINE
ACEDOBEN
DIMEPRANOL
-AZATHIOPRINE
IMED Healthcare
Ltd.
PPA1463/014/00
1
50 Milligram
Bavarian Nordic
A/S
Sanofi Pasteur
Europe
EU/1/13/855/001
PA2131/012/001
15/15/15mc %v/v
Janssen-Cilag
International NV
Ipsen Pharma
EU/1/11/720/001
375 Milligram
EU/1/07/402/001
10 Mg/Ml
Takeda Global
R&D Centre
Europe Limited
EU/1/13/842/019027
25mg/30
Milligram
Aspen Pharma
Trading Limited
Aspen Pharma
Trading Limited
Aspen Pharma
Trading Limited
Clear Pharma
Limited
PCO
Manufacturing
Imbat Limited
Human Medicines Authorised/Transfer Pending Products
50 Milligram
50 Milligram
50 Milligram
50 Milligram
25 Milligram
L04AX01
PPA
-Per Oral
-Intra-Muscular
L04AX01
-AZATHIOPRINE
SODIUM
-AZATHIOPRINE
L04AX01
-AZATHIOPRINE
-Per Oral
L04AX01
-AZATHIOPRINE
-Per Oral
L04AX01
-AZATHIOPRINE
PPA
L04AX01
-AZATHIOPRINE
PPA
L04AX01
-AZATHIOPRINE
PPA
L04AX01
-AZATHIOPRINE
PPA
-Per Oral
Film Coated
Tablet
L04AX01
-AZATHIOPRINE
PPA
-Per Oral
Suspension for
Injection
Suspension for
Injection
J07BX
-MVA-BN VIRUS
Article 8(3) - Full
new Application
-Subcutaneous
J07BB02
Film Coated
Tablet
Solution for
Injection
Film Coated
Tablet
J05AE11
A/CALIFORNIA/
7/2009
(H1N1)PDM09 DERIVED
STRAIN USED
NYMC X-179A
-A/HONG
KONG/4801/2014
(H3N2) - LIKE
STRAIN
(A/HONG
KONG/4801/201
4, NYMC X263B)
B/BRISBANE/60
/2008 - LIKE
STRAIN
(B/BRISBANE/6
0/2008)
-TELAPREVIR
Article 8(3) - Full
new Application
-Per Oral
H01AC03
-MECASERMIN
A10BD09
-ALOGLIPTIN
(AS BENZOATE)
-PIOGLITAZONE
(AS
HYDROCHLORI
DE)
-Per Oral
-Per Oral
-Subcutaneous
Article 8(3) - Full
new Application
-Per Oral
Page 222 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
INCRESYNC
Takeda Global
R&D Centre
Europe Limited
EU/1/13/842/028036
25mg/45
Milligram
Film Coated
Tablet
A10BD09
INCRESYNC
Takeda Global
R&D Centre
Europe Limited
EU/1/13/842/0109
12.5mg/30
Milligram
Film Coated
Tablet
A10BD09
INCRESYNC
Takeda Global
R&D Centre
Europe Limited
EU/1/13/842/010018
12.5mg/45
Milligram
Film Coated
Tablet
A10BD09
INCRUSE
Glaxo Group
Limited
AstraZeneca UK
Limited
EU/1/14/922/001003
PA0970/010/002
55 Microgram
Powder for
Inhalation
Film Coated
Tablet
R03BB07
INDIUM (111IN)
DTPA
INDIUM (IN111)
CHLORIDE
INDIVINA
Mallinckrodt
Medical B.V.
Mallinckrodt
Medical B.V.
Orion Corporatio
PA0690/009/001
37 MBq/ml
V09AX01
PA0690/008/001
370 MBq/ml
PA1327/005/001
1/2.5 Milligram
Solution for
Injection
Radio-Pharm
Precursor
Tablets
INDIVINA
Orion Corporatio
PA1327/005/002
1/5 Milligram
Tablets
G03FA12
INDIVINA
Orion Corporatio
PA1327/005/003
2/5 Milligram
Tablets
G03FA12
INDORAMIN
Chemidex
Pharma Limited
PA1161/004/001
20 Milligram
Tablets
C02CA02
INDUCTOS
Medtronic
BioPharma B.V.
McDowell
Pharmaceuticals
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
EU/1/02/226/001
%v/v
Implant
M05BC01
DPR1473/042/0
01
PA0035/095/001
10/20 Milligram
Tablets
C10BA02
10/10 Milligram
Tablets
C10BA02
PA0035/095/002
10/20 Milligram
Tablets
C10BA02
Interchangeable
List Code:
IC0034-051-002
PA0035/095/003
10/40 Milligram
Tablets
Interchangeable
List Code:
IC0034-059-002
PA0035/095/004
10/80 Milligram
10/20 Milligram
INDERAL
INEGY
INEGY
INEGY
INEGY
INEGY
INEGY
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
PCO
Manufacturing
Interchangeable
List Code:
IC0034-060-002
PPA0465/223/00
1
10 Milligram
C07AA05
V09IB
G03FA12
Active
Ingredients
-ALOGLIPTIN
(AS BENZOATE)
-PIOGLITAZONE
(AS
HYDROCHLORI
DE)
-ALOGLIPTIN
(AS BENZOATE)
-PIOGLITAZONE
(AS
HYDROCHLORI
DE)
-ALOGLIPTIN
(AS BENZOATE)
-PIOGLITAZONE
(AS
HYDROCHLORI
DE)
-UMECLIDINIUM
BROMIDE
-PROPRANOLOL
HYDROCHLORI
DE
-INDIUM (111 IN)
-PENTETIC ACID
-INDIUM (111 IN)
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Inhalation
-ESTRADIOL
VALERATE
MEDROXYPRO
GESTERONE
ACETATE
-ESTRADIOL
VALERATE
MEDROXYPRO
GESTERONE
ACETATE
-ESTRADIOL
VALERATE
MEDROXYPRO
GESTERONE
ACETATE
-INDORAMIN
HYDROCHLORI
DE
-DIBOTERMIN
ALFA
-EZETIMIBE
-SIMVASTATIN
-EZETIMIBE
-SIMVASTATIN
-EZETIMIBE
-SIMVASTATIN
-Per Oral
C10BA02
-EZETIMIBE
-SIMVASTATIN
-Per Oral
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
-Per Oral
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
Interchangeable
List Code:
IC0034-051-002
Human Medicines Authorised/Transfer Pending Products
Page 223 of 608
Trade Name
INEGY
INEGY
INEGY
INEGY TABLETS
INEGY TABLETS
INEGY TABLETS
INFACOL
INFANRIX HE
INFANRIX HEXA
Licence Holder Licence
Number
PCO
Manufacturing
PPA0465/223/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0034-059-002
PPA0465/223/00
3
PCO
Manufacturing
LTT Pharma
Limited
LTT Pharma
Limited
LTT Pharma
Limited
Forest
Laboratories UK
Ltd
Smith Kline
Biologicals
Smith Kline
Biologicals
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
10/40 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
PPA
-Per Oral
10/80 Milligram
Tablets
C10BA02
-EZETIMIBE
-SIMVASTATIN
PPA
-Per Oral
10/80 Milligram
Tablets
C10BA02
10/20 Milligram
Tablets
C10BA02
10/40 Milligram
Tablets
C10BA02
10/80 Milligram
Tablets
C10BA02
40 Milligram
Oral Drops
Suspension
A03AX13
-EZETIMIBE
-SIMVASTATIN
-EZETIMIBE
-SIMVASTATIN
-EZETIMIBE
-SIMVASTATIN
-EZETIMIBE
-SIMVASTATIN
-DIMETICONE,
ACTIVATED
EU/1/00/152/015
5 Millilitre
Suspension for
Injection
J07CA09
EU/1/00/152/016
5 Millilitre
Solution for
Injection
J07CA09
Interchangeable
List Code:
IC0034-060-002
DPR0465/025/0
03
DPR1562/016/0
01
DPR1562/016/0
02
DPR1562/016/0
03
PA0100/041/001
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
Page 224 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/002
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/003
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/004
5 Millilitre
Suspension for
Injection
J07CA09
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
Page 225 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/005
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/006
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/007
5 Millilitre
Suspension for
Injection
J07CA09
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
Page 226 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/008
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/009
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/010
5 Millilitre
Suspension for
Injection
J07CA09
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
Page 227 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/011
ml Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/012
5 Millilitre
Suspension for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/013
5 Millilitre
Suspension for
Injection
J07CA09
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
Page 228 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/014
5 Millilitre
Solution for
Injection
J07CA09
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/001
5 ml Millilitre
Suspension for
Injection
J07CA09
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-HEPATITIS B
SURFACE
ANTIGEN (HBS
AG)
-HAEMOPHILUS
INFLUENZAE
POLYSACCHAR
IDE-K
-TETANUS
TOXOID
Page 229 of 608
Trade Name
Licence Holder Licence
Number
INFANRIX HEXA
Smith Kline
Biologicals
EU/1/00/152/1920
INFLECTRA
Hospira UK
Limited
EU/1/13/854/001005
INFLUVAC SUBUNIT,
SUSPENSION
FOR INJECT
Mylan Products
Limited
INHIXA
Strength
Dosage Form ATC
Infus/Pdr/Oral
Soln
J07CA09
100 Milligram
Pdr/Conc/Soln for
Infus
L04AB02
PA2136/002/001
0.5 Microgram
Suspension for
Injection
J07BB02
Techdow Europe
AB
EU/1/16/1132/00
1-002
20 mg/0.5ml
B01AB05
INHIXA
Techdow Europe
AB
EU/1/16/1132/00
3-004
40 Milligram
INHIXA
Techdow Europe
AB
EU/1/16/1132/00
9-010
100 Milligram
INHIXA
Techdow Europe
AB
EU/1/16/1132/00
7-008
80 Milligram
INHIXA
Techdow Europe
AB
EU/1/16/1132/00
5-006
60 Milligram
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Solution for
injection in prefilled syringe
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-PERTUSSIS
TOXOID (PT)
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN (69
KDA OUTER
MEMBRANE
PROTEIN - PRN)
-DIPHTHERIA
TOXOID (D)
-TETANUS
TOXOID (T)
-R-DNA
HEPATITIS B
SURFACE
ANTIGEN
(HBSAG)
-INACTIVATED
POLIO VIRUS
TYPE 1
-INACTIVATED
POLIO VIRUS
TYPE 2
-INACTIVATED
POLIO VIRUS
TYPE 3
-CONJUGATE
OF
HAEMOPHILUS
INFLUENZAE
TYPE B
CAPSULAR
POLYSACCHAR
IDE (PRP) AND
TETANUS
TOXOID
-CT-P13
(INFLIXIMAB)
A/CALIFORNIA/
7/2009
(H1N1)PDM09LIKE STRAIN
(A/CALIFORNIA/
7/2009, X-181)
-A/HONG
KONG/4801/2014
(H3N2) - LIKE
STRAIN
(A/HONG
KONG/4801/201
4, NYMC X263B)
B/BRISBANE/60
/2008 - LIKE
STRAIN
(B/BRISBANE/6
0/2008)
-ENOXAPARIN
SODIUM
B01AB05
-ENOXAPARIN
SODIUM
B01AB05
-ENOXAPARIN
SODIUM
B01AB05
-ENOXAPARIN
SODIUM
B01AB05
-ENOXAPARIN
SODIUM
Legal Basis
Routes of
Administration
-Intra-Muscular
Article 10(4) Similar Biological
App
-Intra-venous
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
-Intral-arterial
-Intra-venous
-Subcutaneous
-Intral-arterial
-Intra-venous
-Subcutaneous
-Intral-arterial
-Intra-venous
-Subcutaneous
-Intral-arterial
-Intra-venous
-Subcutaneous
-Intral-arterial
-Intra-venous
-Subcutaneous
Page 230 of 608
Trade Name
Licence Holder Licence
Number
INLYTA
Pfizer Limited
INLYTA
Pfizer Limited
INLYTA
Pfizer Limited
INLYTA
Pfizer Limited
INNOHEP
PCO
Manufacturing
LTT Pharma
Limited
LTT Pharma
Limited
LTT Pharma
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
PCO
Manufacturing
Leo Laboratories
Limited
Leo Laboratories
Limited
PCO
Manufacturing
Strength
L01XE17
-AXITINIB
L01XE17
-AXITINIB
L01XE17
-AXITINIB
B01AB01
B01AB10
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
B01AB10
-TINZAPARIN
B01AB10
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
20,000 IU/ML
Solution for
Injection
B01AB10
-TINZAPARIN
SODIUM
PA0046/060/004
20000 IU/ML
B01AB10
PPA0465/322/00
4
20000 IU/ML
Solution for
Injection
Solution for
Injection
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
Leo Laboratories
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
PA0046/060/008
10000 IU/ML
B01AB10
PA0046/060/009
10000 IU/ML
PA0046/060/007
10000 IU/ML
PA0046/060/012
20,000 IU/ML
PA1286/011/002
5 Milligram
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Tablets
PA1286/011/003
10 Milligram
Tablets
C09AA02
-ENALAPRIL
MALEATE
PA1286/011/004
20 Milligram
Tablets
C09AA02
-ENALAPRIL
MALEATE
PA1286/011/001
2.5 Milligram
Tablets
C09AA02
-ENALAPRIL
MALEATE
PA1286/012/001
20/12.5 Milligram
Tablets
C09BA02
EU/1/01/194/003004
EU/1/01/194/001
EU/1/06/378/1-16
800 ppm
Inhalation Gas
R07AX01
INOMAX
INOVELON
INO Therapeutics
AB
AGA AB
Eisai Ltd.
-ENALAPRIL
MALEATE
HYDROCHLOR
OTHIAZIDE
-NITRIC OXIDE
-NITRIC OXIDE
-RUFINAMIDE
-Per Oral
Eisai Ltd.
EU/1/06/378/017
Inhalation Gas
Film Coated
Tablet
Oral Suspension
R07AX01
N03AF03
INOVELON
400 ppm mo Litre
100/200/40
Milligram
40 Mg/Ml
N03AF03
-RUFINAMIDE
-Per Oral
INNOHEP
INNOHEP
INNOHEP 10,000
IU IN 0.5 ML
INNOHEP 10,000
IU IN 0.5 ML
INNOHEP 12,000
IU IN 0.6ML
INNOHEP 14,000
IU IN 0.7 ML
INNOHEP
14000IU IN
0.7ML
INNOHEP
16,000IU IN
0.8ML
INNOHEP 18,000
IU IN 0.9 ML
INNOHEP
18000IU IN
0.9ML
INNOHEP 2,500
IU
INNOHEP 3,500
IU
INNOHEP 4,500
IU
INNOHEP 8,000
IU IN 0.4ML
INNOVACE
INNOVACE
INNOVACE
INNOVACE
INNOZIDE 20
MG/12.5 MG
TABLETS
INOMAX
20000 IU/ML
PA0046/060/010
20000 IU/ML
PPA0465/322/00
1
PA0046/060/013
20000 IU/ML
PA0046/060/011
20000 IU/ML
PPA0465/322/00
3
20000 IU/ML
Leo Laboratories
Limited
PA0046/060/014
Leo Laboratories
Limited
PCO
Manufacturing
Human Medicines Authorised/Transfer Pending Products
7 Milligram
1 Milligram
5 Milligram
4,500
International Unit
20000 IU/ML
20000 IU/ML
20000 IU/ML
10000 IU/ML
20,000 IU/ML
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
B01AB10
C09AA02
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-TINZAPARIN
SODIUM
-ENALAPRIL
MALEATE
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Routes of
Administration
-AXITINIB
INNOHEP
PA0046/060/003
Legal Basis
L01XE17
INNOHEP
3 Milligram
Active
Ingredients
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
INNOHEP
EU/1/12/777/007009
EU/1/12/777/010012
EU/1/12/777/001003
EU/1/12/777/004006
PPA0465/322/00
2
PPA1562/134/00
1
PPA1562/134/00
3
PPA1562/134/00
2
PA0046/060/002
Dosage Form ATC
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Per Oral
Page 231 of 608
Trade Name
INSOMNIGER
Licence Holder Licence
Number
INSPRA
Generics (UK)
Limited
Generics (UK)
Limited
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
McDowell
Pharmaceuticals
Clear Pharmacy
INSPRA
B & S Healthcare
INSPRA
Imbat Limited
INSPRA
Imbat Limited
INSPRA
PCO
Manufacturing
PCO
Manufacturing
Takeda Danmark
A/S
Takeda Danmark
A/S
Takeda Danmark
A/S
Takeda Danmark
A/S
Takeda Danmark
A/S
Takeda Danmark
A/S
Farco-Pharma
GmbH
INSOMNIGER
INSPRA
INSPRA
INSPRA
INSPRA
INSTANYL
INSTANYL
INSTANYL
INSTANYL
INSTANYL
INSTANYL
INSTILLAGEL
INSTILLAGEL
Farco-Pharma
GmbH
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0405/004/003
10 Milligram
Tablets
N05CD07
-TEMAZEPAM
-Per Oral
PA0405/004/004
20 Milligram
Tablets
N05CD07
-TEMAZEPAM
-Per Oral
PA0822/020/001
25 Milligram
C03DA04
-EPLERENONE
-Per Oral
PA0822/020/002
50 Milligram
C03DA04
-EPLERENONE
-Per Oral
DPR1473/047/0
01
PPA1596/048/00
1
DPR1328/016/0
02
PPA1151/132/00
1
PPA1151/132/00
2
PPA0465/297/00
1
PPA0465/297/00
2
EU/1/09/531/010013
EU/1/09/531/014017
EU/1/09/531/018021
EU/1/09/531/1-3
25 Milligram
Film Coated
Tablet
Film Coated
Tablet
Tablets
C03DA04
-EPLERENONE
-Per Oral
Film Coated
Tablet
Tablets
C03DA04
-EPLERENONE
C03DA04
-EPLERENONE
C03DA04
-EPLERENONE
C03DA04
-EPLERENONE
C03DA04
-EPLERENONE
PPA
-Per Oral
C03DA04
-EPLERENONE
PPA
-Per Oral
N02AB03
EU/1/09/531/4-6
1.0 Micromol
EU/1/09/531/7-9
2.0 Micromol
PA0328/001/001
6 Millilitre
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Nasal Spray
Solution
Nasal Spray
Solution
Nasal Spray
Solution
Nasal Spray
Solution
Nasal Spray
Solution
Nasal Spray
Solution
Gel
PA0328/001/002
11 Millilitre
Gel
N01BB52
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-FENTANYL
CITRATE
-LIDOCAINE
HYDROCHLORI
DE
CHLORHEXIDIN
E
DIGLUCONATE
(AS
CHLORHEXIDIN
E
DIGLUCONATE
SOLUTION (20%
W/V) PH.EUR.
-METHYL
PARAHYDROX
YBENZOATE
-PROPYL
PARAHYDROX
YBENZOATE
PH.EUR. (0431)
-LIDOCAINE
HYDROCHLORI
DE
CHLORHEXIDIN
E
DIGLUCONATE
(AS
CHLORHEXIDIN
E
DIGLUCONATE
SOLUTION (20%
W/V) PH.EUR.
-METHYL
PARAHYDROX
YBENZOATE
-PROPYL
PARAHYDROX
YBENZOATE
PH.EUR. (0431)
Human Medicines Authorised/Transfer Pending Products
25 Milligram
50 Milligram
25 Milligram
50 Milligram
25 Milligram
50 Milligram
50 Microgram
100 Microgram
200 Microgram
0.5 Micromol
N02AB03
N02AB03
N02AB03
N02AB03
N02AB03
N01BB52
PPA
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
-Nasal
-Nasal
-Nasal
-Nasal
-Nasal
-Nasal
Page 232 of 608
Trade Name
Licence Holder Licence
Number
Strength
INSULATARD
Novo Nordisk A/S
EU/1/02/233/1-15
IU/ml IU/ML
INSULATARD
Novo Nordisk A/S
100 IU/ML
INSULATARD
FLEXPEN
INSULATARD
INNOLET
INSULATARD
PENFILL
INSULIN HUMAN
WINTHROP
BASAL
INSULIN HUMAN
WINTHROP
BASAL
INSULIN HUMAN
WINTHROP
COMB 15
INSULIN HUMAN
WINTHROP
COMB 15
INSULIN HUMAN
WINTHROP
COMB 25
INSULIN HUMAN
WINTHROP
COMB 25
INSULIN HUMAN
WINTHROP
COMB 30
INSULIN HUMAN
WINTHROP
COMB 50
INSULIN HUMAN
WINTHROP
COMB 50
INSULIN HUMAN
WINTHROP
INFUSAT
INSULIN HUMAN
WINTHROP
RAPID
INSULIN HUMAN
WINTHROP
RAPID
INSUMAN
BASAL
Novo Nordisk A/S
EU/1/02/233/003004
EU/1/02/233/013
EU/1/02/233/010012
EU/1/02/233/005007
EU/1/6/368/2028,64-69,89
100 IU/ML
EU/1/06/368/3-4
INSUMAN
BASAL
INSUMAN
BASAL
INSUMAN
BASAL
INSUMAN
BASAL
INSUMAN
BASAL
INSUMAN
BASAL
INSUMAN
BASAL
INSUMAN
BASAL 100IU/ML
Novo Nordisk A/S
Novo Nordisk A/S
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Dosage Form ATC
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
A10AC01
40 IU/ML
Suspension for
Injection
A10AC01
EU/1/06/368/5-6
40 IU/ML
Suspension for
Injection
A10AD01
EU/1/6/368/2937,71-75,90
100 IU/ML
Suspension for
Injection
A10AD01
EU/1/6/368/3846,76-81,91
100 IU/ML
Suspension for
Injection
A10AD01
EU/1/06/368/7-8
40 IU/ML
Suspension for
Injection
A10AD01
EU/1/06/368/143168
100 IU/ML
Suspension for
Injection
A10AD01
EU/1/06/368/9-10
40 IU/ML
Suspension for
Injection
A10AD01
EU/1/6/368/4755,82-87,92
100 IU/ML
Suspension for
Injection
A10AD01
EU/1/06/368/5657
100 IU/ML
Solution for
Injection
A10AB01
EU/1/6/368/1119,58-63,88
100 IU/ML
Solution for
Injection
A10AB01
EU/1/06/368/1-2
40 IU/ML
Solution for
Injection
A10AB01
EU/1/97/030/069
100 IU/ML
Solution for
Injection
A10AC01
EU/1/97/030/070
100 IU/ML
Suspension for
Injection
EU/1/97/030/071
100 IU/ML
EU/1/97/030/072
100 IU/ML
100 IU/ML
100 IU/ML
A10AC01
A10AC01
A10AC01
A10AC01
A10AC01
Active
Ingredients
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN HR1799
Legal Basis
Routes of
Administration
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN GT
HR1799
-INSULIN
HUMAN
-Intra-venous
-Subcutaneous
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
100 IU/ML
Suspension for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/037
40 International
Unit
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/029
International Unit
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/057
100 Units/ml
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/058
100 Units/ml
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/034
100 International
Unit
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-Muscular
-Subcutaneous
Page 233 of 608
Trade Name
INSUMAN
BASAL 100IU/ML
INSUMAN
BASAL 100IU/ML
INSUMAN
BASAL 40IU/ML
INSUMAN COMB
15
INSUMAN COMB
15
INSUMAN COMB
15
INSUMAN COMB
15
INSUMAN COMB
15
INSUMAN COMB
15
INSUMAN COMB
15 100 IU/ML
INSUMAN COMB
15 100IU/ML
INSUMAN COMB
15 100IU/ML
INSUMAN COMB
15 40IU/ML
INSUMAN COMB
15 40IU/ML
INSUMAN COMB
25
INSUMAN COMB
25
INSUMAN COMB
25
INSUMAN COMB
25
INSUMAN COMB
25
INSUMAN COMB
25
INSUMAN COMB
25 100IU/ML
INSUMAN COMB
25 100IU/ML
INSUMAN COMB
25 100IU/ML
INSUMAN COMB
25 40IU/ML
INSUMAN COMB
25 40IU/ML
Licence Holder Licence
Number
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
EU/1/97/030/035
100 International
Unit
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/033
100 International
Unit
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/036
40 International
Unit
Suspension for
Injection
A10AC01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/059
100 Units/ml
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/060
100 Units/ml
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/073
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/074
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/075
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/076
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/038
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/039
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/040
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/041
40 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/042
40 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/061
100 Units/ml
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/062
100 Units/ml
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/077
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/078
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/079
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/080
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/044
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/045
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/043
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/046
40 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/047
40 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
Human Medicines Authorised/Transfer Pending Products
Page 234 of 608
Trade Name
INSUMAN COMB
30
INSUMAN COMB
50
INSUMAN COMB
50
INSUMAN COMB
50
INSUMAN COMB
50
INSUMAN COMB
50
INSUMAN COMB
50
INSUMAN COMB
50 100IU/ML
INSUMAN COMB
50 100IU/ML
INSUMAN COMB
50 100IU/ML
INSUMAN COMB
50 40IU/ML
INSUMAN COMB
50 40IU/ML
INSUMAN
IMPLANTABLE
INSUMAN
INFUSAT
100IU/ML
INSUMAN
INFUSAT
100IU/ML
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPI
INSUMAN RAPID
40IU/ML
Licence Holder Licence
Number
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
EU/1/97/030/170189
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN HR1799
EU/1/97/030/063
100 Units/ml
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/064
100 Units/ml
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/081
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/082
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/083
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/084
100 IU/ML
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/048
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/049
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/050
100 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/051
40 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/052
40 International
Unit
Suspension for
Injection
A10AD01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/202203
400 IU/ML
Solution for
Infusion
A10AB01
-INSULIN
HUMAN
EU/1/97/030/053
100 International
Unit
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/054
100 International
Unit
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/055
100 Units/ml
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/056
100 Units/ml
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/065
100 IU/ML
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/030
100 International
Unit
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/031
40 International
Unit
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/028
100 IU/ML
International Unit
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/066
100 IU/ML
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/067
100 IU/ML
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/068
100 IU/ML
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
EU/1/97/030/032
40 International
Unit
Solution for
Injection
A10AB01
-INSULIN
HUMAN
-Intra-Muscular
-Subcutaneous
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
Routes of
Administration
Article 8(3) - Full
new Application
-Subcutaneous
-Intra-perintoneal
Page 235 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
INTANZA
Sanofi Pasteur
Europe
EU/1/08/505/001003
9 Microgram
Suspension for
Injection
J07BB02
INTANZA
Sanofi Pasteur
Europe
EU/1/08/505/004006
15 Microgram
Suspension for
Injection
J07BB02
INTEGRILIN
Glaxo Group
Limited
Glaxo Group
Limited
Janssen-Cilag
International NV
Janssen-Cilag
International NV
Janssen-Cilag
International NV
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Fresenius Kabi
Limited
Biotest Pharma
GmbH
EU/1/99/109/001
0.75 Mg/Ml
B01AC16
EU/1/99/109/002
2 Mg/Ml
B01AC16
-EPTIFIBATIDE
EU/1/08/468/1
100 Milligram
Solution for
Infusion
Solution for
Infusion
Tablets
-SPLIT
INFLUENZA
VIRUS,INACTIV
ATED
CONTAING
ANTIGENS
-SPLIT
INFLUENZA
VIRUS,INACTIV
ATED
CONTAING
ANTIGENS
-EPTIFIBATIDE
J05AG04
-ETRAVIRINE
EU/1/08/468/002
200 Milligram
Tablets
J05AG04
-ETRAVIRINE
EU/1/08/468/003
25 Milligram
Tablets
J05AG04
-ETRAVIRINE
PA0566/019/013
10 %w/v
B05BA02
PA0566/019/014
20 %w/v
PA0566/019/010
10 Per Cent
B05BA02
-SOYA-BEAN
OIL, REFINED
-SOYA-BEAN
OIL, REFINED
-SOYA OIL
PA0566/019/011
20 Per Cent
B05BA02
-SOYA OIL
PA0566/019/005
20 %w/v
B05BA02
-SOYA OIL
PA0592/007/001
50 g/l
Emulsion for
Infusion
Emulsion for
Infusion
Emulsion for
Infusion
Emulsion for
Infusion
Emulsion for
Infusion
Solution for
Infusion
J06BA02
INTRATECT
Biotest Pharma
GmbH
PA0592/007/002
100 g/l
Solution for
Infusion
J06BA02
INTRONA
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Schering Plough
Europe
Merck Sharp and
Dohme Limited
Schering Plough
Europe
Merck Sharp and
Dohme Limited
Schering Plough
Europe
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
EU/1/99/127/034
30,000,000
International Unit
International Unit
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Solution for
Injection
L03AB05
-HUMAN
PLASMA
PROTEIN >96%
IMMUNOGLOB
ULINS
-HUMAN
PLASMA
PROTEIN
IMMUNOGLOB
ULIN G
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
INTEGRILIN
INTELENCE
INTELENCE
INTELENCE
INTRALIPID
INTRALIPID
INTRALIPID
INTRALIPID
INTRALIPID
INTRATECT
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
EU/1/99/127/035
EU/1/99/127/036
EU/1/99/127/037
EU/1/99/127/038
EU/1/99/127/039
EU/1/99/127/001
EU/1/99/127/002
EU/1/99/127/004
EU/1/99/127/005
EU/1/99/127/006
EU/1/99/127/007
EU/1/99/127/008
EU/1/99/127/009
EU/1/99/127/010
EU/1/99/127/011
Human Medicines Authorised/Transfer Pending Products
30,000,000
International Unit
60,000,000
International Unit
60,000,000
International Unit
60,000,000
International Unit
1,000,000
International Unit
3,000,000
International Unit
5,000,000
International Unit
5,000,000
International Unit
10,000,000
International Unit
10,000,000
International Unit
10,000,000
International Unit
18,000,000
International Unit
30,000,000
International Unit
3,000,000
International Unit
B05BA02
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Page 236 of 608
Trade Name
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTRONA
INTUNIV
INTUNIV
INTUNIV
INTUNIV
INVANZ
INVEGA
INVEGA 12 MG
PROLONGEDRELEASE
TABLETS
INVEGA 3 MG
PROLONGEDRELEASE
TABLETS
INVEGA 6 MG
PROLONGEDRELEASE
TABLETS
Licence Holder Licence
Number
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Merck Sharp and
Dohme Limited
Shire
Pharmaceuticals
Ireland Limited
Shire
Pharmaceuticals
Ireland Limited
Shire
Pharmaceuticals
Ireland Limited
Shire
Pharmaceuticals
Ireland Limited
Merck Sharp and
Dohme Limited
Janssen-Cilag
International NV
Janssen-Cilag
International NV
EU/1/99/127/012
EU/1/99/127/013
EU/1/99/127/014
EU/1/99/127/015
EU/1/99/127/016
EU/1/99/127/017
EU/1/99/127/018
EU/1/99/127/019
EU/1/99/127/020
EU/1/99/127/021
EU/1/99/127/022
EU/1/99/127/023
EU/1/99/127/024
EU/1/99/127/025
EU/1/99/127/026
EU/1/99/127/027
EU/1/99/127/028
EU/1/99/127/029
EU/1/99/127/030
EU/1/99/127/031
EU/1/99/127/032
EU/1/99/127/033
EU/1/99/127/003
EU/1/15/1040/00
1-002
Strength
3,000,000
International Unit
3,000,000
International Unit
3,000,000
International Unit
5,000,000
International Unit
5,000,000
International Unit
5,000,000
International Unit
5,000,000
International Unit
10,000,000
International Unit
10,000,000
International Unit
10,000,000
International Unit
10,000,000
International Unit
18,000,000
International Unit
18,000,000
International Unit
18,000,000
International Unit
18,000,000
International Unit
25,000,000
International Unit
25,000,000
International Unit
25,000,000
International Unit
25,000,000
International Unit
18,000,000
International Unit
18,000,000
18,000,000
International Unit
3,000,000
International Unit
1 Milligram
Dosage Form ATC
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Pdr+Solv for Soln
for Inj
Modified-release
Tablets
L03AB05
Routes of
Administration
N05AX13
N05AX13
-PALIPERIDONE
-Per Oral
Tablet Prolonged
Release
N05AX13
-PALIPERIDONE
-Per Oral
Tablet Prolonged
Release
N05AX13
-PALIPERIDONE
-Per Oral
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
L03AB05
C02AC02
2 Milligram
Modified-release
Tablets
C02AC02
EU/1/15/1040/00
6-007
3 Milligram
Modified-release
Tablets
C02AC02
EU/1/15/1040/00
8-009
4 Milligram
Modified-release
Tablets
C02AC02
EU/1/02/216/001
1 Grams
J01DH03
EU/1/07/395/07795
EU/1/07/395/1620
1.5 Milligram
Concentrate for
Soln for Inf
Tablet Prolonged
Release
Tablet Prolonged
Release
Janssen-Cilag
International NV
EU/1/07/395/1-5
3 Milligram
Janssen-Cilag
International NV
EU/1/07/395/6-10
6 Milligram
Human Medicines Authorised/Transfer Pending Products
Legal Basis
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-INTERFERON
ALFA-2B
-GUANFACINE
HYDROCHLORI
DE
-GUANFACINE
HYDROCHLORI
DE
-GUANFACINE
HYDROCHLORI
DE
-GUANFACINE
HYDROCHLORI
DE
-ERTAPENEM
SODIUM
-PALIPERIDONE
EU/1/15/1040/00
3-005
12 Milligram
Active
Ingredients
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
Page 237 of 608
Trade Name
INVEGA 9 MG
PROLONGEDRELEASE
TABLETS
INVIRASE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Janssen-Cilag
International NV
EU/1/07/395/1115
9 Milligram
Tablet Prolonged
Release
N05AX13
-PALIPERIDONE
-Per Oral
Roche
Registration
Limited
Roche
Registration
Limited
Janssen-Cilag
International NV
NV Organon
EU/1/96/026/002
500 Milligram
Coated Tablets
J05AE01
-SAQUINAVIR
-Per Oral
EU/1/96/026/001
200 Milligram
Capsule
J05AE01
-SAQUINAVIR
EU/1/13/884/001004
EU/1/11/689/001002
100 Milligram
Film Coated
Tablet
Film Coated
Tablet
A10BX11
IODINE
LINIMENT
STRONG
SOLUTION
IODINE
TINCTURE
Ovelle Limited
PA0206/026/001
10 6 %w/v
Cutaneous
Solution
D08AG03
CANAGLIFLOZI
NOMEGESTROL
ACETATE
-ESTRADIOL
HEMIHYDRATE
-IODINE
-POTASSIUM
IODIDE
Ovelle Limited
PA0206/025/001
2.5/2.5 %w/v
Cutaneous
Solution
D08AG03
IOMERON 150
Bracco UK
Limited
Bracco UK
Limited
Bracco UK
Limited
Bracco UK
Limited
Bracco UK
Limited
Bracco UK
Limited
Bracco UK
Limited
Fresenius Kabi
Limited
PA1022/001/001
150 Micromol
V08AB10
PA1022/002/001
200 Micromol
V08AB10
-IOMEPROL
PA1022/003/001
250 Micromol
V08AB10
-IOMEPROL
PA1022/004/001
300 Micromol
V08AB10
-IOMEPROL
PA1022/007/001
300 Mg/Ml
V08AB10
-IOMEPROL
PA1022/005/001
350 Micromol
V08AB10
-IOMEPROL
PA1022/006/001
400 Micromol
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Infusion
-IODINE
-POTASSIUM
IODIDE
-IOMEPROL
V08AB10
-IOMEPROL
B05BB01
Incline
Therapeutics
Europe Ltd
Novartis
Pharmaceuticals
UK Ltd
EU/1/15/1050/00
1
40 Microgram
Unknown
N02AB03
PA0013/129/001
5 Mg/Ml
Eye Drops
Solution
S01EA03
IOPIDINE
Novartis
Pharmaceuticals
UK Ltd
PA0013/129/002
1 %w/v
Eye Drops
Solution
S01EA03
IPECAC
A. Nelson &
Company Limited
Norton
Healthcare
Limited T/A IVAX
Pharmaceuticals
UK
Norton
Healthcare
Limited T/A IVAX
Pharmaceuticals
UK
HOR1149/017/0
01
PA0282/079/001
4X-MM %v/v
Pillules
0.5/2.5 mg/mg
Nebuliser
Solution
R03AL02
PA0282/085/001
250
Microgram/ML
Nebuliser
Solution
R03BB01
-SODIUM
ACETATE
TRIHYDRATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-SODIUM
HYDROXIDE
-FENTANYL
HYDROCHLORI
DE
APRACLONIDIN
E
HYDROCHLORI
DE
APRACLONIDIN
E
HYDROCHLORI
DE
-URAGOGA
IPECACUANHA
-IPRATROPIUM
BROMIDE
MONOHYDRATE
-SALBUTAMOL
SULFATE
-IPRATROPIUM
BROMIDE
INVIRASE
INVOKANA
IOA
IOMERON 200
IOMERON 250
IOMERON 300
IOMERON 300
IOMERON 350
IOMERON 400
IONOLYTE
IONSYS
IOPIDINE
IPRAMOL
STERI-NEB
IPRATROPIUM
STERI-NEB
2.5/1.5 Milligram
PA0566/074/001
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
Article 10b Fixed
Combination
-Per Oral
Article 10a Bibliographical
App
-Intra-venous
Article 8(3) - Full
new Application
-Transdermal
-Per Oral
-Inhalation
Page 238 of 608
Trade Name
IPREZIV
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
GlaxoSmithKline
(Ireland) Limited
EU/1/11/735/001004
EU/1/11/735/005008
EU/1/11/735/009011
PA1077/108/001
20 Milligram
Tablets
C09CA09
40 Milligram
Tablets
C09CA09
80 Milligram
Tablets
C09CA09
0.5 Millilitre
Suspension for
Injection
J07CA02
IPV-BOOSTRIX
(PRE-FILLED
SYRINGE)
GlaxoSmithKline
(Ireland) Limited
PA1077/101/001
0.5 ml %v/v
Suspension for
Injection
J07CA02
IRBESAN
Rowex Ltd
PA0711/155/001
75 Milligram
Film Coated
Tablet
C09CA04
-AZILSARTAN
MEDOXOMIL
-AZILSARTAN
MEDOXOMIL
-AZILSARTAN
MEDOXOMIL
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID (IPTT)
-POLIO VIRUS
TYPE 1
INACTIVATED
-POLIO VIRUS
TYPE 2
INACTIVATED
-POLIO VIRUS
TYPE 3
INACTIVATED
-DIPHTHERIA
TOXOID
-TETANUS
TOXOID
-PERTUSSIS
TOXOID
-FILAMENTOUS
HAEMAGGLUTI
NIN (FHA)
-PERTACTIN
(PRN, OR 69KDA
OMP)
-POLIO VIRUS
TYPE 1
INACTIVATED
-POLIO VIRUS
TYPE 2
INACTIVATED
-POLIO VIRUS
TYPE 3
INACTIVATED
-IRBESARTAN
IRBESAN
Rowex Ltd
PA0711/155/002
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESAN
Rowex Ltd
PA0711/155/003
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
ACCORD
PA1390/053/001
75 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
PA1390/053/003
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
PA1390/053/002
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
CLONMEL
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Clonmel
Healthcare Ltd
PA0126/205/001
75 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/205/002
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
CLONMEL
Clonmel
Healthcare Ltd
PA0126/205/003
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IPREZIV
IPREZIV
IPV INFANRIX
SUSPENSION
FOR INJECTION
IRBESARTAN
ACCORD
IRBESARTAN
ACCORD
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Intra-Muscular
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 239 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
IRBESARTAN
HCT ZENTIVA
sanofi-aventis
groupe
EU/1/06/377/15,11-16
150/12.5
Milligram
Tablets
C09DA04
IRBESARTAN
HCT ZENTIVA
Sanofi aventis
EU/1/06/377/610,17-22
300/12.5
Milligram
Tablets
C09DA04
IRBESARTAN
HCT ZENTIVA
Sanofi aventis
EU/1/06/377/2328
300/25 Milligram
Tablets
C09DA04
IRBESARTAN
NICHE
Niche Generics
Limited
PA1063/056/001
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
IRBESARTAN
NICHE
Niche Generics
Limited
PA1063/056/002
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
PHARMATHEN
Pharmathen S.A.
EU/1/12/765/001002
75 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
PHARMATHEN
Pharmathen S.A.
EU/1/12/765/003004
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
PHARMATHEN
Pharmathen S.A.
EU/1/12/765/005006
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
TEVA
Teva B.V.
EU/1/09/576/1-13
75 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
TEVA
Teva B.V.
EU/1/09/576/1426
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
TEVA
Teva B.V.
EU/1/09/576/2739
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRBESARTAN
WINTHROP
IRBESARTAN
WINTHROP
IRBESARTAN
WINTHROP
IRBESARTAN
WINTHROP
IRBESARTAN
WINTHROP
IRBESARTAN
WINTHROP
IRBESARTAN
WINTHROP
IRBESARTAN/H
YDROCHLORO
THIAZIDE TEVA
Sanofi aventis
75 Milligram
-IRBESARTAN
C09CA04
-IRBESARTAN
C09CA04
-IRBESARTAN
C09CA04
-IRBESARTAN
75 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Tablets
C09CA04
Sanofi aventis
EU/1/06/376/1-516-21
EU/1/06/376/2833
EU/1/06/376/2227
EU/1/06/376/1621
EU/1/06/376/1-5
C09CA04
-IRBESARTAN
Sanofi aventis
EU/1/06/376/6-10
150 Milligram
Tablets
C09CA04
-IRBESARTAN
Sanofi aventis
EU/1/06/376/1115
EU/1/09/583/1-24
300 Milligram
Tablets
C09CA04
-IRBESARTAN
150/12.5
Milligram
Film Coated
Tablet
C09DA04
IRBESARTAN/H
YDROCHLORO
THIAZIDE TEVA
Teva B.V.
EU/1/09/583/2548
300/12.5
Milligram
Film Coated
Tablet
C09DA04
IRBESARTAN/H
YDROCHLORO
THIAZIDE TEVA
Teva B.V.
EU/1/09/583/4972
300/25 Milligram
Film Coated
Tablet
C09DA04
IRESSA
AstraZeneca AB
EU/1/09/526/001
250 Milligram
L01XE02
IREVEN
Pharmathen S.A.
PA1368/002/001
75 Milligram
Film Coated
Tablet
Prolonged
Release
Capsules
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE,
MICRONISED
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE,
MICRONISED
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE,
MICRONISED
-GEFITINIB
Sanofi aventis
Sanofi aventis
Sanofi aventis
Teva B.V.
Interchangeable
List Code:
IC0026-028-030
Human Medicines Authorised/Transfer Pending Products
300 Milligram
150 Milligram
75 Milligram
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
Legal Basis
Routes of
Administration
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 240 of 608
Trade Name
IREVEN
Licence Holder Licence
Number
Pharmathen S.A.
Strength
Dosage Form ATC
Active
Ingredients
150 Milligram
N06AX16
-VENLAFAXINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0026-062-030
PA1422/001/001
Prolonged
Release
Capsules
20 Milligram
Concentrate for
Soln for Inf
L01XX09
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Intra-venous
-IRINOTECAN
HYDROCHLORI
DE
TRIHYDRATE
Article 10(1) Generic
Application
-Intra-venous
Fresenius Kabi
Oncology Plc
IRINOTECAN
HYDROCHLORI
DE
Actavis Group hf
PA1366/002/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01XX19
IRINOTECAN
HYDROCHLORI
DE
Hospira UK
Limited
PA0437/051/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01XX19
IRINOTECAN
HYDROCHLORI
DE
Accord
Healthcare
Limited
PA1390/113/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01XX19
IRINOTECAN
HYDROCHLORI
DE 20 MG/ML
CONCENTRATE
FOR
IRINOTECAN
MEDAC
Fresenius Kabi
Oncology Plc
PA1422/016/001
20 Micromol
Concentrate for
Soln for Inf
L01XX19
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Irish Botanica
PA0623/013/001
20 Mg/Ml
Concentrate for
Soln for Inf
L01XX19
TR1723/001/001
2.5 Millilitre
Liquid
IRPRESTAN
Actavis Group
PTC ehf
PA1380/021/001
75 Milligram
Film Coated
Tablet
C09CA04
-TINCTURE
FROM DRIED
ECHINACEA
PURPUREA (L.)
MOENCH RADIX
(1:3)
-IRBESARTAN
IRPRESTAN
Actavis Group
PTC ehf
PA1380/021/002
150 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRPRESTAN
Actavis Group
PTC ehf
PA1380/021/003
300 Milligram
Film Coated
Tablet
C09CA04
-IRBESARTAN
IRPREZIDE
Actavis Group
PTC ehf
PA1380/080/001
150/12.5
Milligram
Film Coated
Tablet
C09DA04
IRPREZIDE
Actavis Group
PTC ehf
PA1380/080/002
300/12.5
Milligram
Film Coated
Tablet
C09DA04
IRPREZIDE
Actavis Group
PTC ehf
PA1380/080/003
300/25 Milligram
Film Coated
Tablet
C09DA04
IRUXOL MONO
T.J. Smith &
Nephew
PA0518/007/001
1.2 Units/Gram
Ointment
D03BA52
ISANIVA
Actavis Group
PTC ehf
PA1380/133/001
75 Microgram
Film Coated
Tablet
G03AC09
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-PROTEASE
CLOSTRIDIOPE
PTIDASE A
-DESOGESTREL
MICRONIZED
ISCOVER
sanofi-aventis
groupe
EU/1/98/070/001
75 Milligram
Film Coated
Tablet
B01AC04
Interchangeable
List Code:
IC0005-028-003
EU/1/98/070/8-10
-CLOPIDOGREL
HYDROGENSU
LFATE
300 Milligram
Film Coated
Tablet
B01AC04
-CLOPIDOGREL
HYDROGENSU
LFATE
ISCOVER
sanofi-aventis
groupe
Routes of
Administration
PA1368/002/002
IRINOTECAN
IRISH
BOTANICA
ECHINACEA
ORAL LIQUID
Legal Basis
Interchangeable
List Code:
IC0005-029-003
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Topical
Article 10(1) Generic
Application
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Page 241 of 608
Trade Name
ISENTRESS
ISENTRESS
ISENTRESS
ISENTRESS
ISOKET
ISOKET
ISOKET
AMPOULES
ISOMEL SR
ISOMONIT
RETARD
ISOPTIN
ISOPTIN
ISOPTIN
ISOPTIN
ISOPTIN SR
ISOTREX
ISOTREXIN
ISTIN
ISTIN
ISTIN
ISTIN
ISTIN
ISTIN
Licence Holder Licence
Number
Strength
Merck Sharp and
Dohme Limited
Merck Sharp &
Dohme Ltd
Merck Sharp &
Dohme Ltd
Merck Sharp &
Dohme Ltd
Merus Labs
Luxco II S.à.R.L.
Merus Labs
Luxco II S.à.R.L.
Merus Labs
Luxco II S.à.R.L.
Dexcel-Pharma
Limited
Rowex Ltd
EU/1/07/436/1-2
400 Milligram
EU/1/07/436/005
100 Milligram
EU/1/07/436/003
25 Milligram
EU/1/07/436/004
100 Milligram
PA2118/003/003
0.05 %w/v
PA2118/003/002
0.1 %w/v
PA2118/003/001
0.1 %w/v
PA0895/001/001
60 Milligram
PA0711/023/001
60 Milligram
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
PA2010/003/001
40 Milligram
PA2010/003/002
Dosage Form ATC
Film Coated
Tablet
Granules for Oral
Suspension
Tablets
Chewable
Tablets
Chewable
Solution for
Infusion
Concentrate for
Soln for Inf
Concentrate for
Soln for Inf
Tablet Prolonged
Release
Tablet Prolonged
Release
Film Coated
Tablet
J05AX08
80 Milligram
Film Coated
Tablet
C08DA01
PA2010/003/003
120 Milligram
Film Coated
Tablet
C08DA01
PA2010/003/004
2.5 Mg/Ml
Solution for Inj/Inf
C08DA01
PA2010/003/005
240 Milligram
C08DA01
PA1077/122/001
0.05 %w/w
Prolonged
Release
Capsules
Gel
PA1077/123/001
20+0.5 mg/g
Gel
D10AD54
LTT Pharma
Limited
PPA1562/055/00
1
10 Milligram
Tablets
C08CA01
LTT Pharma
Limited
Interchangeable
List Code:
IC0045-002-008
PPA1562/055/00
2
5 Milligram
Tablets
C08CA01
McDowell
Pharmaceuticals
Interchangeable
List Code:
IC0045-001-008
PPA1473/041/00
1
5 Milligram
Tablets
McDowell
Pharmaceuticals
Interchangeable
List Code:
IC0045-001-008
PPA1473/041/00
2
10 Milligram
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0045-002-008
PPA1463/010/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0045-001-008
PPA1463/010/00
2
Active
Ingredients
J05AX08
-RALTEGRAVIR
POTASSIUM
-RALTEGRAVIR
J05AX08
-RALTEGRAVIR
J05AX08
-RALTEGRAVIR
C01DA08
-ISOSORBIDE
DINITRATE
-ISOSORBIDE
DINITRATE
-ISOSORBIDE
DINITRATE
-ISOSORBIDE
MONONITRATE
-ISOSORBIDE
MONONITRATE
-VERAPAMIL
HYDROCHLORI
DE
-VERAPAMIL
HYDROCHLORI
DE
-VERAPAMIL
HYDROCHLORI
DE
-VERAPAMIL
HYDROCHLORI
DE
-VERAPAMIL
HYDROCHLORI
DE
-ISOTRETINOIN
C01DA08
C01DA08
C01DA14
C01DA14
C08DA01
D10AD04
-ISOTRETINOIN
ERYTHROMYCI
N
-AMLODIPINE
BESILATE
Legal Basis
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Cutaneous
PPA
-Per Oral
-AMLODIPINE
BESILATE
PPA
-Per Oral
C08CA01
-AMLODIPINE
BESYLATE
PPA
-Per Oral
Tablets
C08CA01
-AMLODIPINE
BESYLATE
PPA
-Per Oral
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
PPA
-Per Oral
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
PPA
-Per Oral
Interchangeable
List Code:
IC0045-002-008
Human Medicines Authorised/Transfer Pending Products
Page 242 of 608
Trade Name
ISTIN
ISTIN
ISTIN
ISTIN
ISTIN
ISTIN
ISTOLDE
ISTOLDE
ITRACONAZOLE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Pfizer Limited
PA0019/045/001
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Pfizer Limited
Interchangeable
List Code:
IC0045-001-008
PA0019/045/002
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0045-002-008
PPA0465/065/00
1
5 Milligram
Tablets
C08CA01
-AMLODIPINE
PPA
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0045-001-008
PPA0465/065/00
2
10 Milligram
Tablets
C08CA01
-AMLODIPINE
PPA
-Per Oral
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
PPA
-Per Oral
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESYLATE
PPA
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA1380/014/001
5 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-001-008
PA1380/014/002
Article 10(1) Generic
Application
10 Milligram
Tablets
C08CA01
-AMLODIPINE
BESILATE
-Per Oral
Interchangeable
List Code:
IC0045-002-008
PA1312/016/001
Article 10(1) Generic
Application
10 Mg/Ml
Oral Solution
J02AC02
ITRACONAZOLE
-Per Oral
PA1338/009/001
10 Mg/Ml
Oral Solution
J02AC02
ITRACONAZOLE
PA0126/292/001
2.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
Imbat Limited
Imbat Limited
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0045-001-008
PPA1151/010/00
2
IVABRADINE
Clonmel
Healthcare Ltd
PA0126/292/002
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
IVABRADINE
Clonmel
Healthcare Ltd
PA0126/292/003
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
IVABRADINE
JENSONR
(PREVIOUSLY
KNOWN AS
IVABRADINE
MYLAN
IVABRADINE
JENSONR
(PREVIOUSLY
KNOWN AS
IVABRADINE
MYLAN)
IVABRADINE
ANPHARM
Mylan S.A.S.
EU/1/16/1145/00
1-017
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Mylan S.A.S.
EU/1/16/1145/01
8-034
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Anpharm
Przedsiebiorstwo
Farmaceutyczne
S.A
EU/1/15/1041/00
1-007
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
HYDROCHLORI
DE
Article 10c Informed Consen
-Per Oral
ITRACONAZOLE
IVABRADINE
Beacon
Pharmaceuticals
Ltd
Focus
Pharmaceuticals
Ltd
Clonmel
Healthcare Ltd
Interchangeable
List Code:
IC0045-002-008
PPA1151/010/00
1
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 243 of 608
Trade Name
IVABRADINE
ANPHARM
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Anpharm
Przedsiebiorstwo
Farmaceutyczne
S.A
Chanelle Medical
EU/1/15/1041/00
8-014
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
HYDROCHLORI
DE
Article 10c Informed Consen
-Per Oral
PA0688/046/001
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
-Per Oral
Chanelle Medical
PA0688/046/002
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
Krka d.d., Novo
mesto
PA1347/065/001
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
IVABRADINE
KRKA
Krka d.d., Novo
mesto
PA1347/065/002
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
IVABRADINE
MYLAN
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Rowex Ltd
PA0577/186/001
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
OXALATE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
PA0577/186/002
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
OXALATE
Article 10(1) Generic
Application
-Per Oral
PA0711/265/001
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
-Per Oral
IVABRADINE
ROWEX
Rowex Ltd
PA0711/265/002
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
IVABRADINE
TEVA
Teva B.V.
PA1986/029/001
5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
ADIPATE
IVABRADINE
TEVA
Teva B.V.
PA1986/029/002
7.5 Milligram
Film Coated
Tablet
C01EB17
-IVABRADINE
ADIPATE
IVABRADINE
ZENTIVA
Zentiva k.s.
EU/1/16/1144/00
1-007
5 Milligram
Film Coated
Tablet
C01EB17
IVABRADINE
ZENTIVA
Zentiva k.s.
EU/1/16/1144/00
8-014
7.5 Milligram
Film Coated
Tablet
C01EB17
IVEMEND
Merck Sharp &
Dohme Ltd
EU/1/07/437/003004
150 Milligram
Pdr for Soln for
Infusion
A04AD12
IVEMEND
Merck Sharp and
Dohme Limited
EU/1/07/437/0012
115 Milligram
Pdr for Soln for
Infusion
A04AD12
IVIVERZ
Actavis Group
PTC ehf
PA1380/192/001
600/300 Milligram
Film Coated
Tablet
J05AR02
-IVABRADINE
HYDROCHLORI
DE
-IVABRADINE
HYDROCHLORI
DE
FOSAPREPITA
NT
DIMEGLUMINE
FOSAPREPITA
NT
DIMEGLUMINE
-LAMIVUDINE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
IVONKANA
Janssen-Cilag
International NV
Intercell Austria
AG
Grünenthal Ltd
EU/1/13/884/005008
EU/1/08/501/1-2
300 Milligram
A10BX11
PA1189/005/001
37.5/325
Milligram
Film Coated
Tablet
Suspension for
Injection
Film Coated
Tablet
37.5/325
Milligram
Tablets
Effervescent
N02AJ13
37.5/325
Milligram
Film Coated
Tablet
N02AJ13
IVABRADINE
CHANELLE
MEDICAL
IVABRADINE
CHANELLE
MEDICAL
IVABRADINE
KRKA
IVABRADINE
MYLAN
IVABRADINE
ROWEX
IXIARO
IXPRIM
IXPRIM
Grünenthal Ltd
Interchangeable
List Code:
IC0077-133-014
PA1189/005/002
IXPRIM
LTT Pharma
Limited
PPA1562/121/00
1
Interchangeable
List Code:
IC0077-133-014
Human Medicines Authorised/Transfer Pending Products
6 Microgram
J07BA02
N02AJ13
CANAGLIFLOZI
-INACTIVATED
JE VIRUS
-TRAMADOL
HYDROCHLORI
DE
-PARACETAMOL
-PARACETAMOL
-TRAMADOL
HYDROCHLORI
DE
-TRAMADOL
HYDROCHLORI
DE
-PARACETAMOL
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Intra-Muscular
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
-Per Oral
Page 244 of 608
Trade Name
IXPRIM
IXPRIM
IXPRIM
Licence Holder Licence
Number
Strength
Dosage Form ATC
37.5/325
Milligram
Film Coated
Tablet
N02AJ13
PPA
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0077-133-014
PPA0465/282/00
1
-TRAMADOL
HYDROCHLORI
DE
-PARACETAMOL
37.5/325
Milligram
Film Coated
Tablet
N02AJ13
PPA
-Per Oral
Primecrown 2010
Ltd
Interchangeable
List Code:
IC0077-133-014
PPA1633/044/00
1
-TRAMADOL
HYDROCHLORI
DE
-PARACETAMOL
37.5/325
Milligram
Film Coated
Tablet
N02AX52
-Per Oral
Interchangeable
List Code:
IC0077-133-014
PPA1097/010/00
1
-TRAMADOL
HYDROCHLORI
DE
-PARACETAMOL
37.5/325
Milligram
Film Coated
Tablet
N02AX52
-TRAMAZOLINE
HYDROCHLORI
DE
-PARACETAMOL
-TRAVOPROST
-Per Oral
IZBA
Alcon
Laboratories (UK)
Ltd
Novartis
Europharm Ltd
EU/1/13/905/001002
30 Microgram/ML
Eye Drops
Solution
S01EE04
EU/1/12/773/013016
10 Milligram
Tablets
L01XE18
JAKAVI
Novartis
Europharm Ltd
EU/1/12/773/001
5 Milligram
Tablets
L01XE18
JAKAVI
Novartis
Europharm Ltd
EU/1/12/773/002
15 Milligram
Tablets
L01XE18
JAKAVI
Novartis
Europharm Ltd
EU/1/12/773/003
20 Milligram
Tablets
L01XE18
JALRA
Novartis
Europharm
Limited
Merck Sharp and
Dohme Limited
EU/1/08/485/1-11
50 Milligram
Tablets
A10BD08
EU/1/08/455/1-7
50/850 Milligram
Film Coated
Tablet
A10BD07
JANUMET
Merck Sharp and
Dohme Limited
EU/1/08/455/8-14
50/1000 Milligram
Film Coated
Tablet
A10BD07
JANUVIA
Merck Sharp and
Dohme Limited
EU/1/07/383/1-6
25 Milligram
Tablets
A10BH01
JANUVIA
Merck Sharp and
Dohme Limited
EU/1/07/383/7-12
50 Milligram
Tablets
A10BH01
JANUVIA
Merck Sharp and
Dohme Limited
EU/1/07/383/1318
100 Milligram
Tablets
A10BH01
JARDIANCE
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Pierre Fabre
Medicament
Bayer Limited
EU/1/14/930/010018
10 Milligram
Film Coated
Tablet
A10BX12
EU/1/14/930/001009
25 Milligram
Film Coated
Tablet
EU/1/09/550/1-12
25 Mg/Ml
PA1410/068/001
13.5 Milligram
Concentrate for
Soln for Inf
Intrauterine
delivery system
JARDIANCE
JAVLOR
JAYDESS
Routes of
Administration
PPA1463/052/00
1
Lexon (UK) Ltd
JANUMET
Legal Basis
IMED Healthcare
Ltd.
IXPRIM
JAKAVI
Active
Ingredients
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
-Ocular
-RUXOLITINIB
(AS
PHOSPHATE)
-RUXOLITINIB
(AS
PHOSPHATE)
-RUXOLITINIB
(AS
PHOSPHATE)
-RUXOLITINIB
(AS
PHOSPHATE)
-VILDAGLIPTIN
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 10c Informed Consen
-Per Oral
-SITAGLIPTIN
PHOSPHATE
-METFORMIN
HYDROCHLORI
DE
-SITAGLIPTIN
PHOSPHATE
-METFORMIN
HYDROCHLORI
DE
-SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
-SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
-SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
A10BX12
EMPAGLIFLOZI
N
Article 8(3) - Full
new Application
L01CA05
-VINFLUNINE
DITARTRATE
LEVONORGEST
REL,
MICRONIZED
G02BA03
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
Article 8(3) - Full
new Application
-Intra-uterine
Page 245 of 608
Trade Name
JENTADUETO
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
EU/1/12/780/001014
2.5/850 Milligram
Film Coated
Tablet
A10BD11
-LINAGLIPTIN
-METFORMIN
Article 8(3) - Full
new Application
-Per Oral
EU/1/12/780/015028
2.5/1000
Milligram
Film Coated
Tablet
A10BD11
-LINAGLIPTIN
-METFORMIN
Article 8(3) - Full
new Application
-Per Oral
EU/1/13/819/001
0.5/0.2 Mg/Ml
-OCRIPLASMIN
EU/1/13/819/002
0.375/0.3 Mg/Ml
S01XA
-OCRIPLASMIN
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
EU/1/11/676/001
60/1.5 Mg/Ml
L01CD04
-CABAZITAXEL
JEXT
ALK-Abello A/S
PA1255/006/001
150 Microgram
C01CA24
-EPINEPHRINE
JEXT
ALK-Abello A/S
PA1255/006/002
300 Microgram
C01CA24
-EPINEPHRINE
JINARC
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Otsuka
Pharmaceutical
Europe Ltd
Pinewood
Laboratories Ltd,
EU/1/15/1000/00
1-002
15 Milligram
Solution for
Injection
Solution for
Injection
Concentrate and
solvent for
solution for
infusion
Solution for
injection in prefilled pen
Solution for
injection in prefilled pen
Tablets
S01XA22
JEVTANA
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
ThromboGenics
NV
ThromboGenics
NV
Sanofi aventis
C03XA01
-TOLVAPTAN
EU/1/15/1000/00
3-004
30 Milligram
Tablets
C03XA01
EU/1/15/1000/00
5-007
15 + 45 Milligram
Tablets
EU/1/15/1000/00
8-010
30 + 60 Milligram
EU/1/15/1000/01
1-013
PA0281/002/001
Laboratoire
AGUETTANT
PA1968/006/001
Therakind Limite
EU/1/17/1172/00
1
JENTADUETO
JETREA
JETREA
JINARC
JINARC
JINARC
JINARC
JUNIOR
PARAPAED
PARACETAMOL
JUNYELT,
CONCENTRATE
FOR SOLUTION
FOR INFUSION
JYLAMVO
2MG/ML ORAL
SOLUTION
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 8(3) - Full
new Application
-Intra-Muscular
-TOLVAPTAN
Article 8(3) - Full
new Application
-Per Oral
C03XA01
-TOLVAPTAN
Article 8(3) - Full
new Application
-Per Oral
Tablets
C03XA01
-TOLVAPTAN
Article 8(3) - Full
new Application
-Per Oral
30 + 90 Milligram
Tablets
C03XA01
-TOLVAPTAN
Article 8(3) - Full
new Application
-Per Oral
MG/5ml
Oral Suspension
N02BE01
-PARACETAMOL
Concentrate for
Soln for Inf
B05XA31
-ZINC
GLUCONATE
-COPPER
GLUCONATE
-MANGANESE
GLUCONATE
-POTASSIUM
IODIDE
-SODIUM
SELENITE
Article 10a Bibliographical
App
-Intra-venous
Oral Solution
L01BA01
Article 10(1) Generic
Application
-Per Oral
2 Mg/Ml
-Intra-Muscular
-Per Oral
Page 246 of 608
Trade Name
KABIVEN
Licence Holder Licence
Number
Fresenius Kabi
Limited
PA0566/003/001
Human Medicines Authorised/Transfer Pending Products
Strength
%w/v
Dosage Form ATC
Emulsion for
Infusion
B05BA10
Active
Ingredients
-SOYBEAN OIL
-GLUCOSE
ANHYDROUS
-ALANINE
-ARGININE
-ASPARTIC
ACID
-GLUTAMIC
ACID
-GLYCINE
HYDROCHLORI
DE
-HISTIDINE
-ISOLEUCINE
-LEUCINE
-LYSINE
-L-METHIONINE
PHENYLALANIN
E
-PROLINE
-SERINE
-THREONINE
-TRYPTOPHAN,
L-TYROSINE
-VALINE
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
GLYCEROPHO
SPHATE
ANHYDROUS
-MAGNESIUM
SULFATE
-POTASSIUM
CHLORIDE
-SODIUM
ACETATE
Legal Basis
Routes of
Administration
-Intra-venous
Page 247 of 608
Trade Name
KABIVEN
Licence Holder Licence
Number
Fresenius Kabi
Limited
PA0566/003/003
Human Medicines Authorised/Transfer Pending Products
Strength
%w/v
Dosage Form ATC
Emulsion for
Infusion
B05BA10
Active
Ingredients
Legal Basis
Routes of
Administration
-SOYBEAN OIL
-GLUCOSE
ANHYDROUS
-ALANINE
-ARGININE
-ASPARTIC
ACID
-GLUTAMIC
ACID
-AMINOACETIC
ACID
-HISTIDINE
-ISOLEUCINE
-LEUCINE
-LYSINE
-DLMETHIONINE
PHENYLALANIN
E
-PROLINE
-SERINE
-THREONINE
-TRYPTOPHAN,
L-TYROSINE
-VALINE
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
GLYCEROPHO
SPHATE
ANHYDROUS
-MAGNESIUM
SULFATE
-POTASSIUM
CHLORIDE
-SODIUM
ACETATE
Page 248 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
KABIVEN
PERIPHERAL
Fresenius Kabi
Limited
PA0566/003/004
%w/v
Emulsion for
Infusion
B05BA10
KABIVEN
PERIPHERAL
Fresenius Kabi
Limited
PA0566/003/002
%w/v
Emulsion for
Infusion
B05BA10
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-SOYA OIL
-GLUCOSE
ANHYDROUS
-ALANINE
-ARGININE
-ASPARTIC
ACID
-GLUTAMIC
ACID
-GLYCINE
-HISTIDINE
-ISOLEUCINE
-LEUCINE
-LYSINE
-DLMETHIONINE
PHENYLALANIN
E
-PROLINE
-SERINE
-THREONINE
-TRYPTOPHAN,
L-TYROSINE
-VALINE
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
GLYCEROPHO
SPHATE
ANHYDROUS
-MAGNESIUM
SULFATE
-POTASSIUM
CHLORIDE
-SODIUM
ACETATE
-SOYBEAN OIL
-GLUCOSE
ANHYDROUS
-ALANINE
-ARGININE
-ASPARTIC
ACID
-GLUTAMIC
ACID
-GLYCINE
-HISTIDINE
-ISOLEUCINE
-LEUCINE
-LYSINE
-METHIONINE
PHENYLALANIN
E
-PROLINE
-SERINE
-THREONINE
-TRYPTOPHAN,
L-TYROSINE
-VALINE
-CALCIUM
CHLORIDE
DIHYDRATE
-SODIUM
GLYCEROPHO
SPHATE
ANHYDROUS
-POTASSIUM
CHLORIDE
-SODIUM
ACETATE
Page 249 of 608
Trade Name
KADCYLA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Roche
Registration
Limited
Roche
Registration
Limited
LTT Pharma
Limited
EU/1/13/885/001
100 Milligram
Pdr for Soln for
Infusion
L01XC14
-TRASTUZUMAB
EMTANSINE
Article 8(3) - Full
new Application
-Intra-venous
EU/1/13/885/002
160 Milligram
Pdr for Soln for
Infusion
L01XC14
-TRASTUZUMAB
EMTANSINE
Article 8(3) - Full
new Application
-Intra-venous
PPA1562/161/00
1
500/800 mg/IU
Tablets
Chewable
A12A
KALCIPOS-D
FORTE
Meda AB
PA1051/008/002
500/800 mg/IU
Tablets
Chewable
A12AX
KALCIPOS-D
FORTE
Imbat Limited
PPA1151/162/00
1
500mg/800
International Unit
Tablets
Chewable
A12AX
KALCIPOS-D
FORTE
Meda AB
PA1051/009/001
500mg/800
International Unit
Film Coated
Tablet
A12AX
KALETRA
AbbVie Ltd
EU/1/01/172/001
Capsule
J05AE03
KALETRA
AbbVie Ltd
EU/1/01/172/003
133,3/33,3
Milligram
80+20 Mg/Ml
J05AE03
KALETRA
AbbVie Ltd
200/50 Milligram
KALETRA
AbbVie Ltd
EU/1/01/172/45,7-8
EU/1/01/172/006
Infus/Pdr/Oral
Soln
Tablets
J05AE06
KALI. BICH.
A. Nelson &
Company Limited
A. Nelson &
Company Limited
HOR1149/018/0
01
HOR1149/019/0
01
6C - MM
Film Coated
Tablet
Pillules
6C - MM
Pillules
KALIUM
BICHROMICUM
(KALI. BIC.) (6C
& 30C)
KALIUM
PHOSPHORICU
M (KALI. PHOS.)
(6C & 30C)
KALMS DAY
Weleda (UK)
Limited
HOR0407/005/0
01
6C & 30C
Tablets
-CALCIUM
COLECALCIFE
ROL
-CALCIUM
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-CALCIUM
CARBONATE
COLECALCIFE
ROL
-RITONAVIR
-LOPINAVIR
-RITONAVIR
-LOPINAVIR
-LOPINAVIR
-RITONAVIR
-LOPINAVIR
-RITONAVIR
-KALIUM
BICHROMICUM
-KALIUM
PHOSPHORICU
M
-KALIUM
BICHROMICUM
Weleda (UK)
Limited
HOR0407/045/0
01
6C & 30C
Unknown
Tablets
GR Lane Health
Products Ltd
TR0257/002/001
Film Coated
Tablet
N05CM
KALMS NIGHT
GR Lane Health
Products Ltd
TR0257/001/001
Unknown
N05CM
KALYDECO
Vertex
Pharmaceuticals
(U.K.) Limited
Vertex
Pharmaceuticals
(U.K.) Limited
Vertex
Pharmaceuticals
(U.K.) Limited
Chefaro Ireland
DAC
Krka d.d., Novo
mesto
EU/1/12/782/001002
150 Milligram
Film Coated
Tablet
EU/1/12/782/003
50 Milligram
EU/1/12/782/004
KADCYLA
KALCIPOS - D
FORTE
KALI. PHOS.
KALYDECO
KALYDECO
KAMILLOSAN
CHAMOMILE
KAMIREN
KANUMA
KAPAKE
Alexion Europe
SAS
Galen Limited
100/25 Milligram
J05AE03
-Per Oral
Article 10a Bibliographical
App
-Per Oral
PPA
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-KALIUM
PHOSPHORICU
M
-Per Oral
-Per Oral
R07AX02
-VALERIAN DRY
HYDROALCOH
OLIC EXTRACT
-HOPS DRY
EXTRACT
-VALERIAN DRY
HYDROALCOH
OLIC EXTRACT
-IVACAFTOR
Granules
R07AX02
75 Milligram
Granules
PA1186/007/001
10.5 %w/w
PA1347/038/001
Interchangeable
List Code:
IC0021-008-024
EU/1/15/1033/00
1
PA1329/003/001
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-IVACAFTOR
Article 8(3) - Full
new Application
-Per Oral
R07AX
-IVACAFTOR
Article 8(3) - Full
new Application
-Per Oral
Ointment
D04AX
-CHAMOMILE
4 Milligram
Tablet Prolonged
Release
C02CA04
-DOXAZOSIN
MESILATE
-Per Oral
2 Mg/Ml
Concentrate for
Soln for Inf
Tablets
A16AB14
-SEBELIPASE
ALFA
-PARACETAMOL
-CODEINE
PHOSPHATE
HEMIHYDRATE
-Intra-venous
15/500 Milligram
N02BE51
Article 10(3) Hybrid
Application
-Per Oral
Page 250 of 608
Trade Name
KAPAKE
30MG/500MG
TABLETS
KARVEA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Galen Limited
PA1329/003/002
500/30 Milligram
Tablets
N02AA59
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
Bristol Myers
Squibb Pharma
EEIG
sanofi-aventis
groupe
sanofi-aventis
groupe
EU/1/97/049/002
75 Milligram
Tablets
C09CA04
-PARACETAMOL
-CODEINE
PHOSPHATE
-IRBESARTAN
EU/1/97/049/003
75 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/005
150 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/006
150 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/008
300 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/009
300 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/001
75 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/004
150 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/97/049/007
300 Milligram
Tablets
C09CA04
-IRBESARTAN
EU/1/98/085/001
150 Milligram
Tablets
C09DA04
KARVEZIDE
sanofi-aventis
groupe
EU/1/98/085/004
300 Milligram
Tablets
C09DA04
KARVEZIDE
sanofi-aventis
groupe
EU/1/98/085/002
150 Milligram
Tablets
C09DA04
KARVEZIDE
sanofi-aventis
groupe
EU/1/98/085/003
150 Milligram
Tablets
C09DA04
KARVEZIDE
sanofi-aventis
groupe
EU/1/98/085/005
300 Milligram
Tablets
C09DA04
KARVEZIDE
sanofi-aventis
groupe
EU/1/98/085/006
300 Milligram
Tablets
C09DA04
KARVEZIDE
sanofi-aventis
groupe
EU/1/98/85/23-28
300/25 Milligram
Tablets
C09DA04
KAY-CEE-L
SYRUP
KEFLEX
Geistlich Sons
Limited
Flynn Pharma Ltd
PA0143/004/001
7.5 %w/v
Oral Solution
A12BA01
PA1226/002/002
Flynn Pharma Ltd
PA1226/002/001
Powder for Oral
Suspension
Capsules Hard
J01DB01
KEFLEX
125 Anhyd
mg/5ml
250 Milligram
KEFLEX
Flynn Pharma Ltd
PA1226/002/003
Flynn Pharma Ltd
PA1226/002/004
KEFLEX
Imbat Limited
KEFLEX
PCO
Manufacturing
Imbat Limited
PPA1151/166/00
1
PPA0465/010/00
2
PPA1151/166/00
2
PPA0465/010/00
3
Powder for Oral
Suspension
Film Coated
Tablet
Capsule
J01DB01
KEFLEX
250 mg/5 m
Anhyd mg/5ml
500 mg Anhyd
Milligrams
250 Anhyd
Milligrams
250 Milligram
Capsules Hard
J01DB01
500 Milligram
Film Coated
Tablet
Film Coated
Tablet
J01DB01
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-IRBESARTAN
HYDROCHLOR
OTHIAZIDE
-POTASSIUM
CHLORIDE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
-CEFALEXIN
MONOHYDRATE
KARVEA
KARVEA
KARVEA
KARVEA
KARVEA
KARVEA
KARVEA
KARVEA
KARVEZIDE
KEFLEX
KEFLEX
PCO
Manufacturing
Human Medicines Authorised/Transfer Pending Products
500 Milligram
J01DB01
J01DB01
J01DB01
J01DB01
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
PPA
-Per Oral
-Per Oral
Page 251 of 608
Trade Name
KEFLEX
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
LTT Pharma
Limited
Laboratorios
LICONSA, S.A.
PPA1562/181/00
1
PA1239/014/001
250 Milligram
Capsules Hard
J01DB01
150 Base
Milligrams
Film Coated
Tablet
M05BA06
Strides Shasun
(UK) Ltd
Strides Shasun
(UK) Ltd
Strides Shasun
(UK) Ltd
Strides Shasun
(UK) Ltd
Aspen Pharma
Trading Limited
PA0894/004/001
250 Milligram
Capsule
J01DC08
PA0894/004/002
500 Milligram
Capsules Hard
J01DC08
PA0894/004/003
125 MG/5ml
J01DC08
PA0894/004/004
250 MG/5ml
PA1691/005/001
5 Milligram
Powder for Oral
Suspension
Powder for Oral
Suspension
Tablets
KEMADRIN
LTT Pharma
Limited
PPA1562/196/00
1
5 Milligram
Tablets
N04AA04
KENGREXAL
The Medicines
Company UK
Limited
Nicobrand
EU/1/15/994/001
50 Milligram
Pdr/Conc/Soln/In
j/Inf
B01AC
EU/1/03/270/1-2
3.9 mg Milligram
G04BD04
-OXYBUTYNIN
KENTERA
(4MG/24H)
Nicobrand
EU/1/03/270/004005
90.7 mg/g
Transdermal
Patch
Gel
G04BD04
KEPPRA
UCB Pharma
S.A.
EU/1/00/146/030
100 Mg/Ml
Concentrate for
Soln for Inf
N03AX14
KEPPRA
UCB Pharma
S.A.
EU/1/00/146/014019
750 Milligram
Film Coated
Tablet
N03AX14
KEPPRA
UCB Pharma
S.A.
EU/1/00/146/020026
1000 Milligram
Film Coated
Tablet
N03AX14
KEPPRA
UCB Pharma
S.A.
EU/1/00/146/006013
500 Milligram
Film Coated
Tablet
N03AX14
KEPPRA
UCB Pharma
S.A.
EU/1/00/146/027
100 Mg/Ml
Oral Solution
N03AX14
KEPPRA
LEVETIRACETA
M
KERAL
UCB Pharma
S.A.
EU/1/00/146/001
250 Milligram
Film Coated
Tablet
N03AX14
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
IMED Healthcare
Ltd.
PA0865/002/001
12.5 Milligram
Film Coated
Tablet
M01AE17
-OXYBUTYNIN
HYDROCHLORI
DE
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
DEXKETOPROF
EN
PA0865/002/002
25 Milligram
Film Coated
Tablet
M01AE17
DEXKETOPROF
EN
Solution for
Injection
M01AE17
DEXKETOPROF
EN
Menarini
International
Operations
Luxembourg S.A.
Pfizer Healthcare
Ireland
DEXKETOPROF
EN
TROMETAMOL
DEXKETOPROF
EN
TROMETAMOL
DEXKETOPROF
EN
DEXKETOPROF
EN
KEFORT
KEFTID
KEFTID
KEFTID
KEFTID
KEMADRIN
KENTERA
KERAL
KERAL
KERAL
KERAL
KERAL
KERAL 25 MG
ORAL
SOLUTION
KETALAR
PA0865/002/003
50
J01DC08
N04AA04
PA0865/002/004
12.5 Milligram
Granules for oral
solution
M01AE17
PA0865/002/005
25 Milligram
Granules for oral
solution
M01AE17
PPA1463/089/00
1
25 Milligram
Film Coated
Tablet
M01AE17
PA0865/002/006
25 Milligram
Oral Solution
M01AE17
PA0822/013/001
10 Mg/Ml
Solution for Inj/Inf
N01AX03
Human Medicines Authorised/Transfer Pending Products
-CEFALEXIN
MONOHYDRATE
-IBANDRONATE
SODIUM
MONOHYDRATE
-CEFACLOR
MONOHYDRATE
-CEFACLOR
MONOHYDRATE
-CEFACLOR
MONOHYDRATE
-CEFACLOR
MONOHYDRATE
-PROCYCLIDINE
HYDROCHLORI
DE
-PROCYCLIDINE
HYDROCHLORI
DE
-CANGRELOR
TETRASODIUM
-KETAMINE
HYDROCHLORI
DE
Legal Basis
Routes of
Administration
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
-Transdermal
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Intra-venous
Page 252 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
KETALAR
Pfizer Healthcare
Ireland
PA0822/013/002
50 Mg/Ml
Solution for Inj/Inf
N01AX03
KETEK
Aventis Pharma
S.A.
Aventis Pharma
S.A.
Aventis Pharma
S.A.
Aventis Pharma
S.A.
Laboratoire HRA
Pharma
EU/1/01/191/002
400 Milligram
Tablets
J01FA15
-Per Oral
EU/1/01/191/003
400 Milligram
Tablets
J01FA15
-Per Oral
EU/1/01/191/004
400 Milligram
Tablets
J01FA15
-Per Oral
EU/1/01/191/001
400 Milligram
Tablets
J01FA15
-Per Oral
EU/1/14/965 /001
200 Milligram
Tablets
J02AB02
KETOFALL
Pharma Stulln
GmbH
PA1815/002/001
0.25 Mg/Ml
Eye Drops
Solution
S01GX08
KETOPINE
Pinewood
Laboratories Ltd,
PA0281/125/001
2 %w/w
Shampoo
D01AC08
KETOVITE
Essential
Pharmaceuticals
Limited
PA1806/002/001
0 %v/v
Tablets
A11EX
KETOVITE
LIQUID
Essential
Pharmaceuticals
Limited
PA1806/001/001
0 %v/v
Infus/Pdr/Oral
Soln
A11BA
KETOZOL 2%
W/W DANDRUFF
SHAMPOO
KEYTRUDA
Rowex Ltd
PA0711/076/002
2 Per Cent
Shampoo
D01AC08
Merck Sharp &
Dohme Ltd
EU/1/15/1024/00
1
50 Milligram
Pdr for Soln for
Infusion
L01XC18
KEYTRUDA
Merck Sharp &
Dohme Ltd
EU/1/15/1024/00
2
25 Mg/Ml
Concentrate for
Soln for Inf
L01XC18
KINERET
Swedish Orphan
Biovitrum
International AB
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Bayer Schering
Pharma AG
EU/1/02/203/005007
100mg/0.67
Millilitre
Solution for
Injection
L04AC03
KETOCONAZOL
E
-KETOTIFEN
HYDROGEN
FUMARATE
KETOCONAZOL
E
-THIAMINE
HYDROCHLORI
DE
-RIBOFLAVIN
-PYRIDOXINE
HYDROCHLORI
DE
-NICOTINAMIDE
-CALCIUM
PANTOTHENAT
E
-ASCORBIC
ACID
-INOSITOL
-BIOTIN
-FOLIC ACID
-MENADIOL
DIACETATE
-TOCOPHERYL
ACETATE
-RETINOL
PALMITATE
ERGOCALCIFE
ROL
-CHOLINE
CHLORIDE
CYANOCOBALA
MIN
KETOCONAZOL
E
PEMBROLIZUM
AB
PEMBROLIZUM
AB
-ANAKINRA
EU/1/02/203/001
150 Mg/Ml
L04AC03
-ANAKINRA
-Subcutaneous
EU/1/02/203/002
150 Mg/Ml
L04AC03
-ANAKINRA
-Subcutaneous
EU/1/02/203/003
150 Mg/Ml
L04AC03
-ANAKINRA
-Subcutaneous
EU/1/02/203/004
150 Mg/Ml
L04AC03
-ANAKINRA
-Subcutaneous
EU/1/02/214/001
40/12.5 mg/mg
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Tablets
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
KETEK
KETEK
KETEK
KETOCONAZOL
E
KINERET
KINERET
KINERET
KINERET
KINZALKOMB
Interchangeable
List Code:
IC0050-099-014
Human Medicines Authorised/Transfer Pending Products
-KETAMINE
HYDROCHLORI
DE
Routes of
Administration
-Intra-venous
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
-Per Oral
-Ocular
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Subcutaneous
Page 253 of 608
Trade Name
KINZALKOMB
KINZALKOMB
KINZALMONO
Licence Holder Licence
Number
Bayer Schering
Pharma AG
EU/1/02/214/006010
Bayer Schering
Pharma AG
Interchangeable
List Code:
IC0050-081-014
EU/1/02/214/1115
Bayer Pharma
AG
Interchangeable
List Code:
IC0050-100-014
EU/1/98/091/001
Strength
Dosage Form ATC
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
80/25 mg/mg
Tablets
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
40 Milligram
Tablets
C09CA07
-TELMISARTAN
-Per Oral
20 Milligram
Tablets
C09CA07
-TELMISARTAN
-Per Oral
80 Milligram
Tablets
C09CA07
-TELMISARTAN
-Per Oral
-HUMAN
NORMAL
IMMUNOGLOB
ULIN
-TAMSULOSIN
HYDROCHLORI
DE
-Intra-venous
Bayer Pharma
AG
Interchangeable
List Code:
IC0049-003-014
EU/1/98/091/005008
KIOVIG
Baxter
Interchangeable
List Code:
IC0049-005-014
EU/1/05/329/1-5
100 Mg/Ml
Solution for
Infusion
J06BA02
KIRNOM XL
Wockhardt UK
Limited
PA1339/020/001
400 Microgram
Prolonged
Release
Capsules
G04CA02
4 Milligram
Capsules Hard
L01XE29
10 Milligram
Capsules Hard
L01XE29
600mg Milligram
Tablets
J05AR02
PA2010/004/006
250 MG/5ml
Granules for Oral
Suspension
J01FA09
PA2010/004/001
250 Milligram
Film Coated
Tablet
J01FA09
250 Milligram
Film Coated
Tablet
500 Milligram
KISPLYX
Eisai Europe Ltd
KISPLYX
Eisai Europe Ltd
KIVEXA
ViiV Healthcare
UK Ltd
KLACID
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
KLACID
KLACID
KLACID FORTE
KLACID FORTE
KLACID FORTE
Imbat Limited
Mylan IRE
Healthcare
Limited
Imbat Limited
PCO
Manufacturing
Interchangeable
List Code:
IC0024-066-044
EU/1/16/1128/00
1
EU/1/16/1128/00
2
EU/1/04/298/1-2
Interchangeable
List Code:
IC0072-130-003
PPA1151/046/00
3
Interchangeable
List Code:
IC0072-130-003
PA2010/004/002
Interchangeable
List Code:
IC0072-117-003
PPA1151/046/00
2
Interchangeable
List Code:
IC0072-117-003
PPA0465/051/00
2
Routes of
Administration
Tablets
Bayer Pharma
AG
KINZALMONO
Legal Basis
80/12.5 mg/mg
Interchangeable
List Code:
IC0049-004-014
EU/1/98/091/009012
KINZALMONO
Active
Ingredients
-Per Oral
Article 10a Bibliographical
App
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-LENVATINIB
MESILATE
-LENVATINIB
MESILATE
-ABACAVIR
SULFATE
-LAMIVUDINE
CLARITHROMY
CIN
CLARITHROMY
CIN
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
J01FA09
CLARITHROMY
CIN
PPA
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
PPA
-Per Oral
500 Milligram
Film Coated
Tablet
J01FA09
CLARITHROMY
CIN
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0072-117-003
Human Medicines Authorised/Transfer Pending Products
Page 254 of 608
Trade Name
KLACID IV
KLACID LA
KLACID LA
KLACID LA
KLACID
PAEDIATRIC
SUSPENSION
KLARAM LA
KLARIGER
Licence Holder Licence
Number
Mylan IRE
Healthcare
Limited
Mylan IRE
Healthcare
Limited
PCO
Manufacturing
Imbat Limited
Mylan IRE
Healthcare
Limited
Actavis Group
PTC ehf
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Strength
Dosage Form ATC
Active
Ingredients
PA2010/004/003
500 Milligram
Pdr/Conc/Soln for
Infus
J01FA09
PA2010/004/004
500 Milligram
Modified-release
Tablets
J01FA09
500 Milligram
Modified-release
Tablets
J01FA09
CLARITHROMY
CIN
500 Milligram
Modified-release
Tablets
J01FA09
CLARITHROMY
CIN
Interchangeable
List Code:
IC0072-117-050
PA2010/004/005
125 MG/5ml
Granules for Oral
Suspension
J01FA09
PA1380/102/001
500 Milligram
Tablet Prolonged
Release
J01FA09
Interchangeable
List Code:
IC0072-117-050
PA0577/093/002
CLARITHROMY
CIN
CLARITHROMY
CIN CITRATE
500 Milligram
Film Coated
Tablet
J01FA09
Interchangeable
List Code:
IC0072-117-003
PA0294/017/001
CLARITHROMY
CIN
Per Cent
Powder for Oral
Solution
A06AD65
Interchangeable
List Code:
IC0072-117-050
PPA0465/051/00
4
Interchangeable
List Code:
IC0072-117-050
PPA1151/046/00
1
CLARITHROMY
CIN
CLARITHROMY
CIN
KLEAN-PREP
POWDER FOR
ORAL
SOLUTION
Helsinn Birex
Pharmaceuticals
Limited
KLIOGEST
Novo Nordisk A/S
PA0218/022/001
2/1 Milligram
Film Coated
Tablet
G03FA01
KOGENATE
BAYER
Bayer AG
EU/1/00/143/001
250IU
International Unit
Infus/Pdr/Oral
Soln
B02BD02
KOGENATE
BAYER
KOGENATE
BAYER
KOGENATE
BAYER
KOGENATE
BAYER
KOGENATE
BAYER
KOGENATE
BAYER
KOGENATE
BAYER
KOLBAM
Bayer AG
EU/1/00/143/002
EU/1/00/143/003
Bayer AG
EU/1/00/143/005
Bayer AG
EU/1/00/143/006
Bayer AG
EU/1/00/143/004
Bayer AG
EU/1/00/143/1011
EU/1/00/143/012013
EU/1/13/895/001
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Capsules Hard
B02BD02
Bayer AG
500 International
Unit
1000
International Unit
IU International
Unit
IU International
Unit
250 International
Unit
2000
International Unit
3000
International Unit
50 Milligram
A05AA03
-SODIUM
SULFATE
ANHYDROUS
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MACROGOL
-ESTRADIOL
HEMIHYDRATE
NORETHISTER
ONE ACETATE
-OCTOCOG
ALFA
-R-DNA (BABY
HAMSTER
KIDNEY
EXPRESSION
SYSTEM)
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-CHOLIC ACID
EU/1/13/895/002
250 Milligram
Capsules Hard
A05AA03
-CHOLIC ACID
KOLBAM
Bayer AG
Retrophin Europe
Limited
Retrophin Europe
Limited
Human Medicines Authorised/Transfer Pending Products
B02BD02
B02BD02
B02BD02
B02BD02
B02BD02
B02BD02
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
PPA
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
Page 255 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
KOMBOGLYZE
AstraZeneca AB
EU/1/11/731/001006
2.5/850 Milligram
Film Coated
Tablet
A10BD10
KOMBOGLYZE
Bristol-Myers
Squibb /
AstraZeneca
EEIG
Roche Products
Limited
EU/1/11/731/007012
2.5/1000
Milligram
Film Coated
Tablet
A10BD10
PA0050/076/001
10 Mg/Ml
Solution for
Injection
B02BA01
Roche Products
Limited
PA0050/076/002
Solution for
Injection
B02BA01
Menarini
International
Operations
Luxembourg S.A.
PA0865/017/001
2 mg/ 0.2 ml
Milligrams per
Ampule
20/5 mg/mg
Film Coated
Tablet
C09DB02
Interchangeable
List Code:
IC0046-092-003
PA0865/017/002
40/5 mg/mg
Film Coated
Tablet
C09DB02
Interchangeable
List Code:
IC0046-094-003
PA0865/017/003
40/10 mg/mg
Film Coated
Tablet
40/10 mg/mg
KONAKION MM
AMPOULES
KONAKION MM
PAEDIATRIC
AMPOULES
KONVERGE
KONVERGE
KONVERGE
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
-Per Oral
C09DB02
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
Article 10b Fixed
Combination
-Per Oral
Film Coated
Tablet
C09DB02
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
-Per Oral
20/5 mg/mg
Film Coated
Tablet
C09DB02
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
40/5 mg/mg
Film Coated
Tablet
C09DB02
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
20/5 Milligram
Film Coated
Tablet
C09DB02
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0046-092-003
PPA0465/313/00
1
KONVERGE
LTT Pharma
Limited
Interchangeable
List Code:
IC0046-094-003
PPA1562/175/00
1
KONVERGE
LTT Pharma
Limited
PPA1562/175/00
2
40/5 Milligram
Film Coated
Tablet
C09DB02
KONVERGE
LTT Pharma
Limited
PPA1562/175/00
3
40/10 Milligram
Film Coated
Tablet
C09DB02
KONVERGE
IMED Healthcare
Ltd.
PPA1463/104/00
1
20/5 mg/mg
Film Coated
Tablet
C09DB02
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0046-092-003
PPA1463/104/00
2
40/5 mg/mg
Film Coated
Tablet
C09DB02
Interchangeable
List Code:
IC0046-094-003
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Article 10b Fixed
Combination
PCO
Manufacturing
KONVERGE
-Per Oral
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
Interchangeable
List Code:
IC0046-093-003
PPA0465/313/00
3
KONVERGE
Routes of
Administration
-Per Oral
PCO
Manufacturing
KONVERGE
-SAXAGLIPTIN
-METFORMIN
HYDROCHLORI
DE
-SAXAGLIPTIN
-METFORMIN
HYDROCHLORI
DE
PHYTOMENADI
ONE
PHYTOMENADI
ONE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
Legal Basis
Article 10b Fixed
Combination
Interchangeable
List Code:
IC0046-093-003
PPA0465/313/00
2
KONVERGE
Active
Ingredients
-Per Oral
-Per Oral
-Per Oral
Page 256 of 608
Trade Name
KONVERGE
KONVERGE
KONVERGE
Licence Holder Licence
Number
IMED Healthcare
Ltd.
Imbat Limited
Imbat Limited
PPA1463/104/00
3
Interchangeable
List Code:
IC0046-093-003
PPA1151/255/00
1
Interchangeable
List Code:
IC0046-094-003
PPA1151/255/00
2
Strength
Dosage Form ATC
Legal Basis
Routes of
Administration
40/10 mg/mg
Film Coated
Tablet
C09DB02
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
40/5 mg/mg
Film Coated
Tablet
C09D
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
40/10 mg/mg
Film Coated
Tablet
C09D
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESYLATE
-Per Oral
20/5/12.5
Milligram
Film Coated
Tablet
C09DX03
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
AS AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
AS AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
AS AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
AS AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-Per Oral
KONVERGE
PLUS
LTT Pharma
Limited
Interchangeable
List Code:
IC0046-093-003
PPA1562/174/00
1
KONVERGE
PLUS
LTT Pharma
Limited
PPA1562/174/00
2
40/5/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
LTT Pharma
Limited
PPA1562/174/00
3
40/10/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
LTT Pharma
Limited
PPA1562/174/00
4
40/10/25
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
PCO
Manufacturing
PPA0465/421/00
1
20/5/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
PCO
Manufacturing
PPA0465/421/00
2
40/5/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
PCO
Manufacturing
PPA0465/421/00
3
40/10/12.5
Milligram
Film Coated
Tablet
C09DX03
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 257 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
KONVERGE
PLUS
PCO
Manufacturing
PPA0465/421/00
4
40/5/25 Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
PCO
Manufacturing
PPA0465/421/00
5
40/10/25
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
Menarini
International
Operations
Luxembourg S.A.
PA0865/019/001
20/5/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
Menarini
International
Operations
Luxembourg S.A.
PA0865/019/002
40/5/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
Menarini
International
Operations
Luxembourg S.A.
PA0865/019/003
40/10/12.5
Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
Menarini
International
Operations
Luxembourg S.A.
PA0865/019/004
40/5/25 Milligram
Film Coated
Tablet
C09DX03
KONVERGE
PLUS
Menarini
International
Operations
Luxembourg S.A.
PA0865/019/005
40/10/25
Milligram
Film Coated
Tablet
C09DX03
KOPEN
Athlone
Laboratories Ltd
PA0298/007/001
250 Milligram
Tablets
J01CE02
KOPEN
Athlone
Laboratories Ltd
PA0298/007/002
125 MG/5ml
Powder for Oral
Solution
J01CE02
KOPEN SUGAR
FREE
Athlone
Laboratories Ltd
PA0298/007/003
250 MG/5ml
Powder for Oral
Solution
J01CE02
KOVALTRY
Bayer AG
Bayer Pharma
AG
Bayer Pharma
AG
Bayer Pharma
AG
Bayer Pharma
AG
Mallinckrodt
Medical B.V.
BioMarin
International
Limited
250 International
Unit
500 International
Unit
1000
International Unit
2000
International Unit
3000
International Unit
74 - 740 MBq
EU/1/08/481/1-3
100 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Radionuclide
Generator
Tablets
B02BD02
KOVALTRY
EU/1/15/1076/00
1-002
EU/1/15/1076/00
3-004
EU/1/15/1076/00
5-006
EU/1/15/1076/00
7-008
EU/1/15/1076/00
9-010
PA0690/007/001
KOVALTRY
KOVALTRY
KOVALTRY
KRYPTOSCAN
(81MKR)
KUVAN 100 MG
SOLUBLE
TABLETS
Human Medicines Authorised/Transfer Pending Products
B02BD02
B02BD02
B02BD02
B02BD02
V09EX01
A16AX07
Active
Ingredients
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
-OLMESARTAN
MEDOXOMIL
-AMLODIPINE
BESILATE
HYDROCHLOR
OTHIAZIDE
PHENOXYMET
HYLPENICILLIN
PHENOXYMET
HYLPENICILLIN
POTASSIUM
PHENOXYMET
HYLPENICILLIN
POTASSIUM
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-OCTOCOG
ALFA
-KRYPTON (81M
KR)
-SAPROPTERIN
DIHYDROCHLO
RIDE
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
Page 258 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
KWELLS
Bayer Limited
PA1410/048/002
300 Microgram
Tablets
A04AD01
KYLEENA 19.5
MG
INTRAUTERINE
DELIVERY
SYSTEM
KYPROLIS
Bayer Limited
PA1410/081/001
19.5 Milligram
Intrauterine
delivery system
G02BA03
-HYOSCINE
HYDROBROMID
E
LEVONORGEST
REL,
MICRONIZED
Amgen Europe
B.V.
Roche Products
Limited
EU/1/15/1060/00
1
PA0050/149/002
60 Milligram
Pdr for Soln for
Injection
Solution for
Injection
L01XX45
-CARFILZOMIB
-Intra-venous
A04AA02
-Intra-venous
KYTRIL
Roche Products
Limited
PA0050/149/003
3 Mg/Ml
Solution for
Injection
A04AA02
KYTRIL
Roche Products
Limited
PA0050/149/004
1 Milligram
Film Coated
Tablet
A04AA02
KYTRIL
Roche Products
Limited
PA0050/149/005
2 Milligram
Film Coated
Tablet
A04AA02
LACRI-LUBE
EYE OINTMENT
Allergan
Pharmaceuticals
Ireland
PA0148/038/001
%w/w
Eye Ointment
S01XA20
LACTECON
BGP Products
Ltd
Fresenius Kabi
Austria GmbH
PA2007/011/001
3.335 g/5ml
Oral Solution
A06AD11
-GRANISETRON
HYDROCHLORI
DE
-GRANISETRON
HYDROCHLORI
DE
-GRANISETRON
HYDROCHLORI
DE
-GRANISETRON
HYDROCHLORI
DE
-WHITE SOFT
PARAFFIN
-PARAFFIN,
LIQUID
-WOOL
ALCOHOLS
-LACTULOSE
PA0773/004/001
10 g/15ml
Oral Solution
A06AD11
-LACTULOSE
PA1240/017/001
3.335 g/5ml
Oral Solution
A06AD11
-LACTULOSE
LACTULOSE
FRESENIUS
Bristol
Laboratories
Limited
Fresenius Kabi
Austria GmbH
PA0773/003/001
670 Mg/Ml
Oral Solution
A06AD11
-LACTULOSE
LAEVOLAC
PLUM
Fresenius Kabi
Austria GmbH
PA0773/005/001
10 g/15ml
Oral Solution
A06AD11
-LACTULOSE,
LIQUID
LAMATER
Wockhardt UK
Limited
PA1339/018/001
250 Milligram
Tablets
D01BA02
LAMBERTS
VALERIAN
TR2029/001/001
300 Milligram
Film Coated
Tablet
N05CM09
LAMICTAL
Lamberts
Healthcare
Limited
Lexon (UK) Ltd
-TERBINAFINE
HYDROCHLORI
DE
-VALERIAN
EXTRACT
25 Milligram
-LAMOTRIGINE
-Per Oral
Lexon (UK) Ltd
50 Milligram
Chewable/Disper
sible tablet
Tablets
N03AX09
LAMICTAL
N03AX09
-LAMOTRIGINE
-Per Oral
LAMICTAL
Lexon (UK) Ltd
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
LAMICTAL
Lexon (UK) Ltd
25 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
LAMICTAL
Lexon (UK) Ltd
50 Milligram
-LAMOTRIGINE
-Per Oral
Lexon (UK) Ltd
N03AX09
-LAMOTRIGINE
-Per Oral
LAMICTAL
Lexon (UK) Ltd
N03AX09
-LAMOTRIGINE
-Per Oral
LAMICTAL
GlaxoSmithKline
(Ireland) Limited
PCO
Manufacturing
PCO
Manufacturing
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Tablets
N03AX09
LAMICTAL
PPA1097/007/00
1
PPA1097/007/00
2
PPA1097/007/00
3
PPA1097/007/00
7
PPA1097/007/00
4
PPA1097/007/00
5
PPA1097/007/00
6
PA1077/061/001
N03AX09
-LAMOTRIGINE
-Per Oral
PPA0465/092/00
8
PPA0465/092/00
9
PA1077/061/002
50 Milligram
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
50 Milligram
Dispersable
Tablet
Dispersable
Tablet
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
PA1077/061/003
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
PA1077/061/004
200 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
KYTRIL
LACTULOSE
LACTULOSE
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
Human Medicines Authorised/Transfer Pending Products
1 Mg/Ml
100 Milligram
200 M.Bequerel
25 Milligram
200 Milligram
-Per Oral
Article 8(3) - Full
new Application
-Intra-uterine
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 259 of 608
Trade Name
LAMICTAL
Licence Holder Licence
Number
LAMICTAL
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
GlaxoSmithKline
(Ireland) Limited
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
Primecrown 2010
Ltd
Primecrown 2010
Ltd
Primecrown 2010
Ltd
PCO
Manufacturing
PCO
Manufacturing
Imbat Limited
LAMICTAL
Imbat Limited
LAMICTAL
Imbat Limited
LAMICTAL
Imbat Limited
LAMICTAL
LAMICTAL
LTT Pharma
Limited
B & S Healthcare
LAMICTAL
B & S Healthcare
LAMICTAL
B & S Healthcare
LAMICTAL
LAMICTAL
LTT Pharma
Limited
LTT Pharma
Limited
LTT Pharma
Limited
Profind
Wholesale Ltd
Imbat Limited
LAMICTAL
Imbat Limited
LAMICTAL
LAMICTAL
McDowell
Pharmaceuticals
McDowell
Pharmaceuticals
Imbat Limited
LAMICTAL
Imbat Limited
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
LAMICTAL
Strength
PA1077/061/006
5 Milligram
PA1077/061/007
25 Milligram
PA1077/061/009
100 Milligram
PA1077/061/008
50 Milligram
PA1077/061/010
200 Milligram
PA1077/061/005
2 Milligram
PPA0465/092/00
5
PPA0465/092/00
6
PPA0465/092/00
7
PPA0465/092/01
1
PPA0465/092/01
2
PPA1463/066/00
4
PPA1463/066/00
5
PPA1463/066/00
6
PPA1633/041/00
1
PPA1633/041/00
2
PPA1633/041/00
3
PPA0465/092/01
3
PPA0465/092/01
0
PPA1151/115/00
6
PPA1151/115/00
7
PPA1151/115/00
8
PPA1151/115/00
9
PPA1562/011/00
4
PPA1328/128/00
2
PPA1328/128/00
3
PPA1328/128/00
1
PPA1562/011/00
1
PPA1562/011/00
2
PPA1562/011/00
3
PPA1500/046/00
1
PPA1151/115/00
1
PPA1151/115/00
2
PPA1473/050/00
1
PPA1473/050/00
2
PPA1151/115/00
3
PPA1151/115/00
4
5 Milligram
Human Medicines Authorised/Transfer Pending Products
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
N03AX09
-LAMOTRIGINE
PPA
N03AX09
-LAMOTRIGINE
PPA
25 Milligram
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
50 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
25 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
25 Milligram
N03AX09
-LAMOTRIGINE
-Per Oral
25 Milligram
Dispersable
Tablet
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
50 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
200 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
25 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
50 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
200 Milligram
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
200 Milligram
Tablets
N03AX09
-LAMOTRIGINE
25 Milligram
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
25 Milligram
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Tablets
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
50 Milligram
Tablets
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
25 Milligram
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
50 Milligram
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Tablets
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
100 Milligram
Dispersable
Tablet
Dispersable
Tablet
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
25 Milligram
100 Milligram
200 Milligram
100 Milligram
25 Milligram
50 Milligram
200 Milligram
PPA
-Per Oral
Page 260 of 608
Trade Name
Licence Holder Licence
Number
LAMICTAL
Imbat Limited
LAMICTAL
WPR Healthcare
Limited
WPR Healthcare
Limited
WPR Healthcare
Limited
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
Imbat Limited
LAMICTAL
LAMICTAL
LAMICTAL
DISPERSIBLE
LAMICTAL
DISPERSIBLE
LAMICTAL
DISPERSIBLE
LAMISIL
Strength
PPA1151/115/00
5
PPA0565/050/00
1
PPA0565/050/00
2
PPA0565/050/00
3
PPA1463/066/00
1
PPA1463/066/00
2
PPA1463/066/00
3
PPA1151/029/00
2
5 Milligram
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
N03AX09
-LAMOTRIGINE
PPA
-Per Oral
1 %w/w
Dispersable
Tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Chewable/Disper
sible tablet
Tablets
Chewable
Tablets
Chewable
Tablets
Chewable
Cream
D01AE15
-TERBINAFINE
HYDROCHLORI
DE
-TERBINAFINE
HYDROCHLORI
DE
-TERBINAFINE
PPA
-TERBINAFINE
HYDROCHLORI
DE
-TERBINAFINE
HYDROCHLORI
DE
PPA
-TERBINAFINE
HYDROCHLORI
DE
-TERBINAFINE
HYDROCHLORI
DE
PPA
25 Milligram
50 Milligram
100 Milligram
50 Milligram
100 Milligram
200 Milligram
LAMISIL
PCO
Manufacturing
PPA0465/096/00
1
250 Milligram
Tablets
D01AE15
LAMISIL
Novartis
Pharmaceuticals
UK Ltd
Imbat Limited
PA0013/045/003
250 Milligram
Tablets
D01BA02
PPA1151/029/00
1
250 Milligram
Tablets
D01BA02
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PCO
Manufacturing
PA0678/121/001
1%w/w %w/w
Cream
D01AE15
PPA0465/151/00
1
1 %w/w
Cream
D01AE15
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Teva B.V.
PA0678/121/002
1.0 %w/w
Cream
D01AE15
PA0678/121/003
1 Per Cent
Cutaneous
Solution
D01AE15
-TERBINAFINE
HYDROCHLORI
DE
EU/1/09/566/1-5
100 Milligram
Film Coated
Tablet
J05AF05
-LAMIVUDINE
Teva B.V.
EU/1/09/596/1-7
150 Milligram
Film Coated
Tablet
J05AF05
-LAMIVUDINE
Teva B.V.
EU/1/09/596/8-14
300 Milligram
Film Coated
Tablet
J05AF05
-LAMIVUDINE
Teva B.V.
EU/1/10/663/001002
150/300 Milligram
Film Coated
Tablet
J05AR01
-LAMIVUDINE
-ZIDOVUDINE
PA0281/128/001
5 Milligram
N03AX07
-LAMOTRIGINE
-Per Oral
PA0281/128/002
25 Milligram
N03AX09
-LAMOTRIGINE
-Per Oral
PA0281/128/003
50 Milligram
N03AX09
-LAMOTRIGINE
-Per Oral
PA0281/128/004
100 Milligram
N03AX09
-LAMOTRIGINE
-Per Oral
PA0281/128/005
200 Milligram
N03AX09
-LAMOTRIGINE
-Per Oral
PA0577/077/004
200 Milligram
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Tablets
N03AX09
-LAMOTRIGINE
-Per Oral
LAMOTRIGINE
AUROBINDO
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Aurobindo
Pharma Limited
PA1311/013/001
25 Milligram
Tablets
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Aurobindo
Pharma Limited
PA1311/013/002
50 Milligram
Tablets
N03AX09
-LAMOTRIGINE
LAMISIL
LAMISIL
LAMISIL 1%
W/W CREAM
LAMISIL AT
LAMISIL ONCE
LAMIVUDINE
TEVA
LAMIVUDINE
TEVA PHARMA
B.V.
LAMIVUDINE
TEVA PHARMA
B.V.
LAMIVUDINE/ZI
DOVUDINE
TEVA
LAMORO
LAMORO
LAMORO
LAMORO
LAMORO
LAMOT
Human Medicines Authorised/Transfer Pending Products
PPA
-Topical
-Cutaneous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 261 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
LAMOTRIGINE
AUROBINDO
Aurobindo
Pharma Limited
PA1311/013/003
100 Milligram
Tablets
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Aurobindo
Pharma Limited
PA1311/013/004
200 Milligram
Tablets
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Milpharm Limited
PA1050/009/001
5 Milligram
Dispersable
Tablet
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Milpharm Limited
PA1050/009/002
25 Milligram
Dispersable
Tablet
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Milpharm Limited
PA1050/009/003
50 Milligram
Dispersable
Tablet
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Milpharm Limited
PA1050/009/004
100 Milligram
Dispersable
Tablet
N03AX09
-LAMOTRIGINE
LAMOTRIGINE
AUROBINDO
Milpharm Limited
PA1050/009/005
200 Milligram
Dispersable
Tablet
N03AX09
-LAMOTRIGINE
LANOXIN 250
MICROGRAM
TABLETS
LANOXIN PG
Aspen Pharma
Trading Limited
PA1691/001/004
0.25mg Milligram
Tablets
C01AA05
-DIGOXIN
-Per Oral
Aspen Pharma
Trading Limited
Aspen Pharma
Trading Limited
PA1691/001/002
50 Microgram/ML
Oral Solution
C01AA05
-DIGOXIN
-Per Oral
PA1691/001/003
62.5 Microgram
Tablets
C01AA05
-DIGOXIN
-Per Oral
Aspen Pharma
Trading Limited
PA1691/001/001
0.25 %v/v
Solution for
Injection
C01AA05
-DIGOXIN
-Intra-Muscular
Rowex Ltd
PA0711/244/001
15 Milligram
Orodispersible
Tablet
A02BC03
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0008-032-033
PA0711/244/002
LANSOPRAZOL
E
30 Milligram
Orodispersible
Tablet
A02BC03
Article 10(1) Generic
Application
-Per Oral
WPR Healthcare
Limited
Interchangeable
List Code:
IC0008-033-033
PPA0565/063/00
1
LANSOPRAZOL
E
15 Milligram
Capsules GastroResistant
A02BC03
LANSOPRAZOL
E
-Per Oral
WPR Healthcare
Limited
Interchangeable
List Code:
IC0008-032-033
PPA0565/063/00
2
30 Milligram
Capsules GastroResistant
A02BC03
LANSOPRAZOL
E
-Per Oral
Interchangeable
List Code:
IC0008-033-033
PA1380/131/001
15 Milligram
Capsules GastroResistant
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-032-033
PA1380/131/002
LANSOPRAZOL
E
30 Milligram
Capsules GastroResistant
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-033-033
PA1347/062/002
LANSOPRAZOL
E
30 Milligram
Capsules GastroResistant
A02BC03
-Per Oral
Interchangeable
List Code:
IC0008-033-033
PA1347/062/001
LANSOPRAZOL
E
15 Milligram
Capsules GastroResistant
A02BC03
LANSOPRAZOL
E
-Per Oral
LANOXIN PG
62.5
MICROGRAM
TABLETS
LANOXIN
SOLUTION FOR
INJECTION
LANSOPRAZOL
E
LANSOPRAZOL
E
LANSOPRAZOL
E
LANSOPRAZOL
E
LANSOPRAZOL
E ACTAVIS
LANSOPRAZOL
E ACTAVIS
LANSOPRAZOL
E KRKA
LANSOPRAZOL
E KRKA
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0008-032-033
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 262 of 608
Trade Name
LANSOPRAZOL
E MYLAN
LANSOPRAZOL
E MYLAN
LANSOPRAZOL
E PINEWOOD
LANSOPRAZOL
E PINEWOOD
LANSOPRAZOL
E TEVA
LANSOPRAZOL
E TEVA
Licence Holder Licence
Number
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Pinewood
Laboratories Ltd,
Pinewood
Laboratories Ltd,
Teva Pharma
B.V.
Teva Pharma
B.V.
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0577/151/001
15 Milligram
Capsules GastroResistant
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-032-033
PA0577/151/002
LANSOPRAZOL
E
30 Milligram
Capsules GastroResistant
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-033-033
PA0281/151/001
LANSOPRAZOL
E
15 Milligram
Capsules GastroResistant
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-032-033
PA0281/151/002
LANSOPRAZOL
E (I.N.N.)
30 Milligram
Capsules GastroResistant
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-033-033
PA0749/024/003
LANSOPRAZOL
E
15 Milligram
Orodispersible
Tablet
A02BC03
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0008-032-033
PA0749/024/004
LANSOPRAZOL
E
30 Milligram
Orodispersible
Tablet
A02BC03
LANSOPRAZOL
E
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Capsules GastroResistant
A02BC03
LANSOPRAZOL
E
Article 10(3) Hybrid
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
LANSOPRAZOL
E TEVA
PHARMA
Teva B.V.
Interchangeable
List Code:
IC0008-033-033
PA1986/008/001
LANSOPRAZOL
E TEVA
PHARMA
Teva B.V.
Interchangeable
List Code:
IC0008-032-033
PA1986/008/002
30 Milligram
Capsules GastroResistant
A02BC03
LANTUS
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Aspen Pharma
Trading Limited
Rowex Ltd
Interchangeable
List Code:
IC0008-033-033
EU/1/00/134/8-37
LANSOPRAZOL
E
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/001
100IU/ml
International Unit
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/002
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/003
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/004
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/005
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/006
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
EU/1/00/134/007
100 IU/ML
Solution for
Injection
A10AE04
-INSULIN
GLARGINE
-Subcutaneous
PA1691/006/001
40 Milligram
Tablets
L01BB03
-TIOGUANINE
-Per Oral
PA0711/067/001
15 Milligram
Capsules GastroResistant
A02BC03
LANSOPRAZOL
E
-Per Oral
LANTUS
LANTUS
LANTUS
LANTUS
LANTUS
LANTUS
LANTUS
LANVIS
LANZOL
Interchangeable
List Code:
IC0008-032-033
Human Medicines Authorised/Transfer Pending Products
Page 263 of 608
Trade Name
LANZOL
Licence Holder Licence
Number
Rowex Ltd
Strength
Dosage Form ATC
Active
Ingredients
30 Milligram
Capsules GastroResistant
A02BC03
Interchangeable
List Code:
IC0008-033-033
PA1353/002/001
LANSOPRAZOL
E
10 Micromol
Solution for
Injection
N02AF02
-NALBUPHINE
HYDROCHLORI
DE
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
N03AX09
-LAMOTRIGINE
-Per Oral
L01XC27
-OLARATUMAB
C03CA01
-FUROSEMIDE
-ZINC OXIDE
-SALICYLIC
ACID
-ZINC OXIDE
-SALICYLIC
ACID
-LATANOPROST
Orpha-Devel
Handels und
Vertriebs GmbH
Rowex Ltd
PA0711/085/002
25 Milligram
LARIG
Rowex Ltd
PA0711/085/003
50 Milligram
LARIG
Rowex Ltd
PA0711/085/004
100 Milligram
LARIG
Rowex Ltd
PA0711/085/005
200 Milligram
LARTRUVO
EU/1/16/1143/00
1
PA0540/052/002
10 Mg/Ml
20mg/2ml Mg/Ml
LASSARS
Eli Lilly
Nederland B.V.
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Ovelle Limited
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Dispersable
Tablet
Concentrate for
Soln for Inf
Solution for Inj/Inf
PA0206/014/001
24/2 %w/w
Cutaneous Paste
D02AF
LASSARS
Ovelle Limited
PA0206/014/002
23/2 %w/w
Cream
D02AF
LATACRIS
NTC Srl
PA2122/001/001
50 Microgram/ML
Eye Drops
Solution
S01EE01
LATANEAU
PLUS
Alapis S.A.
PA1608/001/001
50mcg/ml + 5
Mg/Ml
Eye Drops
Solution
S01ED51
LATANOPROST
Generics (UK)
Limited
PA0405/068/001
50 Microgram/ML
Eye Drops
Solution
S01EE01
LATANOPROST
/ TIMOLOL
ACTAVIS
LATANOPROST
ACTAVIS
Actavis Group
PTC ehf
PA1380/090/001
50mcg/ml + 5
Mg/Ml
Eye Drops
Solution
S01ED51
Actavis Group
PTC ehf
PA1380/107/001
50 Microgram/ML
Eye Drops
Solution
S01EE01
-LATANOPROST
-TIMOLOL
MALEATE
-LATANOPROST
LATANOPROST
TEVA
Teva Pharma
B.V.
PA0749/173/001
50 Microgram/ML
Eye Drops
Solution
S01EE01
-LATANOPROST
LATANOPROST
/TIMOLOL
Actavis Group
PTC ehf
PA1380/149/001
50mcg/ml + 5
Mg/Ml
Eye Drops
Solution
S01ED51
LATANOPROST
/TIMOLOL
ZENTIVA
LATOP
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Rowex Ltd
PA0540/173/001
50mcg/ml + 5
Mg/Ml
Eye Drops
Solution
S01ED51
PA0711/177/001
50 Microgram/ML
Eye Drops
Solution
S01EE01
-LATANOPROST
-TIMOLOL
MALEATE
-LATANOPROST
-TIMOLOL
MALEATE
-LATANOPROST
LATOP-COMP
Rowex Ltd
PA0711/184/001
50mcg/ml + 5
Mg/Ml
Eye Drops
Solution
S01ED51
LATUDA
Sunovion
Pharmaceuticals
Europe Ltd
Sunovion
Pharmaceuticals
Europe Ltd
Sunovion
Pharmaceuticals
Europe Ltd
Glaxo Group
Limited
EU/1/14/913/001007
18.5 Milligram
Film Coated
Tablet
N05AE05
EU/1/14/913/008014
37 Milligram
Film Coated
Tablet
N05AE05
EU/1/14/913/015021
74 Milligram
Film Coated
Tablet
N05AE05
EU/1/14/899/001003
55/22 Microcurie
Powder for
Inhalation
R03AL03
Helsinn Birex
Pharmaceuticals
Limited
PA0294/022/001
5.9 Grams
Powder for Oral
Solution
A06AD65
LATUDA
LATUDA
LAVENTAIR
LAXACLEAR
Routes of
Administration
PA0711/067/002
LAPAINOL 10
MG/ML
SOLUTION FOR
INJECTION
LARIG
LASIX
Legal Basis
Human Medicines Authorised/Transfer Pending Products
-LATANOPROST
-TIMOLOL
MALEATE
-LATANOPROST
-LATANOPROST
-TIMOLOL
MALEATE
-LURASIDONE
HYDROCHLORI
DE
-LURASIDONE
HYDROCHLORI
DE
-LURASIDONE
HYDROCHLORI
DE
-UMECLIDINIUM
BROMIDE
-VILANTEROL
TRIFENATATE
-MACROGOL
3350
-Per Oral
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Intra-venous
-Intra-venous
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Ocular
-Ocular
-Ocular
-Ocular
-Ocular
-Ocular
-Ocular
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
-Ocular
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Article 8(3) - Full
new Application
-Inhalation
Article 10a Bibliographical
App
-Per Oral
-Ocular
-Ocular
-Per Oral
Page 264 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LAXAGOL
Auden Mckenzie
(Pharma Division)
Ltd
PA1352/005/001
13.8 Grams
Powder for Oral
Solution
A06AD65
LAXATEV
Teva Pharma
B.V.
PA0749/200/001
13.8 Grams
Powder for Oral
Solution
A06AD65
LAXATEV
PAEDIATRIC
Teva Pharma
B.V.
PA0749/200/002
6.9 Grams
Powder for Oral
Solution
A06AD65
LAXIDO
Galen Limited
PA1329/002/002
13.7 Grams
Powder for Oral
Solution
A06AD65
LAXIDO
ORANGE
Galen Limited
PA1329/002/001
13.8 N/A
Powder for Oral
Solution
A06AD65
LAXIDO
PAEDIATRIC
PLAIN
Galen Limited
PA1329/002/003
6.9 Grams
Powder for Oral
Solution
A06AD65
LAXOSE
Pinewood
Laboratories Ltd,
Actavis Group
PTC ehf
PA0281/079/001
3.35 g/5ml
Oral Solution
A06AD11
PA1380/036/001
10 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0020-002-003
PA1380/036/002
20 Milligram
Interchangeable
List Code:
IC0020-003-003
EU/1/16/1171/00
1
160
Micrograms/g
LECALPIN
LECALPIN
LEDAGA
Actavis Group
PTC ehf
Actelion
Registration Ltd
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
Legal Basis
Routes of
Administration
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-LACTULOSE
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
C08CA13
LERCANIDIPINE
HCI
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
C08CA13
LERCANIDIPINE
HCI
Article 10(1) Generic
Application
-Per Oral
Gel
L01AA05
CHLORMETHIN
E
HYDROCHLORI
DE
Article 10(3) Hybrid
Application
-Cutaneous
-Per Oral
Page 265 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
LEDERMIX FOR
DENTAL USE
Henry Schein UK
Holdings Limited
PA1321/002/001
3 %v/v
Dental Solution
A01AC01
LEFLUNOMIDE
Morningside
Healthcare
Limited
Morningside
Healthcare
Limited
Morningside
Healthcare
Limited
Aspire Pharma
Limited
PA1333/011/001
10 Milligram
Tablets
L04AA13
DEMECLOCYCL
INE
HYDROCHLORI
DE IN PASTE
TRIAMCINOLO
NE ACETONIDE
IN PASTE
DEMECLOCYCL
INE
HYDROCHLORI
DE IN POWDER
TRIAMCINOLO
NE ACETONIDE
IN POWDER
-EUGENOL IN
HARDENER F
-EUGENOL IN
HARDENER S
-LEFLUNOMIDE
PA1333/011/002
20 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
PA1333/011/003
100 Milligram
Tablets
L04AA13
-LEFLUNOMIDE
PA1619/002/001
10 Milligram
Film Coated
Tablet
L04AA13
-LEFLUNOMIDE
LEFLUNOMIDE
Aspire Pharma
Limited
PA1619/002/002
20 Milligram
Film Coated
Tablet
L04AA13
-LEFLUNOMIDE
LEFLUNOMIDE
MEDAC
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Ratiopharm
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Sanofi-Aventis
Deutschland
GmbH
Schwarz Pharma
Ireland Ltd
Schwarz Pharma
Ireland Ltd
Schwarz Pharma
Ireland Ltd
Schwarz Pharma
Ireland Ltd
Schwarz Pharma
Ireland Ltd
Schwarz Pharma
Ireland Ltd
EU/1/10/637/001004
10 Milligram
Film Coated
Tablet
L04AA13
-LEFLUNOMIDE
EU/1/10/637/005009
20 Milligram
Film Coated
Tablet
L04AA13
EU/1/10/637/010012
15 Milligram
Film Coated
Tablet
L04AA13
EU/1/10/654/003004
EU/1/09/604/1-4
20 Milligram
Film Coated
Tablet
Film Coated
Tablet
L04AA13
L04AA13
-LEFLUNOMIDE
Article 10c Informed Consen
-Per Oral
EU/1/09/604/5-9
20 Milligram
Film Coated
Tablet
L04AA13
-LEFLUNOMIDE
Article 10c Informed Consen
-Per Oral
EU/1/09/604/10
100 Milligram
Film Coated
Tablet
L04AA13
-LEFLUNOMIDE
Article 10c Informed Consen
-Per Oral
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
N04BC09
N04BC09
-ROTIGOTINE
-Transdermal
N04BC09
-ROTIGOTINE
N04BC09
-ROTIGOTINE
N04BC09
-ROTIGOTINE
N04BC09
-ROTIGOTINE
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
Article 10c Informed Consen
LEFLUNOMIDE
LEFLUNOMIDE
LEFLUNOMIDE
LEFLUNOMIDE
MEDAC
LEFLUNOMIDE
MEDAC
LEFLUNOMIDE
RATIOPHARM
LEFLUNOMIDE
WINTHROP
LEFLUNOMIDE
WINTHROP
LEFLUNOMIDE
WINTHROP
LEGANTO
LEGANTO
LEGANTO
LEGANTO
LEGANTO
LEGANTO
10 Milligram
EU/1/11/695/055
EU/1/11/695/001009
EU/1/11/695/010018
EU/1/11/695/019027
EU/1/11/695/028036
EU/1/11/695/037046
Human Medicines Authorised/Transfer Pending Products
1/24 mg/24 hours
2/24 mg/24 hours
3/24 mg/24 hours
4/24 mg/24 hours
6/24 mg/24 hours
-Dental
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-LEFLUNOMIDE
Article 10(1) Generic
Application
-Per Oral
-LEFLUNOMIDE
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Transdermal
-Transdermal
-Transdermal
-Transdermal
Page 266 of 608
Trade Name
LEGANTO
LEMILVO
LEMILVO
LEMILVO
LEMILVO
LEMILVO
LEMILVO
LEMILVO
Licence Holder Licence
Number
Schwarz Pharma
Ireland Ltd
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Actavis Group
PTC ehf
EU/1/11/695/046054
PA1380/174/001
Strength
8/24 mg/24 hours
Dosage Form ATC
Active
Ingredients
N04BC09
-ROTIGOTINE
5 Milligram
Transdermal
Patch
Tablets
N05AX12
-ARIPIPRAZOLE
Interchangeable
List Code:
IC0092-001-056
PA1380/174/002
10 Milligram
Tablets
N05AX12
Interchangeable
List Code:
IC0092-002-056
PA1380/174/003
15 Milligram
Tablets
Interchangeable
List Code:
IC0092-032-056
PA1380/174/004
30 Milligram
Interchangeable
List Code:
IC0092-033-056
PA1380/174/005
Legal Basis
Routes of
Administration
Article 10c Informed Consen
Article 10(1) Generic
Application
-Transdermal
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
Tablets
N05AX12
-ARIPIPRAZOLE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-002-056
PA1380/174/006
Article 10(1) Generic
Application
15 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-032-056
PA1380/174/007
Article 10(1) Generic
Application
30 Milligram
Orodispersible
Tablet
N05AX12
-ARIPIPRAZOLE
-Per Oral
Interchangeable
List Code:
IC0092-033-056
PA0979/026/001
Article 10(1) Generic
Application
50 MG/5ml
Oral Solution
R05CA03
-GUAIFENESIN
Article 10a Bibliographical
App
-Per Oral
-Per Oral
LEMSIP
CHESTY
COUGH
LEMSIP COLD &
FLU
Reckitt Benckiser
Ireland Ltd
Reckitt Benckiser
Ireland Ltd
PA0979/051/001
500 Milligram
Tablets
N02BE51
-PARACETAMOL
DC
LEMSIP COLD &
FLU HEADCOLD
LEMSIP COLD &
FLU HOT
LEMON
LEMSIP COLD
AND FLU
CAPSULES
WITH CAFFEINE
LEMSIP COUGH
AND COLD
CAPSULES
WITH CAFFEINE
LEMSIP
DECONGESTA
NT & FLU
BLACKCURRAN
T
Reckitt Benckiser
Ireland Ltd
Reckitt Benckiser
Ireland Ltd
PA0979/014/001
500 Milligram
N02BE51
-PARACETAMOL
-Per Oral
PA0979/013/001
500 Milligram
Powder for Oral
Solution
Powder for Oral
Solution
N02BE51
-PARACETAMOL
-Per Oral
Reckitt Benckiser
Ireland Ltd
PA0979/024/001
500/65 Milligram
Capsule
N02BE01
-PARACETAMOL
-CAFFEINE
Reckitt Benckiser
Ireland Ltd
PA0979/029/001
500mg/100m
Milligram
Capsules Hard
N02BE51
Reckitt Benckiser
Ireland Ltd
PA0979/050/002
500 / 6.1
Milligram
Tablets
N02BE51
LEMSIP
DECONGESTA
NT & FLU
CAPSULES
WITH CAFFEINE
Reckitt Benckiser
Ireland Ltd
PA0979/027/001
500/6.1/25
Milligram
Capsule
N02BE51
LEMSIP
DECONGESTA
NT & FLU
LEMON
Reckitt Benckiser
Ireland Ltd
PA0979/050/001
500 / 6.1
Milligram
Tablets
N02BE51
-PARACETAMOL
-GUAIFENESIN
-CAFFEINE
ANHYDROUS
-PARACETAMOL
PHENYLEPHRI
NE
HYDROCHLORI
DE
-PARACETAMOL
-CAFFEINE
PHENYLEPHRI
NE
HYDROCHLORI
DE
-PARACETAMOL
PHENYLEPHRI
NE
HYDROCHLORI
DE
Human Medicines Authorised/Transfer Pending Products
Article 10a Bibliographical
App
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-Per Oral
Article 10a Bibliographical
App
-Per Oral
Page 267 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
LEMSIP DRY
COUGH
LEMSIP MAX
COLD AND FLU
BLACKCURRAN
T
LEMSIP MAX
COLD AND FLU
HOT LEMON
LEMSIP MAX
COUGH & COLD
LEMSIP MAX
SINUS & FLU
HOT LEMON
Reckitt Benckiser
Ireland Ltd
Reckitt Benckiser
Ireland Ltd
PA0979/025/001
0.25 ml/5ml
Oral Solution
R05
-GLYCEROL
PA0979/021/003
1000 Milligram
Powder for Oral
Solution
N02BE01
-PARACETAMOL
Reckitt Benckiser
Ireland Ltd
PA0979/021/001
1000 Milligram
Powder for Oral
Solution
N02BE51
-PARACETAMOL
-Per Oral
Reckitt Benckiser
Ireland Ltd
Reckitt Benckiser
Ireland Ltd
PA0979/028/001
1000/200
Milligram
%v/v
Powder for Oral
Solution
Powder for Oral
Solution
N02BE51
-Per Oral
LEMSIP MULTIRELIEF
CAPSULES
Reckitt Benckiser
Ireland Ltd
PA0979/053/001
500/6.1/10
Milligram
Capsules Hard
N02BE51
LEMTRADA
EU/1/13/869/001
12 Milligram
4 Milligram
LENVIMA
Eisai Europe Ltd
10 Milligram
Capsules Hard
L01X
LENZETTO
1.53 Milligram
Unknown
G03CA03
LEONORE
Gedeon Richter
Plc
Rowex Ltd
EU/1/15/1002/00
1
EU/1/15/1002/00
2
PA1330/017/001
Concentrate for
Soln for Inf
Capsules Hard
L04AA34
LENVIMA
Genzyme
Therapeutics Ltd
Eisai Europe Ltd
-PARACETAMOL
-GUAIFENESIN
-PARACETAMOL
PSEUDOEPHE
DRINE
HYDROCHLORI
DE
-PARACETAMOL
PHENYLEPHRI
NE
HYDROCHLORI
DE
-GUAIFENESIN
-ALEMTUZUMAB
PA0711/127/001
100/20
Microgram
Coated Tablets
G03AA07
LERCANIDIPINE
CLONMEL
Clonmel
Healthcare Ltd
PA0126/187/001
10 Milligram
Film Coated
Tablet
C08CA13
Interchangeable
List Code:
IC0020-002-003
PA0126/187/002
20 Milligram
Film Coated
Tablet
C08CA13
Interchangeable
List Code:
IC0020-003-003
PA0577/155/001
10 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0020-002-003
PA0577/155/002
20 Milligram
Interchangeable
List Code:
IC0020-003-003
PA0749/115/001
LERCANIDIPINE
CLONMEL
LERCANIDIPINE
MYLAN
LERCANIDIPINE
MYLAN
LERCANIDIPINE
TEVA
LERCANIDIPINE
TEVA
LERCANIDIPINE
TEVA PHARMA
Clonmel
Healthcare Ltd
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
PA0979/020/001
N02BE51
Article 10a Bibliographical
App
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
LERCANIDIPINE
HCI
HEMIHYDRATE
Article 10(1) Generic
Application
-Per Oral
C08CA13
LERCANIDIPINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
C08CA13
LERCANIDIPINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
C08CA13
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0020-002-003
PA0749/115/002
LERCANIDIPINE
HYDROCHLORI
DE
20 Milligram
Film Coated
Tablet
C08CA13
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0020-003-003
PA0749/183/001
LERCANIDIPINE
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
C08CA13
LERCANIDIPINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0020-002-003
Human Medicines Authorised/Transfer Pending Products
L01X
-LENVATINIB
MESYLATE
-LENVATINIB
MESYLATE
-ESTRADIOL
HEMIHYDRATE
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LERCANIDIPINE
HCI
HEMIHYDRATE
-Per Oral
-Per Oral
-Transdermal
-Per Oral
Page 268 of 608
Trade Name
LERCANIDIPINE
TEVA PHARMA
Licence Holder Licence
Number
Teva Pharma
B.V.
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0749/183/002
20 Milligram
Film Coated
Tablet
C08CA13
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0020-003-003
PA1404/002/003
LERCANIDIPINE
HYDROCHLORI
DE
20/20 Milligram
Film Coated
Tablet
C09BB02
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 10b Fixed
Combination
-Per Oral
LERCARIL
Recordati Ireland
Limited
LERCARIL
Recordati Ireland
Limited
PA1404/002/001
10/10 Milligram
Film Coated
Tablet
C09BB02
LERCARIL
Recordati Ireland
Limited
PA1404/002/002
20/10 Milligram
Film Coated
Tablet
C09BB02
LERCARIL
Lexon (UK) Ltd
PPA1097/003/00
1
20/10 Milligram
Film Coated
Tablet
C09BB02
LESCOL
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
PCO
Manufacturing
IMED Healthcare
Ltd.
LTT Pharma
Limited
Actavis Group
PTC ehf
PA0013/053/001
20 Milligram
Capsules Hard
C10AA04
-ENALAPRIL
MALEATE
LERCANIDIPINE
HYDROCHLORI
DE
LERCANIDIPINE
HYDROCHLORI
DE
-ENALAPRIL
MALEATE
-ENALAPRIL
MALEATE
LERCANIDIPINE
HYDROCHLORI
DE
-ENALAPRIL
MALEATE
LERCANIDIPINE
HYDROCHLORI
DE
-FLUVASTATIN
PA0013/053/002
40 Milligram
Capsules Hard
C10AA04
-FLUVASTATIN
-Per Oral
PA0013/053/003
80 Base
Milligrams
Tablet Prolonged
Release
C10AA04
-FLUVASTATIN
-Per Oral
PPA0465/404/00
1
PPA1463/101/00
1
PPA1562/039/00
1
PA1380/007/001
80 Milligram
C10AA04
-FLUVASTATIN
-Per Oral
C10AA04
2.5 Milligram
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablets
-FLUVASTATIN
SODIUM
-FLUVASTATIN
SODIUM
-LISINOPRIL
DIHYDRATE
LESTACE
Actavis Group
PTC ehf
PA1380/007/002
5 Milligram
Tablets
C09AA03
-LISINOPRIL
DIHYDRATE
LESTACE
Actavis Group
PTC ehf
PA1380/007/003
10 Milligram
Tablets
C09AA03
-LISINOPRIL
DIHYDRATE
LESTACE
Actavis Group
PTC ehf
PA1380/007/004
20 Milligram
Tablets
C09AA03
-LISINOPRIL
DIHYDRATE
LETROZOLE
Accord
Healthcare
Limited
Clonmel
Healthcare Ltd
PA1390/031/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
PA0126/198/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
LETROZOLE
Fresenius Kabi
Oncology Plc
PA1422/007/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
LETROZOLE
ACTAVIS
Actavis Group
PTC ehf
PA1380/038/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
LETROZOLE
BLUEFISH
Bluefish
Pharmaceuticals
AB
Medipha Sante
SN
PA1436/013/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
PA1566/001/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
LESCOL
LESCOL XL
LESCOL XL
LESCOL XL
LESCOL XL
LESTACE
LETROZOLE
LETROZOLE
MEDIPHA
SANTE
Human Medicines Authorised/Transfer Pending Products
80 Milligram
80 Milligram
C10AA04
C09AA03
-Per Oral
-Per Oral
PPA
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 269 of 608
Trade Name
LETROZOLE
MYLAN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Synthon BV
PA0577/116/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
Article 10(1) Generic
Application
-Per Oral
PA0840/009/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
-Per Oral
LETROZOLE
TEVA
Teva Pharma
B.V.
PA0749/085/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
LETZO
Rowex Ltd
PA0711/190/001
2.5 Milligram
Film Coated
Tablet
L02BG04
-LETROZOLE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
LEUCOVORINTEVA
LEUKERAN
Teva Pharma
B.V.
Aspen Pharma
Trading Limited
Immunomedics
GmbH
Rowex Ltd
PA0749/001/001
10 Mg/Ml
V03AF03
PA1691/007/001
2 Milligram
EU/1/97/032/001
%v/v
-CALCIUM
FOLINATE
CHLORAMBUCI
-SULESOMAB
PA0711/188/001
5 Milligram
Concentrate for
Soln for Inf
Film Coated
Tablet
Pdr for Soln for
Injection
Implant
L02AE02
-LEUPRORELIN
ACETATE
LEUPRORELIN
1-MONTH
DEPOT
LEUPRORELIN
3-MONTH
DEPOT
LEVACT
GP-Pharm, S.A.
PA1766/001/001
3.75 Milligram
Pdr+Solv for PR
for Susp for Inj
L02AE02
GP-Pharm, S.A.
PA1766/001/002
22.5 Milligram
Pdr+Solv for PR
for Susp for Inj
Astellas Pharma
GmbH
PA0731/005/002
100 Milligram
LEVACT
Astellas Pharma
GmbH
PA0731/005/001
LEVEMIR
Novo Nordisk A/S
LEVEMIR
(INSULIN
DETEMIR)
LEVETIRACETA
M
LEVETIRACETA
M ACCORD
LETROZOLE
SYNTHON
LEUKOSCAN
LEUPREX 3
L01AA02
V09HA04
-Per Oral
-Per Oral
-Per Oral
-Subcutaneous
-LEUPRORELIN
ACETATE
Article 10(3) Hybrid
Application
Article 8(3) - Full
new Application
L02AE02
-LEUPRORELIN
ACETATE
Article 8(3) - Full
new Application
-Intra-Muscular
Pdr/Conc/Soln for
Infus
L01AA09
25 Milligram
Pdr/Conc/Soln for
Infus
L01AA09
100 Units/ml
Solution for
Injection
Solution for
Injection
A10AE05
Novo Nordisk A/S
EU/1/04/278/010011
EU/1/04/278/1-9
BENDAMUSTINE
HYDROCHLORI
DE
BENDAMUSTINE
HYDROCHLORI
DE
-INSULIN
DETERMIR
-INSULIN
DETEMIR
Actavis Group
PTC ehf
EU/1/11/738/001003
100 Mg/Ml
Oral Solution
N03AX14
EU/1/11/712/001007
250 Milligram
Film Coated
Tablet
N03AX14
EU/1/11/712/008013
500 Milligram
Film Coated
Tablet
N03AX14
EU/1/11/712/022028
1000 Milligram
Film Coated
Tablet
N03AX14
EU/1/11/712/015021
750 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M ACTAVIS
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Actavis Group
PTC ehf
EU/1/11/713/001010
250 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M ACTAVIS
Actavis Group
PTC ehf
EU/1/11/713/011020
500 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M ACTAVIS
Actavis Group
PTC ehf
EU/1/11/713/021030
750 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M ACTAVIS
Actavis Group
PTC ehf
EU/1/11/713/031040
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M AUROBINDO
Milpharm Limited
PA1050/003/001
250 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M AUROBINDO
Milpharm Limited
PA1050/003/002
500 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M ACCORD
LEVETIRACETA
M ACCORD
LEVETIRACETA
M ACCORD
Human Medicines Authorised/Transfer Pending Products
100 U/ml Units/ml
A10AE05
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
-Intra-Muscular
-Intra-venous
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 270 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LEVETIRACETA
M AUROBINDO
Milpharm Limited
PA1050/003/003
750 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M AUROBINDO
Milpharm Limited
PA1050/003/004
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M BLUEFISH
PA1436/020/001
250 Milligram
Film Coated
Tablet
N03AX14
PA1436/020/002
500 Milligram
Film Coated
Tablet
N03AX14
PA1436/020/003
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M BRISTOL
LABS
LEVETIRACETA
M CIPLA
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bristol
Laboratories
Limited
Cipla (EU)
Limited
Infus/Pdr/Oral
Soln
N03AX14
PA1809/012/001
250 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M CIPLA
Cipla (EU)
Limited
PA1809/012/002
500 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M CIPLA
Cipla (EU)
Limited
PA1809/012/003
750 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M CIPLA
Cipla (EU)
Limited
PA1809/012/004
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M CLONMEL
Clonmel
Healthcare Ltd
PA0126/218/001
250 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M CLONMEL
Clonmel
Healthcare Ltd
PA0126/218/002
500 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M CLONMEL
Clonmel
Healthcare Ltd
PA0126/218/004
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M HOSPIRA
Hospira UK
Limited
EU/1/13/889/001002
100 Mg/Ml
Concentrate for
Soln for Inf
N03AX14
LEVETIRACETA
M MYLAN
PA0577/143/001
250 Milligram
Film Coated
Tablet
N03AX14
PA0577/143/002
500 Milligram
Film Coated
Tablet
PA0577/143/003
1000 Milligram
LEVETIRACETA
M RATIOPHARM
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Ratiopharm
GmbH
EU/1/11/702/004009
LEVETIRACETA
M RATIOPHARM
Ratiopharm
GmbH
LEVETIRACETA
M RATIOPHARM
Active
Ingredients
Legal Basis
Routes of
Administration
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
N03AX14
LEVETIRACETA
M
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
N03AX14
LEVETIRACETA
M
Article 10(1) Generic
Application
-Per Oral
250 Milligram
Film Coated
Tablet
N03AX14
500 Milligram
Film Coated
Tablet
N03AX14
Ratiopharm
GmbH
EU/1/11/702/018024
750 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M RATIOPHARM
Ratiopharm
GmbH
EU/1/11/702/025031
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M RATIOPHARM
Ratiopharm
GmbH
EU/1/11/702/001003
100 Mg/Ml
Oral Solution
N03AX14
LEVETIRACETA
M SUN
Sun
Phamaceutical
Industries Europe
B.V.
EU/1/11/741/001
100 Mg/Ml
Concentrate for
Soln for Inf
N03AX14
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
EU/1/11/702/010017
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M BLUEFISH
LEVETIRACETA
M BLUEFISH
LEVETIRACETA
M MYLAN
LEVETIRACETA
M MYLAN
PA1240/029/001
Human Medicines Authorised/Transfer Pending Products
100
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
Page 271 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LEVETIRACETA
M TEVA
Teva B.V.
EU/1/11/701/001004
250 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M TEVA
Teva B.V.
EU/1/11/701/008014
500 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M TEVA
Teva Pharma
B.V.
EU/1/11/701/015021
750 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M TEVA
Teva B.V.
EU/1/11/701/022028
1000 Milligram
Film Coated
Tablet
N03AX14
LEVETIRACETA
M THAME
PA1861/015/001
100 Mg/Ml
Oral Solution
N03AX14
LEVETIRACETA
M WOCKHARDT
SYRI Limited, t/a
Thame
Laboratories
Wockhardt UK
Limited
PA1339/054/001
100 Mg/Ml
Concentrate for
Soln for Inf
N03AX14
LEVITRA
Bayer AG
EU/1/03/248/01315
10 Milligram
Orodispersible
Tablet
G04BE09
LEVITRA
Bayer AG
EU/1/03/248/1-12
5 mg Milligram
Tablets
G04BE09
LEVOBUPIVAC
AINE
Fresenius Kabi
Limited
PA0566/066/001
0.625 Mg/Ml
Solution for
Infusion
N01BB10
LEVOBUPIVAC
AINE
Fresenius Kabi
Limited
PA0566/066/002
1.25 Mg/Ml
Solution for
Infusion
N01BB10
LEVOBUPIVAC
AINE
Fresenius Kabi
Limited
PA0566/066/003
2.5 Mg/Ml
Solution for Inj/Inf
N01BB10
LEVOBUPIVAC
AINE
Fresenius Kabi
Limited
PA0566/066/004
5 Mg/Ml
Solution for Inj/Inf
N01BB10
LEVOBUPIVAC
AINE
Fresenius Kabi
Limited
PA0566/066/005
7.5 Mg/Ml
Solution for
Infusion
N01BB10
LEVOCETIRIZIN
E
Imbat Limited
PPA1151/149/00
1
5 Milligram
Film Coated
Tablet
R06AE09
Interchangeable
List Code:
IC0095-001-003
PA1240/003/001
5 Milligram
Film Coated
Tablet
R06AE09
Interchangeable
List Code:
IC0095-001-003
PA1462/004/001
5 Milligram
Film Coated
Tablet
R06AE09
Interchangeable
List Code:
IC0095-001-003
PA1347/043/001
5 Milligram
Film Coated
Tablet
R06AE09
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
Bristol
Laboratories
Limited
LEVOCETIRIZIN
E GLENMARK
Glenmark
Pharmaceuticals
Europe Limited
LEVOCETIRIZIN
E KRKA
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0095-001-003
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
-VARDENAFIL
HYDROCHLORI
DE
TRIHYDRATE
-VARDENAFIL
(AS
HYDROCHLORI
DE
TRIHYDRATE)
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOBUPIVAC
AINE
HYDROCHLORI
DE
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
Legal Basis
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Epidural
Article 10(1) Generic
Application
-Epidural
Article 10(1) Generic
Application
-Epidural
Article 10(1) Generic
Application
-Epidural
Article 10(1) Generic
Application
-Epidural
PPA
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 272 of 608
Trade Name
LEVOCETIRIZIN
E TEVA
Licence Holder Licence
Number
Teva Pharma
B.V.
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE MYLA
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE ORION
Generics (UK)
Limited
PA0749/046/001
Interchangeable
List Code:
IC0095-001-003
PA0405/090/001
Strength
Dosage Form ATC
5 Milligram
Film Coated
Tablet
R06AE09
50/12.5/200
Milligram
Film Coated
Tablet
N04BA03
Generics (UK)
Limited
PA0405/090/002
75/18.75/200
Milligram
Film Coated
Tablet
N04BA03
Generics (UK)
Limited
PA0405/090/003
100/25/200
Milligram
Film Coated
Tablet
N04BA03
Generics (UK)
Limited
PA0405/090/004
125/31.25/200
Milligram
Film Coated
Tablet
N04BA03
Generics (UK)
Limited
PA0405/090/005
150/37.5/200
Milligram
Film Coated
Tablet
N04BA03
Generics (UK)
Limited
PA0405/090/006
175/43.75/200
Milligram
Film Coated
Tablet
N04BA03
Generics (UK)
Limited
PA0405/090/007
200/50/200
Milligram
Film Coated
Tablet
N04BA03
Orion Corporatio
EU/1/11/706/03438
175/43.75/200
Milligram
Film Coated
Tablet
N04BA03
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE ORION
Orion Corporatio
EU/1/11/706/007011
Milligram
Film Coated
Tablet
N04BA03
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE ORION
Orion Corporatio
EU/1/11/706/012017
100/25/200
Milligram
Film Coated
Tablet
N04BA03
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE ORION
Orion Corporatio
EU/1/11/706/018022
125/31.25/200
Milligram
Film Coated
Tablet
N04BA03
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE ORION
Orion Corporatio
EU/1/11/706/023028
150/37.5/200
Milligram
Film Coated
Tablet
N04BA03
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE ORION
Orion Corporatio
EU/1/11/706/029033
200/50/200
Milligram
Film Coated
Tablet
N04BA03
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
Orion Corporatio
EU/1/13/859/001006
50/12.5/200
Milligram
Film Coated
Tablet
N04BA03
Orion Corporatio
EU/1/13/859/007011
75/18.75/200
Milligram
Film Coated
Tablet
N04BA03
Orion Corporatio
EU/1/13/859/034038
200/50/200
Milligram
Film Coated
Tablet
N04BA03
Orion Corporatio
EU/1/13/859/029033
175/43.75/200
Milligram
Film Coated
Tablet
N04BA03
Orion Corporatio
EU/1/13/859/023028
150/37.5/200
Milligram
Film Coated
Tablet
N04BA03
Orion Corporatio
EU/1/13/859/018022
125/31.25/200
Milligram
Film Coated
Tablet
N04BA03
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
-ENTACAPONE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
Legal Basis
Routes of
Administration
Article 10(3) Hybrid
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 273 of 608
Trade Name
LEVODOPA/CA
RBIDOPA/ENTA
CAPONE
SANDOZ
LEVOFLOXACIN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Orion Corporatio
EU/1/13/859/012017
100/25/200
Milligram
Film Coated
Tablet
N04BA03
Hikma
Farmaceutica
(Portugal) SA
Hikma
Farmaceutica
(Portugal) SA
Claris
Lifesciences (UK)
Limited
Claris
Lifesciences (UK)
Limited
Noridem
Enterprises Ltd
PA1217/008/002
5 Mg/Ml
Solution for
Infusion
J01MA12
PA1217/008/001
5 Mg/Ml
Solution for
Infusion
J01MA12
PA1389/013/001
5 Mg/Ml
Solution for
Infusion
J01MA12
PA1389/013/002
5 Mg/Ml
Solution for
Infusion
J01MA12
PA1122/013/001
5 Mg/Ml
Solution for
Infusion
J01MA12
LEVOFLOXACIN
Fresenius Kabi
Limited
PA0566/050/002
5 Mg/Ml
Solution for
Infusion
J01MA12
LEVOFLOXACIN
Fresenius Kabi
Limited
PA0566/050/001
5 Mg/Ml
Solution for
Infusion
J01MA12
LEVOFLOXACIN
LEVOFLOXACIN
BLUEFISH
PA1436/019/001
250 Milligram
Film Coated
Tablet
J01MA12
LEVOFLOXACIN
PA1436/019/002
500 Milligram
Film Coated
Tablet
J01MA12
LEVOFLOXACIN
LEVOFLOXACIN
KRKA
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Krka d.d., Novo
mesto
PA1347/048/001
250 Milligram
Film Coated
Tablet
J01MA12
LEVOFLOXACIN
KRKA
Krka d.d., Novo
mesto
PA1347/048/002
500 Milligram
Film Coated
Tablet
J01MA12
LEVOFLOXACIN
TEVA
Teva Pharma
B.V.
PA0749/071/001
5 Mg/Ml
Solution for
Infusion
J01MA12
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
LEVONORGEST
REL ROWEX
Rowex Ltd
PA0711/267/001
1.5 Milligram
Tablets
G03AD01
LEVONORGEST
REL TEVA
Teva Pharma
B.V.
PA0749/184/001
1.5 Milligram
Tablets
G03AD01
LEVOSERT
PA2103/001/001
52 Milligram
Intrauterine
delivery system
G02BA03
LEVOTHYROXI
NE
Allergan
Pharmaceuticals
International
Limited
Wockhardt UK
Limited
PA1339/044/002
25
Micrograms/5ml
Oral Solution
H03AA01
LEVOTHYROXI
NE
Wockhardt UK
Limited
PA1339/044/003
50
Micrograms/5ml
Oral Solution
H03AA01
LEVOTHYROXI
NE
Wockhardt UK
Limited
PA1339/044/004
100
Micrograms/5ml
Oral Solution
H03AA01
LEVOTHYROXI
NE CLONMEL
Clonmel
Healthcare Ltd
PA0126/257/001
25 Microgram
Tablets
H03AA01
LEVOTHYROXI
NE CLONMEL
Clonmel
Healthcare Ltd
PA0126/257/002
50 Microgram
Tablets
H03AA01
LEVOTHYROXI
NE CLONMEL
Clonmel
Healthcare Ltd
PA0126/257/003
100 Microgram
Tablets
H03AA01
LEVOTHYROXI
NE TEVA
Teva Pharma
B.V.
PA0749/143/001
25 Microgram
Tablets
H03AA01
LEVOTHYROXI
NE TEVA
Teva Pharma
B.V.
PA0749/143/002
50 Microgram
Tablets
H03AA01
LEVOFLOXACIN
LEVOFLOXACIN
LEVOFLOXACIN
LEVOFLOXACIN
LEVOFLOXACIN
BLUEFISH
Human Medicines Authorised/Transfer Pending Products
-ENTACAPONE
-LEVODOPA
-CARBIDOPA
MONOHYDRATE
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
HEMIHYDRATE
LEVOFLOXACIN
LEVONORGEST
REL
LEVONORGEST
REL
LEVONORGEST
REL
MICRONIZED
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
LEVOTHYROXI
NE SODIUM
Legal Basis
Routes of
Administration
Article 10c Informed Consen
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
-Intra-uterine
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 274 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LEVOTHYROXI
NE TEVA
Teva Pharma
B.V.
PA0749/143/003
100 Microgram
Tablets
H03AA01
LEXAPRO
Imbat Limited
PPA1151/025/00
5
15 Milligram
Film Coated
Tablet
N06AB10
15 Milligram
Film Coated
Tablet
15 Milligram
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXAPRO
LEXOTAN
LEXOTAN
Primecrown 2010
Ltd
Interchangeable
List Code:
IC0071-032-015
PPA1633/014/00
3
PCO
Manufacturing
Interchangeable
List Code:
IC0071-032-015
PPA0465/129/00
4
Imbat Limited
Imbat Limited
Imbat Limited
Interchangeable
List Code:
IC0071-032-015
PPA1151/025/00
4
Interchangeable
List Code:
IC0071-002-015
PPA1151/025/00
2
Interchangeable
List Code:
IC0071-001-015
PPA1151/025/00
3
Active
Ingredients
Legal Basis
Routes of
Administration
LEVOTHYROXI
NE SODIUM
ESCITALOPRAM
OXALATE
Article 10(1) Generic
Application
PPA
-Per Oral
N06AB10
ESCITALOPRAM
PPA
-Per Oral
Film Coated
Tablet
N06AB10
ESCITALOPRAM
OXALATE
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
PPA
-Per Oral
5 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
PPA
-Per Oral
20 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
OXALATE
PPA
-Per Oral
20 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
OXALATE
PPA
-Per Oral
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0071-003-015
PPA0465/129/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0071-002-015
PPA0465/129/00
2
H. Lundbeck A/S
Interchangeable
List Code:
IC0071-003-015
PA0805/002/001
5 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
H. Lundbeck A/S
Interchangeable
List Code:
IC0071-001-015
PA0805/002/002
10 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
H. Lundbeck A/S
Interchangeable
List Code:
IC0071-002-015
PA0805/002/003
15 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
H. Lundbeck A/S
Interchangeable
List Code:
IC0071-032-015
PA0805/002/004
20 Milligram
Film Coated
Tablet
N06AB10
ESCITALOPRAM
-Per Oral
Interchangeable
List Code:
IC0071-003-015
PA0050/049/001
1.5 Milligram
Tablets
N05BA08
-BROMAZEPAM
PA0050/049/002
3 Milligram
Tablets
N05BA08
-BROMAZEPAM
Roche Products
Limited
Roche Products
Limited
Human Medicines Authorised/Transfer Pending Products
Page 275 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
LG-OCTAPLAS
Octapharma
Limited
PA0521/004/002
%v/v
Solution for
Infusion
B05AA
LIBERTEK
AstraZeneca AB
500 Microgram
Coated Tablets
R03DX07
LIBRIUM
Meda Health
Sales Ireland
Limited
EU/1/11/666/001003
PA1332/033/001
5 Milligram
Capsule
N05BA02
LIBRIUM
Meda Health
Sales Ireland
Limited
PA1332/033/002
10 Milligram
Capsule
N05BA02
LICOLIN
Laboratorios
LICONSA, S.A.
PA1239/011/001
75 Milligram
Tablets
C09CA04
CHLORDIAZEP
OXIDE
HYDROCHLORI
DE
CHLORDIAZEP
OXIDE
HYDROCHLORI
DE
-IRBESARTAN
LICOLIN
Laboratorios
LICONSA, S.A.
PA1239/011/002
150 Milligram
Tablets
C09CA04
-IRBESARTAN
LICOLIN
Laboratorios
LICONSA, S.A.
PA1239/011/003
300 Milligram
Tablets
C09CA04
-IRBESARTAN
LIDOCAINE
Ferndale
Pharmaceuticals
Ltd
Grünenthal Ltd
PA1155/008/001
40 mg/g
Cream
D04AB01
-LIDOCAINE
N01BB02
-LIDOCAINE
LIDOCAINE
HYDROCHLORI
DE
LIDOCAINE
HYDROCHLORI
DE
LIDOCAINE
HYDROCHLORI
DE
LIDOCAINE
HYDROCHLORI
DE INJECTION
BP
LIDOCAINE
HYDROCHLORI
DE INJECTION
BP
LIDOCAINE
HYDROCHLORI
DE INJECTION
BP MINIJET
LIDOCAINE
HYDROCHLORI
DE INJECTION
BP MINIJET
LIDOCAINE
HYDROCHLORI
DE INJECTION
BP MINIJET
LIDOCAINE
HYDROCHLORI
DE INJECTION
BP MINIJET
LIDOTEC
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
B. Braun Medical
Limited
PA0073/112/001
0.5 %w/v
Medicated
Plaster
Solution for
Injection
N01BB02
PA0073/112/006
2.0 %w/v
Solution for
Injection
N01BB02
PA0073/112/002
1 %w/v
Solution for
Injection
N01BB02
PA0179/037/001
1 %w/v
Solution for
Injection
N01BB02
-LIDOCAINE
HYDROCHLORI
DE
-LIDOCAINE
HYDROCHLORI
DE
-LIDOCAINE
HYDROCHLORI
DE
-LIDOCAINE
HYDROCHLORI
DE
B. Braun Medical
Limited
PA0179/037/004
2 %w/v
Solution for
Injection
N01BB02
-LIDOCAINE
HYDROCHLORI
DE
International
Medication
Systems (UK) Ltd
PA0255/004/002
%w/v
Solution for
Injection
C01BB01
-LIDOCAINE
HYDROCHLORI
DE
International
Medication
Systems (UK) Ltd
PA0255/004/002
%w/v
Solution for
Injection
N01BB02
-LIDOCAINE
HYDROCHLORI
DE
International
Medication
Systems (UK) Ltd
PA0255/004/005
2 %w/v
Solution for
Injection
C01BB01
-LIDOCAINE
HYDROCHLORI
DE
International
Medication
Systems (UK) Ltd
PA0255/004/005
2 %w/v
Solution for
Injection
N01BB02
-LIDOCAINE
HYDROCHLORI
DE
Grünenthal Ltd
PA1189/012/001
5 Per Cent
N01BB02
-LIDOCAINE
LIFMIOR
Pfizer Limited
EU/1/16/1165/00
1
10 Milligram
Medicated
Plaster
Pdr+Solv for Soln
for Inj
L04AB01
-ETANERCEPT
LIFMIOR
Pfizer Limited
EU/1/16/1165/00
2-004
25 Milligram
Pdr+Solv for Soln
for Inj
L04AB01
-ETANERCEPT
LIFMIOR
Pfizer Limited
EU/1/16/1165/00
5-007
25 Milligram
Solution for
injection in prefilled syringe
L04AB01
-ETANERCEPT
LIDOCAINE
PA1189/010/002
Human Medicines Authorised/Transfer Pending Products
5
-HUMAN
PLASMA
PROTEIN
-ROFLUMILAST
Legal Basis
Routes of
Administration
-Intra-venous
Article 10c Informed Consen
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10a Bibliographical
App
Article 8(3) - Full
new Application
-Per Oral
Article 10c Informed Consen
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Cutaneous
-Per Oral
-Per Oral
-Cutaneous
-Cutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
Page 276 of 608
Trade Name
Licence Holder Licence
Number
Strength
LIFMIOR
Pfizer Limited
EU/1/16/1165/01
1-013
50 Milligram
LIFMIOR
Pfizer Limited
EU/1/16/1165/00
8-010
50 Milligram
LIFSAR
PULMOJET
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/174/001
50/500
Microgram
LIGNOSPAN
SPECIAL
Septodont
PA0196/013/001
LIGNOSPAN
SPECIAL
Septodont
LINEZOLID
Dosage Form ATC
Active
Ingredients
Solution for
injection in prefilled pen
Solution for
injection in prefilled syringe
Powder for
Inhalation
L04AB01
-ETANERCEPT
L04AB01
-ETANERCEPT
R03AK06
1.8 ml Millilitre
Solution for
Injection
N01BB52
PA0196/013/002
2.2 ml Millilitre
Solution for
Injection
N01BB52
Accord
Healthcare
Limited
Wockhardt UK
Limited
PA1390/098/001
600 Milligram
Film Coated
Tablet
J01XX08
-SALMETEROL
XINAFOATE
-FLUTICASONE
PROPIONATE
-LIDOCAINE
HYDROCHLORI
DE
-EPINEPHRINE
-LIDOCAINE
HYDROCHLORI
DE
-LINEZOLID
(FORM III)
PA1339/062/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
(FORM II)
LINEZOLID
Actavis Group
PTC ehf
PA1380/178/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
LINEZOLID
Fresenius Kabi
Limited
PA0566/069/001
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
Rowex Ltd
PA0711/230/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
LINEZOLID
Teva Pharma
B.V.
PA0749/113/001
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
Cipla (EU)
Limited
PA1809/023/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
(FORM II)
LINEZOLID
Krka d.d., Novo
mesto
PA1347/057/002
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
Generics (UK)
Limited
PA0405/094/001
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
CLONMEL
Clonmel
Healthcare Ltd
PA0126/238/002
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
CLONMEL
Clonmel
Healthcare Ltd
PA0126/238/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
LINEZOLID
KRKA
Krka d.d., Novo
mesto
PA1347/057/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
LINEZOLID
PFIZER
Pfizer Healthcare
Ireland
PA0822/181/001
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
PFIZER
Pfizer Healthcare
Ireland
PA0822/181/002
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
LINEZOLID
PFIZER
Pfizer Healthcare
Ireland
PA0822/181/003
100 MG/5ml
Granules for Oral
Suspension
J01XX08
-LINEZOLID
LINEZOLID
ROWEX
Rowex Ltd
PA0711/230/002
2 Mg/Ml
Solution for
Infusion
J01XX08
-LINEZOLID
LINEZOLID
TEVA
Teva Pharma
B.V.
PA0749/204/001
600 Milligram
Film Coated
Tablet
J01XX08
-LINEZOLID
LINEZOLID
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Subcutaneous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Subcutaneous
-Inhalation
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Intra-venous
-Per Oral
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
-Per Oral
-Intra-venous
-Per Oral
Page 277 of 608
Trade Name
Licence Holder Licence
Number
LINOFORCE
Bioforce (UK) Ltd
TR0725/006/001
LIORESAL 10
MG TABLETS
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Primecrown 2010
Ltd
BGP Products
Ltd
BGP Products
Ltd
BGP Products
Ltd
PCO
Manufacturing
BGP Products
Ltd
LTT Pharma
Limited
Primecrown 2010
Ltd
Imbat Limited
PA0013/058/001
LIORESAL
5MG/5ML ORAL
SOLUTION
LIPANTIL MICR
LIPANTIL MICR
LIPANTIL MICR
LIPANTIL
SUPRA
LIPANTIL
SUPRA
LIPANTIL
SUPRA
LIPANTIL
SUPRA
LIPANTIL
SUPRA
LIPANTIL
SUPRA
LIPIODOL
ULTRA FLUID
LIPITOR
LIPITOR
LIPITOR
LIPITOR
Strength
Dosage Form ATC
Granules
A06AB
10 Milligram
Tablets
PA0013/058/002
5 MG/5ml
PPA1633/036/00
1
PA2007/012/001
Active
Ingredients
Legal Basis
Routes of
Administration
-Per Oral
M03BX01
-LINUM
USITATISSIMUM
L., SEMEN
(LINSEEDS,
WHOLE)
-CASSIA SENNA
L. AND/OR
CASSIA
ANGUSTIFOLIA
VAHL, FOLIUM
(SENNA
LEAVES,
COMMINUTED)
-RHAMNUS
FRANGULA L.,
CORTEX
(FRANGULA
BARK,
COMMIMNUTE
D)
-BACLOFEN
Oral Solution
M03BX01
-BACLOFEN
-Per Oral
200 Milligram
Capsules Hard
C10AB05
-FENOFIBRATE
-Per Oral
67 Milligram
Capsules Hard
C10AB05
-FENOFIBRATE
-Per Oral
PA2007/012/002
200 Milligram
Capsules Hard
C10AB05
-FENOFIBRATE
-Per Oral
PA2007/012/003
145 Milligram
C10AB05
-FENOFIBRATE
-Per Oral
PPA0465/409/00
1
PA2007/012/004
145 Milligram
Film Coated
Tablet
Tablets
C10AB05
-FENOFIBRATE
-Per Oral
C10AB05
-FENOFIBRATE
-Per Oral
145 Milligram
C10AB05
-FENOFIBRATE
C10AB05
-FENOFIBRATE
C10AB05
-FENOFIBRATE
GUERBET
PPA1562/124/00
1
PPA1633/036/00
2
PPA1151/180/00
1
PA0686/004/001
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Solution for
Injection
V08AD01
PCO
Manufacturing
PPA0465/075/00
1
10 Milligram
Film Coated
Tablet
C10AA05
-POPPY SEED
OIL IODISED
FATTY ACID
ETHYLESTERS
ATORVASTATI
N-CALCIUM
PCO
Manufacturing
Interchangeable
List Code:
IC0001-002-003
PPA0465/075/00
2
20 Milligram
Film Coated
Tablet
C10AA05
PCO
Manufacturing
Interchangeable
List Code:
IC0001-003-003
PPA0465/075/00
3
40 Milligram
Film Coated
Tablet
PCO
Manufacturing
Interchangeable
List Code:
IC0001-004-003
PPA0465/075/00
4
80 Milligram
Film Coated
Tablet
215 Milligram
145 Milligram
145 Milligram
38 %w/v
-Per Oral
-Per Oral
PPA
-Per Oral
PPA
-Per Oral
ATORVASTATI
N-CALCIUM
PPA
-Per Oral
C10AA05
ATORVASTATI
N-CALCIUM
PPA
-Per Oral
C10AA05
ATORVASTATIN
CALCIUM
PPA
-Per Oral
Interchangeable
List Code:
IC0001-005-003
Human Medicines Authorised/Transfer Pending Products
Page 278 of 608
Trade Name
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
LIPITOR
Licence Holder Licence
Number
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Pfizer Ireland
Pharmaceuticals
Clear Pharmacy
Clear Pharmacy
Clear Pharmacy
Clear Pharmacy
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1740/001/001
10 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PA1740/001/002
ATORVASTATIN
CALCIUM
TRIHYDRATE
20 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-003-003
PA1740/001/003
ATORVASTATIN
CALCIUM
TRIHYDRATE
40 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-004-003
PA1740/001/004
ATORVASTATIN
CALCIUM
TRIHYDRATE
80 Milligram
Film Coated
Tablet
C10AA05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0001-005-003
PA1740/001/005
ATORVASTATIN
CALCIUM
TRIHYDRATE
5 Milligram
C10AA05
-Per Oral
10 Milligram
--Unknown--
-Per Oral
PA1740/001/007
20 Milligram
--Unknown--
-Per Oral
PA1740/001/008
40 Milligram
--Unknown--
-Per Oral
PPA1596/005/00
4
10 Milligram
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATIN
ATORVASTATI
N-CALCIUM
--Unknown--
PA1740/001/006
Tablets
Chewable
Tablets
Chewable
Tablets
Chewable
Tablets
Chewable
Film Coated
Tablet
PPA
-Per Oral
20 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATI
N-CALCIUM
PPA
-Per Oral
40 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATI
N-CALCIUM
PPA
-Per Oral
80 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATI
N-CALCIUM
PPA
-Per Oral
10 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
-Per Oral
20 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
CALCIUM
-Per Oral
40 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
-Per Oral
80 Milligram
Film Coated
Tablet
C10AA05
ATORVASTATIN
-Per Oral
Interchangeable
List Code:
IC0001-002-003
PPA1596/005/00
1
Interchangeable
List Code:
IC0001-003-003
PPA1596/005/00
2
Interchangeable
List Code:
IC0001-004-003
PPA1596/005/00
3
LTT Pharma
Limited
Interchangeable
List Code:
IC0001-005-003
PPA1562/099/00
1
LTT Pharma
Limited
Interchangeable
List Code:
IC0001-002-003
PPA1562/099/00
2
LTT Pharma
Limited
Interchangeable
List Code:
IC0001-003-003
PPA1562/099/00
3
LTT Pharma
Limited
Interchangeable
List Code:
IC0001-004-003
PPA1562/099/00
4
C10AA05
C10AA05
C10AA05
C10AA05
Interchangeable
List Code:
IC0001-005-003
Human Medicines Authorised/Transfer Pending Products
Page 279 of 608
Trade Name
LIPOSIC
LIPOSTAT
LIPOSTAT
LIPOSTAT
LIPROLOG
LIPROLOG
LIPROLOG
LIPROLOG
LIPROLOG
MIX25
LIPROLOG
MIX25 PEN
LIPROLOG
MIX50
LIPROLOG
MIX50 PEN
LIPROLOG-PEN
LIQUIVISC
LISINOPRIL
LISINOPRIL
LISINOPRIL
LISINOPRIL
LISINOPRIL
LISINOPRIL/HY
DROCHLOROT
HIAZIDE
Licence Holder Licence
Number
Bausch & Lomb
UK Limited
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly and
Company Limited
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Eli Lilly
Nederland B.V.
Laboratoires
Thea
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Essential
Pharmaceuticals
Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Strength
Dosage Form ATC
Eyegel
S01XA20
-CARBOMER
PA0002/055/004
10 Milligram
Tablets
C10AA03
-PRAVASTATIN
SODIUM
-Per Oral
Interchangeable
List Code:
IC0014-002-014
PA0002/055/005
20 Milligram
Tablets
C10AA03
-PRAVASTATIN
SODIUM
-Per Oral
Interchangeable
List Code:
IC0014-003-014
PA0002/055/006
40 Milligram
Tablets
C10AA03
-PRAVASTATIN
SODIUM
-Per Oral
Interchangeable
List Code:
IC0014-004-014
EU/1/01/195/001
100 Units/ml
A10AB04
100 Units/ml
EU/1/01/195/2227
EU/1/01/195/028029
EU/1/01/195/003
100 Units/ml
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-Subcutaneous
EU/1/01/195/002
100 Units/ml
EU/1/01/195/004
100 Units/ml
EU/1/01/195/007
100 Units/ml
EU/1/01/195/005
100 Units/ml
PA1107/002/001
2.5 mg/g
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-INSULIN
LISPRO
-CARBOMER
-Subcutaneous
EU/1/01/195/006
Solution for
Injection
Solution for
Injection
Suspension for
Injection
Infus/Pdr/Oral
Soln
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Suspension for
Injection
Solution for
Injection
Eyegel
PA0577/161/001
2.5 Milligram
Tablets
C09AA03
-LISINOPRIL (AS
DIHYDRATE)
Article 10(1) Generic
Application
-Per Oral
PA0577/161/002
5 Milligram
Tablets
C09AA03
-LISINOPRIL (AS
DIHYDRATE)
Article 10(1) Generic
Application
-Per Oral
PA0577/161/003
10 Milligram
Tablets
C09AA03
-LISINOPRIL (AS
DIHYDRATE)
Article 10(1) Generic
Application
-Per Oral
PA0577/161/004
20 Milligram
Tablets
C09AA03
-LISINOPRIL (AS
DIHYDRATE)
Article 10(1) Generic
Application
-Per Oral
PA1806/003/001
1 Mg/Ml
Oral Solution
C09AA03
-LISINOPRIL
DIHYDRATE
-Per Oral
PA0577/165/001
10/12.5 Milligram
Tablets
C09BA03
-LISINOPRIL (AS
DIHYDRATE)
HYDROCHLOR
OTHIAZIDE
-LISINOPRIL (AS
DIHYDRATE)
HYDROCHLOR
OTHIAZIDE
-LISINOPRIL
DIHYDRATE
-LISINOPRIL
DIHYDRATE
-LISINOPRIL
DIHYDRATE
-LISINOPRIL
DIHYDRATE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
200 Units/ml
100 Units/ml
A10AB04
A10AB04
A10AB04
A10AB04
A10AB04
A10AB04
A10AB04
S01XA20
20/12.5 Milligram
Tablets
C09BA03
LISOPRESS
Gedeon Richter
Plc
Gedeon Richter
Plc
Gedeon Richter
Plc
Gedeon Richter
Plc
PA1330/013/001
2.5mg Milligram
Tablets
C09AA03
PA1330/013/002
5mg Milligram
Tablets
C09AA03
PA1330/013/003
10mg Milligram
Tablets
C09AA03
PA1330/013/004
20mg Milligram
Tablets
C09AA03
Human Medicines Authorised/Transfer Pending Products
-Subcutaneous
A10AB04
PA0577/165/002
LISOPRESS
Routes of
Administration
2 mg/g
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
LISOPRESS
Legal Basis
PA0555/008/001
LISINOPRIL/HY
DROCHLOROT
HIAZIDE
LISOPRESS
Active
Ingredients
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Subcutaneous
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 280 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LISPRIL
Rowex Ltd
PA0711/047/002
5 Milligram
Tablets
C09AA03
LISPRIL
Rowex Ltd
PA0711/047/003
10 Milligram
Tablets
C09AA03
LISPRIL
Rowex Ltd
PA0711/047/004
20 Milligram
Tablets
C09AA03
LISPRILHYDROCHLOR
OTHIAZIDE
Rowex Ltd
PA0711/051/001
10/12.5 Milligram
Tablets
C09BA03
LISPRILHYDROCHLOR
OTHIAZIDE
Rowex Ltd
PA0711/051/002
20/12.5 Milligram
Tablets
C09BA03
LISVY
Gedeon Richter
Plc
PA1330/019/001
Transdermal
Patch
G03AA10
LITAK
Lipomed GmbH
EU/1/04/275/002
2 mg/ml Mg/Ml
L01BB04
LITHIUM
CHLORIDE
LIVAZO
LiDCO Ltd
PA1183/001/001
0.15 mMol/ml
Kowa
Pharmaceutical
Europe Co. Ltd
Kowa
Pharmaceutical
Europe Co. Ltd
Kowa
Pharmaceutical
Europe Co. Ltd
NV Organon
Imbat Limited
PA1532/001/001
2 Base Milligrams
Solution for
Injection
Solution for
Injection
Film Coated
Tablet
PA1532/001/002
4 Base Milligrams
Film Coated
Tablet
PA1532/001/003
1 Base Milligrams
PA0964/006/001
PPA1151/103/00
1
PPA1562/105/00
1
PPA0465/081/00
1
EU/1/15/993/001
EU/1/15/993/002
30 Milligram
EU/1/15/993/003
60 Milligram
PPA1151/214/00
1
PPA1463/081/00
1
PPA0465/234/00
1
PPA1562/053/00
1
PA0590/018/001
5 %w/v
PA1025/006/001
LIVAZO
LIVAZO 1MG
FILM-COATED
TABLETS
LIVIAL
LIVIAL
LIVIAL
LIVIAL
LIXIANA
LIXIANA
LIXIANA
LOCERYL
LOCERYL
LOCERYL
LOCERYL
LOCERYL
LOCOID CREAM
LTT Pharma
Limited
PCO
Manufacturing
Daiichi Sankyo
Europe GmbH
Daiichi Sankyo
Europe GmbH
Daiichi Sankyo
Europe GmbH
Imbat Limited
IMED Healthcare
Ltd.
PCO
Manufacturing
LTT Pharma
Limited
Galderma (UK)
Ltd
LEO Pharma A/S
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Transdermal
Article 8(3) - Full
new Application
-Per Oral
C10AA08
-PITAVASTATIN
CALCIUM
Article 8(3) - Full
new Application
-Per Oral
Film Coated
Tablet
C10AA08
-PITAVASTATIN
CALCIUM
2.5 Milligram
2.5 Milligram
Tablets
Tablets
G03CX01
G03CX01
-TIBOLONE
-TIBOLONE
2.5 Milligram
Tablets
G03CX01
-TIBOLONE
2.5 Milligram
Tablets
G03CX01
-TIBOLONE
PPA
15 Milligram
B01AF03
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
D01AE16
-EDOXABAN
TOSILATE
-EDOXABAN
TOSILATE
-EDOXABAN
TOSILATE
-AMOROLFINE
D01AE16
-AMOROLFINE
D01AE16
-AMOROLFINE
PPA
D01AE16
-AMOROLFINE
PPA
D01AE16
-AMOROLFINE
0.1 %w/w
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Medicated Nail
Lacquer
Medicated Nail
Lacquer
Medicated Nail
Lacquer
Medicated Nail
Lacquer
Medicated Nail
Lacquer
Cream
D07AB02
HYDROCORTIS
ONE BUTYRATE
HYDROCORTIS
ONE BUTYRATE
HYDROCORTIS
ONE BUTYRATE
HYDROCORTIS
ONE BUTYRATE
5 %w/v
5 %w/v
5.0 %w/v
C10AA08
B01AF03
B01AF03
LOCOID
LIPOCREAM
LEO Pharma A/S
PA1025/006/002
0.1 %w/w
Cream
D07AB02
LOCOID
OINTMENT
LEO Pharma A/S
PA1025/006/003
0.1 %w/w
Ointment
D07AB02
LOCOID SCALP
LOTION
LEO Pharma A/S
PA1025/006/004
0.1 %w/v
Cutaneous
Solution
D07AB02
Human Medicines Authorised/Transfer Pending Products
-LISINOPRIL
DIHYDRATE
-LISINOPRIL
DIHYDRATE
-LISINOPRIL
DIHYDRATE
-LISINOPRIL
DIHYDRATE
HYDROCHLOR
OTHIAZIDE
-LISINOPRIL
DIHYDRATE
HYDROCHLOR
OTHIAZIDE
ETHINYLESTRA
DIOL
-GESTODENE
-CLADRIBINE
Legal Basis
-LITHIUM
CHLORIDE
-PITAVASTATIN
CALCIUM
5 %w/v
N05AN01
Active
Ingredients
-Intra-venous
-Per Oral
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 281 of 608
Trade Name
Licence Holder Licence
Number
LOGYNON
Bayer Limited
PA1410/005/001
LOGYNON
Clear Pharma
Limited
PPA1823/006/00
1
LOGYNON
PCO
Manufacturing
PPA0465/311/00
1
LOGYNON
IMED Healthcare
Ltd.
PPA1463/072/00
1
Human Medicines Authorised/Transfer Pending Products
Strength
%v/v
Milligram
Dosage Form ATC
Tablets
G03AB03
Coated Tablets
G03AB03
Tablets
G03AB03
Tablets
G03AB03
Active
Ingredients
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
Legal Basis
Routes of
Administration
-Per Oral
PPA
Page 282 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LOGYNON
Imbat Limited
PPA1151/218/00
1
Tablets
G03AB03
LOGYNON
LTT Pharma
Limited
PPA1562/127/00
1
Tablets
G03AB03
LOJUXTA
Aegerion
Pharmaceuticals
Aegerion
Pharmaceuticals
Aegerion
Pharmaceuticals
Aegerion
Pharmaceuticals
Limited
Aegerion
Pharmaceuticals
Limited
Aegerion
Pharmaceuticals
Limited
Recordati
Industria Chimica
e Farmaceutica
SpA
EU/1/13/851/004
30
C10AX12
EU/1/13/851/005
40
EU/1/13/851/006
60
LOJUXTA
LOJUXTA
LOJUXTA
LOJUXTA
LOJUXTA
LOMEXIN 2%
W/V
CUTANEOUS
SPRAY,
SOLUTION
LOMEXIN 2%
W/W CREAM
LOMEXIN 2%
W/W
CUTANEOUS
POWDER
LOMOTIL
LONITEN
LONQTIV
Active
Ingredients
Legal Basis
Routes of
Administration
LEVONORGEST
REL
ETHINYLESTRA
DIOL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
LEVONORGEST
REL
ETHINYLESTRA
DIOL
-LOMITAPIDE
MESYLATE
-LOMITAPIDE
MESYLATE
-LOMITAPIDE
MESYLATE
-LOMITAPIDE
MESYLATE
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
EU/1/13/851/001
5 Milligram
Infus/Pdr/Oral
Soln
Infus/Pdr/Oral
Soln
Infus/Pdr/Oral
Soln
Capsules Hard
EU/1/13/851/003
20 Milligram
Capsules Hard
C10AX12
-LOMITAPIDE
MESYLATE
Article 8(3) - Full
new Application
-Per Oral
EU/1/13/851/002
10 Milligram
Capsules Hard
C10AX12
-LOMITAPIDE
MESYLATE
Article 8(3) - Full
new Application
-Per Oral
PA0812/002/005
2 %w/v
Cutaneous Spray
Solution
D01AC12
FENTICONAZO
LE NITRATE
Recordati
Industria Chimica
e Farmaceutica
SpA
Recordati
Industria Chimica
e Farmaceutica
SpA
Mercury
Pharmaceuticals
Ltd
PA0812/002/001
2 %w/w
Cream
D01AC12
FENTICONAZO
LE NITRATE
PA0812/002/004
2 %w/w
Cutaneous
Powder
D01AC12
FENTICONAZO
LE NITRATE
-Cutaneous
PA0899/007/001
2.5/0.025
Milligram
Tablets
A07DA01
-Per Oral
Pfizer Healthcare
Ireland
Grünenthal Ltd
PA0822/130/001
5 Milligram
Tablets
C02DC01
DIPHENOXYLA
TE
HYDROCHLORI
DE
-ATROPINE
SULFATE
-MINOXIDIL
PA1189/014/001
700 Milligram
Medicated
Plaster
N01BB02
-LIDOCAINE
Human Medicines Authorised/Transfer Pending Products
C10AX12
C10AX12
C10AX12
-Per Oral
-Per Oral
-Per Oral
-Cutaneous
Article 10c Informed Consen
-Cutaneous
Page 283 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
LONQUEX
UAB "Sicor
Biotech
EU/1/13/856/001002
6 Milligram
Solution for
Injection
L03AA14
LONSURF
Taiho Pharma
Europe, Limited
Taiho Pharma
Europe, Limited
PCO
Manufacturing
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Mylan S.A.S.
EU/1/16/1096/00
1-003
EU/1/16/1096/00
4-006
PPA0465/320/00
1
PA0822/014/001
15/6.14 Milligram
Film Coated
Tablet
Film Coated
Tablet
Film Coated
Tablet
Capsules Hard
L01BC59
-XM22 DRUG
SUBSTANCE
LIPEGFILGRAS
TIM
-TRIFLURIDINE
L01BC
-TRIFLURIDINE
C10AB04
-GEMFIBROZIL
C10AB04
-GEMFIBROZIL
PA0822/014/002
600mg Milligram
C10AB04
-GEMFIBROZIL
EU/1/15/1067/00
1-003
100mg/25
Milligram
Film Coated
Tablet
Infus/Pdr/Oral
Soln
J05AE03
-LOPINAVIR
-RITONAVIR
LOPINAVIR/RIT
ONAVIR MYLAN
Mylan S.A.S.
EU/1/15/1067/00
4-008
200mg/50
Milligram
Infus/Pdr/Oral
Soln
J05AR10
-LOPINAVIR
-RITONAVIR
LOPINAVIR/RIT
ONAVIR
SANDOZ
LORAT
LORAZEPAM
Rowex Ltd
PA0711/239/001
200/50 Milligram
Film Coated
Tablet
J05A
Rowex Ltd
Morningside
Healthcare
Limited
Morningside
Healthcare
Limited
Clonmel
Healthcare Ltd
PA0711/088/001
PA1333/013/001
10 Milligram
1 Milligram
Tablets
Tablets
R06AX13
N05BA06
-LOPINAVIR
(AMORPHOUS)
-RITONAVIR
-LORATADINE
-LORAZEPAM
PA1333/013/002
2.5 Milligram
Tablets
N05BA06
-LORAZEPAM
PA0126/115/001
20 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
100/12.5
Milligram
Film Coated
Tablet
C09DA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0031-026-003
PA1436/011/001
50/12.5 Milligram
Film Coated
Tablet
C09DA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0031-025-003
PA1436/011/002
100/25 Milligram
Film Coated
Tablet
C09DA01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0031-027-003
PA1347/020/001
25 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-022-003
PA1347/020/002
Article 10(3) Hybrid
Application
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA1347/020/003
Article 10(1) Generic
Application
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA0577/160/001
Article 10(1) Generic
Application
12.5 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-021-003
PA0577/160/002
Article 10(1) Generic
Application
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
Article 10(1) Generic
Application
-Per Oral
LONSURF
LOPID
LOPID
LOPID
LOPINAVIR/RIT
ONAVIR MYLAN
LORAZEPAM
LOSAMEL
LOSARTAN /
HYDROCHLOR
OTHIAZIDE
MYLAN
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
LOSARTAN
/HYDROCHLOR
OTHIAZIDE
BLUEFISH
Bluefish
Pharmaceuticals
AB
LOSARTAN
/HYDROCHLOR
OTHIAZIDE
BLUEFISH
Bluefish
Pharmaceuticals
AB
LOSARTAN
KRKA
Krka d.d., Novo
mesto
LOSARTAN
KRKA
LOSARTAN
KRKA
LOSARTAN
MYLAN
LOSARTAN
MYLAN
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Interchangeable
List Code:
IC0010-003-016
PA0577/152/002
Interchangeable
List Code:
IC0003-023-003
Human Medicines Authorised/Transfer Pending Products
20/8.19 Milligram
600 Milligram
300 Milligram
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 284 of 608
Trade Name
LOSARTAN
MYLAN
LOSARTAN
POTASSIUM
LOSARTAN
POTASSIUM
LOSARTAN
POTASSIUM
LOSARTAN
POTASSIUM
LOSARTAN
POTASSIUM
LOSARTAN
POTASSIUM
Licence Holder Licence
Number
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Wockhardt UK
Limited
Wockhardt UK
Limited
Wockhardt UK
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA0577/160/003
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA1339/029/001
Article 10(1) Generic
Application
25 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-022-003
PA1339/029/002
Article 10(1) Generic
Application
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA1339/029/003
Article 10(1) Generic
Application
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA1390/003/001
Article 10(1) Generic
Application
25 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-022-003
PA1390/003/002
Article 10(3) Hybrid
Application
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA1390/003/003
Article 10(1) Generic
Application
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA1286/024/001
Article 10(1) Generic
Application
50/12.5 Milligram
Film Coated
Tablet
C09DA01
Article 10c Informed Consen
-Per Oral
100/12.5
Milligram
Film Coated
Tablet
C09DA01
Article 10c Informed Consen
-Per Oral
Interchangeable
List Code:
IC0031-026-003
PA1286/024/003
100/25 Milligram
Film Coated
Tablet
C09DA01
Article 10c Informed Consen
-Per Oral
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
Article 10(1) Generic
Application
-Per Oral
LOSARTAN
POTASSIUM /
HYDROCHLOR
OTHIAZIDE MSD
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
LOSARTAN
POTASSIUM /
HYDROCHLOR
OTHIAZIDE MSD
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
LOSARTAN
POTASSIUM /
HYDROCHLOR
OTHIAZIDE MSD
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
LOSARTAN
POTASSIUM
MILPHARM
Milpharm Limited
Interchangeable
List Code:
IC0031-027-003
PA1050/025/001
LOSARTAN
POTASSIUM
MILPHARM
Milpharm Limited
Interchangeable
List Code:
IC0003-023-003
PA1050/025/002
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
LOSARTAN
POTASSIUM
MSD
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Interchangeable
List Code:
IC0003-024-003
PA1286/023/001
Article 10(1) Generic
Application
12.5 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
Article 10c Informed Consen
-Per Oral
LOSARTAN
POTASSIUM
MSD
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Interchangeable
List Code:
IC0003-021-003
PA1286/023/002
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
Article 10c Informed Consen
-Per Oral
LOSARTAN
POTASSIUM
MSD
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Interchangeable
List Code:
IC0003-023-003
PA1286/023/003
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
Article 10c Informed Consen
-Per Oral
Interchangeable
List Code:
IC0031-025-003
PA1286/024/002
Interchangeable
List Code:
IC0003-024-003
Human Medicines Authorised/Transfer Pending Products
Page 285 of 608
Trade Name
Licence Holder Licence
Number
LOSARTAN
POTASSIUM
PINEWOOD
Pinewood
Laboratories Ltd,
LOSARTAN
POTASSIUM
PINEWOOD
Pinewood
Laboratories Ltd,
LOSARTAN
POTASSIUM
PINEWOOD
Pinewood
Laboratories Ltd,
LOSARTAN
TEVA
Teva Pharma
B.V.
LOSARTAN
TEVA
Teva Pharma
B.V.
Strength
Dosage Form ATC
Routes of
Administration
12.5 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-021-003
PA0281/154/002
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA0281/154/003
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA0749/090/003
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA0749/090/004
Article 10(1) Generic
Application
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
Article 10(1) Generic
Application
-Per Oral
50/12.5 Milligram
Film Coated
Tablet
C09DA01
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHOLO
THIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-OMEPRAZOLE
MAGNESIUM
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-OMEPRAZOLE
PPA
-Per Oral
LOSARTAN/HY
DROCHLOROT
HIAZIDE
Rowex Ltd
LOSARTAN/HY
DROCHLOROT
HIAZIDE
Rowex Ltd
Interchangeable
List Code:
IC0031-025-003
PA0711/139/002
100/25 Milligram
Film Coated
Tablet
C09DA01
LOSARTAN/HY
DROCHLOROT
HIAZIDE KRKA
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0031-027-003
PA1347/040/001
50/12.5 Milligram
Film Coated
Tablet
C09DA01
LOSARTAN/HY
DROCHLOROT
HIAZIDE KRKA
Krka d.d., Novo
mesto
100/12.5
Milligram
Film Coated
Tablet
C09DA01
LOSARTAN/HY
DROCHLOROT
HIAZIDE KRKA
Krka d.d., Novo
mesto
Interchangeable
List Code:
IC0031-026-003
PA1347/040/003
100/25 Milligram
Film Coated
Tablet
C09DA01
LOSARTAN/HY
DROCHLOROT
HIAZIDE TEVA
Teva Pharma
B.V.
Interchangeable
List Code:
IC0031-027-003
PA0749/026/001
50/12.5 Milligram
Film Coated
Tablet
C09DA01
LOSARTAN/HY
DROCHLOROT
HIAZIDE TEVA
Teva Pharma
B.V.
Interchangeable
List Code:
IC0031-025-003
PA0749/026/002
100/25 Milligram
Tablets
C09DA01
LOSEC
CONTROL
Bayer Limited
Interchangeable
List Code:
IC0031-027-003
PA1410/066/001
20 Milligram
Tablets GastroResistant
A02BC01
20 Milligram
Tablets GastroResistant
A02BC01
Clear Pharmacy
Legal Basis
PA0281/154/001
Interchangeable
List Code:
IC0003-024-003
PA0711/139/001
LOSEC MUPS
Active
Ingredients
Interchangeable
List Code:
IC0031-025-003
PA1347/040/002
Interchangeable
List Code:
IC0010-003-016
PPA1596/027/00
1
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0010-003-016
Human Medicines Authorised/Transfer Pending Products
Page 286 of 608
Trade Name
LOSEC MUPS
LOSEC MUPS
LOSEC MUPS
LOSEC MUPS
LOSEC MUPS
LOSEC MUPS
LOTANOS
LOTANOS
LOTANOS
COMP
LOTANOS
COMP
LOTEMAX
LOTRIDERM
Licence Holder Licence
Number
Imbat Limited
Imbat Limited
AstraZeneca UK
Limited
AstraZeneca UK
Limited
AstraZeneca UK
Limited
PPA1151/007/00
1
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
20 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
MAGNESIUM
PPA
-Per Oral
10 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
MAGNESIUM
PPA
-Per Oral
Interchangeable
List Code:
IC0010-002-016
PA0970/044/006
10 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
MAGNESIUM
-Per Oral
Interchangeable
List Code:
IC0010-002-016
PA0970/044/007
20 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
MAGNESIUM
-Per Oral
Interchangeable
List Code:
IC0010-003-016
PA0970/044/008
40 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
MAGNESIUM
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC01
-OMEPRAZOLE
MAGNESIUM
-Per Oral
Interchangeable
List Code:
IC0010-003-016
PPA1151/007/00
2
PCO
Manufacturing
Interchangeable
List Code:
IC0010-004-016
PPA0465/423/00
1
Rowex Ltd
Interchangeable
List Code:
IC0010-003-016
PA0711/123/003
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0003-023-003
PA0711/123/005
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA0074/072/001
50/12.5 Milligram
Film Coated
Tablet
C09DA01
Interchangeable
List Code:
IC0031-025-003
PA0074/072/002
100/25 Milligram
Film Coated
Tablet
C09DA01
Interchangeable
List Code:
IC0031-027-003
PA1245/001/001
0.5 %w/v
Eye Drops
Suspension
S01BA14
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOSARTAN
POTASSIUM
HYDROCHLOR
OTHIAZIDE
-LOTEPREDNOL
ETABONATE
PA1286/031/001
0.064/1.0
Cream
D07CC01
Rowa
Pharmaceuticals
Limited
Rowa
Pharmaceuticals
Limited
Dr. Gerhard
Mann, chem.pharm. Fabrik
GmbH
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
LOW CENTYL K
Leo Laboratories
Limited
PA0046/019/002
1.25/573
Milligram
Modified-release
Tablets
C03AB01
LOXENTIA
Krka d.d., Novo
mesto
PA1347/051/001
20 Milligram
Capsules GastroResistant
N06AX21
Interchangeable
List Code:
IC0091-003-006
Human Medicines Authorised/Transfer Pending Products
BETAMETHASO
NE
DIPROPIONATE
CLOTRIMAZOLE
BENDROFLUM
ETHIAZIDE
-POTASSIUM
CHLORIDE
-DULOXETINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Page 287 of 608
Trade Name
LOXENTIA
LUCENTIS
LUCOMET SR
Licence Holder Licence
Number
Krka d.d., Novo
mesto
Novartis
Europharm
Limited
Consilient Health
Limited
Strength
Dosage Form ATC
Active
Ingredients
PA1347/051/003
40 Milligram
Capsules GastroResistant
N06AX21
Interchangeable
List Code:
IC0091-004-006
EU/1/06/374/001
-DULOXETINE
HYDROCHLORI
DE
10 Mg/Ml
Solution for
Injection
S01LA04
-RANIBIZUMAB
PA1876/001/001
750 Milligram
Tablet Prolonged
Release
A10BA02
1 Millilitre
Radio-Pharm
Precursor
V10X
Interchangeable
List Code:
IC0067-141-024
EU/1/15/1013/00
1
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
-Per Oral
-METFORMIN
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Article 10a Bibliographical
App
LUMARK
IDB Holland B.V.,
LUMIGAN
Allergan
Pharmaceuticals
Ireland
Allergan
Pharmaceuticals
Ireland
Lantheus MI UK
Limited
Merck Sharp &
Dohme Ltd
EU/1/02/205/3-4
0.1 Mg/Ml
Eye Drops
Solution
S01EE03
-LUTETIUM,
ISOTOPE OF
MASS 177
-BIMATOPROST
EU/1/02/205/0012
0.3 Mg/Ml
Eye Drops
Solution
S01EE03
-BIMATOPROST
EU/1/06/361/01-2
6.52 Mg/Ml
V08DA04
-PERFLUTREN
EU/1/16/1162/00
1-003
100 Units/ml
Suspension for
Injection
Solution for
injection in prefilled pen
A10AE04
-INSULIN
GLARGINE
Article 10(4) Similar Biological
App
-Subcutaneous
Imbat Limited
PPA1151/002/00
2
50 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
PPA
-Per Oral
100 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
PPA
-Per Oral
50 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
PPA
-Per Oral
100 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
PPA
-Per Oral
Interchangeable
List Code:
IC0064-024-003
PA0822/001/004
50 Milligram
Film Coated
Tablet
N06AB06
-Per Oral
Interchangeable
List Code:
IC0064-023-003
PA0822/001/005
-SERTRALINE
HYDROCHLORI
DE
100 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
-Per Oral
50 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
PPA
-Per Oral
100 Milligram
Film Coated
Tablet
N06AB06
-SERTRALINE
HYDROCHLORI
DE
PPA
-Per Oral
LUMIGAN
LUMINITY
LUSDUNA
((FORMELY
KNOWN AS
INSULIN
GLARGINE
MSD))
LUSTRAL
LUSTRAL
LUSTRAL
LUSTRAL
LUSTRAL
LUSTRAL
LUSTRAL
LUSTRAL
Imbat Limited
Interchangeable
List Code:
IC0064-023-003
PPA1151/002/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0064-024-003
PPA0465/062/00
1
PCO
Manufacturing
Interchangeable
List Code:
IC0064-023-003
PPA0465/062/00
2
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0064-024-003
PPA1463/026/00
1
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0064-023-003
PPA1463/026/00
2
-Ocular
-Ocular
Interchangeable
List Code:
IC0064-024-003
Human Medicines Authorised/Transfer Pending Products
Page 288 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
LUTINUS
Ferring Ireland
Ltd
PA1009/022/001
100 Milligram
Vaginal Tablets
G03DA04
LUTRATE 1
MONTH DEPOT
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Serono Europe
Limited
Serono Europe
Limited
Serono Europe
Limited
Serono Europe
Limited
Serono Europe
Limited
Serono Europe
Limited
Actavis Group
PTC ehf
PA0899/044/001
3.75 Milligram
Infus/Pdr/Oral
Soln
L02AE02
PA0899/044/002
22.5 Milligram
Infus/Pdr/Oral
Soln
EU/1/00/155/001
75 International
Unit
75 International
Unit
75 International
Unit
75 International
Unit
75 International
Unit
75 International
Unit
300 Base
Milligrams
PA1186/003/001
1 %w/w
PA1077/066/001
LYMPHOSEEK
Chefaro Ireland
DAC
GlaxoSmithKline
(Ireland) Limited
Weleda (UK)
Limited
A. Nelson &
Company Limited
Norgine B.V.
LYNPARZA
Active
Ingredients
Legal Basis
Routes of
Administration
PROGESTERO
NE
-LEUPRORELIN
ACETATE
Article 8(3) - Full
new Application
-Intra-Muscular
L02AE02
-LEUPRORELIN
ACETATE
Article 8(3) - Full
new Application
-Intra-Muscular
Pdr+Solv for soln
for Inf
Pdr+Solv for soln
for Inf
Pdr+Solv for Soln
for Inj
Pdr+Solv for soln
for Inf
Pdr+Solv for soln
for Inf
Pdr+Solv for soln
for Inf
Capsules Hard
G03GA07
J01AA04
-LUTROPIN
ALFA
-LUTROPIN
ALFA
-LUTROPIN
ALFA
-LUTROPIN
ALFA
-LUTROPIN
ALFA
-LUTROPIN
ALFA
-LYMECYCLINE
Article 10(1) Generic
Application
-Per Oral
P03AC04
-PERMETHRIN
5 %w/w
Cutaneous
Solution
Cream
P03AC04
-PERMETHRIN
HOR0407/028/0
01
HOR1149/020/0
01
EU/1/14/955/001
6C & 30C
Tablets
6X-MM %v/v
V09IA
AstraZeneca AB
EU/1/14/959/001
50 Milligram
Infus/Pdr/Oral
Soln
Kit for
radiopharmaceut
ical preparation
Capsules Hard
-LYCOPODIUM
CLAVATUM
-LYCOPODIUM
CLAVATUM
-TILMANOCEPT
L01XX46
-OLAPARIB
LYRICA
LYRICA
Pfizer Limited
Pfizer Limited
EU/1/04/279/044
EU/1/04/279/1-25
Oral Solution
Capsules Hard
N03AX16
N03AX16
-PREGABALIN
-PREGABALIN
LYRICA
LYRINEL XL
Pfizer Limited
Janssen-Cilag
Ltd
EU/1/4/279/33-35
PA0748/052/001
20 Mg/Ml
25,50,75,150,300
%v/v
225 Milligram
5 Milligram
Capsules Hard
Tablet Prolonged
Release
N03AX16
G04BD04
LYRINEL XL
Janssen-Cilag
Ltd
PA0748/052/002
10 Milligram
Tablet Prolonged
Release
G04BD04
LYSODREN
Laboratoire HRA
Pharma
Boehringer
Ingelheim Limited
EU/1/04/273/001
500 mg Milligram
Tablets
L01XX23
-PREGABALIN
-OXYBUTYNIN
HYDROCHLORI
DE
-OXYBUTYNIN
HYDROCHLORI
DE
-MITOTANE
PA0007/063/002
17.86 Mg/Ml
Oromucosal
Spray
R02AD
LYSOPADOL
BLACKCURRAN
T
LYSOPADOL
LEMON
Boehringer
Ingelheim Limited
PA0007/065/001
20 Milligram
Lozenges
R05CB06
Boehringer
Ingelheim Limited
PA0007/064/001
20 Milligram
Lozenges
R05CB06
LYSOPADOL
MINT
Boehringer
Ingelheim Limited
PA0007/063/001
20 Milligram
Lozenges
R05CB06
LYXUMIA
Sanofi-Aventis
Groupe
EU/1/12/811/001
10 Microgram
LYXUMIA
Sanofi-Aventis
Groupe
EU/1/12/811/002005
20 Microgram
MAALOX
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/110/001
200/175 MG/5ml
Solution for
injection in prefilled pen
Solution for
injection in prefilled pen
Oral Suspension
LUTRATE 3
MONTH DEPOT
LUVERIS
LUVERIS
LUVERIS
LUVERIS
LUVERIS
LUVERIS
LYCIMOR
LYCLEAR
CREME RINSE
LYCLEAR
DERMAL
LYCOPODIUM
LYCOPODIUM
LYSOPADOL
EU/1/00/155/003
EU/1/00/155/004
EU/1/00/155/005
EU/1/00/155/006
EU/1/00/155/002
PA1380/130/001
Human Medicines Authorised/Transfer Pending Products
250 Microgram
G03GA07
G03GA07
G03GA07
G03GA07
G03GA07
-Vaginal
-Topical
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Intra-dermal
-Subcutaneous
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Oromucosal
Article 8(3) - Full
new Application
-Oromucosal
Article 8(3) - Full
new Application
-Oromucosal
A10BX10
-AMBROXOL
HYDROCHLORI
DE
-AMBROXOL
HYDROCHLORI
DE
-AMBROXOL
HYDROCHLORI
DE
-AMBROXOL
HYDROCHLORI
DE
-LIXISENATIDE
Article 8(3) - Full
new Application
-Subcutaneous
A10BX10
-LIXISENATIDE
Article 8(3) - Full
new Application
-Subcutaneous
A02AD01
-MAGNESIUM
HYDROXIDE
-ALUMINIUM
HYDROXIDE
-Per Oral
Page 289 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
MAALOX
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/110/004
400/400 Milligram
Tablets
Chewable
A02AD01
MAALOX PLUS
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/109/001
200/175/25
MG/5ml
Oral Suspension
A02AF02
MAALOX PLUS
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/109/002
200/200/25
Milligram
Tablets
Chewable
A02AF02
MAALOX
SACHETS
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/110/006
460/400 Milligram
Oral Suspension
A02AB10
MAALOX
SUGAR-FREE
CHEWABLE
TABLETS
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/110/007
400/400 Milligram
Tablets
Chewable
A02AB10
MABTHERA
Roche
Registration
Limited
Genentech, Inc.
EU/1/98/067/003
1400 Milligram
Solution for
Injection
L01XC02
-MAGNESIUM
HYDROXIDE
-ALUMINIUM
HYDROXIDE
GEL, DRIED
-ALUMINIUM
HYDROXIDE
-MAGNESIUM
HYDROXIDE
-DIMETICONE,
ACTIVATED
-ALUMINIUM
OXIDE,
HYDRATED PH.
EUR
-MAGNESIUM
HYDROXIDE PH.
EUR.
-DIMETICONE
PH. EUR. (AS
SIMETICONE
PH. EUR.)
-ALUMINIUM
OXIDE
HYDRATED
-MAGNESIUM
HYDROXIDE
-ALUMINIUM
OXIDE
HYDRATED
-MAGNESIUM
HYDROXIDE
-RITUXIMAB
EU/1/98/067/004
1600 Milligram
L01XC02
-RITUXIMAB
Roche
Registration
Limited
Roche
Registration
Limited
Genzyme Europe
B.V.
EU/1/98/067/001
100 mg Milligram
Solution for
Injection
Infus/Pdr/Oral
Soln
L01XC02
-RITUXIMAB
EU/1/98/067/002
500 Milligram
Concentrate for
Soln for Inf
L01XC02
-RITUXIMAB
EU/1/13/847/001
500000/100
Implant
M09AX02
MACO PHARMA
SODIUM
CHLORIDE
Maco Pharma
(UK) Ltd
PA0931/004/001
%w/v
Solution for
Infusion
B05BB02
MACROBID
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
Ltd
Rowex Ltd
PA0899/014/001
100 Milligram
J01XE01
PA0899/012/001
50 Milligram
Prolonged
Release
Capsules
Capsules Hard
PA0899/012/002
100 Milligram
Capsules Hard
J01XE01
PA0711/224/001
13.8 Grams
Powder for Oral
Solution
A06AD65
PharOS Pharmaceutical
Oriented Services
Ltd
Pfizer Limited
PA1539/006/001
10 Grams
Powder for Oral
Solution
A06AD15
-AUTOLOGOUS
CHONDROCYT
ES
-SODIUM
CHLORIDE
-GLUCOSE
MONOHYDRATE
NITROFURANT
OIN
NITROFURANT
OIN
NITROFURANT
OIN
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
4000
EU/1/05/325/001
0.3 Milligram
Solution for
Injection
S01LA03
MABTHERA
MABTHERA
MABTHERA
MACI
MACRODANTIN
MACRODANTIN
MACROLIEF
MACROSOFT
MACUGEN
Human Medicines Authorised/Transfer Pending Products
J01XE01
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10a Bibliographical
App
-Per Oral
-PEGAPTANIB
SODIUM
Page 290 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
MADOPAR
Roche Products
Limited
PA0050/043/002
200/50 Milligram
Capsules Hard
N04BA02
MADOPAR
Roche Products
Limited
PA0050/043/005
50/12.5 Milligram
Tablets
N04BA02
MADOPAR
Roche Products
Limited
PA0050/043/006
100/25 Milligram
Tablets
N04BA02
MADOPAR
HARD
CAPSULES
B & S Healthcare
DPR1328/022/0
03
200/50 Milligram
Capsules Hard
N04BA02
MAGNASPART
ATE
Kora Corporation
Ltd t/a Kora
Healthcare
Foran Healthcare
Limited
Aurum
Pharmaceuticals
Limited T/A
Martindale
Pharma
Rowa
Pharmaceuticals
Limited
PA1748/002/001
243 Milligram
Powder for Oral
Solution
A12CC05
PA0484/021/001
38.5 %w/w
Cutaneous Paste
D11AX05
PA1176/001/001
50 %w/v
Solution for
Injection and
Concentrate for
Infusion
A12CC02
PA0074/062/001
5 mMol.
Granules for oral
solution
A12CC05
-MAGNESIUM
ASPARTATE
DIHYDRATE
Bayer Limited
PA1410/006/001
0.5 mMol/ml
Solution for
Injection
V08CA01
MAGNEVIST
Bayer Limited
PA1410/006/002
469 Micromol
Solution for
Injection
V08CA01
MAJOVEN XL
Bristol
Laboratories
Limited
Bristol
Laboratories
Limited
Bristol
Laboratories
Limited
GlaxoSmithKline
(Ireland) Limited
PA1240/021/001
37.5 Milligram
N06AX16
PA1240/021/003
150 Milligram
PA1240/021/002
75 Milligram
PA1077/111/001
250 / 100
Milligram
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Prolonged
Release
Capsules
Film Coated
Tablet
GADOPENTETA
TE
DIMEGLUMINE
GADOPENTETA
TE
DIMEGLUMINE
-VENLAFAXINE
(FORM B)
MALARONE
IMED Healthcare
Ltd.
PPA1463/095/00
1
250/100 Milligram
Film Coated
Tablet
P01BB51
MALUSONE
Clonmel
Healthcare Ltd
PA0126/233/001
250/100 Milligram
Film Coated
Tablet
P01BB51
MANERIX
Meda Health
Sales Ireland
Limited
Baxter
Healthcare
Limited
Baxter
Healthcare
Limited
Baxter
Healthcare
Limited
PA1332/028/001
150 Milligram
Film Coated
Tablet
PA0167/037/017
15 %w/v
PA0167/037/015
PA0167/037/009
MAGNESIUM
SULFATE
MAGNESIUM
SULPHATE
MAGNESIUM
VERLA 5 MMOL
GRANULES FOR
ORAL
SOLUTION
MAGNEVIST
MAJOVEN XL
MAJOVEN XL
MALARONE
MANNITOL
MANNITOL
MANNITOL
INTRAVENOUS
INFUSION BP
Human Medicines Authorised/Transfer Pending Products
-LEVODOPA
-BENSERAZIDE
HYDROCHLORI
DE
-LEVODOPA
-BENSERAZIDE
HYDROCHLORI
DE
-LEVODOPA
-BENSERAZIDE
HYDROCHLORI
DE
-BENSERAZIDE
HYDROCHLORI
DE
-LEVODOPA
-MAGNESIUM
ASPARTATE
DIHYDRATE
-MAGNESIUM
SULFATE
-MAGNESIUM
SULFATE
HEPTAHYDRAT
E
N06AX16
-VENLAFAXINE
(FORM B)
N06AX16
-VENLAFAXINE
(FORM B)
P01BB51
N06AG02
-ATOVAQUONE
-PROGUANIL
HYDROCHLORI
DE
-ATOVAQUONE
-PROGUANIL
HYDROCHLORI
DE
-ATOVAQUONE
-PROGUANIL
HYDROCHLORI
DE
-MOCLOBEMIDE
Solution for
Infusion
B05BC01
-MANNITOL
10 Per Cent
Solution for
Infusion
B05BC01
-MANNITOL
20 %w/v
Solution for
Infusion
B05BC01
-MANNITOL
Legal Basis
Article 10a Bibliographical
App
Routes of
Administration
-Per Oral
-Intra-venous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10a Bibliographical
App
-Intra-venous
Page 291 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
MARCAIN 0.25%
WITH
ADRENALINE
AstraZeneca UK
Limited
PA0970/046/001
0.25/0.5%w %v/v
Solution for
Injection
N01BB51
MARCAIN 0.5%
WITH
ADRENALINE
AstraZeneca UK
Limited
PA0970/046/002
0.5%/0.55% %v/v
Solution for
Injection
N01BB51
MARCAIN
HEAVY
STERIPACK
0.5% W/V
MARCAIN
POLYAMP
STERIPACK
MARCAIN
POLYAMP
STERIPACK
MARIXINO
Aspen Pharma
Trading Limited
PA1691/024/003
5mg/80mg/m
%v/v
Solution for
Injection
N01BB01
AstraZeneca UK
Limited
PA0970/045/002
0.5 %w/v
Solution for
Injection
N01BB01
AstraZeneca UK
Limited
PA0970/045/001
0.25 %w/v
Solution for
Injection
N01BB01
Consilient Health
Limited
EU/1/13/820/1-13
10 Milligram
Film Coated
Tablet
N06DX01
20 Milligram
Film Coated
Tablet
150/30
Microgram
PA0407/021/001
MARIXINO
MARVIOL 150/30
MICROGRAM
TABLETS.
Consilient Health
Limited
Interchangeable
List Code:
IC0022-002-003
EU/1/13/820/1426
Interchangeable
List Code:
IC0022-003-003
PA1286/051/001
Active
Ingredients
Legal Basis
Routes of
Administration
-BUPIVACAINE
HYDROCHLORI
DE
-EPINEPHRINE
BITARTRATE
-BUPIVACAINE
HYDROCHLORI
DE
-EPINEPHRINE
BITARTRATE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-BUPIVACAINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Tablets
G03AA09
%v/v
Cutaneous
Solution
M02AX10
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
MASSAGE BALM
WITH ARNICA
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Weleda (UK)
Limited
MATEVER
Pharmathen S.A.
EU/1/11/711/001006
250 Milligram
Film Coated
Tablet
N03AX14
MATEVER
Pharmathen S.A.
EU/1/11/711/007014
500 Milligram
Film Coated
Tablet
N03AX14
MATEVER
Pharmathen S.A.
EU/1/11/711/015022
750 Milligram
Film Coated
Tablet
N03AX14
MATEVER
Pharmathen S.A.
EU/1/11/711/023029
1000 Milligram
Film Coated
Tablet
N03AX14
MATEVER
Pharmathen S.A.
EU/1/11/711/030
100 Mg/Ml
Concentrate for
Soln for Inf
N03AX14
MATRIFEN
Takeda UK
Limited
Takeda UK
Limited
Takeda UK
Limited
Takeda UK
Limited
Takeda UK
Limited
Bracco Imaging
spa
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
PA1547/004/001
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Powder for Oral
Suspension
Eye Drops
Suspension
N02AB03
N02AB03
-FENTANYL
-Transdermal
N02AB03
-FENTANYL
-Transdermal
N02AB03
-FENTANYL
-Transdermal
N02AB03
-FENTANYL
-Transdermal
V08BA01
PA0013/130/001
12 Microgram per
hour
25 Microgram per
hour
50 Microgram per
hour
75 Microgram per
hour
100 Microgram
per hour
98.45%w/w
%w/w
0.1 %w/v
-DESOGESTREL
ETHINYLESTRA
DIOL
-ARNICA
MONTANA
-BETULA ALBA
-BIRCH LEAF
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
LEVETIRACETA
M
-FENTANYL
PA0013/130/002
0.1 %w/w
Eye Ointment
S01BA01
-BARIUM
SULFATE
DEXAMETHAS
ONE
DEXAMETHAS
ONE
MATRIFEN
MATRIFEN
MATRIFEN
MATRIFEN
MAXIBAR
MAXIDEX
MAXIDEX
PA1547/004/002
PA1547/004/003
PA1547/004/004
PA1547/004/005
PA1826/002/001
Human Medicines Authorised/Transfer Pending Products
S01BA01
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Transdermal
Page 292 of 608
Trade Name
Licence Holder Licence
Number
MAXILIEF
EFFERVESCEN
T
Clonmel
Healthcare Ltd
PA0126/113/001
MAXITROL
Novartis
Pharmaceuticals
UK Ltd
PA0013/131/002
MAXITROL 0.1%
W/V, 6000 IU/ML,
3500 IU/ML EYE
Novartis
Pharmaceuticals
UK Ltd
PA0013/131/001
MAXOLON
Amdipharm
Limited
MAXOLON
Strength
Active
Ingredients
Legal Basis
N02BE51
Eye Ointment
S01CA01
%w/v
Eye Drops
Suspension
S01CA01
PA1142/011/001
5 Mg/Ml
Solution for
Injection
A03FA01
Amdipharm
Limited
PA1142/011/003
10 Milligram
Tablets
A03FA01
MEDIAM
STANNOUS
AGENT
MEDiAM
PA1229/002/001
4.0 ; 6.8 Milligram
Pdr for Soln for
Infusion
V09GA06
MEDICAL AIR
BOC Gases
Ireland Ltd
BOC Gases
Ireland Ltd
PA0208/009/001
21 %v/v
V03AN01
PA0208/006/001
99.5 %w/v
Medicinal gas,
compressed
Medicinal gas,
compressed
V03AN02
-CARBON
DIOXIDE
BOC Gases
Ireland Ltd
BOC Gases
Ireland Ltd
BOC Gases
Ireland Ltd
BOC Gases
Ireland Ltd
Industrial
Pressure Testing
Ltd
SOL S.p.A.
PA0208/008/001
99.5 %v/v
V03AN03
-HELIUM
PA0208/002/001
99.5 %v/v
V03AN01
-OXYGEN
PA0208/001/001
>98 %v/v
N01AX13
PA0208/003/001
99.5 %v/v
V03AN01
-NITROUS
OXIDE
-OXYGEN
PA1357/001/001
100 %v/v
Medicinal gas,
compressed
Medicinal gas,
liquefied
Medicinal gas,
compressed
Medicinal gas,
compressed
Inhalation Gas
V03AN01
-OXYGEN
--Unknown--
-Inhalation
PA1848/002/001
21.75 %v/v
Medicinal gas,
compressed
V03AN01
-OXYGEN
Article 10a Bibliographical
App
-Inhalation
MEDICINAL
OXYGEN/CARB
ON DIOXIDE
MIXTURES
MEDICINAL
OXYGEN/CARB
ON DIOXIDE
MIXTURES
MEDIJEL
BOC Gases
Ireland Ltd
PA0208/004/001
Per Cent
Medicinal gas,
compressed
V03AN01
-OXYGEN
-CARBON
DIOXIDE
BOC Gases
Ireland Ltd
PA0208/004/001
Per Cent
Medicinal gas,
compressed
V03AN02
-OXYGEN
-CARBON
DIOXIDE
D.D.D. Limited
PA0302/001/001
0.66/0.05 %w/w
Oromucosal Gel
N01BB52
MEDIKINET
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/006
5 Milligram
Tablets
N06BA04
-LIDOCAINE
HYDROCHLORI
DE
AMINOACRIDIN
E
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
Article 10(3) Hybrid
Application
-Per Oral
MEDICINAL AIR
SYNTHETIC SO
Human Medicines Authorised/Transfer Pending Products
-PARACETAMOL
-CODEINE
PHOSPHATE
-CAFFEINE
-NEOMYCIN
SULFATE
-POLYMYXIN B
SULFATE
DEXAMETHAS
ONE
DEXAMETHAS
ONE
-POLYMYXIN B
SULFATE
-NEOMYCIN
SULFATE
METOCLOPRA
MIDE
HYDROCHLORI
DE
METOCLOPRA
MIDE
HYDROCHLORI
DE
-STANNOUS
FLUORIDE
-MEDRONIC
ACID
-OXYGEN
Routes of
Administration
Tablets
Effervescent
MEDICAL
CARBON
DIOXIDE
MEDICAL
HELIUM
MEDICAL
LIQUID OXYGEN
MEDICAL
NITROUS OXIDE
MEDICAL
OXYGEN
MEDICAL
OXYGEN
500/8/30
Milligram
Dosage Form ATC
-Per Oral
Page 293 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
MEDIKINET
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/007
10 Milligram
Tablets
N06BA04
MEDIKINET
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/008
20 Milligram
Tablets
N06BA04
MEDIKINET MR
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/001
5 Milligram
Capsules
Modified Release
N06BA04
MEDIKINET MR
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/002
10 Milligram
Capsules
Modified Release
N06BA04
MEDIKINET MR
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/003
20 Milligram
Capsules
Modified Release
N06BA04
MEDIKINET MR
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/004
30 Milligram
Capsules
Modified Release
N06BA04
MEDIKINET MR
Medice
Arzneimittel
Putter GmbH &
Co. K.G
PA1555/001/005
40 Milligram
Capsules
Modified Release
N06BA04
MEDISIP WITH
DECONGESTA
NT POWDER
FOR ORAL
SOLUTION
Actavis Group
PTC ehf
PA1380/160/001
500/12.2
Milligram
Powder for Oral
Solution
N02BE51
MEFAC
Rowa
Pharmaceuticals
Limited
Rowa
Pharmaceuticals
Limited
Generics (UK)
Limited
PCO
Manufacturing
LTT Pharma
Limited
PCO
Manufacturing
PharmaSwiss
Ceska republika
s.r.o.
PharmaSwiss
Ceska republika
s.r.o.
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Novartis
Europharm
Limited
Rowex Ltd
Rowex Ltd
Clonmel
Healthcare Ltd
PA0074/015/001
250 Milligram
Capsule
M01AG01
PA0074/015/002
500 mg Milligram
Tablets
M01AG01
-MEFENAMIC
ACID
PA0405/014/001
250 Milligram
Capsules Hard
M01AG01
PPA0465/323/00
1
PPA1562/194/00
1
PPA0465/323/00
2
PA1696/002/001
40 Mg/Ml
Oral Suspension
L02AB01
160 Milligram
Tablets
L02AB01
160 Milligram
Tablets
L02AB01
160 Milligram
Tablets
L02AB01
-MEFENAMIC
ACID
-MEGESTROL
ACETATE
-MEGESTROL
ACETATE
-MEGESTROL
ACETATE
-MEGESTROL
ACETATE
PA1696/002/002
40 Mg/Ml
Oral Suspension
L02AB01
-MEGESTROL
ACETATE
EU/1/14/931/0102
0.5 Milligram
Film Coated
Tablet
L01XE25
-TRAMETINIB
Article 8(3) - Full
new Application
-Per Oral
EU/1/14/931/0304
1 Milligram
Film Coated
Tablet
L01XE25
-TRAMETINIB
Article 8(3) - Full
new Application
-Per Oral
EU/1/14/931/0506
2 Milligram
Film Coated
Tablet
L01XE25
-TRAMETINIB
Article 8(3) - Full
new Application
-Per Oral
PA0711/060/001
PA0711/060/002
PA0126/012/001
7.5 Milligram
15 Milligram
200 Milligram
Tablets
Tablets
Film Coated
Tablet
M01AC06
M01AC06
M01AE01
-MELOXICAM
-MELOXICAM
-IBUPROFEN
MEFAC
MEFENAMIC
ACID
MEGACE
MEGACE
MEGACE
MEGACE 160
MG TABLETS
MEGACE 40
MG/ML ORAL
SUSPENSION
MEKINIST
MEKINIST
MEKINIST
MELCAM
MELCAM
MELFEN
Human Medicines Authorised/Transfer Pending Products
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
-PARACETAMOL
PHENYLEPHRI
NE
HYDROCHLORI
DE
-MEFENAMIC
ACID
Legal Basis
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 294 of 608
Trade Name
MELFEN
MELOXICAM
MELOXICAM
MELOXICAM
CHANELLE
MEDICAL
MELOXICAM
CHANELLE
MEDICAL
MEMANTINE
MEMANTINE
ACCORD
MEMANTINE
ACCORD
MEMANTINE
ACCORD
MEMANTINE
CLONMEL
MEMANTINE
CLONMEL
Licence Holder Licence
Number
Clonmel
Healthcare Ltd
WPR Healthcare
Limited
WPR Healthcare
Limited
Chanelle Medical
PA0126/012/002
400 Milligram
PPA0565/041/00
1
PPA0565/041/00
2
PA0688/005/001
Chanelle Medical
Ranbaxy Ireland
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
MEMANTINE
HYDROCHLORI
DE
Rosemont
Pharmaceuticals
Ltd
MEMANTINE
HYDROCHLORI
DE
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
MEMANTINE
HYDROCHLORI
DE NICHE
Niche Generics
Limited
MEMANTINE
HYDROCHLORI
DE NICHE
Niche Generics
Limited
MEMANTINE
LEK
Pharmathen S.A.
MEMANTINE
LEK
Strength
Pharmathen S.A.
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
M01AE01
-IBUPROFEN
7.5 Milligram
Film Coated
Tablet
Tablets
M01AC06
-MELOXICAM
PPA
-Per Oral
15 Milligram
Tablets
M01AC06
-MELOXICAM
PPA
-Per Oral
7.5 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
PA0688/005/002
15 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
PA0408/093/001
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-Per Oral
5+10+15+20
Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-Per Oral
Interchangeable
List Code:
IC0022-003-003
PA0126/255/002
10 Milligram
Film Coated
Tablet
N06DX01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-002-003
PA0126/255/001
-MEMANTINE
HYDROCHLORI
DE
10 Mg/Ml
Oral Solution
N06DX01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-107-019
PA0312/032/001
-MEMANTINE
HYDROCHLORI
DE
10 Mg/Ml
Oral Solution
N06DX01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-107-019
PA0577/176/001
-MEMANTINE
HYDROCHLORI
DE
10 Mg/Ml
Oral Solution
N06DX01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-107-019
PA1063/057/001
-MEMANTINE
HYDROCHLORI
DE
10 Milligram
Film Coated
Tablet
N06DX01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-002-003
PA1063/057/002
-MEMANTINE
HYDROCHLORI
DE
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-002-003
EU/1/13/880/001008
Interchangeable
List Code:
IC0022-002-003
EU/1/13/880/013
Interchangeable
List Code:
IC0022-106-003
EU/1/13/880/0912
Interchangeable
List Code:
IC0022-003-003
EU/1/13/826/001006
Interchangeable
List Code:
IC0022-002-003
EU/1/13/826/007011
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-003-003
Human Medicines Authorised/Transfer Pending Products
Page 295 of 608
Trade Name
MEMANTINE
MERZ
MEMANTINE
MERZ
MEMANTINE
MERZ
MEMANTINE
MERZ
MEMANTINE
MYLAN
MEMANTINE
MYLAN
MEMANTINE
RATIOPHARM
MEMANTINE
RATIOPHARM
MEMANTINE
RATIOPHARM
MEMANTINE
SANDOZ
MENINGITEC
Licence Holder Licence
Number
Merz
Pharmaceuticals
GmbH
Merz
Pharmaceuticals
GmbH
Merz
Pharmaceuticals
GmbH
Merz
Pharmaceuticals
GmbH
EU/1/12/799/025026
Interchangeable
List Code:
IC0022-106-003
EU/1/12/799/001012
Interchangeable
List Code:
IC0022-002-003
EU/1/12/799/013024
Interchangeable
List Code:
IC0022-003-003
EU/1/12/799/027029
Generics (UK)
Limited
Interchangeable
List Code:
IC0022-107-019
EU/1/13/827/001018
Generics (UK)
Limited
Interchangeable
List Code:
IC0022-002-003
EU/1/13/827/019036
Ratiopharm
GmbH
Interchangeable
List Code:
IC0022-003-003
EU/1/13/836/023
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
5+10+15+20
Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
(FREE BASE)
Article 10c Informed Consen
-Per Oral
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
(FREE BASE)
Article 10c Informed Consen
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
(FREE BASE)
Article 10c Informed Consen
-Per Oral
5 mg/pump
actuation
Oral Solution
N06DX01
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
(FREE BASE)
Article 10c Informed Consen
-Per Oral
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
5+10+15+20
Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Ratiopharm
GmbH
Interchangeable
List Code:
IC0022-106-003
EU/1/13/836/00112
Ratiopharm
GmbH
Interchangeable
List Code:
IC0022-002-003
EU/1/13/836/01322
Rowex Ltd
Interchangeable
List Code:
IC0022-003-003
PA0711/214/001
10 Milligram
Film Coated
Tablet
N06DX01
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0022-002-003
PA1886/001/001
-MEMANTINE
HYDROCHLORI
DE
0.5 Millilitre
Solution for
Injection
J07AH07
-NEISSERIA
MENINGITIDIS
SEROGROUP C
(STRAIN C11)
POLYSACCHAR
IDE
CORYNEBACTE
RIUM
DIPHTHERIAE
CRM197
CARRIER
PROTEIN
-ALUMINIUM
PHOSPHATE
Article 8(3) - Full
new Application
-Intra-Muscular
Nuron Biotech
B.V.
Human Medicines Authorised/Transfer Pending Products
Page 296 of 608
Trade Name
Licence Holder Licence
Number
MENITORIX
GlaxoSmithKline
(Ireland) Limited
PA1077/116/001
MENJUGATE
KIT
GSK Vaccines
S.r.l.
PA0919/004/002
MENJUGATE
LIQUID
GSK Vaccines
S.r.l.
MENJUGATE
LIQUID
Strength
Dosage Form ATC
Pdr+Solv for Soln
for Inj
J07AG53
10 Microgram
Pdr+Solv for
Susp for Inj
J07AH05
PA0919/004/003
10 Microgram
Suspension for
Injection
J07AH05
GSK Vaccines
S.r.l.
PA0919/004/004
10 Microgram
Suspension for
Injection
J07AH05
MENOFORCE
SAGE
Bioforce (UK) Ltd
TR0725/004/001
MENOPUR
Ferring Ireland
Ltd
Ferring Ireland
Ltd
Ferring Ireland
Ltd
PA1009/015/002
Ovelle Limited
PA0206/022/001
MENOPUR
MENOPUR
MENTHOL AND
WINTERGREEN
PA1009/015/003
PA1009/015/001
Human Medicines Authorised/Transfer Pending Products
Tablets
600 International
Unit
1200
International Unit
75/75IU IU/ML
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
G03GA02
5.00 0.2 2.00
13.18 %w/w
Cream
M02AC
G03GA02
G03GA02
Active
Ingredients
-CONJUGATE
OF
HAEMOPHILUS
INFLUENZAE
TYPE B
CAPSULAR
POLYSACCHAR
IDE
(POLYRIBOSYL
RIBITOL
PHOSPHATE)
AND TETANUS
-CONJUGATE
OF NEISSERIA
MENINGITIDES
C CAPSULAR
POLYSACCHAR
IDE AND
TETANUS
TOXOID (MEAN
TT/PS RATIO :1)
-NEISSERIA
MENINGITIDIS C
CORYNEBACTE
RIUM
DIPHTHERIAE
CRM197
CARRIER
PROTEIN
MENINGOCOC
CAL GROUP C
OLIGOSACCHA
RIDE
CORYNEBACTE
RIUM
DIPHTHERIAE
CRM197
PROTEIN
MENINGOCOC
CAL GROUP C
OLIGOSACCHA
RIDE
CORYNEBACTE
RIUM
DIPHTHERIAE
CRM197
PROTEIN
-DRY EXTRACT
SALVIA
OFFICINALIS L.
-MENOTROPHIN
BP
-MENOTROPHIN
BP
-FOLLICLESTIMULATING
HORMONE,
HUMAN
-LUTEINISING
HORMONE
-METHYL
SALICYLATE
-LEVOMENTHOL
-OLEORESIN
CAPSICUM
-TURPENTINE
OIL
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Intra-Muscular
Article 8(3) - Full
new Application
-Intra-Muscular
Article 8(3) - Full
new Application
-Intra-Muscular
-Per Oral
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
-Subcutaneous
-Intra-Muscular
Page 297 of 608
Trade Name
Licence Holder Licence
Number
MENTHOLATUM
DEEP HEAT
The Mentholatum
Company Ltd.
PA0076/002/001
MENTHOLATUM
DEEP HEAT
SPRAY
The Mentholatum
Company Ltd.
PA0076/003/001
MENVEO
GSK Vaccines
S.r.l.
EU/1/10/614/002003
MEPACT
Takeda France
SAS
MEPTID
Strength
Cream
M02AC
Cutaneous Spray
Solution
M02AC
0.5 Millilitre
Pdr+Solv for Soln
for Inj
J07AH08
EU/1/08/502/001
4 Milligram
L03AX15
Almirall, S.A.
PA0968/005/001
100 mg/ml
Micromol
Powder for
suspension for
infusion
Solution for
Injection
MEPTID
Almirall, S.A.
PA0968/005/002
200 mg Milligram
Tablets
N02AX05
MERC. SOL.
A. Nelson &
Company Limited
HOR1149/021/0
01
6C - MM
Pillules
MERCILON
150/20
MICROGRAM
TABLETS.
MERCUIRIUS
SOLUBILIS
HAHNEMANII
(MERC. SOL.)
MERCURIUS
VIVUS
MEROCAINE
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
Weleda (UK)
Limited
PA1286/052/001
150/20
Microgram
Tablets
HOR0407/006/0
01
6C & 30C
Tablets
Helios
Homeopathy Ltd
Sanofi-Aventis
Ireland Limited
T/A SANOFI
HOR1154/013/0
01
PA0540/178/001
6c-200c
1.4 / 10 Milligram
Infus/Pdr/Oral
Soln
Lozenges
R02AA06
MEROCETS
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/176/001
1.4 Milligram
Lozenges
R02AA06
PA0540/177/001
1.4 Milligram
Lozenges
R02AA06
AstraZeneca UK
Limited
AstraZeneca UK
Limited
PA0970/012/003
1 Grams
J01DH02
PA0970/012/002
500 Milligram
Pdr for Soln
Inj/Inf
Pdr for Soln
Inj/Inf
MEROCETS
PLUS
MERONEM
MERONEM I.V.
Human Medicines Authorised/Transfer Pending Products
%w/w
Dosage Form ATC
N02AX05
G03AA09
J01DH02
Active
Ingredients
-METHYL
SALICYLATE
RACEMENTHOL
-EUCALYPTUS
GLOBULUS
-TURPENTINE
OIL
-METHYL
NICOTINATE
-GLYCOL
SALICYLATE
-ETHYL
SALICYLATE
-METHYL
SALICYLATE
MENINGOCOC
CAL GROUP A
OLIGOSACCHA
RIDE
MENINGOCOC
CAL GROUP C
OLIGOSACCHA
RIDE
MENINGOCOC
CAL GROUP W135
OLIGOSACCHA
RIDE
MENINGOCOC
CAL GROUP Y
OLIGOSACCHA
RDIE
-MIFAMURTIDE
-MEPTAZINOL
HYDROCHLORI
DE
-MEPTAZINOL
HYDROCHLORI
DE
-MERCURIUS
SOLUBILIS
HAHNEMANNI
-DESOGESTREL
ETHINYLESTRA
DIOL
-MERCURIUS
SOLUBILIS
HAHNEMANNI
Legal Basis
Routes of
Administration
-Intra-Muscular
Article 8(3) - Full
new Application
-Intra-venous
-Per Oral
-Per Oral
-Per Oral
-MERCURY
-Per Oral
CETYLPYRIDINI
UM CHLORIDE
-BENZOCAINE
CETYLPYRIDINI
UM CHLORIDE
CETYLPYRIDINI
UM CHLORIDE
-MENTHOL
-EUCALYPTUS
GLOBULUS
-MEROPENEM
TRIHYDRATE
-MEROPENEM
TRIHYDRATE
-Per Oral
-Per Oral
Page 298 of 608
Trade Name
MEROPENEM
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
PA1217/006/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
PA1217/006/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
MEROPENEM
Hikma
Farmaceutica
(Portugal) SA
Hikma
Farmaceutica
(Portugal) SA
Pharmathen S.A.
PA1368/016/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Pharmathen S.A.
PA1368/016/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Fresenius Kabi
Limited
PA0566/056/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Fresenius Kabi
Limited
PA0566/056/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Venus Pharma
GmbH
PA1610/001/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Venus Pharma
GmbH
PA1610/001/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Noridem
Enterprises Ltd
PA1122/015/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
Noridem
Enterprises Ltd
PA1122/015/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
HOSPIRA
Hospira UK
Limited
PA0437/064/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
HOSPIRA
Hospira UK
Limited
PA0437/064/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
MEDIPHA
SANTE
MEROPENEM
MEDIPHA
SANTE
MEROPENEM
MILPHARM
Medipha Sante
SN
PA1566/002/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
Medipha Sante
SN
PA1566/002/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
Milpharm Limited
PA1050/028/001
500 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
-MEROPENEM
-MEROPENEM
TRIHYDRATE
-MEROPENEM
-MEROPENEM
TRIHYDRATE
MEROPENEM
MILPHARM
Milpharm Limited
PA1050/028/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
SANDOZ
Sandoz B.V.
PA1681/001/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPENEM
SANDOZ
Sandoz B.V.
PA1681/001/002
1000 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPONIA
Clonmel
Healthcare Ltd
PA0126/225/001
500 Milligram
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MEROPONIA
Clonmel
Healthcare Ltd
PA0126/225/002
1 Grams
Pdr for Soln
Inj/Inf
J01DH02
-MEROPENEM
TRIHYDRATE
MESTINON
LTT Pharma
Limited
PPA1562/166/00
1
60 Milligram
Tablets
N07AA02
-Per Oral
MESTINON
60MG TABLETS
Meda Health
Sales Ireland
Limited
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
PA1332/034/001
60 Milligram
Tablets
N07AA02
EU/1/00/169/004
30 Milligram
Pdr+Solv for Soln
for Inj
B01AD11
PYRIDOSTIGMI
NE BROMIDE
PYRIDOSTIGMI
NE BROMIDE
TENECTEPLASE
EU/1/00/169/005
40 Milligram
Pdr+Solv for Soln
for Inj
B01AD11
TENECTEPLASE
-Intra-venous
MEROPENEM
METALYSE
METALYSE
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Routes of
Administration
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Intra-venous
-Per Oral
-Intra-venous
Page 299 of 608
Trade Name
METALYSE
METASTRON 37
MBQ/ML
SOLUTION FOR
INJECTION
METATONE
TONIC
METFORMIN
AUROBINDO
METFORMIN
AUROBINDO
METFORMIN
AUROBINDO
METFORMIN
BLUEFISH
METFORMIN
BLUEFISH
METFORMIN
BLUEFISH
Licence Holder Licence
Number
Active
Ingredients
Legal Basis
Routes of
Administration
EU/1/00/169/006
50 Milligram
Pdr+Solv for Soln
for Inj
B01AD11
TENECTEPLASE
PA0240/006/001
37.5 MBq/ml
Solution for
Injection
V10BX01
-STRONTIUM (89
SR) CHLORIDE
Chefaro Ireland
DAC
PA1186/004/001
300 N/A
Syrup
A13A
Aurobindo
Pharma Limited
PA1311/015/001
500 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-117-003
PA1311/015/002
-THIAMINE
HYDROCHLORI
DE
-CALCIUM
GLYCEROPHO
SPHATE
-POTASSIUM
GLYCEROPHO
SPHATE
-SODIUM
GLYCEROPHO
SPHATE
-MANGANESE
GLYCEROPHO
SPHATE
-METFORMIN
HYDROCHLORI
DE
850 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-118-003
PA1311/015/003
-METFORMIN
HYDROCHLORI
DE
1000 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-119-003
PA1436/009/001
-METFORMIN
HYDROCHLORI
DE
500 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-117-003
PA1436/009/002
-METFORMIN
HYDROCHLORI
DE
850 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-118-003
PA1436/009/003
-METFORMIN
HYDROCHLORI
DE
1000 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-119-003
PA0312/011/001
-METFORMIN
HYDROCHLORI
DE
500 MG/5ml
Infus/Pdr/Oral
Soln
A10BA02
-METFORMIN
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
A10BA02
-METFORMIN
HYDROCHLORI
DE
Aurobindo
Pharma Limited
Aurobindo
Pharma Limited
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Rosemont
Pharmaceuticals
Ltd
METFORMIN
HYDROCHLORI
DE
LTT Pharma
Limited
METFORMIN
MYLAN
Dosage Form ATC
Boehringer
Ingelheim
International
GmbH
GE Healthcare
Limited
METFORMIN
HYDROCHLORI
DE
METFORMIN
MYLAN
Strength
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Interchangeable
List Code:
IC0067-140-019
PPA1562/137/00
1
500 MG/5ml
-Intra-venous
-Per Oral
-Per Oral
Interchangeable
List Code:
IC0067-140-019
PA0577/132/001
500 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-117-003
PA0577/132/002
-METFORMIN
HYDROCHLORI
DE
850 Milligram
Film Coated
Tablet
A10BA02
-METFORMIN
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-118-003
Human Medicines Authorised/Transfer Pending Products
Page 300 of 608
Trade Name
METFORMIN
MYLAN
METFORMIN
TEVA
METFORMIN
TEVA
METFORMIN
TEVA
METHADONE
METHADONE
MIXTURE DTF
(SUGAR FREE)
METHADONE
SUGAR FREE
METHOFILL
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
Licence Holder Licence
Number
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Auden Mckenzie
(Pharma Division)
Ltd
Martindale
Pharmaceuticals
Ltd
Rosemont
Pharmaceuticals
Ltd
Accord
Healthcare
Limited
Eurodrug Ltd
Rosemont
Pharmaceuticals
Ltd
Accord
Healthcare
Limited
Morningside
Healthcare
Limited
Morningside
Healthcare
Limited
Strength
Dosage Form ATC
Routes of
Administration
1000 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-119-003
PA0749/185/001
-METFORMIN
HYDROCHLORI
DE
500 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-117-003
PA0749/185/002
-METFORMIN
HYDROCHLORI
DE
850 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-118-003
PA0749/185/003
-METFORMIN
HYDROCHLORI
DE
1000 Milligram
Film Coated
Tablet
A10BA02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0067-119-003
PA1352/003/001
-METFORMIN
HYDROCHLORI
DE
1 Mg/Ml
Oral Solution
N07BC02
Article 10(1) Generic
Application
-Per Oral
PA0361/007/006
1 Mg/Ml
Oral Solution
N07BC02
PA0312/007/002
1 Mg/Ml
Oral Solution
N07BC02
PA1390/099/001
50 Mg/Ml
Solution for
Injection
L04AX03
DPR1392/070/0
01
2.5 Milligram
Tablets
L04AX03
PA0312/034/001
2 Mg/Ml
Oral Solution
L04AX03
-METHADONE
HYDROCHLORI
DE
-METHADONE
HYDROCHLORI
DE
-METHADONE
HYDROCHLORI
DE
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E DISODIUM
PA1390/051/002
100 Mg/Ml
Concentrate for
Soln for Inf
L01BA01
PA1333/009/002
2.5 Milligram
Tablets
L04AX03
Interchangeable
List Code:
IC0098-018-002
PA1333/009/001
10 Milligram
Tablets
L01BA01
Interchangeable
List Code:
IC0098-002-002
PA1390/051/001
25 Mg/Ml
Solution for
Injection
L01BA01
Accord
Healthcare
Limited
METHOTREXAT
E
Hospira UK
Limited
PA0437/005/001
5mg/2ml mg/2ml
Solution for
Injection
L01BA01
METHOTREXAT
E
Hospira UK
Limited
PA0437/005/003
50mg/2ml
Micromol
Solution for
Injection
L01BA01
METHOTREXAT
E
Hospira UK
Limited
PA0437/005/006
500mg/20ml
Micromol
Solution for
Injection
L01BA01
METHOTREXAT
E
Hospira UK
Limited
PA0437/005/007
2.5 Milligram
Tablets
L04AX03
Interchangeable
List Code:
IC0098-018-002
PA0437/005/008
10 Milligram
Tablets
L04AX03
Hospira UK
Limited
Legal Basis
PA0577/132/003
METHOTREXAT
E
METHOTREXAT
E
Active
Ingredients
Interchangeable
List Code:
IC0098-002-002
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Article 10(3) Hybrid
Application
-Intra-Muscular
-Intra-venous
-Subcutaneous
-Per Oral
-Per Oral
METHOTREXAT
E
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
METHOTREXAT
E
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Intral-arterial
-Intra-Muscular
-Intrathecal
-Intra-venous
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
-Intra-Muscular
-Per Oral
-Per Oral
-Per Oral
Page 301 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
METHOTREXAT
E
Hospira UK
Limited
PA0437/005/009
1g/10ml Micromol
Solution for
Injection
L01BA01
METHOTREXAT
E
Hospira UK
Limited
PA0437/005/010
5g/50ml Mg/Ml
Solution for
Injection
L01BA01
METHOTREXAT
E
Orion Corporatio
PA1327/009/001
2.5 Milligram
Tablets
L04AX03
Orion Corporatio
Interchangeable
List Code:
IC0098-018-002
PA1327/009/002
10 Milligram
Tablets
Interchangeable
List Code:
IC0098-002-002
PA0899/031/001
2.5 Milligram
Interchangeable
List Code:
IC0098-018-002
PA1390/116/001
Active
Ingredients
Legal Basis
Routes of
Administration
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
Article 10(1) Generic
Application
-Per Oral
L04AX03
METHOTREXAT
E
Article 10(1) Generic
Application
-Per Oral
Tablets
L01BA01
METHOTREXAT
E SODIUM
2.5 Milligram
Tablets
L01BA01
-Per Oral
Interchangeable
List Code:
IC0098-018-002
PA1390/116/002
Article 10(1) Generic
Application
10 Milligram
Tablets
L01BA01
-Per Oral
Orion Corporatio
Interchangeable
List Code:
IC0098-002-002
PA1327/019/001
Article 10(1) Generic
Application
2.5 Milligram
Tablets
L01BA01
Article 10(1) Generic
Application
-Per Oral
Orion Corporatio
Interchangeable
List Code:
IC0098-018-002
PA1327/019/001
METHOTREXAT
E DISODIUM
2.5 Milligram
Tablets
L04AX03
Article 10(1) Generic
Application
-Per Oral
METHOTREXAT
E ORION
Orion Corporatio
Interchangeable
List Code:
IC0098-018-002
PA1327/019/002
METHOTREXAT
E DISODIUM
10 Milligram
Tablets
L01BA01
Orion Corporatio
PA1327/019/002
10 Milligram
Tablets
L04AX03
METHYLPREDN
ISOLONE
Beacon
Pharmaceuticals
Ltd
PA1312/010/001
500 Milligram
Pdr+Solv for soln
for inf/inj
H02AB04
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
METHOTREXAT
E ORION
METHYLPREDN
ISOLONE
Beacon
Pharmaceuticals
Ltd
PA1312/010/002
1000 Milligram
Pdr+Solv for soln
for inf/inj
H02AB04
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
METHYLTHIONI
NIUM
CHLORIDE
PROVEBLUE
METIDATE XL
Provepharm SAS
EU/1/11/682/001
5 Mg/Ml
Solution for
Injection
V03AB17
Article 10(3) Hybrid
Application
-Intra-venous
Rowex Ltd
PA0711/200/004
27 Milligram
Tablet Prolonged
Release
N06BA04
METHOTREXAT
E DISODIUM
METHOTREXAT
E DISODIUM
METHYLPREDN
ISOLONE
SODIUM
SUCCINATE
METHYLPREDN
ISOLONE
SODIUM
SUCCINATE
METHYLTHIONI
NIUM
CHLORIDE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
Article 10(3) Hybrid
Application
-Per Oral
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E
METHOTREXAT
E ORION
METHOTREXAT
E ORION
Mercury
Pharmaceuticals
Ltd
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Intra-Muscular
-Intra-venous
Page 302 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
METIDATE XL
Rowex Ltd
PA0711/200/003
54 Milligram
Tablet Prolonged
Release
N06BA04
METIDATE XL
Rowex Ltd
PA0711/200/001
18 Milligram
Tablet Prolonged
Release
N06BA04
METIDATE XL
Rowex Ltd
PA0711/200/002
36 Milligram
Tablet Prolonged
Release
N06BA04
METOCLOPRA
MIDE
Mercury
Pharmaceuticals
(Ireland) Ltd
PA0073/084/001
5 Mg/Ml
Solution for
Injection
A03FA01
METOCLOPRA
MIDE
HYDROCHLORI
DE
Accord
Healthcare
Limited
PA1390/120/001
10 Milligram
Tablets
A03FA01
METOCOR
Rowex Ltd
PA0711/008/001
50 Milligram
Tablets
C07AB02
METOCOR
Rowex Ltd
PA0711/008/002
100 Milligram
Tablets
C07AB02
METOJECT
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Rowex Ltd
PA0623/014/001
50 Mg/Ml
Solution for
Injection
L04AX03
PA0711/147/001
500 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0067-117-003
PA0711/147/002
850 Milligram
Interchangeable
List Code:
IC0067-118-003
PA1166/003/001
METOPHAGE
METOPHAGE
METOPIRONE
METROGEL
METRONIDAZO
LE
Rowex Ltd
Laboratoire HRA
Pharma
Galderma (UK)
Ltd
B. Braun
Melsungen AG
Active
Ingredients
Legal Basis
Routes of
Administration
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METHYLPHENI
DATE
HYDROCHLORI
DE
METOCLOPRA
MIDE
HYDROCHLORI
DE
METOCLOPRA
MIDE
HYDROCHLORI
DE
-METOPROLOL
TARTRATE
-METOPROLOL
TARTRATE
METHOTREXAT
E
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Intra-Muscular
-Intra-venous
-Subcutaneous
A10BA02
-METFORMIN
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
A10BA02
-METFORMIN
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
250 Milligram
Capsules, Soft
V04CD01
-METYRAPONE
-Per Oral
PA0590/015/001
0.75 %w/w
Gel
D06BX01
-Topical
PA0736/002/001
0.5 %w/v
Unknown
J01XD01
METRONIDAZO
LE
METRONIDAZO
LE
-SODIUM
CHLORIDE
-SODIUM
PHOSPHATE
DIBASIC
DODECAHYDR
ATE
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Intra-venous
Page 303 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
METROTOP
Ayrton Saunders
Ltd
PA0501/008/001
8 Mg/Ml
Gel
D06BX01
METVIX
Galderma (UK)
Ltd
PA0590/020/001
160 Milligram
Cream
L01XD03
MEVLUXA
Wockhardt UK
Limited
PA1339/056/001
100 Mg/Ml
Oral Solution
N03AX14
MEZAVANT XL
LTT Pharma
Limited
IMED Healthcare
Ltd.
PCO
Manufacturing
MPT Pharma Ltd
PPA1562/114/00
1
PPA1463/093/00
1
PPA0465/289/00
1
PPA1825/002/00
1
PPA1823/002/00
1
DPR1633/016/0
01
1200 Milligram
A07EC02
A07EC02
-MESALAZINE
A07EC02
-MESALAZINE
PPA
-Per Oral
A07EC02
-MESALAZINE
PPA
-Per Oral
A07EC02
-MESALAZINE
-Per Oral
A07EC02
-MESALAZINE
-Per Oral
PPA1151/153/00
1
PA0689/004/001
1200 Milligram
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablet Prolonged
Release
Gastro-resistant,
prolonged
release granules
Tablet Prolonged
Release
Tablet Prolonged
Release
METRONIDAZO
LE
-METHYL
AMINOLEVULIN
ATE
HYDROCHLORI
DE
LEVETIRACETA
M
-MESALAZINE
A07EC02
-MESALAZINE
A07EC02
-MESALAZINE
-Per Oral
PA1994/004/001
100 IU/ML
Solution for Inj/Inf
H05BA01
PA1994/004/002
50 IU/ML
Solution for Inj/Inf
H05BA01
PA0690/005/001
74 MBq/ml
Solution for
Injection
V09IX01
EU/1/98/090/001
40 Milligram
Tablets
C09CA07
-CALCITONIN,
SALMON
-CALCITONIN,
SALMON
-META-IODOBENZYLGUANI
DINE (I-131)
-TELMISARTAN
-Per Oral
80 Milligram
Tablets
C09CA07
-TELMISARTAN
-Per Oral
20 Milligram
Tablets
C09CA07
-TELMISARTAN
-Per Oral
80/12.5 mg/mg
Tablets
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
40/12.5 mg/mg
Tablets
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
80/25 mg/mg
Tablets
C09DA07
-TELMISARTAN
HYDROCHLOR
OTHIAZIDE
-Per Oral
MEZAVANT XL
MEZAVANT XL
MEZAVANT XL
MEZAVANT XL
MEZAVANT XL
Clear Pharma
Limited
Primecrown 2010
Ltd
MEZAVANT XL
Imbat Limited
MEZAVANT XL
Shire
Pharmaceutical
Contracts Ltd
Essential Pharma
Ltd
Essential Pharma
Ltd
Mallinckrodt
Medical B.V.
MIACALCIC
MIACALCIC
MIBG (I123)
MICARDIS
MICARDIS
MICARDIS
MICARDISPLUS
MICARDISPLUS
MICARDISPLUS
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Interchangeable
List Code:
IC0049-004-014
EU/1/98/090/005008
Interchangeable
List Code:
IC0049-005-014
EU/1/98/090/009012
Interchangeable
List Code:
IC0049-003-014
EU/1/02/213/006010
Interchangeable
List Code:
IC0050-081-014
EU/1/02/213/001005
Interchangeable
List Code:
IC0050-099-014
EU/1/02/213/1723
Interchangeable
List Code:
IC0050-100-014
Human Medicines Authorised/Transfer Pending Products
1200 Milligram
1200 Milligram
1200 Milligram
1200 Milligram
1200 Milligram
1200 Milligram
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
PPA
-Per Oral
Page 304 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
MICOLETTE
MICRO-ENEMA
Pinewood
Laboratories Ltd,
PA0281/115/001
45, 450, 625
MG/5ml
Rectal Solution
A06AG
MICROLAX
SODIUM
CITRATE
McNeil
Healthcare
(Ireland) Ltd
PA0823/046/001
450 & 45 MG/5ml
Rectal Solution
A06AG11
MICROLITE
Bayer Limited
PA1410/007/001
100/20
Microgram
Tablets
G03AA07
MIDAZOLAM
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Martindale
Pharmaceuticals
Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Accord
Healthcare
Limited
Accord
Healthcare
Limited
PCO
Manufacturing
PA1390/010/001
1 Mg/Ml
Solution for
Injection
N05CD08
-SODIUM
LAURYL
SULFOACETATE
-GLYCEROL
-SODIUM
CITRATE
-SODIUM
CITRATE
-SODIUM
LAURYL
SULFOACETATE
ETHINYLESTRA
DIOL
LEVONORGEST
REL
-MIDAZOLAM
PA1390/010/002
5 Mg/Ml
Solution for
Injection
N05CD08
-MIDAZOLAM
PA0361/021/001
5 Mg/Ml
Solution for Inj/Inf
N05CD08
PA0073/147/001
5 Mg/Ml
Solution for Inj/Inf
N05CD08
-MIDAZOLAM
HYDROCHLORI
DE
-MIDAZOLAM
PA0073/147/002
2 Mg/Ml
Solution for Inj/Inf
N05CD08
-MIDAZOLAM
-Intra-Muscular
-Intra-venous
PA1390/010/005
2 Mg/Ml
Solution for Inj/Inf
N05CD08
-MIDAZOLAM
-Intra-Muscular
-Intra-venous
PA1390/010/006
5 Mg/Ml
Solution for Inj/Inf
N05CD08
-MIDAZOLAM
-Intra-Muscular
-Intra-venous
PPA0465/276/00
2
5 Milligram
Tablets
C01CA17
MIDON
PCO
Manufacturing
PPA0465/276/00
1
2.5 Milligram
Tablets
C01CA17
MIDON
Takeda UK
Limited
PA1547/006/001
2.5 Milligram
Tablets
C01CA17
MIDON
Takeda UK
Limited
PA1547/006/002
5 Milligram
Tablets
C01CA17
MIDON
LTT Pharma
Limited
PPA1562/159/00
1
2.5 Milligram
Tablets
C01CA17
MIGRALEVE
McNeil
Healthcare
(Ireland) Ltd
PA0823/036/003
500 8 6.25
Milligram
Film Coated
Tablet
N02BE51
MIGRALEVE
PINK
McNeil
Healthcare
(Ireland) Ltd
PA0823/036/001
500/8/6.25
Milligram
Film Coated
Tablet
N02BE51
MIGRALEVE
YELLOW
McNeil
Healthcare
(Ireland) Ltd
Menarini
International
Operations
Luxembourg S.A.
PA0823/036/002
500/8 Milligram
Film Coated
Tablet
N02BE51
PA0865/008/001
2.5 Milligram
Film Coated
Tablet
N02CC07
-MIDODRINE
HYDROCHLORI
DE
-MIDODRINE
HYDROCHLORI
DE
-MIDODRINE
HYDROCHLORI
DE
-MIDODRINE
HYDROCHLORI
DE
-MIDODRINE
HYDROCHLORI
DE
-PARACETAMOL
-CODEINE
PHOSPHATE
-BUCLIZINE
HYDROCHLORI
DE
-PARACETAMOL
-CODEINE
PHOSPHATE
-PARACETAMOL
-CODEINE
PHOSPHATE
-BUCLIZINE
HYDROCHLORI
DE
-PARACETAMOL
-CODEINE
PHOSPHATE
FROVATRIPTAN
SUCCINATE
MONOHYDRATE
MIDAZOLAM
MIDAZOLAM
MIDAZOLAM
MIDAZOLAM
MIDAZOLAM
INJECTION BP
MIDAZOLAM
INJECTION BP
MIDON
MIGUAR
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
-Intra-Muscular
-Intra-venous
-Intra-venous
-Intra-Muscular
-Intra-venous
PPA
PPA
-Per Oral
Page 305 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
MILK OF
MAGNESIA
TRADITIONAL
MINT
FLAVOURED
LIQUID
MIL-PAR ORAL
SUSPENSION
Chefaro Ireland
DAC
PA1186/010/001
MG/5ml
Oral Suspension
A02AA04
-MAGNESIUM
HYDROXIDE
Seven Seas Ltd
PA0417/014/001
300/1.25ml
MG/5ml
Oral Suspension
A02AX
MILRINONE
Wockhardt UK
Limited
PA1339/068/001
1 Mg/Ml
Solution for
Injection
C01CE02
-MAGNESIUM
HYDROXIDE
-PARAFFIN,
LIQUID
-MILRINONE
MIMPARA
Amgen Europe
B.V.
EU/1/04/292/1-12
30mg Milligram
Coated Tablets
H05BX01
MINATEV LA
Teva Pharma
B.V.
PA0749/147/001
500 Milligram
Tablet Prolonged
Release
J01FA09
Interchangeable
List Code:
IC0072-117-050
PA0822/144/001
60/15 Microgram
Film Coated
Tablet
G03AA10
-CINACALCET
HYDROCHLORI
DE
CLARITHROMY
CIN
MINESSE
Pfizer Healthcare
Ireland
MINIMS
ARTIFICIAL
TEARS
Bausch & Lomb
UK Limited
PA0555/016/001
0.35 + 0.44 %w/
Eye Drops
Solution
S01AX07
MINIMS
ATROPINE
SULPHATE
MINIMS
CHLORAMPHE
NICOL 0.5 %
EYE DROPS,
SOLUTION
MINIMS
CYCLOPENTOL
ATE
HYDROCHLORI
DE
MINIMS
FLUORESCEIN
SODIUM
MINIMS
FLUORESCEIN
SODIUM
MINIMS
LIDOCAINE &
FLUORESCEIN
Bausch & Lomb
UK Limited
PA0555/017/001
1 %w/v
Eye Drops
Solution
S01FA01
Bausch & Lomb
UK Limited
PA0555/013/001
0.5 Per Cent
Eye Drops
Solution
S01AA01
CHLORAMPHE
NICOL
Bausch & Lomb
UK Limited
PA0555/018/001
1.0 %w/v
Eye Drops
Solution
S01FA04
Bausch & Lomb
UK Limited
PA0555/019/001
1 %w/v
Eye Drops
Solution
S01JA01
CYCLOPENTOL
ATE
HYDROCHLORI
DE
-FLUORESCEIN
SODIUM
Bausch & Lomb
UK Limited
PA0555/019/002
2.0 %w/v
Eye Drops
Solution
S01JA01
-FLUORESCEIN
SODIUM
Bausch & Lomb
UK Limited
PA0555/012/001
4.0/0.25 % %w/v
Eye Drops
Solution
S01JA51
MINIMS
OXYBUPROCAI
NE
HYDROCHLORI
DE
MINIMS
PHENYLEPHRI
NE
HYDROCHLORI
DE
MINIMS
PHENYLEPHRI
NE
HYDROCHLORI
DE
MINIMS
PILOCARPINE
NITRATE
MINIMS
POVIDONE
IODINE
Bausch & Lomb
UK Limited
PA0555/020/001
0.4 %w/v
Eye Drops
Solution
S01HA02
Bausch & Lomb
UK Limited
PA0555/014/001
10 %w/v
Eye Drops
Solution
S01GA05
Bausch & Lomb
UK Limited
PA0555/014/002
2.5 %w/v
Eye Drops
Solution
S01GA05
Bausch & Lomb
UK Limited
PA0555/022/001
2.0 %w/v
Eye Drops
Solution
S01EB01
-LIDOCAINE
HYDROCHLORI
DE
-FLUORESCEIN
SODIUM
OXYBUPROCAI
NE
HYDROCHLORI
DE
PHENYLEPHRI
NE
HYDROCHLORI
DE
PHENYLEPHRI
NE
HYDROCHLORI
DE
-PILOCARPINE
NITRATE
Bausch & Lomb
UK Limited
PA0555/010/001
5 %w/v
Eye Drops
Solution
S01AX18
Human Medicines Authorised/Transfer Pending Products
Legal Basis
-Per Oral
Article 10(1) Generic
Application
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
-GESTODENE
ETHINYLESTRA
DIOL
-SODIUM
CHLORIDE
HYDROXYETHY
LCELLULOSE
-ATROPINE
SULFATE
-IODINATED
POVIDONE
Routes of
Administration
-Per Oral
-Per Oral
-Topical
Article 10(3) Hybrid
Application
-Ocular
Page 306 of 608
Trade Name
MINIMS
PREDNISOLONE
SODIUM
PHOSPHATE
MINIMS
PROXYMETACA
INE
HYDROCHLORI
DE W/V, EYE
DROPS
MINIMS SALINE
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Bausch & Lomb
UK Limited
PA0555/023/001
0.5 %w/v
Eye Drops
Solution
S01BA04
Bausch & Lomb
UK Limited
PA0555/024/001
0.5 %w/v
Eye Drops
Solution
S01HA04
Bausch & Lomb
UK Limited
Bausch & Lomb
UK Limited
PA0555/025/001
0.9 %w/v
S01AX03
PA0555/021/001
0.5 %w/v
Eye Drops
Solution
Eye Drops
Solution
Bausch & Lomb
UK Limited
PA0555/021/002
1.0 %w/v
Eye Drops
Solution
S01HA03
-TETRACAINE
HYDROCHLORI
DE
Bausch & Lomb
UK Limited
PA0555/015/001
0.5% %w/v
Eye Drops
Solution
S01FA06
-TROPICAMIDE
-Ocular
Bausch & Lomb
UK Limited
PA0555/015/002
1.0 % %w/v
Eye Drops
Solution
S01FA06
-TROPICAMIDE
-Ocular
LTT Pharma
Limited
PPA1562/132/00
1
100 Milligram
Capsules
Modified Release
J01AA08
MINOCIN SA
IMED Healthcare
Ltd.
PPA1463/097/00
1
100 Milligram
Capsules
Modified Release
J01AA08
MINOCIN SA
PCO
Manufacturing
PPA0465/329/00
1
100 Milligram
Capsules
Modified Release
J01AA08
MINOCIN SA
Primecrown 2010
Ltd
PPA1633/027/00
1
100 Milligram
Capsule
J01AA08
MINOCIN SA
Imbat Limited
PPA1151/088/00
1
100 Milligram
Capsule
J01AA08
MINOCIN SA
Meda Health
Sales Ireland
Limited
Pinewood
Laboratories Ltd,
PA1332/023/001
100 mg Milligram
Capsule
J01AA08
PA0281/132/001
100 Milligram
Capsules
Modified Release
J01AA08
MINOX
Rowex Ltd
PA0711/013/001
50 Milligram
Film Coated
Tablet
J01AA08
MINOX
Imbat Limited
PPA1151/138/00
1
50 Milligram
Film Coated
Tablet
J01AA08
MINULET
Pfizer Healthcare
Ireland
PA0822/093/001
30/75mcg
Microgram
Coated Tablets
G03AA10
MIOCHOL-E
Dr. Gerhard
Mann, chem.pharm. Fabrik
GmbH
Stasisport
Pharma N.V.
PA1245/002/001
20 Milligram
-MINOCYCLINE
HYDROCHLORI
DE
-MINOCYCLINE
HYDROCHLORI
DE DIHYDRATE
-MINOCYCLINE
HYDROCHLORI
DE DIHYDRATE
-MINOCYCLINE
HYDROCHLORI
DE DIHYDRATE
-MINOCYCLINE
HYDROCHLORI
DE DIHYDRATE
-MINOCYCLINE
HYDROCHLORI
DE
-MINOCYCLINE
HYDROCHLORI
DE
-MINOCYCLINE
HYDROCHLORI
DE
-MINOCYCLINE
HYDROCHLORI
DE
ETHINYLESTRA
DIOL
-GESTODENE
ACETYLCHOLI
NE CHLORIDE
PA1750/003/001
200 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
MIOFEN
Stasisport
Pharma N.V.
PA1750/003/002
400 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
MIOFEN
Stasisport
Pharma N.V.
PA1750/003/003
600 Milligram
Film Coated
Tablet
M01AE01
-IBUPROFEN
MINIMS
TETRACAINE
HYDROCHLORI
DE
MINIMS
TETRACAINE
HYDROCHLORI
DE
MINIMS
TROPICAMIDE
0.5% W/V EYE
DROPS
SOLUTION
MINIMS
TROPICAMIDE
1.0% W/V EYE
DROPS
SOLUTION
MINOCIN SA
MINOSIL
MIOFEN
Human Medicines Authorised/Transfer Pending Products
S01HA03
S01EB09
PREDNISOLONE
SODIUM
PHOSPHATE
PROXYMETACA
INE
HYDROCHLORI
DE
-SODIUM
CHLORIDE
-TETRACAINE
HYDROCHLORI
DE
-Per Oral
-Per Oral
PPA
Article 10(1) Generic
Application
-Per Oral
PPA
-Per Oral
-Per Oral
-Ocular
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
Page 307 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
MIRAMEL
Clonmel
Healthcare Ltd
PA0126/173/001
0.088 Milligram
Tablets
N04BC05
MIRAMEL
Clonmel
Healthcare Ltd
PA0126/173/002
0.18 Milligram
Tablets
N04BC05
MIRAMEL
Clonmel
Healthcare Ltd
PA0126/173/003
0.7 Milligram
Tablets
N04BC05
MIRAP
Rowex Ltd
PA0711/062/001
15 Milligram
Film Coated
Tablet
N06AX11
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRATE
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRATE
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRATE
-MIRTAZAPINE
Rowex Ltd
Interchangeable
List Code:
IC0061-032-015
PA0711/062/002
30 Milligram
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0061-033-015
PA0711/062/003
45 Milligram
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0061-110-015
PA0711/094/003
45 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0061-110-015
PA0711/094/001
15 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Rowex Ltd
Interchangeable
List Code:
IC0061-032-015
PA0711/094/002
30 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
0.26 Milligram
Tablet Prolonged
Release
N04BC05
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
-Per Oral
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
-Per Oral
MIRAP
MIRAP
MIRAP DIS TAB
MIRAP DISTAB
MIRAP DISTAB
Interchangeable
List Code:
IC0061-033-015
EU/1/97/051/1315
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/1618
0.52 Milligram
Tablet Prolonged
Release
N04BC05
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/1921
1.05 Milligram
Tablet Prolonged
Release
N04BC05
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/2224
2.1 Milligram
Tablet Prolonged
Release
N04BC05
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/2527
3.15 Milligram
Tablet Prolonged
Release
N04BC05
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/001
0.088 Milligram
Tablets
N04BC05
EU/1/97/051/011
0.35 Base
Milligrams
Tablets
N04BC05
MIRAPEXIN
Human Medicines Authorised/Transfer Pending Products
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 308 of 608
Trade Name
MIRAPEXIN
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/002
0.088 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/003
0.18 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/004
0.18 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/005
0.7 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/006
0.7 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/007
0.88 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/009
1.1 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/010
1.1 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
EU/1/97/051/012
0.35 Milligram
Tablets
N04BC05
-PRAMIPEXOLE
DIHYDROXHLO
RIDE
-Per Oral
EU/1/97/051/02830
1.57 Milligram
Tablet Prolonged
Release
N04BC05
-Per Oral
MIRAPEXIN
Boehringer
Ingelheim
International
GmbH
EU/1/97/051/03133
2.62 Milligram
Tablet Prolonged
Release
N04BC05
MIRCERA
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
EU/1/07/400/21
360/0.6
Microgram/ML
Solution for
Injection
B03XA03
EU/1/07/400/18
40/0.3
Microgram/ML
Solution for
Injection
B03XA03
EU/1/07/400/17
30/0.3
Microgram/ML
Solution for
Injection
B03XA03
EU/1/07/400/19
60/0.3
Microgram/ML
Solution for
Injection
B03XA03
EU/1/07/400/001
50/1
Microgram/ML
Solution for
Injection
B03XA01
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-PRAMIPEXOLE
DIHYDROCHLO
RIDE
MONOHYDRAT
E, MILLED
-METHOXY
PEG-EPOETIN
BETA
-METHOXY
PEG-EPOETIN
BETA
-METHOXY
PEG-EPOETIN
BETA
-METHOXY
PEG-EPOETIN
BETA
-RO0503821
EU/1/07/400/002
100/1
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/003
200/1
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/004
300/1
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/005
400/1
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRAPEXIN
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
Human Medicines Authorised/Transfer Pending Products
-Per Oral
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Page 309 of 608
Trade Name
MIRCERA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
EU/1/07/400/006
600/1
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/007
1000/1
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/008
50/0.3
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/009
75/0.3
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/10
100/0.3
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/11
150/0.3
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/12
200/0.3
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/13
250/0.3
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/14
400/0.6
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/15
600/0.6
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/16
800/0.6
Microgram/ML
Solution for
Injection
B03XA01
-RO0503821
-Intra-venous
-Subcutaneous
EU/1/07/400/20
120/0.3
Microgram/ML
Solution for
Injection
B03XA03
-METHOXY
PEG-EPOETIN
BETA
Bayer Limited
PA1410/008/001
52 Milligram
Intrauterine
Device
G03AC03
MIRENA
PCO
Manufacturing
PPA0465/292/00
1
52 Milligram
Intrauterine
Device
G03AC03
MIRENA
IMED Healthcare
Ltd.
PPA1463/111/00
1
52 Milligram
Intrauterine
delivery system
G03AC03
MIRPRESOC
Laboratorios
LICONSA, S.A.
PA1239/017/001
20 Milligram
Tablets
C09CA07
LEVONORGEST
REL
LEVONORGEST
REL
LEVONORGEST
REL
-TELMISARTAN
Interchangeable
List Code:
IC0049-003-014
PA1239/017/002
40 Milligram
Tablets
C09CA07
Interchangeable
List Code:
IC0049-004-014
PA1239/017/003
80 Milligram
Tablets
Interchangeable
List Code:
IC0049-005-014
PA1380/025/001
15 Milligram
Interchangeable
List Code:
IC0061-032-015
PA1380/025/002
30 Milligram
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA
MIRCERA 120
MICROGRAMS/
0.3 ML
SOLUTION FOR
INJECTI
MIRENA
MIRPRESOC
MIRPRESOC
MIRTAZAPINE
ACTAVIS
MIRTAZAPINE
ACTAVIS
Laboratorios
LICONSA, S.A.
Laboratorios
LICONSA, S.A.
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Article 8(3) - Full
new Application
-Intra-venous
-Subcutaneous
PPA
Article 10(1) Generic
Application
-Per Oral
-TELMISARTAN
Article 10(1) Generic
Application
-Per Oral
C09CA07
-TELMISARTAN
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Interchangeable
List Code:
IC0061-033-015
Human Medicines Authorised/Transfer Pending Products
Page 310 of 608
Trade Name
MIRTAZAPINE
ACTAVIS
MIRTAZAPINE
AUROBINDO
MIRTAZAPINE
AUROBINDO
MIRTAZAPINE
AUROBINDO
MIRTAZAPINE
AUROBINDO
MIRTAZAPINE
AUROBINDO
MIRTAZAPINE
AUROBINDO
MIRTAZAPINE
BLUEFISH
MIRTAZAPINE
BLUEFISH
MIRTAZAPINE
BLUEFISH
MIRTAZAPINE
TEVA
MIRVASO
MITOMYCIN
MITOMYCIN
MITOMYCIN-C
KYOWA
MITOMYCIN-C
KYOWA
MITOXANA
Licence Holder Licence
Number
Actavis Group
PTC ehf
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PA1380/025/003
45 Milligram
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
Interchangeable
List Code:
IC0061-110-015
PA1311/012/001
15 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Interchangeable
List Code:
IC0061-032-015
PA1311/012/002
Article 10(1) Generic
Application
30 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Interchangeable
List Code:
IC0061-033-015
PA1311/012/003
Article 10(1) Generic
Application
45 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0061-110-015
PA1050/020/001
Article 10(1) Generic
Application
15 Milligram
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0061-032-015
PA1050/020/002
Article 10(1) Generic
Application
30 Milligram
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0061-033-015
PA1050/020/003
Article 10(1) Generic
Application
45 Milligram
Film Coated
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Interchangeable
List Code:
IC0061-110-015
PA1436/001/001
Article 10(1) Generic
Application
15 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Interchangeable
List Code:
IC0061-032-015
PA1436/001/002
Article 10(1) Generic
Application
30 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
-Per Oral
Interchangeable
List Code:
IC0061-033-015
PA1436/001/003
Article 10(1) Generic
Application
45 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
Article 10(1) Generic
Application
-Per Oral
30 Milligram
Orodispersible
Tablet
N06AX11
-MIRTAZAPINE
PPA
-Per Oral
3 mg/g
Gel
D11AX
-BRIMONIDINE
-Cutaneous
20 Milligram
Pdr+Solv/Soln/In
travesical Use
L01DC03
-MITOMYCIN
Article 8(3) - Full
new Application
Article 10(1) Generic
Application
PA0623/016/002
40 Milligram
Pdr+Solv/Soln/In
travesical Use
L01DC03
-MITOMYCIN
Article 10(1) Generic
Application
-Intra Vesical
PA1049/011/001
10 Milligram
L01DC03
-MITOMYCIN
Kyowa Kirin Ltd
PA1049/011/002
40 Milligram
L01DC03
-MITOMYCIN
Baxter
Healthcare
Limited
PA0167/135/001
1 Grams
Pdr for Soln for
Injection
Pdr for Soln for
Injection
Pdr/Conc/Soln for
Infus
L01AA06
-IFOSFAMIDE
Aurobindo
Pharma Limited
Aurobindo
Pharma Limited
Aurobindo
Pharma Limited
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
WPR Healthcare
Limited
Galderma
International
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Medac
Gesellschaft fur
Klinische
Spezialpraparate
mbH
Kyowa Kirin Ltd
Interchangeable
List Code:
IC0061-110-015
PPA0565/043/00
1
Interchangeable
List Code:
IC0061-033-015
EU/1/13/904/001003
PA0623/016/001
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Intra Vesical
-Intral-arterial
-Intra-venous
-Intra-articular
-Intra-venous
-Intra-venous
Page 311 of 608
Trade Name
MITOXANA
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Baxter
Healthcare
Limited
Hospira UK
Limited
PA0167/135/002
2 Grams
Pdr/Conc/Soln for
Infus
L01AA06
-IFOSFAMIDE
PA0437/050/001
2 Base mg/ml
Concentrate for
Soln for Inf
L01DB07
PA1077/069/001
2 Mg/Ml
EU/1/02/231/1-25
100 %v/v
MIXTARD
Novo Nordisk A/S
EU/1/02/231/00335,37
100 IU/ML
Solution for
Injection
Suspension for
Injection
Suspension for
Injection
M03AC10
MIXTARD
GlaxoSmithKline
(Ireland) Limited
Novo Nordisk A/S
M-M-RVAXPRO
Sanofi Pasteur
MSD
EU/1/06/337/1-13
%v/v
Pdr+Solv for
Susp for Inj
J07BD52
MOBIC
PA0775/001/005
15 Milligram
Tablets
M01AC06
PA0775/001/004
7.5 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
PA1063/020/001
7.5 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
PA1063/020/002
15 Milligram
Tablets
M01AC06
-MELOXICAM
-Per Oral
MODAFINIL
Boehringer
Ingelheim
International
GmbH
Boehringer
Ingelheim
International
GmbH
Niche Generics
Limited
Niche Generics
Limited
Fannin Limited
MITOXANTRON
E
HYDROCHLORI
DE
-MIVACURIUM
CHLORIDE
-INSULIN
HUMAN
-INSULIN
HUMAN
-INSULIN
HUMAN
-MEASLES
VIRUS LIVE
ATTENUATED
DERIVED FROM
THE
EDMONSTON B
STRAIN
-MUMPS VIRUS
LIVE
ATTENUATED
JERYL LYNN
STRAIN
-RUBELLA
VIRUS (WISTAR
RA 27/3 STRAIN)
LIVE
ATTENUATED
-MELOXICAM
PA1457/014/001
100 Milligram
Tablets
N06BA07
-MODAFINIL
MODAFINIL
Fannin Limited
PA1457/014/002
200 Milligram
Tablets
N06BA07
-MODAFINIL
MODAFINIL
Chanelle Medical
PA0688/033/001
100 Milligram
Tablets
N06BA07
-MODAFINIL
MODAFINIL
Chanelle Medical
PA0688/033/002
200 Milligram
Tablets
N06BA07
-MODAFINIL
MODECATE
PA0002/031/005
25 Mg/Ml
Solution for
Injection
N05AB02
-FLUPHENAZINE
DECANOATE
-Intra-Muscular
PA0002/031/001
100 Mg/Ml
Solution for
Injection
N05AB02
-FLUPHENAZINE
DECANOATE
-Intra-Muscular
MODERIBA
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
AbbVie Limited
PA1824/006/001
200 Milligram
Film Coated
Tablet
J05AB04
-RIBAVIRIN
MODERIBA
AbbVie Limited
PA1824/006/002
400 Milligram
Film Coated
Tablet
J05AB04
-RIBAVIRIN
MODERIBA
AbbVie Limited
PA1824/006/003
600 Milligram
Film Coated
Tablet
J05AB04
-RIBAVIRIN
MITOXANTRON
E
MIVACRON
MOBIC
MOBIGLAN
MOBIGLAN
MODECATE
CONCENTRATE
Human Medicines Authorised/Transfer Pending Products
A10AD01
A10AD01
-Intra-venous
-Subcutaneous
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 312 of 608
Trade Name
MODIGRAF
Licence Holder Licence
Number
Strength
Astellas Pharma
Europe BV
Astellas Pharma
Europe BV
Aspire Pharma
Limited
EU/1/09/523/001
0.2 Milligram
EU/1/09/523/002
1 Milligram
PA1619/005/001
MODRASONE
Aspire Pharma
Limited
MODURET 25
MG/2.5 MG
TABLETS
MOGADON
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
L04AD02
-TACROLIMUS
-Per Oral
L04AD02
-TACROLIMUS
-Per Oral
0.05 %w/w
Granules for Oral
Suspension
Granules for Oral
Suspension
Cream
D07AB10
PA1619/005/002
0.05 %w/w
Ointment
D07AB10
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
PA1286/014/001
25/2.5 Milligram
Tablets
C03EA01
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
PA1332/035/001
5 Milligram
Tablets
N05CD02
ALCLOMETASO
NE
DIPROPIONATE
ALCLOMETASO
NE
DIPROPIONATE
HYDROCHLOR
OTHIAZIDE
-AMILORIDE
HYDROCHLORI
DE
-NITRAZEPAM
PA1332/038/001
13.125/350
Powder for Oral
Solution
A06AD65
MOLAXOLE
Primecrown 2010
Ltd
PPA1633/034/00
1
Powder for Oral
Solution
A06AD65
MOLIPAXIN
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Aziende
Chimiche Riunite
Angelini
Francesco
Aziende
Chimiche Riunite
Angelini
Francesco
Rowex Ltd
PA0540/056/001
50 Milligram
Capsules Hard
N06AX05
PA0540/056/002
100 Milligram
Capsules Hard
N06AX05
PA0540/056/004
150 Milligram
Film Coated
Tablet
N06AX05
PA0959/002/001
220 Milligram
Film Coated
Tablet
M01AE02
PA0959/002/002
10 %w/w
Gel
PA0711/196/001
50
Mcg/Acutuation
PA1352/018/001
MOMETASONE
FUROATE TEVA
Auden Mckenzie
(Pharma Division)
Ltd
Auden Mckenzie
(Pharma Division)
Ltd
Teva Pharma
B.V.
MONOPOST
UNIDOSE
MONOTRIM
MODIGRAF
MODRASONE
MOLAXOLE
MOLIPAXIN
MOLIPAXIN
MOMENDOL
MOMENDOL
MOMETASONE
MOMETASONE
FUROATE
MOMETASONE
FUROATE
MONOTRIM
-Per Oral
-Per Oral
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
-POTASSIUM
CHLORIDE
-TRAZODONE
HYDROCHLORI
DE
-TRAZODONE
HYDROCHLORI
DE
-TRAZODONE
HYDROCHLORI
DE
-NAPROXEN
SODIUM
Article 10(1) Generic
Application
M02AA12
-NAPROXEN
Article 10(3) Hybrid
Application
-Cutaneous
Nasal Spray
Suspension
R01AD09
-MOMETASONE
FUROATE
-Nasal
0.1 %w/w
Cream
D07AC13
-MOMETASONE
FUROATE
PA1352/018/002
0.1 %w/w
Ointment
D07AC13
-MOMETASONE
FUROATE
PA0749/188/001
50
Mcg/Acutuation
Nasal Spray
Suspension
R01AD09
Laboratoires
Thea
PA1107/007/001
50 Microgram/ML
Eye Drops
Solution
S01EE01
-MOMETASONE
FUROATE
MONOHYDRATE
-LATANOPROST
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Chemidex
Pharma Limited
Chemidex
Pharma Limited
PA1161/002/002
100 Milligram
Tablets
J01EA01
PA1161/002/003
200 Milligram
Tablets
J01EA01
Human Medicines Authorised/Transfer Pending Products
TRIMETHOPRIM
TRIMETHOPRIM
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Cutaneous
-Cutaneous
-Nasal
-Ocular
-Per Oral
-Per Oral
Page 313 of 608
Trade Name
MONOTRIM
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Chemidex
Pharma Limited
Pharmacosmos
A/S
PA1161/002/001
10 Mg/Ml
Oral Suspension
J01EA01
PA0982/002/002
100 Mg/Ml
Solution for Inj/Inf
B03AC
MONOVER
Pharmacosmos
A/S
PA0982/002/001
100 Mg/Ml
Solution for Inj/Inf
B03AC
MONOVO
Almirall Hermal
GmbH
PA1548/001/001
1 mg/g
Ointment
D07AC13
MONOVO
Almirall Hermal
GmbH
PA1548/002/001
1 mg/g
Cream
D07AC13
-MOMETASONE
FUROATE
MONOVO
Almirall Hermal
GmbH
PA1548/003/001
1 mg/g
Cutaneous
Emulsion
D07AC13
-MOMETASONE
FUROATE
MONTELAIR
Clonmel
Healthcare Ltd
PA0126/215/001
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
Interchangeable
List Code:
IC0023-008-007
PA0126/215/002
5 Milligram
Tablets
Chewable
R03DC03
Interchangeable
List Code:
IC0023-001-007
PA0126/215/003
10 Milligram
Film Coated
Tablet
Interchangeable
List Code:
IC0023-002-003
PA1390/030/003
10 Milligram
Interchangeable
List Code:
IC0023-002-003
PA1050/007/001
MONOVER
MONTELAIR
MONTELAIR
MONTELUKAST
MONTELUKAST
MONTELUKAST
MONTELUKAST
MONTELUKAST
MONTELUKAST
MONTELUKAST
MONTELUKAST
Clonmel
Healthcare Ltd
Clonmel
Healthcare Ltd
Accord
Healthcare
Limited
Milpharm Limited
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
Krka d.d., Novo
mesto
TRIMETHOPRIM
-IRON (III)
ISOMALTOSIDE
1000
-IRON (III)
ISOMALTOSIDE
1000
-MOMETASONE
FUROATE
Legal Basis
Routes of
Administration
-Intra-venous
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
Article 10(3) Hybrid
Application
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
-Intra-venous
-MONTELUKAST
SODIUM
Article 10(1) Generic
Application
-Per Oral
R03DC03
-MONTELUKAST
SODIUM
Article 10(1) Generic
Application
-Per Oral
Film Coated
Tablet
R03DC03
-MONTELUKAST
SODIUM
Article 10(1) Generic
Application
-Per Oral
10 Milligram
Film Coated
Tablet
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-002-003
PA1347/039/001
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-008-007
PA1347/039/002
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-001-007
PA1347/039/003
10 Milligram
Film Coated
Tablet
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
10 Milligram
Film Coated
Tablet
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
WPR Healthcare
Limited
Interchangeable
List Code:
IC0023-002-003
PPA0565/054/00
1
WPR Healthcare
Limited
Interchangeable
List Code:
IC0023-008-007
PPA0565/054/00
3
WPR Healthcare
Limited
Interchangeable
List Code:
IC0023-002-003
PPA0565/054/00
2
-Cutaneous
-Cutaneous
-Cutaneous
-Per Oral
Interchangeable
List Code:
IC0023-001-007
Human Medicines Authorised/Transfer Pending Products
Page 314 of 608
Trade Name
MONTELUKAST
ACTAVIS
MONTELUKAST
MYLAN
MONTELUKAST
MYLAN
MONTELUKAST
MYLAN
MONTELUKAST
PAEDIATRIC
MONTELUKAST
PAEDIATRIC
MONTELUKAST
PAEDIATRIC
MONTELUKAST
PAEDIATRIC
Licence Holder Licence
Number
Actavis Group
PTC ehf
Routes of
Administration
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-002-003
PA0577/119/001
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-002-003
PA0577/131/001
Article 10(1) Generic
Application
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-008-007
PA0577/131/002
Article 10(1) Generic
Application
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-001-007
PA1390/030/001
Article 10(1) Generic
Application
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-008-007
PA1390/030/002
Article 10(1) Generic
Application
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0023-001-007
PA1050/007/002
Article 10(1) Generic
Application
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Milpharm Limited
Interchangeable
List Code:
IC0023-008-007
PA1050/007/003
Article 10(1) Generic
Application
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-001-007
PA1380/070/002
Article 10(1) Generic
Application
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-008-007
PA1380/070/003
Article 10(1) Generic
Application
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-001-007
PA0749/048/004
Article 10(1) Generic
Application
4 Milligram
Granules
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-008-041
PA0749/048/003
Article 10(1) Generic
Application
10 Milligram
Film Coated
Tablet
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-002-003
PA0749/048/001
Article 10(1) Generic
Application
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-008-007
PA0749/048/002
Article 10(1) Generic
Application
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
-Per Oral
Interchangeable
List Code:
IC0023-001-007
PA0711/172/001
Article 10(1) Generic
Application
4 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
Article 10(1) Generic
Application
-Per Oral
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Accord
Healthcare
Limited
Accord
Healthcare
Limited
Actavis Group
PTC ehf
MONTELUKAST
TEVA
Teva Pharma
B.V.
MONTUL
PAEDIATRIC
Legal Basis
Film Coated
Tablet
MONTELUKAST
PAEDIATRIC
ACTAVIS
MONTELUKAST
TEVA
Active
Ingredients
10 Milligram
Actavis Group
PTC ehf
MONTELUKAST
TEVA
Dosage Form ATC
PA1380/070/001
MONTELUKAST
PAEDIATRIC
ACTAVIS
MONTELUKAST
TEVA
Strength
Teva Pharma
B.V.
Teva Pharma
B.V.
Teva Pharma
B.V.
Rowex Ltd
Interchangeable
List Code:
IC0023-008-007
Human Medicines Authorised/Transfer Pending Products
Page 315 of 608
Trade Name
MONTUL
PAEDIATRIC
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Rowex Ltd
PA0711/172/002
5 Milligram
Tablets
Chewable
R03DC03
-MONTELUKAST
SODIUM
MONURIL
Zambon S.p.A.
Interchangeable
List Code:
IC0023-001-007
PA1441/002/002
3 Grams
J01XX01
MORHULIN
PA1380/064/001
11.4/38 %w/w
MORPHINE
SULFATE
Actavis Group
PTC ehf
Wockhardt UK
Limited
Granules for oral
solution
Ointment
PA1339/051/001
20 Mg/Ml
Oral Solution
N02AA01
-FOSFOMYCIN
TROMETAMOL
-COD LIVER OIL
-ZINC OXIDE
-MORPHINE
SULPHATE
MORPHINE
SULFATE
Wockhardt UK
Limited
PA1339/051/002
10 MG/5ml
Oral Solution
N02AA01
-MORPHINE
SULPHATE
MORPHINE
SULPHATE
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Mercury
Pharmaceuticals
(Ireland) Ltd
Martindale
Pharmaceuticals
Ltd
Martindale
Pharmaceuticals
Ltd
McNeil
Healthcare
(Ireland) Ltd
PA0073/020/001
10 Mg/Ml
Solution for
Injection
N02AA01
-MORPHINE
SULFATE
PA0073/020/003
1 MG/5ml
Solution for
Injection
N02AA01
-MORPHINE
SULFATE
PA0073/020/004
30 Mg/Ml
Solution for
Injection
N02AA01
-MORPHINE
SULFATE
PA0073/020/008
60 Mg/Ml
Solution for
Injection
N02AA01
-MORPHINE
SULFATE
PA0361/004/004
10mg in 1
Millilitre
Solution for
Injection
N02AA01
-MORPHINE
SULFATE
-Intra-venous
PA0361/004/005
30 Mg/Ml
Solution for
Injection
N02AA01
-MORPHINE
SULFATE
-Intra-venous
PA0823/051/006
1 Mg/Ml
Oral Suspension
A03FA03
-DOMPERIDONE
-Per Oral
Interchangeable
List Code:
IC0085-047-027
PA0823/051/002
10 Milligram
Film Coated
Tablet
A03FA03
-DOMPERIDONE
-Per Oral
PPA0465/272/00
1
PA0823/051/001
10 Milligram
Film Coated
Tablet
Orodispersible
Tablet
A03FA03
-DOMPERIDONE
A03FA03
-DOMPERIDONE
-Per Oral
PA0823/051/007
10 Milligram
Film Coated
Tablet
A03FA03
-DOMPERIDONE
-Per Oral
12.5 Milligram
Film Coated
Tablet
Film Coated
Tablet
Powder for Oral
Solution
A06AH03
Powder for Oral
Solution
A06AD65
-NALOXEGOL
OXALATE
-NALOXEGOL
OXALATE
-MACROGOL
3350
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
MORPHINE
SULPHATE
MORPHINE
SULPHATE
MORPHINE
SULPHATE
MORPHINE
SULPHATE
INJECTION BP
MORPHINE
SULPHATE
INJECTION BP
MOTILIUM
MOTILIUM
MOTILIUM
MOTILIUM
FASTMELTS
MOTILIUM RX
McNeil
Healthcare
(Ireland) Ltd
PCO
Manufacturing
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
MOVENTIG
Kyowa Kirin Ltd
MOVENTIG
Kyowa Kirin Ltd
MOVICOL
Primecrown 2010
Ltd
Interchangeable
List Code:
IC0085-002-014
EU/1/14/962/001003
EU/1/14/962/004007
PPA1633/007/00
1
MOVICOL
IMED Healthcare
Ltd.
PPA1463/035/00
1
Human Medicines Authorised/Transfer Pending Products
10 Milligram
25 Milligram
13.8 Grams
13.8 Grams
D03AA
A06AH03
A06AD65
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
PPA
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
PPA
Page 316 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
MOVICOL
Imbat Limited
PPA1151/089/00
1
13.8 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
LTT Pharma
Limited
PPA1562/004/00
1
13.8 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
Eurodrug Ltd
DPR1392/032/0
01
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PCO
Manufacturing
PPA0465/159/00
1
13.8 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
Norgine Limited
PA0102/023/002
13.8 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
Novalus
Healthcare
Limited
PPA1925/002/00
1
13.8 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
CHOCOLATE
Norgine Limited
PA0102/023/005
13.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
CHOCOLATE
Imbat Limited
PPA1151/089/00
2
13.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
LIQUID ORANGE
FLAVOUR
Norgine B.V.
PA1336/002/004
13.9/25
Concentrate for
Oral Solution
A06AD65
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-MACROGOL
35000
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
BICARBONATE
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
-POTASSIUM
CHLORIDE
Legal Basis
Routes of
Administration
PPA
PPA
-Per Oral
PPA
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
PPA
-Per Oral
-Per Oral
Page 317 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
MOVICOL
PAEDIATRIC
PCO
Manufacturing
PPA0465/159/00
2
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PAEDIATRIC
CHOCOLATE
FLAVOUR
SACHET
Norgine Limited
PA0102/023/003
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PAEDIATRIC
PLAIN
Norgine Limited
PA0102/023/004
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PAEDIATRIC
PLAIN
Primecrown 2010
Ltd
DPR1633/005/0
01
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PAEDIATRIC
PLAIN
PCO
Manufacturing
DPR0465/042/0
01
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PAEDIATRIC
PLAIN 6.9G
POWDER FOR
ORAL
SOLUTION
Imbat Limited
PPA1151/089/00
3
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL
PAEDIATRIC
PLAIN SACHET
IMED Healthcare
Ltd.
DPR1463/034/0
01
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVICOL PLAIN
SACHET
Norgine Limited
PA0102/023/006
13.7 Grams
Powder for Oral
Solution
A06AD65
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
(E500)
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
(E500)
-POTASSIUM
CHLORIDE
-MACROGOL
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
(E500)
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
(E500)
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
(E500)
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
(E500)
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-SODIUM
CHLORIDE
PH.EUR.
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
Legal Basis
PPA
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
Page 318 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
MOVICOL
READY TO
TAKE
Norgine B.V.
PA1336/002/006
13.9g/25 Millilitre
Oral Solution
A06AD65
MOVILIEF
Clonmel
Healthcare Ltd
PA0126/217/001
13.7 Grams
Powder for Oral
Solution
A06AD65
MOVILIEF
PAEDIATRIC
Clonmel
Healthcare Ltd
PA0126/217/002
6.9 Grams
Powder for Oral
Solution
A06AD65
MOVIPREP
Norgine B.V.
PA1336/001/001
N/A
Powder for Oral
Solution
A06AD65
MOVIPREP
LTT Pharma
Limited
PPA1562/168/00
1
Powder for Oral
Solution
A06AD65
MOVIPREP
PCO
Manufacturing
PPA0465/428/00
1
Powder for Oral
Solution
A06AD65
Human Medicines Authorised/Transfer Pending Products
Active
Ingredients
-MACROGOL
3350
-SODIUM
CHLORIDE
-SODIUM
BICARBONATE
-POTASSIUM
CHLORIDE
-MACROGOL
3350
-POTASSIUM
CHLORIDE
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
-MACROGOL
3350
-POTASSIUM
CHLORIDE
-SODIUM
CHLORIDE
-SODIUM
HYDROGEN
CARBONATE
-MACROGOL
3350
-SODIUM
SULFATE
ANHYDROUS
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-ASCORBIC
ACID
-SODIUM
ASCORBATE
-MACROGOL
3350
-SODIUM
SULFATE
ANHYDROUS
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-ASCORBIC
ACID
-SODIUM
ASCORBATE
-MACROGOL
3350
-SODIUM
SULPHATE
ANHYDROUS
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-ASCORBIC
ACID
-SODIUM
ASCORBATE
Legal Basis
Routes of
Administration
Article 8(3) - Full
new Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 319 of 608
Trade Name
Licence Holder Licence
Number
MOVIPREP
ORANGE
Norgine B.V.
PA1336/001/002
MOVYMIA
Stada
Arzneimittel AG
EU/1/16/1161/00
1-002
MOXIFLOXACIN
Fresenius Kabi
Limited
MOXIFLOXACIN
MOXIVIG
MOZOBIL
MST CONTINUS
MST CONTINUS
MST CONTINUS
MST CONTINUS
MST CONTINUS
MST CONTINUS
MST CONTINUS
MST CONTINUS
MST CONTINUS
MUCODYNE
MUCODYNE
MUCODYNE
PAEDIATRIC
SYRUP
125MG/5ML
MULTAQ
MULTIHANCE
MULTIHANCE
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
Powder for Oral
Solution
A06AD65
20micrograms/80
Microlitre
Solution for
Injection
H05AA02
PA0566/063/001
400/250 Mg/Ml
Solution for
Infusion
J01MA14
Fresenius Kabi
Limited
PA0566/063/002
400/250 Mg/Ml
Solution for
Infusion
J01MA14
Novartis
Pharmaceuticals
UK Ltd
Genzyme Europe
B.V.
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Mundipharma
Pharmaceuticals
Limited
Ipsen
Pharmaceuticals
Limited
Ipsen
Pharmaceuticals
Limited
Ipsen
Pharmaceuticals
Limited
PA0013/132/001
0.5 %w/v
Eye Drops
Solution
S01AE07
EU/1/09/537/001
20 Micromol
L03AX16
PA1688/004/002
10 Milligram
Solution for
Injection
Tablet Prolonged
Release
N02AA01
-MORPHINE
SULFATE
PA1688/004/004
30 Milligram
Tablet Prolonged
Release
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/005
60 Milligram
Tablet Prolonged
Release
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/006
100 Milligram
Tablet Prolonged
Release
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/001
5 Milligram
Tablet Prolonged
Release
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/003
15 Milligram
Tablet Prolonged
Release
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/008
20 Milligram
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/009
30 Milligram
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA1688/004/010
60 Milligram
N02AA01
-MORPHINE
SULFATE
-Per Oral
PA0869/009/001
375 Milligram
Granules
Prolonged
Release
Granules
Prolonged
Release
Granules
Prolonged
Release
Capsules Hard
R05CB03
-Per Oral
PA0869/009/003
250 MG/5ml
Syrup
R05CB03
PA0869/009/002
125 MG/5ml
Syrup
R05CB03
CARBOCISTEIN
E
CARBOCISTEIN
E
CARBOCISTEIN
E
Sanofi-Aventis
Groupe
EU/1/09/591/1-4
400 Milligram
Film Coated
Tablet
C01BD07
-Per Oral
Bracco Imaging
spa
Bracco Imaging
spa
PA1826/001/001
0.5M Micromol
V08CA08
PA1826/001/002
529 Micromol
Solution for
Injection
Solution for
Injection
DRONEDARONE
HYDROCHLORI
DE
-GADOBENATE
DIMEGLUMINE
-GADOBENATE
DIMEGLUMINE
Human Medicines Authorised/Transfer Pending Products
V08CA08
-MACROGOL
3350
-SODIUM
SULPHATE
ANHYDROUS
-SODIUM
CHLORIDE
-POTASSIUM
CHLORIDE
-ASCORBIC
ACID
-SODIUM
ASCORBATE
-TERIPARATIDE
Legal Basis
-MOXIFLOXACIN
HCI,
ANHYDROUS
-MOXIFLOXACIN
HCI,
ANHYDROUS
-MOXIFLOXACIN
HYDROCHLORI
DE
-PLERIXAFOR
-Per Oral
Article 10(4) Similar Biological
App
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Subcutaneous
-Intra-venous
-Intra-venous
-Ocular
Article 8(3) - Full
new Application
-Subcutaneous
-Intra-venous
Page 320 of 608
Trade Name
MUNTEL
Licence Holder Licence
Number
Dosage Form ATC
-ALPROSTADIL
-Urethral
Stick/Urethral
G04BE01
-ALPROSTADIL
-Urethral
500 Microgram
Stick/Urethral
G04BE01
-ALPROSTADIL
-Urethral
PA1332/004/004
1000 Microgram
Stick/Urethral
G04BE01
-ALPROSTADIL
-Urethral
EU/1/08/448/002
100 Milligram
Solution for
Infusion
J02AX05
-MICAFUNGIN
SODIUM
-Intra-venous
Astellas Pharma
GmbH
EU/1/08/448/001
50 Milligram
Solution for
Infusion
J02AX05
-MICAFUNGIN
SODIUM
-Intra-venous
Herbert J.
Passauer GmbH
& Co. KG
Herbert J.
Passauer GmbH
& Co. KG
Pfizer Healthcare
Ireland
Rowex Ltd
EU/1/10/647/003004
250 Milligram
Capsules Hard
L04AA06
500 Milligram
Film Coated
Tablet
L04AA06
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
EU/1/10/647/001002
PA0822/109/001
150 Milligram
Capsules Hard
J04AB04
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
-RIFABUTIN
PA0711/129/001
250 Milligram
Capsules Hard
L04AA06
PA0711/129/002
500 Milligram
Film Coated
Tablet
L04AA06
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
Rowex Ltd
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
Accord
Healthcare
Limited
Wockhardt UK
Limited
PA1390/001/001
500 Milligram
Film Coated
Tablet
L04AA06
500 Milligram
Film Coated
Tablet
L04AA06
MYCOPHENOL
ATE MOFETIL
ACCORD
MYCOPHENOL
ATE MOFETIL
CLONMEL
MYCOPHENOL
ATE MOFETIL
CLONMEL
MYCOPHENOL
ATE MOFETIL
TEVA
MYCOPHENOL
ATE MOFETIL
TEVA
MYCOSTATIN
Accord
Healthcare
Limited
Clonmel
Healthcare Ltd
PA1390/044/001
250 Milligram
Capsule
L04AA06
PA0126/195/001
250 Milligram
Capsules Hard
L04AA06
Clonmel
Healthcare Ltd
PA0126/195/002
500 Milligram
Film Coated
Tablet
L04AA06
Teva B.V.
EU/1/07/439/1-2
250 Milligram
Capsules Hard
L04AA06
Teva B.V.
EU/1/07/439/3-4
500 Milligram
Film Coated
Tablet
L04AA06
Imbat Limited
100,000 Units/ml
Oral Suspension
D01AA01
MYCOSTATIN
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
PPA1151/068/00
1
PA0002/007/007
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
PPA
-Per Oral
PA1339/028/001
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
-NYSTATIN
100,000 IU/ML
Oral Suspension
A07AA02
-NYSTATIN
MUSE
MYCAMINE 100
MG POWDER
FOR SOLUTION
FOR INFUSION
MYCAMINE 50
MG POWDER
FOR SOLUTION
FOR INFUSION
MYCLAUSEN
MYCLAUSEN
MYCOBUTIN
MYCOLAT
MYCOLAT 500
MG FILMCOATED
TABLETS
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
Film Coated
Tablet
R06AE09
Interchangeable
List Code:
IC0095-001-003
PA1118/001/001
0.012 %w/v
Eye Drops
Solution
S01GA51
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Meda Health
Sales Ireland
Limited
Astellas Pharma
GmbH
PA1332/004/001
125 Microgram
Stick/Urethral
PA1332/004/002
250 Microgram
PA1332/004/003
Routes of
Administration
G04BE01
MUSE
5 Milligram
Legal Basis
-Per Oral
MUSE
PA0891/006/001
Active
Ingredients
LEVOCETIRIZIN
E
DIHYDROCHLO
RIDE
-NAPHAZOLINE
HYDROCHLORI
DE
MURINE
IRRITATION &
REDNESS
RELIEF
MUSE
UCB (Pharma)
Ireland Limited
Strength
Prestige Brands
(UK) Limited
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 321 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
MYDRILATE
Intrapharm
Laboratories
Limited
PA0997/004/001
0.5 %w/v
Eye Drops
Solution
S01FA04
MYDRILATE
Intrapharm
Laboratories
Limited
PA0997/004/002
1.0 %w/v
Eye Drops
Solution
S01FA04
MYFENAX
Teva B.V.
EU/1/07/438/1-2
250 Milligram
Capsules Hard
L04AA06
MYFENAX
Teva B.V.
EU/1/07/438/3-4
500 Milligram
Film Coated
Tablet
L04AA06
MYFORTIC
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Aspen Pharma
Trading Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0013/115/001
180 Milligram
Tablets GastroResistant
L04AA06
PA0013/115/002
360 Milligram
Tablets GastroResistant
L04AA06
PA1691/008/001
2 Milligram
L01AB01
PA0577/183/001
100/20
Microgram
Film Coated
Tablet
Coated Tablets
MYOCET
Teva B.V.
EU/1/00/141/001
50 Base
Milligrams
Pdr+Solv/Conc/D
ispersion/Inf
L01DB01
MYOVIEW
GE Healthcare
Limited
PA0240/007/002
230 Microgram
V09GA02
MYOZYME
Genzyme Europe
B.V.
EU/1/06/333/1-3
5 Mg/Ml
Kit for
radiopharmaceut
ical preparation
Pdr/Conc/Soln for
Infus
MYSILDECARD
((PREVIOUSLY
KNOWN AS
SILDENAFIL
MYLAN
PHARMA))
MYSIMBA
Mylan S.A.S.
EU/1/16/1134/00
1-003
20 Milligram
Film Coated
Tablet
G04BE03
Interchangeable
List Code:
IC0063-003-003
EU/1/14/988/001
8mg/90 Milligram
Tablet Prolonged
Release
A08AA
MYSODELLE
Ferring Ireland
Ltd
Laboratoires
SERB
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA1009/025/001
200 Microgram
Vaginal Device
G02AD06
-NALTREXONE
HYDROCHLORI
DE
AMFEBUTAMO
NE
HYDROCHLORI
DE
-MISOPROSTOL
PA1777/001/001
250 Milligram
Tablets
N03AA03
-PRIMIDONE
-Per Oral
PA0577/087/002
50 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-023-003
PA0577/087/003
100 Milligram
Film Coated
Tablet
C09CA01
-LOSARTAN
POTASSIUM
-Per Oral
Interchangeable
List Code:
IC0003-024-003
PA2166/001/001
600 Milligram
Tablets
Effervescent
R05CB01
EU/1/05/324/001
1 Mg/Ml
Concentrate for
Soln for Inf
ACETYLCYSTEI
NE
-GALSULFASE
MYFORTIC
MYLERAN
MYLITE
MYSOLINE
MYZAAR
MYZAAR
Orexigen
Therapeutics
Ireland Limited
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
NACSYS
Alpex Pharma
(UK) Limited
NAGLAZYME
BioMarin
Pharmaceutical
Inc.
Human Medicines Authorised/Transfer Pending Products
G03AA07
A16AB07
CYCLOPENTOL
ATE
HYDROCHLORI
DE
CYCLOPENTOL
ATE
HYDROCHLORI
DE
MYCOPHENOL
ATE MOFETIL
MYCOPHENOL
ATE MOFETIL
MYCOPHENOLI
C ACID
MYCOPHENOLI
C ACID
-BUSULFAN
Legal Basis
LEVONORGEST
REL
ETHINYLESTRA
DIOL
-DOXORUBICIN
HYDROCHLORI
DE
-TETROFOSMIN
ALGLUCOSIDA
SE ALFA
-SILDENAFIL
CITRATE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
Article 10b Fixed
Combination
-Per Oral
Article 8(3) - Full
new Application
-Vaginal
Article 10(1) Generic
Application
-Per Oral
Page 322 of 608
Trade Name
NAILDERM
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
Bristol-Myers
Squibb
Pharmaceuticals
Ltd
B. Braun
Melsungen AG
PA0577/068/001
250 Milligram
Tablets
D01BA02
-TERBINAFINE
HYDROCHLORI
DE
-Per Oral
PA0002/070/001
50mg Milligram
Tablets
N07BB04
-NALTREXONE
HYDROCHLORI
DE
-Per Oral
PA0736/026/001
0.40 anhyd mg/m
Solution for Inj/Inf
V03AB15
Orpha-Devel
Handels und
Vertriebs GmbH
Mercury
Pharmaceuticals
(Ireland) Ltd
PA1353/003/001
0.4 Micromol
Solution for Inj/Inf
V03AB15
PA0073/111/002
Microgram/ML
Solution for Inj/Inf
V03AB15
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
-NALOXONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE
International
Medication
Systems (UK) Ltd
AOP Orphan
Pharmaceuticals
AG
Accord
Healthcare
Limited
CIS bio
International
Octapharma
Limited
Octapharma
Limited
Atnahs Pharma
UK Limited
Atnahs Pharma
UK Limited
Teva Pharma
B.V.
PA0255/036/001
400
Microgram/ML
Solution for
Injection
V03AB15
PA0934/003/001
50 Milligram
Film Coated
Tablet
N07BB04
PA1390/020/001
50 Milligram
Film Coated
Tablet
N07BB04
PA0677/006/001
Milligram
V09DB06
PA0521/018/001
PA1967/002/001
500 International
Unit
1000
International Unit
250 Milligram
PA1967/002/002
500 Milligram
PA0749/065/001
2.5 Milligram
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Pdr+Solv for Soln
for Inj
Tablets GastroResistant
Tablets GastroResistant
Film Coated
Tablet
NAROPIN
Aspen Pharma
Trading Limited
PA1691/026/003
10 Mg/Ml
Solution for
Injection
N01BB09
NAROPIN
Aspen Pharma
Trading Limited
PA1691/026/001
2 Mg/Ml
Solution for
Injection
N01BB09
NAROPIN
Aspen Pharma
Trading Limited
PA1691/026/002
7.5 Mg/Ml
Solution for
Injection
N01BB09
NASACORT
IMED Healthcare
Ltd.
DPR1463/003/0
01
55
Mcg/Acutuation
Nasal Spray
Suspension
R01AD11
NASACORT
Eurodrug Ltd
DPR1392/016/0
01
55 Microgram
Nasal Spray
Suspension
C09AA05
NASACORT
McDowell
Pharmaceuticals
DPR1473/014/0
01
55 Mcg/Dose
Nasal Spray
Suspension
R01AD11
NASACORT
PCO
Manufacturing
DPR0465/016/0
01
55 Mcg/Dose
Nasal Spray
Suspension
R01AD11
NASACORT
PCO
Manufacturing
PPA0465/141/00
1
55 Microgram
Nasal Spray
Suspension
R01AD11
NASACORT
Sanofi-Aventis
Ireland Limited
T/A SANOFI
Sanofi-Aventis
Ireland Limited
T/A SANOFI
PA0540/011/001
55
Mcg/Acutuation
Nasal Spray
Suspension
R01AD11
PA0540/011/002
55 Mcg/Dose
Nasal Spray
Suspension
R01AD11
NALOREX
NALOXONE
NALOXONE
NALOXONE
HYDROCHLORI
DE INJECTION
USP
NALOXONE
HYDROCHLORI
DE MINIJET
NALTREXONE
NALTREXONE
HYDROCHLORI
DE
NANOCIS
NANOFIX
NANOFIX
NAPROSYN EC
NAPROSYN EC
NARAVERG
NASACORT
ALLERGY
PA0521/018/002
Human Medicines Authorised/Transfer Pending Products
M01AE02
-NALOXONE
HYDROCHLORI
DE
-NALTREXONE
HYDROCHLORI
DE
-NALTREXONE
HYDROCHLORI
DE
-RHENIUM
SULPHIDE
-FACTOR IX,
HUMAN
-FACTOR IX,
HUMAN
-NAPROXEN
M01AE02
-NAPROXEN
N02CC02
-NARATRIPTAN
HYDROCHLORI
DE
-ROPIVACAINE
HYDROCHLORI
DE
-ROPIVACAINE
HYDROCHLORI
DE
-ROPIVACAINE
HYDROCHLORI
DE
TRIAMCINOLO
NE ACETONIDE
TRIAMCINOLO
NE ACETONIDE
TRIAMCINOLO
NE ACETONIDE
TRIAMCINOLO
NE ACETONIDE
TRIAMCINOLO
NE ACETONIDE
TRIAMCINOLO
NE ACETONIDE
TRIAMCINOLO
NE ACETONIDE
B02BD04
B02BD04
Article 10a Bibliographical
App
Article 10(1) Generic
Application
-Intra-Muscular
-Intra-venous
-Per Oral
Article 10(1) Generic
Application
-Per Oral
-Intra-venous
-Intra-venous
-Per Oral
-Per Oral
Article 10(1) Generic
Application
-Per Oral
PPA
Article 10c Informed Consen
-Nasal
Page 323 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
NASEPTIN
NASAL
Alliance
Pharmaceuticals
Ltd.
PA0943/002/001
0.1% & 0.5%
%v/v
Cream
D06AX04
NASOBEC
AQUEOUS
Norton Waterford
PA0436/028/001
50 Microgram
Nasal Spray
Suspension
R01AD01
NASOFAN
AQUEOUS
Norton
Healthcare
Limited T/A IVAX
Pharmaceuticals
UK
PCO
Manufacturing
PCO
Manufacturing
IMED Healthcare
Ltd.
Imbat Limited
PA0282/090/001
50 Microgram
Nasal Spray
Suspension
R03BA05
PPA0465/146/00
1
DPR0465/008/0
01
DPR1463/008/0
01
PPA1151/062/00
1
PPA1463/102/00
1
PPA1562/173/00
1
PA1286/038/001
50 Mcg/Dose
Nasal Spray
Suspension
Nasal Drops
Susp
Nasal Spray
Suspension
Nasal Spray
Suspension
Nasal Spray
Suspension
Nasal Spray
Suspension
Nasal Spray
Suspension
R01AD09
HOR1149/022/0
01
HOR0652/001/0
01
EU/1/15/1078/00
1
4X - MM
Pillules
6X
Liquid
25 Microgram
Pdr+Solv for Soln
for Inj
H05AA03
NASONEX
NASONEX
NASONEX
NASONEX
NASONEX
NASONEX
NASONEX
AQUEOUS
NAT. MUR.
NAT. MUR. 6X
NATPAR
IMED Healthcare
Ltd.
LTT Pharma
Limited
Merck Sharp &
Dohme Ireland
(Human Health)
Limited
A. Nelson &
Company Limited
New Vistas
Healthcare Ltd
NPS Pharma
Holdings Limited
50 Microgram
140 dose
50
Mcg/Acutuation
50 Microgram
50 Microgram
50 Microgram
R01AD09
R01AD09
R01AD09
R01AD09
R01AD09
R01AD09
Active
Ingredients
Legal Basis
Routes of
Administration
CHLORHEXIDIN
E
HYDROCHLORI
DE
-NEOMYCIN
SULFATE
BECLOMETASO
NE
DIPROPIONATE
-FLUTICASONE
PROPIONATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
-MOMETASONE
FUROATE
PPA
PPA
-NATRUM
CHLORATUM
-NAT MUR 6X
-Per Oral
-Per Oral
NATPAR
NPS Pharma
Holdings Limited
EU/1/15/1078/00
2
50 Microgram
Pdr+Solv for Soln
for Inj
H05AA03
NATPAR
NPS Pharma
Holdings Limited
EU/1/15/1078/00
3
75 Microgram
Pdr+Solv for Soln
for Inj
H05AA03
NATPAR
NPS Pharma
Holdings Limited
EU/1/15/1078/00
4
100 Microgram
Pdr+Solv for Soln
for Inj
H05AA03
NATRILIX SR
Imbat Limited
1.5 Milligram
Les Laboratoires
Servier
Weleda (UK)
Limited
C03BA11
-INDAPAMIDE
-Per Oral
HOR0407/007/0
01
6C & 30C
Tablet Prolonged
Release
Tablet Prolonged
Release
Tablets
C03BA11
NATRILIX SR
PPA1151/096/00
1
PA0568/005/001
-PARATHYROID
HORMONE
(RDNA)
-PARATHYROID
HORMONE
(RDNA)
-PARATHYROID
HORMONE
(RDNA)
-PARATHYROID
HORMONE
(RDNA)
-INDAPAMIDE
-NATRIUM
CHLORATUM
-Per Oral
-ST. JOHN'S
WORT DRY
EXTRACT (AS
DRY EXTRACT)
FROM ST.
JOHN'S WORT
AERIAL PART
(HYPERICUM
PERFORATUM
L)
-AGNUS
CASTUS
EXTRACT (AS
DRY ROOT)
FROM AGNUS
CASTUS FRUIT
(VITEX AGNUSCASTUS L)
-Per Oral
NATRIUM
MURIATICUM
(NAT. MUR.)
TABLETS
NATURE’S
BOUNTY
HYPERICUM
NATURE'S
BOUNTY
AGNUS CASTUS
PMS RELIEF
1.5 Milligram
Holland & Barrett
International
Limited
TR1563/061/002
Capsules Hard
Holland & Barrett
International
Limited
TR1563/045/001
Tablets
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
Article 8(3) - Full
new Application
-Subcutaneous
PPA
-Per Oral
-Per Oral
Page 324 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Routes of
Administration
NATURE'S
BOUNTY
DEVIL'S CLAW
NATURE'S
BOUNTY
ECHINACEA
COLD AND FLU
Holland & Barrett
International
Limited
Holland & Barrett
International
Limited
TR1563/018/001
Capsules Hard
TR1563/019/001
Capsule
NATURE'S
BOUNTY
LEMON BALM
Holland & Barrett
International
Limited
TR1563/020/001
Capsules Hard
NATURE'S
BOUNTY MILK
THISTLE
NATURE'S
BOUNTY
VALERIAN
Holland & Barrett
International
Limited
Holland & Barrett
International
Limited
TR1563/052/001
Capsules Hard
TR1563/017/001
Capsules Hard
N05CM09
NAVELBINE
PA1287/001/005
10 Base mg/ml
L01CA04
PA1287/001/001
20 Base
Milligrams
30 Base
Milligrams
80 Base
Milligrams
250 Milligram
Concentrate for
Soln for Inf
Capsules, Soft
Capsules, Soft
L01CA04
Capsules, Soft
L01CA04
NEBIDO
PIERRE FABRE
Ltd
PIERRE FABRE
Ltd
PIERRE FABRE
Ltd
PIERRE FABRE
Ltd
Bayer Limited
Solution for
Injection
G03BA03
NEBILET
Imbat Limited
PPA1151/083/00
1
5 Milligram
Tablets
C07AB12
5 Milligram
Tablets
C07AB12
-NEBIVOLOL
-Per Oral
5 Milligram
Tablets
C07AB12
-NEBIVOLOL
HYDROCHLORI
DE
-Per Oral
Interchangeable
List Code:
IC0082-001-002
PA0865/015/001
5/12.5 Milligram
Film Coated
Tablet
C07BB12
Article 10b Fixed
Combination
-Per Oral
PA0865/015/002
5/25 Milligram
Film Coated
Tablet
C07BB12
Article 10b Fixed
Combination
-Per Oral
PA0126/165/001
5 Milligram
Tablets
C07AB12
Interchangeable
List Code:
IC0082-001-002
PA1462/011/001
-NEBIVOLOL
HYDROCHLOR
OTHIAZIDE
-NEBIVOLOL
HYDROCHLOR
OTHIAZIDE
-NEBIVOLOL
HYDROCHLORI
DE
10 Milligram
Tablets
C07AB12
PA0749/078/001
5 Milligram
Tablets
C07AB12
-NEBIVOLOL
HYDROCHLORI
DE
-NEBIVOLOL
HYDROCHLORI
DE
Article 10(3) Hybrid
Application
Article 10(1) Generic
Application
NAVELBINE
NAVELBINE
NAVELBINE
NEBILET
NEBILET
NEBILET PLUS
NEBILET PLUS
NEBIMEL
NEBIVOLOL
NEBIVOLOL
TEVA
Menarini
International
Operations
Luxembourg S.A.
PCO
Manufacturing
Menarini
International
Operations
Luxembourg S.A.
Menarini
International
Operations
Luxembourg S.A.
Clonmel
Healthcare Ltd
Glenmark
Pharmaceuticals
Europe Limited
Teva Pharma
B.V.
PA1287/001/002
PA1287/001/004
PA1410/020/001
Interchangeable
List Code:
IC0082-001-002
PA0865/005/001
Interchangeable
List Code:
IC0082-001-002
PPA0465/327/00
1
Interchangeable
List Code:
IC0082-001-002
Human Medicines Authorised/Transfer Pending Products
L01CA04
-DEVIL'S CLAW
EXTRACT (AS
DRY ROOT)
-ECHINACEA
ROOT EXTRACT
(AS DRY ROOT)
FROM
ECHINACEA
ROOT
(ECHINACEA
PURPUREA L)
-DRY EXTRACT
FROM MELISSA
OFFICINALIS L.
FOLIUM (LEMON
BALM LEAF)
-MILK THISTLE
EXTRACT (AS
DRY ROOT)
-VALERIAN DRY
HYDROALCOH
OLIC EXTRACT
PH.EUR.
-VINORELBINE
TARTRATE
-VINORELBINE
TARTRATE
-VINORELBINE
TARTRATE
-VINORELBINE
TARTRATE
TESTOSTERON
E
UNDECANOATE
-NEBIVOLOL
HYDROCHLORI
DE
Legal Basis
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Intra-Muscular
PPA
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 325 of 608
Trade Name
NEBOL
Licence Holder Licence
Number
Rowex Ltd
Strength
Dosage Form ATC
Tablets
C07AB12
-NEBIVOLOL
-Per Oral
Interchangeable
List Code:
IC0082-001-002
PA2033/001/001
Article 10(1) Generic
Application
30 Milligram
Film Coated
Tablet
N02BG06
B05ZB
Article 10(1) Generic
Application
Article 10a Bibliographical
App
-Per Oral
Solution for
Haemofiltration
-NEFOPAM
HYDROCHLORI
DE
-SODIUM
CHLORIDE
PH.EUR.
-SODIUM
BICARBONATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-GLUCOSE
MONOHYDRATE
-SODIUM
CHLORIDE
PH.EUR.
-SODIUM
BICARBONATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-GLUCOSE
MONOHYDRATE
-POTASSIUM
CHLORIDE
-SODIUM
CHLORIDE
PH.EUR.
-SODIUM
BICARBONATE
-CALCIUM
CHLORIDE
DIHYDRATE
-MAGNESIUM
CHLORIDE
HEXAHYDRATE
-GLUCOSE
MONOHYDRATE
-POTASSIUM
CHLORIDE
-NEISSERIA
MENINGITIDIS C
-TETANUS
TOXOID
-NEBIVOLOL
Article 10a Bibliographical
App
-Intra-venous
Article 10a Bibliographical
App
-Intra-venous
Article 10(1) Generic
Application
-Per Oral
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
Article 10(1) Generic
Application
-Per Oral
NEFROSOL
SOLUTION FOR
HAEMOFILTRA
TION
B. Braun Avitum
AG
PA2146/001/001
NEFROSOL
WITH 2 MMOL/L
POTASSIUM
SOLUTION FOR
HAEMOFILTRA
TION
B. Braun Avitum
AG
PA2146/001/002
2 mmol/L
Solution for
Haemofiltration
B05ZB
NEFROSOL
WITH 4 MMOL/L
POTASSIUM
SOLUTION FOR
HAEMOFILTRA
TION
B. Braun Avitum
AG
PA2146/001/003
4 mmol/L
Solution for
Haemofiltration
B05ZB
NEISVAC-C
Pfizer Healthcare
Ireland
PA0822/183/001
N/A
Suspension for
Injection
J07AH
NELET
McDermott
Laboratories Ltd
t/a Gerard
Laboratories
PA0577/106/001
5 Milligram
Tablets
C07AB12
5+10+15+20
Milligram
Film Coated
Tablet
N06DX01
5 Milligram
Film Coated
Tablet
N06DX01
Interchangeable
List Code:
IC0082-001-002
EU/1/13/824/018
Interchangeable
List Code:
IC0022-106-003
NEMDATINE
Actavis Group
PTC ehf
Routes of
Administration
5 Milligram
Rivopharm UK
Ltd
Actavis Group
PTC ehf
Legal Basis
PA0711/120/001
NEFOPAM
NEMDATINE
Active
Ingredients
EU/1/13/824/001002
Human Medicines Authorised/Transfer Pending Products
-Intra-venous
Page 326 of 608
Trade Name
NEMDATINE
Licence Holder Licence
Number
Actavis Group
PTC ehf
EU/1/13/824/003010
NEMDATINE
Actavis Group
PTC ehf
Interchangeable
List Code:
IC0022-002-003
EU/1/13/824/011013
NEMDATINE
Actavis Group
PTC ehf
EU/1/13/824/014017
NEOCLARITYN
Schering Plough
Europe
Interchangeable
List Code:
IC0022-003-003
EU/1/00/161/3546
NEOCLARITYN
Schering Plough
Europe
NEOCLARITYN
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
10 Milligram
Film Coated
Tablet
N06DX01
-MEMANTINE
HYDROCHLORI
DE
Article 10(1) Generic
Application
-Per Oral
15 Milligram
Film Coated
Tablet
N06DX01
Film Coated
Tablet
N06DX01
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
20 Milligram
-MEMANTINE
HYDROCHLORI
DE
-MEMANTINE
HYDROCHLORI
DE
2.5 Milligram
Orodispersible
Tablet
R06AX27
EU/1/00/161/4758
5 Milligram
Orodispersible
Tablet
R06AX27
Merck Sharp and
Dohme Limited
EU/1/00/161/5967
0.5 Mg/Ml
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/001
5 Milligram
Tablets
R06AX
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/002
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/003
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/004
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/005
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/006
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/007
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/008
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/009
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/010
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/011
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/012
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/013
5 Milligram
Tablets
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/022
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/014
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/015
0.5mg/ml Mg/Ml
Syrup
R06AX27
Human Medicines Authorised/Transfer Pending Products
R06AX27
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATADI
NE,
MICRONIZED
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
-Per Oral
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 327 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/016
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Schering Plough
Europe
EU/1/00/161/017
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/020
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/021
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/018
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/019
0.5 Mg/Ml
Syrup
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/023
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/024
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/025
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/026
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/027
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/028
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/029
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/030
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/031
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/032
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/034
5 Milligram
Oral Lyophilisate
R06AX27
NEOCLARITYN
Merck Sharp and
Dohme Limited
EU/1/00/161/033
5 Milligram
Oral Lyophilisate
R06AX27
NEO-CYTAMEN
RPH
Pharmaceuticals
AB
Laboratoires
CTRS
PA1638/004/001
1000
Microgram/ML
Solution for
Injection
B03BA03
EU/1/15/1053/00
1
40 Milligram
Tablets
H02AB02
NEOMERCAZO
LE
NEOMERCAZO
LE
NEOPHYR
Amdipharm
Limited
Amdipharm
Limited
SOL S.p.A.
PA1142/002/002
20 Milligram
Tablets
H03BB01
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
DESLORATIDIN
E
HYDROXOCOB
ALAMIN
DEXAMETHAS
ONE ACETATE
-CARBIMAZOLE
PA1142/002/001
5 Milligram
Tablets
H03BB01
-CARBIMAZOLE
PA1848/001/001
1000 ppm
Medicinal gas,
compressed
R07AX01
-NITRIC OXIDE
NEOPHYR
SOL S.p.A.
PA1848/001/002
450 ppm
Medicinal gas,
compressed
R07AX01
-NITRIC OXIDE
NEOPHYR
SOL S.p.A.
PA1848/001/003
225 ppm
Medicinal gas,
compressed
R07AX01
-NITRIC OXIDE
NEORAL
PCO
Manufacturing
PPA0465/136/00
1
25 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
NEOFORDEX
Human Medicines Authorised/Transfer Pending Products
Legal Basis
Routes of
Administration
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
Article 10a Bibliographical
App
Article 10a Bibliographical
App
Article 10a Bibliographical
App
PPA
-Inhalation
-Inhalation
-Inhalation
-Per Oral
Page 328 of 608
Trade Name
NEORAL
NEORAL
NEORAL
NEORAL
NEORAL
NEORAL
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
Licence Holder Licence
Number
PCO
Manufacturing
PCO
Manufacturing
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Novartis
Pharmaceuticals
UK Ltd
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
PPA0465/136/00
2
PPA0465/136/00
3
PA0013/054/001
50 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
PPA
-Per Oral
100 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
PPA
-Per Oral
25 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
-Per Oral
PA0013/054/002
50 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
-Per Oral
PA0013/054/003
100 Milligram
Capsules, Soft
L04AD01
-CICLOSPORIN
-Per Oral
PA0013/054/004
100 Mg/Ml
Concentrate for
Oral Solution
L04AD01
-CICLOSPORIN
EU/1/97/031/001
500 International
Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/004
1000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/007
2000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/010
5000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/012
10,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/002
500 International
Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/005
1000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/008
2000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/011
5000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/041
4000
International Unit
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/043
6000
International Unit
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/039
60,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Subcutaneous
EU/1/97/031/003
500 International
Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/009
2000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/013
10,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/025
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/026
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/027
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/028
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
Human Medicines Authorised/Transfer Pending Products
Page 329 of 608
Trade Name
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N
NEORECORMO
N FOR RECOPEN
NEORECORMO
N FOR RECOPEN
NEORECORMO
N FOR RECOPEN
NEORECORMO
N MULTIDOSE
NEORECORMO
N MULTIDOSE
NEORECORMO
N RECOPEN
NEOSTIGMINE
METILSULFATE
NEOTIGASON
NEOTIGASON
NEPARVIS
NEPARVIS
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Roche
Registration
Limited
Mercury
Pharmaceuticals
(Ireland) Ltd
Actavis Group
PTC ehf
Actavis Group
PTC ehf
Novartis
Europharm
Limited
EU/1/97/031/029
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/030
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/031
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/032
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/033
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/034
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/035
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/036
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/037
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/038
%v/v
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/040
60,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Subcutaneous
EU/1/97/031/042
4,000
International Unit
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/044
6,000
International Unit
Solution for
Injection
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/31/45-46
30, 000 IU
International Unit
Solution for
Injection
B03XA03
-EPOETIN BETA
EU/1/97/031/021
10,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/022
10,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Subcutaneous
EU/1/97/031/024
20,000
International Unit
Unknown
B03XA03
-EPOETIN BETA
-Subcutaneous
EU/1/97/031/019
50000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Subcutaneous
EU/1/97/031/020
100,000
International Unit
Pdr+Solv for Soln
for Inj
B03XA03
-EPOETIN BETA
-Intra-venous
-Sublingual
EU/1/97/031/023
20,000
International Unit
Pdr for Soln for
Injection
B03XA03
-EPOETIN BETA
-Subcutaneous
PA0073/037/001
2.5/1 Mg/Ml
Solution for
Injection
N07AA01
-NEOSTIGMINE
METILSULFATE
PA1380/050/001
10 Milligram
Capsule
D05BB02
-ACITRETIN
PA1380/050/002
25 Milligram
Capsule
D05BB02
-ACITRETIN
EU/1/16/1103/00
1
24mg/26
Milligram
Film Coated
Tablet
C09DX04
Novartis
Europharm
Limited
EU/1/16/1103/00
5-007
97mg/103
Milligram
Film Coated
Tablet
C09DX04
SACUBITRIL/VA
LSARTAN
(LCZ696-ABA)
SACUBITRIL/VA
LSARTAN
(LCZ696-ABA)
Human Medicines Authorised/Transfer Pending Products
Article 10c Informed Consen
-Per Oral
Article 10c Informed Consen
-Per Oral
Page 330 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
NEPARVIS
Novartis
Europharm
Limited
EU/1/16/1103/00
2-004
49mg/51
Milligram
Film Coated
Tablet
C09DX04
NEPRAMEL
Clonmel
Healthcare Ltd
PA0126/208/001
20 Milligram
Capsules GastroResistant
A02BC05
Interchangeable
List Code:
IC0004-003-016
PA0126/208/002
40 Milligram
Capsules GastroResistant
6 Milligram
PA1026/001/001
30 Units/ml
PA1026/001/007
30 MU/0.5m
Units/ml
48 MU/0.5m
Units/ml
1 mg/24 hours
NEPRAMEL
Clonmel
Healthcare Ltd
NEULASTA
Amgen Europe
B.V.
NEUPOGEN 300
NEURONTIN
Amgen Europe
B.V.
Amgen Europe
B.V.
Amgen Europe
B.V.
Schwarz Pharma
Limited
Schwarz Pharma
Limited
Schwarz Pharma
Limited
Schwarz Pharma
Limited
Schwarz Pharma
Limited
Schwarz Pharma
Limited
Piramal Imaging
GmbH
Elan Pharma
International Ltd
Elan Pharma
International Ltd
Elan Pharma
International Ltd
PCO
Manufacturing
PCO
Manufacturing
PCO
Manufacturing
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
Pfizer Healthcare
Ireland
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
IMED Healthcare
Ltd.
Imbat Limited
NEURONTIN
Imbat Limited
NEURONTIN
PCO
Manufacturing
Teva Pharma
B.V.
NEUPOGEN
SINGLEJECT
NEUPOGEN
SINGLEJECT
NEUPRO
NEUPRO
NEUPRO
NEUPRO
NEUPRO
NEUPRO
NEURACEQ
NEUROBLOC
NEUROBLOC
NEUROBLOC
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEURONTIN
NEUROSTIL
Interchangeable
List Code:
IC0004-004-016
EU/1/02/227/001002
Active
Ingredients
Legal Basis
Routes of
Administration
SACUBITRIL/VA
LSARTAN
(LCZ696-ABA)
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
Article 10c Informed Consen
-Per Oral
Article 10(3) Hybrid
Application
-Per Oral
A02BC05
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
Article 10(3) Hybrid
Application
-Per Oral
Solution for
Injection
L03AA13
L03AA02
PEGFILGRASTI
M
-FILGRASTIM
L03AA02
-FILGRASTIM
L03AA02
-FILGRASTIM
N04BC09
-ROTIGOTINE
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Transdermal
N04BC09
-ROTIGOTINE
-Transdermal
N04BC09
-ROTIGOTINE
N04BC09
-ROTIGOTINE
N04BC09
-ROTIGOTINE
N04BC09
-ROTIGOTINE
V09AX06
-FLORBETABEN
PPA0465/097/00
1
PPA0465/097/00
2
PPA0465/097/00
3
PA0822/015/001
300 Milligram
Solution for
Injection
Solution for
Injection
Solution for
Injection
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
Capsules Hard
400 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
PPA
100 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
PPA
100 mg Milligram
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
PA0822/015/002
300 mg Milligram
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
PA0822/015/003
400 mg Milligram
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
PA0822/015/004
600mg Milligram
N03AX12
-GABAPENTIN
PA0822/015/005
800mg Milligram
N03AX12
-GABAPENTIN
PPA1463/084/00
1
PPA1463/084/00
2
PPA1463/084/00
3
PPA1151/224/00
2
PPA1151/224/00
1
PPA0465/097/00
4
PA0749/164/001
100 Milligram
Film Coated
Tablet
Film Coated
Tablet
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
300 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
600 Milligram
N03AX12
-GABAPENTIN
-Per Oral
300 Milligram
Film Coated
Tablet
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
100 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
-Per Oral
600 Milligram
Film Coated
Tablet
Capsules Hard
N03AX12
-GABAPENTIN
PPA
N03AX12
-GABAPENTIN
Article 10(1) Generic
Application
PA1026/001/008
EU/1/05/331/3846
EU/1/05/331/4755
EU/1/05/331/13,14-20
EU/1/05/331/1012,32-37
EU/1/05/331/79,26-31
EU/1/05/331/46,21-25
EU/1/13/906/001
EU/1/00/166/002
EU/1/00/166/003
EU/1/00/166/001
Human Medicines Authorised/Transfer Pending Products
3 mg/24 hours
2 Milligram
8 Milligram
6 Milligram
4 Milligram
300 MBq/ml
5000 U/ml
Units/ml
5000 U/ml
Units/ml
5,000 Units/ml
100 Milligram
Article 8(3) - Full
new Application
M03AX01
M03AX01
-Intra-Muscular
N03AX12
-BOTULINUM
TOXIN TYPE B
-BOTULINUM
TOXIN TYPE B
-GABAPENTIN
PPA
M03AX01
-Intra-venous
-Intra-Muscular
-Intra-Muscular
-Per Oral
Page 331 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
NEUROSTIL
Teva Pharma
B.V.
PA0749/164/002
300 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
NEUROSTIL
Teva Pharma
B.V.
PA0749/164/003
400 Milligram
Capsules Hard
N03AX12
-GABAPENTIN
NEUTROGENA
T/GEL
Johnson &
Johnson (Ireland)
Limited
Alcon
Laboratories (UK)
Ltd
Alcon
Laboratories (UK)
Ltd
Wockhardt UK
Limited
PA0330/014/001
5 Micromol
Shampoo
D05AA
-COAL TAR
EXTRACT
Eye Drops
Suspension
S01BC10
NEVIRAPINE
TEVA
NEXAVAR
NEVANAC
NEVANAC
NEVIRAPINE
NEXAZOLE
NEXAZOLE
NEXIUM
NEXIUM
NEXIUM
NEXIUM
NEXIUM
NEXIUM
NEXIUM
EU/1/07/433/001
1
Legal Basis
Routes of
Administration
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
-NEPAFENAC
Article 8(3) - Full
new Application
-Ocular
-Per Oral
EU/1/07/433/002
3 Mg/Ml
Eye Drops
Suspension
S01BC10
-NEPAFENAC
Article 8(3) - Full
new Application
-Ocular
PA1339/047/001
200 Milligram
Tablets
J05AG01
-NEVIRAPINE
ANHYDROUS
-Per Oral
Teva B.V.
EU/1/09/598/1-4
200 Milligram
Tablets
J05AG01
-NEVIRAPINE
ANHYDROUS
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Bayer Schering
Pharma AG
Pinewood
Laboratories Ltd,
EU/1/06/342/01
200 Milligram
L01XE05
PA0281/146/001
20 Milligram
Film Coated
Tablet
Capsules GastroResistant
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA0281/146/002
-SORAFENIB
(AS TOSYLATE)
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
40 Milligram
Capsules GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
DIHYDRATE
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
PPA
-Per Oral
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
PPA
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
PPA
-Per Oral
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
PPA
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
PPA
-Per Oral
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
PPA
-Per Oral
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
PPA
-Per Oral
Pinewood
Laboratories Ltd,
Primecrown 2010
Ltd
Interchangeable
List Code:
IC0004-004-016
PPA1633/001/00
1
Primecrown 2010
Ltd
Interchangeable
List Code:
IC0004-003-016
PPA1633/001/00
2
Clear Pharmacy
Clear Pharmacy
Interchangeable
List Code:
IC0004-004-016
PPA1596/008/00
1
Interchangeable
List Code:
IC0004-003-016
PPA1596/008/00
2
LTT Pharma
Limited
Interchangeable
List Code:
IC0004-004-016
PPA1562/065/00
1
LTT Pharma
Limited
Interchangeable
List Code:
IC0004-003-016
PPA1562/065/00
2
Chemilines
Healthcare
(Ireland) Limited
Interchangeable
List Code:
IC0004-004-016
PPA1915/002/00
2
A02BC05
-Per Oral
Interchangeable
List Code:
IC0004-004-016
Human Medicines Authorised/Transfer Pending Products
Page 332 of 608
Trade Name
NEXIUM
NEXIUM
NEXIUM
Licence Holder Licence
Number
Chemilines
Healthcare
(Ireland) Limited
Imbat Limited
Imbat Limited
PPA1915/002/00
1
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
PPA
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
PPA
-Per Oral
40 Milligram
Tablets GastroResistant
A02BC05
PPA
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA0970/027/003
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
40 Milligram
Pdr for Soln
Inj/Inf
A02BC05
ESOMEPRAZOL
E
ESOMEPRAZOL
E
ESOMEPRAZOL
E
--Unknown--
-Intra-venous
Article 8(3) - Full
new Application
-Per Oral
PPA
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PPA1151/017/00
1
Interchangeable
List Code:
IC0004-003-016
PPA1151/017/00
2
NEXIUM
AstraZeneca UK
Limited
NEXIUM
AstraZeneca UK
Limited
PA0970/027/004
10 Milligram
Granules for Oral
Suspension
A02BC05
NEXIUM
IMED Healthcare
Ltd.
PPA1463/002/00
1
20 Milligram
Tablets GastroResistant
A02BC05
IMED Healthcare
Ltd.
Interchangeable
List Code:
IC0004-003-016
PPA1463/002/00
2
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
PPA
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0004-004-016
PPA0465/083/00
1
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
PPA
-Per Oral
PCO
Manufacturing
Interchangeable
List Code:
IC0004-003-016
PPA0465/083/00
2
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
PPA
-Per Oral
Interchangeable
List Code:
IC0004-004-016
PA0970/027/001
20 Milligram
Tablets GastroResistant
A02BC05
--Unknown--
-Per Oral
Interchangeable
List Code:
IC0004-003-016
PA0970/027/002
ESOMEPRAZOL
E
40 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E
--Unknown--
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC05
ESOMEPRAZOL
E MAGNESIUM
TRIHYDRATE
-PARTIALLY
PURIFIED
BROMELAIN
-PARTIALLY
PURIFIED
BROMELAIN
-NICOTINAMIDE
Article 10(3) Hybrid
Application
-Per Oral
Article 8(3) - Full
new Application
-Cutaneous
Article 8(3) - Full
new Application
-Cutaneous
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Oromucosal
NEXIUM
NEXIUM
NEXIUM
NEXIUM
NEXIUM
AstraZeneca UK
Limited
AstraZeneca UK
Limited
Interchangeable
List Code:
IC0004-004-016
EU/1/13/860/001002
NEXIUM
CONTROL
Pfizer Consumer
Healthcare Ltd
NEXOBRID
Teva Pharma
GmbH
EU/1/12/803/001
2 Grams
Powder for
Cutaneous Soln
D03BA03
NEXOBRID
Teva Pharma
GmbH
EU/1/12/803/002
5 Grams
Powder for
Cutaneous Soln
D03BA03
NICAM
PA0278/021/001
4 %w/w
Gel
D10AX
NICOCHEW
FRUIT
Dermal
Laboratories Ltd
Clonmel
Healthcare Ltd
PA0126/263/001
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
NICOCHEW
FRUIT
Clonmel
Healthcare Ltd
PA0126/263/002
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
Human Medicines Authorised/Transfer Pending Products
-Oromucosal
Page 333 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
NICOCHEW
MINT
Clonmel
Healthcare Ltd
PA0126/263/003
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
NICOCHEW
MINT
Clonmel
Healthcare Ltd
PA0126/263/004
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
NICORANDIL
Dexcel-Pharma
Limited
PA0895/009/001
10 Milligram
Tablets
C01DX16
-NICORANDIL
NICORANDIL
Dexcel-Pharma
Limited
PA0895/009/002
20 Milligram
Tablets
C01DX16
-NICORANDIL
NICORETTE
Imbat Limited
2 Milligram
-NICOTINE
Imbat Limited
N07BA01
-NICOTINE
PPA
NICORETTE
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
Imbat Limited
Medicated
Chewing Gum
Medicated
Chewing Gum
Medicated
Chewing Gum
N07BA01
NICORETTE
PPA1151/106/00
1
PPA1151/106/00
2
PA0823/049/004
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 10(1) Generic
Application
PPA
N07BA01
-NICOTINE
RESIN
PA0823/049/003
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESIN
PA0823/049/027
2 Milligram
Lozenges
N07BA01
-NICOTINE
RESINATE
PA0823/049/028
4 Milligram
Lozenges
N07BA01
-NICOTINE
RESINATE
PA0823/049/014
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESIN
PA0823/049/015
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESIN
PA0823/049/002
4 Base Milligrams
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESIN
PPA1151/106/00
3
PPA1151/106/00
4
PA0823/049/024
2 Milligram
Medicated
Chewing Gum
Medicated
Chewing Gum
Medicated
Chewing Gum
N07BA01
-NICOTINE
PPA
N07BA01
-NICOTINE
PPA
N07BA01
-NICOTINE
RESINATE
--Unknown--
-Oromucosal
PA0823/049/025
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
--Unknown--
-Oromucosal
PA0823/049/026
15 Milligram
N07BA01
-NICOTINE
PA0823/049/021
10 mg/16 h
Milligram
Inhalation
Cartridge for
Oromucosal Use
Transdermal
Patch
N07BA01
-NICOTINE
Article 8(3) - Full
new Application
-Transdermal
PA0823/049/022
15 mg/16 h
Milligram
Transdermal
Patch
N07BA01
-NICOTINE
Article 8(3) - Full
new Application
-Transdermal
PA0823/049/023
25 mg / 16
Milligram
Transdermal
Patch
N07BA01
-NICOTINE
Article 8(3) - Full
new Application
-Transdermal
PA0823/049/029
1 Milligram
Oromucosal
Spray, Soln
N07BA01
-NICOTINE
Article 8(3) - Full
new Application
-Oromucosal
PA0678/125/001
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
-Per Oral
PA0678/125/002
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
-Per Oral
PA0678/124/001
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
-Per Oral
NICORETTE
NICORETTE
COOLS
NICORETTE
COOLS
NICORETTE
FRESHFRUIT
NICORETTE
FRESHFRUIT
NICORETTE
FRESHMINT
NICORETTE
FRESHMINT
NICORETTE
FRESHMINT
NICORETTE ICY
WHITE
NICORETTE ICY
WHITE
NICORETTE
INHALER
NICORETTE
INVISI
NICORETTE
INVISI
NICORETTE
INVISI EXTRA
STRENGTH
NICORETTE
QUICKMIST
NICOTINELL
COOL MINT
NICOTINELL
COOL MINT
NICOTINELL
FRUIT
Imbat Limited
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
Human Medicines Authorised/Transfer Pending Products
4 Milligram
4 Milligram
4 Milligram
2 Milligram
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Oromucosal
-Oromucosal
-Per Oral
-Per Oral
-Oromucosal
-Oromucosal
-Oromucosal
Page 334 of 608
Trade Name
NICOTINELL
FRUIT
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
AstraZeneca UK
Limited
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0678/124/002
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
PA0678/142/001
1 Milligram
Lozenges
N07BA01
-NICOTINE
BITARTRATE
DIHYDRATE
Article 10(3) Hybrid
Application
-Per Oral
PA0678/142/002
2 Milligram
Lozenges
N07BA01
-NICOTINE
BITARTRATE
DIHYDRATE
Article 10(3) Hybrid
Application
-Per Oral
PA0678/123/004
1mg Milligram
Lozenges
N07BA01
-NICOTINE
PA0678/123/005
2 Milligram
Lozenges
N07BA01
-NICOTINE
PA0678/134/001
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
Article 10(1) Generic
Application
-Oromucosal
PA0678/134/002
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
Article 10(1) Generic
Application
-Oromucosal
PA0678/135/001
2 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
-Oromucosal
PA0678/135/002
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
-Oromucosal
PA0678/123/001
7 mg/24 hours
Transdermal
Patch
N07BA01
-NICOTINE
PA0678/123/002
14 mg/24 hours
Transdermal
Patch
N07BA01
-NICOTINE
PA0678/123/003
21 mg/24 hours
Transdermal
Patch
N07BA01
-NICOTINE
PA0970/014/001
50/20 Milligram
Capsules Hard
C07FB03
PA0678/021/001
500 Milligram
Capsule
N02BE51
NIGHT NURSE
COLD REMEDY
GlaxoSmithKline
Consumer
Healthcare
(Ireland) Limited
PA0678/014/001
160ml Millilitre
Oral Solution
N02BE51
NIMBEX
GlaxoSmithKline
(Ireland) Limited
PA1077/072/001
2 Mg/Ml
Solution for Inj/Inf
M03AC11
-ATENOLOL
-NIFEDIPINE
-PARACETAMOL
PROMETHAZINE
HYDROCHLORI
DE
DEXTROMETH
ORPHAN
HYDROBROMID
E
-PARACETAMOL
-PROMAZINE
HYDROCHLORI
DE
DEXTROMETH
ORPHAN
HYDROBROMID
E
CISATRACURIU
M
NICOTINELL
FRUITY MINT
NICOTINELL
FRUITY MINT
NICOTINELL
MINT
NICOTINELL
MINT
NICOTINELL
SPEARMINT
NICOTINELL
SPEARMINT
NICOTINELL
TROPICAL
FRUIT
NICOTINELL
TROPICAL
FRUIT
NICOTINELL
TTS 10
NICOTINELL
TTS 20
NICOTINELL
TTS 30
NIF-TEN
NIGHT NURSE
Human Medicines Authorised/Transfer Pending Products
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Page 335 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
Active
Ingredients
Legal Basis
NIMENRIX
Pfizer Limited
EU/1/12/767/001007
5 Microgram
Pdr+Solv for Soln
for Inj
J07AH08
NIMOTOP
Bayer Limited
PA1410/030/002
0.02 %w/v
C08CA06
NIMOTOP
Bayer Limited
PA1410/030/001
30 Milligram
C08CA06
-NIMODIPINE
-Per Oral
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/1-7
1.5 Milligram
Concentrate for
Soln for Inf
Film Coated
Tablet
Capsules Hard
N.MENINGITIDIS
SEROGROUP A
POLYSACCHAR
IDE
CONJUGATED
TO TETANUS
TOXOID
N.MENINGITIDIS
SEROGROUP C
POLYSACCHAR
IDE
CONJUGATED
TO TETANUS
TOXOID
N.MENINGITIDIS
SEROGROUP W
POLYSACCHAR
IDE
CONJUGATED
TO TETANUS
TOXOID
N.MENINGITIDIS
SEROGROUP Y
POLYSACCHAR
IDE
CONJUGATED
TO TETANUS
TOXOID
-NIMODIPINE
N06DA03
-Per Oral
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/8-13
3 Milligram
Capsules Hard
N06DA03
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/1419
4.5 Milligram
Capsules Hard
N06DA03
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/2025
6 Milligram
Capsules Hard
N06DA03
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/2631
1.5 Milligram
Orodispersible
Tablet
N06DA03
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/3236
3 Milligram
Orodispersible
Tablet
N06DA03
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/3741
4.5 Milligram
Orodispersible
Tablet
N06DA03
NIMVASTID
Krka d.d., Novo
mesto
EU/1/09/525/4246
6 Milligram
Orodispersible
Tablet
N06DA03
NINLARO
Takeda Pharma
A/S
Takeda Pharma
A/S
Takeda Pharma
A/S
Bracco Imaging
spa
Bracco Imaging
spa
Bracco Imaging
spa
Bracco Imaging
spa
EU/1/16/1094/00
1
EU/1/16/1094/00
2
EU/1/16/1094/00
3
PA1826/004/001
2.3 Milligram
Capsules Hard
L01XX50
3 Milligram
Capsules Hard
L01XX50
4 Milligram
Capsules Hard
L01XX50
150 Milligram
V08AB04
PA1826/004/002
200 Milligram
V08AB04
-IOPAMIDOL
PA1826/004/003
300 Milligram
V08AB04
-IOPAMIDOL
PA1826/004/004
340 Milligram
Solution for
Injection
Solution for
Injection
Solution for
Injection
Solution for
Injection
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-RIVASTIGMINE
HYDROGEN
TARTRATE
-IXAZOMIB
CITRATE
-IXAZOMIB
CITRATE
-IXAZOMIB
CITRATE
-IOPAMIDOL
V08AB04
-IOPAMIDOL
NINLARO
NINLARO
NIOPAM GLASS
BOTTLES
NIOPAM GLASS
BOTTLES
NIOPAM GLASS
BOTTLES
NIOPAM GLASS
BOTTLES
Human Medicines Authorised/Transfer Pending Products
Article 8(3) - Full
new Application
Routes of
Administration
-Intra-Muscular
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
-Per Oral
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Per Oral
-Per Oral
-Per Oral
Page 336 of 608
Trade Name
NIOPAM GLASS
BOTTLES
NIPENT
Licence Holder Licence
Number
Strength
Bracco Imaging
spa
Hospira UK
Limited
Chefaro Ireland
DAC
PA1826/004/005
370 Milligram
PA0437/060/001
10 Milligram
PA1186/018/008
4 Milligram
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Chefaro Ireland
DAC
PA1186/018/003
21 mg/24 hours
PA1186/018/009
NIQUITIN
Dosage Form ATC
Active
Ingredients
Legal Basis
Routes of
Administration
Solution for
Injection
Pdr for Soln
Inj/Inf
Lozenges
V08AB04
-IOPAMIDOL
L01XX08
-PENTOSTATIN
N07BA01
N07BA01
2 Milligram
Transdermal
Patch
Lozenges
-NICOTINE
POLACRILEX
USP
-NICOTINE
PA1186/018/010
4 Milligram
Lozenges
N07BA01
PA1186/018/002
14 mg/24 hours
N07BA01
PA1186/018/007
2 Milligram
Transdermal
Patch
Lozenges
Chefaro Ireland
DAC
PA1186/019/003
2 Milligram
Medicated
Chewing Gum
N07BA01
NIQUITIN
Chefaro Ireland
DAC
PA1186/019/004
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
NIQUITIN
CLEAR
NIQUITIN
CLEAR
NIQUITIN
CLEAR
NIQUITIN
FRESH MINT
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Chefaro Ireland
DAC
PA1186/018/004
7 mg/24 hours
N07BA01
-NICOTINE
PA1186/018/005
14 mg/24 hours
N07BA01
-NICOTINE
PA1186/018/006
21 mg/24 hours
N07BA01
-NICOTINE
PA1186/019/001
2 Milligram
Transdermal
Patch
Transdermal
Patch
Transdermal
Patch
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
NIQUITIN
FRESH MINT
Chefaro Ireland
DAC
PA1186/019/002
4 Milligram
Medicated
Chewing Gum
N07BA01
-NICOTINE
RESINATE
NIQUITIN MINI
CITRUS
FLAVOUR
Chefaro Ireland
DAC
PA1186/018/016
1.5 Milligram
Lozenges
N07BA01
NIQUITIN MINI
MINT
NIQUITIN MINI
MINT
NIQUITIN
STRIPS MINT
NITOMAN
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Chefaro Ireland
DAC
Lundbeck UK
LLP
PA1186/018/011
1.5 Milligram
Lozenges
N07BA01
-NICOTINE
RESINATE
-NICOTINE
RESINATE
-NICOTINE
PA1186/018/012
4 Milligram
Lozenges
N07BA01
-NICOTINE
PA1186/018/013
2.5 Milligram
N07BA01
-NICOTINE
-Oromucosal
PA1703/001/001
25 Milligram
Tablets
N07XX06
-Per Oral
NITROCINE
Merus Labs
Luxco II S.à.R.L.
Merus Labs
Luxco II S.à.R.L.
PA2118/001/001
1 Mg/Ml
C01DA02
PA2118/001/002
1 Mg/Ml
Solution for
Infusion
Solution for
Infusion
TETRABENAZIN
E
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
LTT Pharma
Limited
Merck Serono
Limited
PCO
Manufacturing
SOL S.p.A.
PPA1562/058/00
1
PA0654/020/001
400 Mcg/Dose
Sublingual Spray
C01DA02
400 Microgram
Sublingual Spray
C01DA02
PPA0465/300/00
1
PA1848/004/001
400 Microgram
Sublingual Spray
C01DA02
100 %v/v
Medicinal gas,
liquefied
N01AX13
NIVESTIM
Hospira UK
Limited
EU/1/10/631/0013
120/0.2
Microgram/ML
Solution for
Injection
L03AA02
-FILGRASTIM
NIVESTIM
Hospira UK
Limited
EU/1/10/631/0046
300/0.5
Microgram/ML
Solution for
Injection
L03AA02
-FILGRASTIM
NIVESTIM
Hospira UK
Limited
EU/1/10/631/0079
480/0.5
Microgram/ML
Solution for
Injection
L03AA02
-FILGRASTIM
NIQUITIN
NIQUITIN
NIQUITIN
NIQUITIN
NIQUITIN
NIQUITIN
NITROCINE 1
MG/ML
SOLUTION FOR
INFUSION, VIAL
NITROLINGUAL
NITROLINGUAL
PUMP SPRAY
NITROLINGUAL
PUMPSPRAY
NITROUS OXIDE
MEDICINAL SOL
Human Medicines Authorised/Transfer Pending Products
N07BA01
N07BA01
C01DA02
-Intra-venous
-NICOTINE
RESINATE
-NICOTINE
RESINATE
-NICOTINE
-NICOTINE
POLACRILEX
USP
-NICOTINE
RESINATE
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
-GLYCERYL
TRINITRATE
-NITROUS
OXIDE
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Oromucosal
Article 10(1) Generic
Application
Article 10(1) Generic
Application
Article 8(3) - Full
new Application
-Oromucosal
Article 8(3) - Full
new Application
Article 8(3) - Full
new Application
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
-Oromucosal
PPA
Article 10a Bibliographical
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
Article 10(4) Similar Biological
App
-Inhalation
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
-Intra-venous
-Subcutaneous
Page 337 of 608
Trade Name
Licence Holder Licence
Number
Strength
Dosage Form ATC
NIZORAL
Imbat Limited
PPA1151/093/00
1
20 mg/g
Shampoo
D01AC08
NIZORAL
PA0823/052/003
20mg/g N/A
Shampoo
D01AC08
PA0823/052/002
20 mg/g
Cream
D01AC08
PA0823/052/001
20 mg/g
Shampoo
D01AC08
NIZORAL
DANDRUFF
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
McNeil
Healthcare
(Ireland) Ltd
PCO
Manufacturing
PPA0465/042/00
1
20 mg/g
Shampoo
D01AC08
NOCTAMID
Bayer Limited
PA1410/009/001
1 Milligram
Tablets
N05CD06
NOCTAMID
Imbat Limited
PPA1151/192/00
1
1 Milligram
Tablets
N05CD06
NOCTAMID
PCO
Manufacturing
PPA0465/402/00
1
1 Milligram
Tablets
N05CD06
NOLETIL XL
Bluefish
Pharmaceuticals
AB
PA1436/024/001
200 Milligram
Tablet Prolonged
Release
N05AH04
Interchangeable
List Code:
IC0019-067-024
PA1436/024/002
300 Milligram
Tablet Prolonged
Release
Interchangeable
List Code:
IC0019-029-024
PA1436/024/003
400 Milligram
Interchangeable
List Code:
IC0019-068-024
PA1347/032/001
NIZORAL 20
MG/G CREAM
NIZORAL
DANDRUFF
NOLETIL XL
NOLETIL XL
Bluefish
Pharmaceuticals
AB
Bluefish
Pharmaceuticals
AB
NOLPACID
Krka d.d., Novo
mesto
NOLPAZA
Krka d.d., Novo
mesto
NOLPAZA
NOLVADEX D
Krka d.d., Novo
mesto
Active
Ingredients
Legal Basis
Routes of
Administration
KETOCONAZOL
E
KETOCONAZOL
E
KETOCONAZOL
E
KETOCONAZOL
E
KETOCONAZOL
E
LORMETAZEPA
M
LORMETAZEPA
M
LORMETAZEPA
M
-QUETIAPINE
HEMIFUMARATE
PPA
Article 10(1) Generic
Application
-Per Oral
N05AH04
-QUETIAPINE
HEMIFUMARATE
Article 10(1) Generic
Application
-Per Oral
Tablet Prolonged
Release
N05AH04
-QUETIAPINE
HEMIFUMARATE
Article 10(1) Generic
Application
-Per Oral
20 Milligram
Tablets GastroResistant
A02BC02
20 Milligram
Tablets GastroResistant
A02BC02
Interchangeable
List Code:
IC0013-003-005
PA1347/006/002
Article 10(1) Generic
Application
Article 10(1) Generic
Application
-Per Oral
PA1347/006/001
40 Milligram
Tablets GastroResistant
A02BC02
Article 10(1) Generic
Application
-Per Oral
Interchangeable
List Code:
IC0013-004-005
PA0970/015/002
20 Milligram
L02BA01
PA2096/005/001
10mg/5 Milligram
Film Coated
Tablet
Prolonged
Release
Capsules
PANTOPRAZOL
E
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
PANTOPRAZOL
E SODIUM
SESQUIHYDRA
TE
-TAMOXIFEN
CITRATE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
-OXYCODONE
HYDROCHLORI
DE
-NALOXONE
HYDROCHLORI
DE DIHYDRATE
NOLXADO
AstraZeneca UK
Limited
HCS bvba
NOLXADO
HCS bvba
PA2096/005/002
20mg/10
Milligram
Prolonged
Release
Capsules
N02AA55
NOLXADO
HCS bvba
PA2096/005/003
40mg/20
Milligram
Prolonged
Release
Capsules
N02AA55
Human Medicines Authorised/Transfer Pending Products
N02AA55
-Topical
-Topical
-Topical