Intravenous iron-containing medicinal products Article-31

Annex I
List of the names, pharmaceutical forms, strengths of the medicinal
products, routes of administration, marketing authorisation holders in the
Member States
1
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
(in EEA)
Austria
Pharmacosmos A/S
Iron (III) hydroxide
CosmoFer 50 mg/ml
Roervangsvej 30
dextran complex
Injektionslösung und
Holbaek DK-4300
50mg/ml
Infusionslösung
Denmark
Austria
VIFOR France SA
Ferric
Ferinject 50 mg Eisen/ml
7-13 Boulevard Paul Emile
carboxymaltose
Injektionslösung oder
Victor
Konzentrat zur Herstellung
92200 Neuilly-sur-Seine
einer Infusionslösung
50mg/ml
injection/infusion
France
Austria
Medice Arzneimittel Pütter
Iron sucrose
FerMed 100 mg/5 ml
GmbH & Co KG
complex
100mg/5ml
Injektionslösung oder
injection
Kuhloweg 37
Konzentrat zur Herstellung
Concentrate for
DE-58638 Iserlohn
einer Infusionslösung
solution for
Germany
Austria
Solution for
Intravenous use
infusion
Fresenius Medical Care
Iron sucrose
Ferrologic 20 mg/ml
Nephrologica Deutschland
complex
Injektionslösung oder
injection
GmbH
Konzentrat zur Herstellung
Concentrate for
Else-Kröner-Strasse 1
einer Infusionslösung
solution for
20mg/ml
61352 Bad Homburg
Solution for
Intravenous use
infusion
Germany
Austria
Pharmacosmos A/S
Iron(III)
Monofer 100 mg/ml
Roervangsvej 30
isomaltoside
Injektions- oder
Holbaek DK-4300
complex
Infusionslösung
Denmark
2
100mg/ml
Solution for
injection/infusion
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Austria
VIFOR France SA
Iron sucrose
Venofer 20 mg/ml -
7-13 Boulevard Paul Emile
complex
20mg/ml
Injektionslösung oder
injection
Victor
Konzentrat zur Herstellung
Concentrate for
92200 Neuilly-sur-Seine
einer Infusionslösung
solution for
France
Belgium
infusion
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
Belgium
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monover
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
Belgium
Belgium
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
Solution for
injection
Victor
Concentrate for
92521 Neuilly-sur-Seine
solution for
France
infusion
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
Carboxymaltose
Intravenous use
Injectafer
50.00 mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Bulgaria
VIFOR France SA
7-13 Boulevard Paul Emile
Ferric
Ferinject
50mg/ml
carboxymaltose
Solution for
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
3
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Bulgaria
Pharmalog AG,
Iron sucrose
33 Cherni vrah blvd.,
complex
Idafer
20mg/ml
injection
1421 Sofia
Bulgaria
Bulgaria
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Solution for
Intravenous use
injection
Holbaek DK-4300
Denmark
Bulgaria
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
Cyprus
VIFOR France SA
7-13 Boulevard Paul Emile
ferric
carboxymaltose
Victor
FERINJECT SOLUTION FOR
50mg/ml
INJECTION OR INFUSION
Solution for
Intravenous use
injection/infusion
50MG IRON/ML
92521 Neuilly-sur-Seine
France
Cyprus
Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Iron(III)
isomaltoside
complex
MONOFER SOLUTION FOR
Iron (III) hydroxide
dextran complex
COSMOFER SOLUTION FOR
100mg/ml
INJECTION OR INFUSION
Solution for
Intravenous use
injection/infusion
100MG/ML
Denmark
Cyprus
Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
INJECTION OR INFUSION
50MG IRON/ML
Denmark
4
50mg/ml
Solution for
injection/infusion
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Cyprus
The Star Medicines
Importers & co ltd,
Iron sucrose
complex
VENOFER INJECTION 100MG
Iron sucrose
complex
FERROLOGIC SOLUTION FOR
100mg/5ml
IRON/5ML
injection
9A Loukis Akritas Street,
P.O.box 50151,
3601 Lemesos, Cyprus
Cyprus
Fresenius Medical Care
Nephrologica Deutschland
20mg/ml
INJECTION/CONCENTRATE
GmbH
FOR SOLUTION FOR
Else-Kröner-Strasse 1
INFUSION 20MG/ML
Solution for
Intravenous use
injection/infusion
61352 Bad Homburg
Germany
Czech
VIFOR France SA
Iron sucrose
Republic
7-13 Boulevard Paul Emile
complex
VENOFER
20mg/ml
Solution for
Intravenous use
injection
Victor
92521 Neuilly-sur-Seine
France
Czech
Fresenius Medical Care
Iron sucrose
Republic
Nephrologica Deutschland
complex
FERROLOGIC 20 MG/ML
20mg/ml
Solution for
Intravenous use
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Czech
PHARMABIDE LTD
Iron sucrose
IRON SUCROSE PHARMABIDE
Republic
20, Lakonias str,
complex
20 MG/ML
20mg/ml
Solution for
injection
15234 Halandri
Concentrate for
Athens - Greece
solution for
infusion
5
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Czech
Orion Corporation,
Iron sucrose
Republic
Orionintie 1,
complex
FERION 20 MG/ML
20mg/ml
injection
FI-02200 Espoo,
Concentrate for
Finland
solution for
infusion
Czech
Sanofi-Aventis, s.r.o.
sodium ferric
Republic
Evropská 846/176a
gluconate complex
FERRLECIT
12.5mg/ml
Solution for
Intravenous use
injection
160 00 Praha 6
Czech Republic
Czech
VIFOR France SA
ferric
Republic
7-13 Boulevard Paul Emile
carboxymaltose
FERINJECT
50mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Denmark
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
Denmark
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Denmark
Orion Corporation,
Iron sucrose
Orionintie 1,
complex
Ferion
20mg/ml
Solution for
injection
FI-02200 Espoo,
Concentrate for
Finland
solution for
infusion
6
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Denmark
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Denmark
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Jerndextran "Pharmacosmos"
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
Denmark
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
MonoFer
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
Denmark
Estonia
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
Solution for
Victor
Concentrate for
92521 Neuilly-sur-Seine
solution for
France
infusion
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Intravenous use
injection
Venofer
20mg/ml
Solution for
injection
Victor
Concentrate for
92521 Neuilly-sur-Seine
solution for
France
infusion
7
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Estonia
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic 20mg/ml
20mg/ml
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Estonia
Orion Corporation,
Iron sucrose
Orionintie 1,
complex
Ferion
20mg/ml
Solution for
Intravenous use
injection
FI-02200 Espoo,
Concentrate for
Finland
solution for
infusion
Estonia
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
Holbaek DK-4300
Denmark
Estonia
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
injection/infusion
Denmark
Estonia
Lek Pharmaceuticals d.d.
Iron (III) hydroxide
Verovškova 57
dextran complex
Ferrum Lek
50mg/ml
Solution for
Intramuscular use
injection
1526 Ljubljana
Slovenia
Finland
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
Solution for
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
8
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Finland
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Finland
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
Victor
Concentrate for
92521 Neuilly-sur-Seine
solution for
infusion
Alternova A/S
Iron sucrose
Lodshusvej 11
complex
Venotrix
20mg/ml
Concentrate for
Intravenous use
solution for
4230 Skaelskoer
infusion/solution
Denmark
Finland
Intravenous use
injection
France
Finland
Solution for
for injection
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
Finland
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
France
VIFOR France SA
Ferric
FERINJECT 50 mg/ml, solution
7-13 Boulevard Paul Emile
Carboxymaltose
injectable/pour perfusion
Victor
92521 Neuilly-sur-Seine
France
9
50mg/ml
Solution for
injection/infusion
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
France
VIFOR France SA
Iron sucrose
VENOFER 20mg/ml, solution
7-13 Boulevard Paul Emile
complex
injectable
Pharmacosmos A/S
Iron (III) hydroxide
FERRISAT 50 mg/ml, solution
Roervangsvej 30
dextran complex
injectable ou pour perfusion
Pharmaki Generics Ltd
Iron sucrose
FER ACTAVIS 100 mg/5 ml,
5 Bourlet Close
complex
solution injectable
IBD3 Pharma Consulting
Iron sucrose
FER IBD3 PHARMA
Immeuble l'Orient
complex
20mg/ml
injection
Victor
92521 Neuilly-sur-Seine
France
France
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
France
100mg/5ml
Solution for
Intravenous use
injection
W1W 7BL London
United Kingdom
France
100mg/5ml
Concentrate for
CONSULTING 100 mg/5 ml,
solution for
10, place Charles
solution à diluer pour
infusion
Béraudier
perfusion
Intravenous use
69003 Lyon
France
France
Mylan SAS
Iron sucrose
FER MYLAN 100 mg/5 ml,
117, allée des Parcs
complex
solution à diluer pour
solution for
perfusion
infusion
69800 Saint-Priest
100mg/5ml
Concentrate for
Intravenous use
France
France
SANDOZ
Iron sucrose
FER SANDOZ 100 mg/5 ml,
49, avenue Georges
complex
solution à diluer pour
solution for
perfusion
infusion
Pompidou
92300 Levallois-Perret
France
10
100mg/5ml
Concentrate for
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
France
TEVA SANTE
Iron sucrose
FER TEVA PHARMA 100 mg/5
100mg/5ml
110, Esplanade du Général
complex
ml, solution injectable (IV)
Fresenius Medical Care
Iron sucrose
Ferrologic 20 mg/ml
Nephrologica Deutschland
complex
Injektionslösung/ Konzentrat
solution for
GmbH
zur Herstellung einer
infusion/solution
Else-Kröner-Strasse 1
Infusionslösung
for injection
injection
de Gaulle
92931 Paris La Défense
Cedex
FRANCE
Germany
1709mg/5ml
Concentrate for
Intravenous use
61352 Bad Homburg
Germany
Germany
Medice Arzneimittel Pütter
Iron sucrose
GmbH & Co KG
complex
FerMed
1563 -
Concentrate for
1887mg/5ml
solution for
Kuhloweg 37
infusion/solution
DE-58638 Iserlohn
for injection
Intravenous use
Germany
Germany
Medice Arzneimittel Pütter
Iron sucrose
GmbH & Co KG
complex
Nefro-Fer
1563 -
Solution for
1887mg/5ml
injection
Intravenous use
Kuhloweg 37
DE-58638 Iserlohn
Germany
Germany
Pharmacosmos A/S
Iron(III)
Monofer 100 mg/ml Lösung
377-
Solution for
Roervangsvej 30
isomaltoside
zur Injektion/Infusion
465mg/ml
injection/infusion
Holbaek DK-4300
complex
Denmark
11
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Pharmaceutical
Route of
form
administration
1288.9mg/3.2
Solution for
Intravenous use
ml
injection
2013.9mg/5m
Solution for
l
injection
312.5mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
Strength
(in EEA)
Germany
Sanofi-Aventis
sodium ferric
Deutschland GmbH
gluconate complex
Ferrlecit 40 mg
Brüningstrasse 50,
D-65926 Frankfurt am
Main Germany
Germany
Sanofi-Aventis
sodium ferric
Deutschland GmbH
gluconate complex
Ferrlecit 62,5 mg
Intravenous use
Brüningstrasse 50,
D-65926 Frankfurt am
Main Germany
Germany
Pharmacosmos A/S
Iron (III) hydroxide
CosmoFer 50 mg/ml
Roervangsvei 30
dextran complex
Injektionslösong und
Holbaek DK-4300
Infusionslösung
Denmark
Germany
VIFOR France SA
Ferric
FERINJECT 50 mg Eisen/ml
7-13 Boulevard Paul Emile
carboxymaltose
Injektions- und
Victor
complex
Infusionslösung
VIFOR France SA
Iron sucrose
Venofer 20 mg FR / ml
7-13 Boulevard Paul Emile
complex
Injektionslösung
180mg/ml
injection/infusion
92521 Neuilly-sur-Seine
France
Germany
2700mg/5ml
Concentrate for
solution for
Victor
infusion/solution
92521 Neuilly-sur-Seine
for injection
France
12
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Greece
Greece
Medicus SA
Iron sucrose
Valaoritou 10
complex
REOXYL
100mg/5ml
injection
Metamorfosi
Concentrate for
Attikis 14452
solution for
Greece
infusion
Vianex S.A.
Iron sucrose
Tatoiou Street
complex
INTRAFER
100mg/5ml
Solution for
Intravenous use
injection
Nea Erythrea 14671
Concentrate for
Greece
solution for
infusion
Greece
Alapis ABEE
Iron sucrose
Aftokratoros Nikolaou 2
complex
FAREMIO
100mg/5ml
Solution for
Intravenous use
injection
Athens 17671
Concentrate for
Greece
solution for
infusion
Greece
Intermed ABEE
Iron sucrose
Kalyftaki 27
complex
DEXTRIFER-S
100mg/5ml
Solution for
Intravenous use
injection
Athens 14564
Concentrate for
Greece
solution for
infusion
Greece
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
VENOFER
100mg/5ml
Solution for
injection
Victor
Concentrate for
92521 Neuilly-sur-Seine
solution for
France
infusion
13
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
(in EEA)
Greece
Demo ABEE
Iron (III) hydroxide
21ST Km National
dextran
COSMOFER
50mg/ml
Highway
Athens-Lamia, 14565
Greece
Greece
Rafarm AEBE
Iron sucrose
Korinthou 12,
complex
FERROVIN
100mg/5ml
injection
N. Psychiko, 15451
Concentrate for
Greece
solution for
infusion
Greece
Nephrotech S.A.
Iron sucrose
Parnithos 44
complex
SUCRO-FER
100mg/5ml
Solution for
Intravenous use
injection
Metamorfosi Attikis 14452
Concentrate for
Greece
solution for
infusion
Greece
Uni-Pharma Kleon Tseitis
Iron sucrose
Pharmaceutical
complex
HEMAFER-S
100mg/5ml
Concentrate for
Intravenous use
solution for
Laboratories
infusion
14KM National Highway
Athens-Lamia
Kifissia 14564
Greece
Greece
Verisfield (UK) Ltd, U.K.
Iron sucrose
41 Chalton street
complex
NEPHROFEROL
100mg/5ml
Solution for
injection
London, NW1 1JD
Concentrate for
United Kingdom
solution for
infusion
14
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Greece
Greece
HELP ABEE
Iron sucrose
Valaoritou 10
complex
FERRINEMIA
100mg/5ml
injection
Metamorfosi
Concentrate for
Attikis, 14452
solution for
Greece
infusion
Specifar AEBE
Iron sucrose
28th October Street 1
complex
ALVOFER
100mg/5ml
Concentrate for
Intravenous use
solution for
Agia Barbara 12351
infusion
Greece
Greece
Alet Pharmaceuticals
Iron sucrose
M. Alexander 121,
complex
SUCROVEN
100mg/5ml
Concentrate for
Intravenous use
solution for
Agia Varvara, 12351
infusion
Greece
Greece
Target Pharma Ltd
Iron sucrose
Menandrou 54
complex
IRONCROSE
20mg/ml
Solution for
Intravenous use
injection
Athens 10431
Concentrate for
Greece
solution for
infusion
Greece
HELP ABEE
Iron (III) hydroxide
Valaoritou 10
dextran complex
IRONATE
50mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
injection/infusion
intramuscular use
Metamorfosi
Attikis, 14452
Greece
Greece
Demo ABEE
Iron(III)
21st km National Highway
isomaltoside
Athens-Lamia, 14565
complex
MONOFER
Greece
15
100mg/ml
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Concentrate for
Intravenous use
(in EEA)
Greece
Viofar EPE
Iron sucrose
Ethnikis Antistaseos &
complex
VENIRON
100mg/5ml
solution for
Trifyllias,
infusion
Aharnai, 13671
Greece
Greece
Medicus SA
Iron (III) hydroxide
IRON (III)-HYDROXIDE
Valaoritou 10
dextran complex
DEXTRAN
Metamorfosi
COMPLEX/BIOMEDIC
Attikis 14452
LABORATORIES
50mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
Greece
Hungary
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Hungary
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Hungary
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
Solution for
injection/infusion
GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany
16
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Hungary
Sanofi-Aventis Zrt
Sodium ferric
Tó utca 1-5,
gluconate complex
Ferrlecit
12.5mg/ml
injection
1045 Budapest
Hungary
Iceland
VIFOR France SA
ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Iceland
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
Solution for
Intravenous use
infusion
Denmark
Iceland
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
Solution for
Intravenous use
injection
Victor
92521 Neuilly-sur-Seine
France
Ireland
Pharmacosmos A/S
Iron (III) hydroxide
CosmoFer 50mg/ml solution
Roervangsvej 30
dextran complex
for infusion and injection
Pharmacosmos A/S
Iron(III)
Monover 100mg/ml solution
Roervangsvej 30
isomaltoside
for injection/infusion
Holbaek DK-4300
complex
(ampoules)
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
Ireland
Denmark
17
100mg/ml
Solution for
injection/infusion
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Ireland
Pharmacosmos A/S
Iron(III)
Monover 100mg/ml solution
Roervangsvej 30
isomaltoside
for injection/infusion (vials)
Holbaek DK-4300
complex
100mg/ml
injection/infusion
Denmark
Ireland
VIFOR France SA
Iron sucrose
Venofer 20 mg iron/ml
7-13 Boulevard Paul Emile
complex
solution for injection or
20mg/ml
injection
Victor
concentrate for solution for
Concentrate for
92521 Neuilly-sur-Seine
infusion, ampoule
solution for
France
Ireland
Solution for
Intravenous use
infusion
VIFOR France SA
ferric
FERINJECT 50 mg iron/ml
7-13 Boulevard Paul Emile
carboxymaltose
solution for injection/infusion
VIFOR France SA
Iron sucrose
Venofer 20 mg iron/ml
7-13 Boulevard Paul Emile
complex)
solution for injection or
50mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Ireland
Victor
concentrate for solution for
92521 Neuilly-sur-Seine
infusion, vial
20mg/ml
Solution for
Intravenous use
injection/infusion
France
Ireland
Fresenius Medical Care
Iron sucrose
FerroLogic 20 mg/ml solution
Nephrologica Deutschland
complex
for injection/concentrate for
GmbH
solution for infusion
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany
18
20mg/ml
Solution for
injection
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Italy
VIFOR France SA
ferric
7-13 Boulevard Paul Emile
carboxymaltose
FERINJECT
50mg/ml
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Italy
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
FERRO SACCARATO FME
20mg/ml
Concentrate for
Intravenous use
solution for
GmbH
infusion/solution
Else-Kröner-Strasse 1
for injection
61352 Bad Homburg
Germany
Italy
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
VENOFER
20mg/ml
Solution for
Intravenous use
injection
Victor
92521 Neuilly-sur-Seine
France
Italy
Sanofi-Aventis SPA
sodium ferric
Viale Luigi Bodio, 37/B
gluconate complex
FERLIXIT
62,5mg/5ml
20158 Milano
Oral solution or
Oral use
solution for
Intravenous use
infusion
Italy
Latvia
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
Solution for
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
19
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Latvia
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
injection
Victor
92521 Neuilly-sur-Seine
France
Latvia
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
FerroLogic
20mg/ml
Solution for
Intravenous use
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Latvia
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
CosmoFer
50mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
Holbaek DK-4300
Denmark
Latvia
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
injection/infusion
Denmark
Lithuania
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
Solution for
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
20
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Lithuania
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
injection
Victor
92521 Neuilly-sur-Seine
France
Lithuania
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
Solution for
Intravenous use
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Lithuania
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
Lithuania
Pharmacosmos A/S
Ferric (III) hydroxide
Roervangsvej 30
dextran complex
CosmoFer
50mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
Holbaek DK-4300
Denmark
Luxembourg
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Injectafer-50mg/l
50mg/ml
injection
Victor
92521 Neuilly-sur-Seine
France
Luxembourg
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer-50mg/ml
50mg/ml
Solution for
injection
Holbaek DK-4300
Denmark
21
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Luxembourg
Medice Arzneimittel Pütter
Iron sucrose
GmbH & Co KG
complex
Fermed-100mg/5ml
100mg/5ml
perfusion
Kuhloweg 37
DE-58638 Iserlohn
Germany
Luxembourg
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic-20mg/ml
20mg/ml
Solution for
Intravenous use
perfusion
GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany
Malta
VIFOR France SA
ferric
FERINJECT 50 mg iron/ml
50mg/ml
Solution for
7-13 Boulevard Paul Emile
carboxymaltose
solution for injection/infusion
Fresenius Medical Care
Iron sucrose
Ferrologic 20 mg/ml solution
Nephrologica Deutschland
complex.
for injection/concentrate for
injection
solution for infusion
Concentrate for
Intravenous use
injection/infusion
Victor
92200 Neuilly-sur-Seine
France
Malta
GmbH
20mg/ml
Solution for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Intravenous use
Germany
Norway
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Solution for
injection/infusion
Holbaek DK-4300
Denmark
22
Parenteral use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Parenteral use
(in EEA)
Norway
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Norway
Orion Corporation,
Iron sucrose
Orionintie 1,
complex
Ferion
20mg/ml
Solution for
Parenteral use
injection
FI-02200 Espoo,
Concentrate for
Finland
solution for
infusion
Norway
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
Solution for
Parenteral use
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Norway
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
Solution for
Parenteral use
injection/infusion
Denmark
Norway
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Uniferon
200mg/ml
Solution for
injection
Holbaek DK-4300
Denmark
23
Parenteral use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Parenteral use
(in EEA)
Norway
Poland
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
injection
Victor
Concentrate for
92521 Neuilly-sur-Seine
solution for
France
infusion
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
CosmoFer
50mg/ml
Solution for
Intravenous use
injection/infusion
Holbaek DK-4300
Denmark
Poland
VIFOR France SA
ferric
123 Rue Jules Guesde
carboxymaltose
Ferinject
50mg/ml
Solution for
Intravenous use
injection
92200 Neuilly-sur-Seine
France
Poland
VIFOR France SA
Iron sucrose
123 Rue Jules Guesde
complex
Venofer
20mg/ml
Solution for
Intravenous use
injection/infusion
92200 Neuilly-sur-Seine
France
Poland
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic 20 mg/ml
20mg/ml
Intravenous use
injection
GmbH
Concentrate for
61346 Bad Homburg
solution for
Germany
Poland
Solution for
infusion
Sandoz GmbH
Iron(III)
Biochemiestrasse 10
isomaltoside
A-6250 Kundl
complex
Ferrum-Lek
50mg/ml
Solution for
injection
Austria
24
Intramuscular use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Poland
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monover
100mg/ml
injection/infusion
Denmark
Portugal
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Referen
100mg/5ml
Solution for
Intravenous use
injection
GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany
Portugal
Vifor France, SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer
100mg/5ml
Solution for
Intravenous use
injection
Victor
92200 Neuilly-sur-Seine
France
Portugal
Combino Pharm Portugal,
Iron sucrose
Óxido Férrico Sacarosado
Unipessoal, Lda.
complex
Combino
100mg/5ml
Solution for
injection
Lagoas Park
Edifício 8
Piso 0 2740-268 Porto
Salvo
Portugal
25
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Portugal
Farmoz - Sociedade
Iron sucrose
Óxido Férrico Sacarosado
Técnico Medicinal, S.A.
complex
Farmoz
Generis Farmacêutica,
Iron sucrose
Óxido Férrico Sacarosado
S.A.
complex
Generis
Laboratórios Normon, S.A.
Iron sucrose
Óxido Férrico Sacarosado
Rua Armando Villar,
complex
Normon
Vifor France, SA
Ferric
Ferinject
7-13 Boulevard Paul Emile
carboxymaltose
100mg/5ml
injection
Rua da Tapada Grande,
2,
Abrunheira
2710-089 Sintra
Portugal
Portugal
100mg/5ml
Solution for
Intravenous use
injection
Rua João de Deus, 19
2700-487 Amadora
Portugal
Portugal
100mg/5ml
Solution for
Intravenous use
injection
Lote 42 1º Dto. Quinta das
Patinhas, Cobre
2750 - 777 Cascais
Portugal
Portugal
50mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92200 Neuilly-sur-Seine
France
Portugal
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Holbaek DK-4300
Denmark
26
Solution for
Intravenous use
injection/infusion
intramuscular use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Portugal
Pharmacosmos A/S
Iron (III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofar
100mg/ml
injection/infusion
Denmark
Romania
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
VENOFER®
20mg/ml
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
injection/infusion
intramuscular use
Solution for
Intravenous use
Victor
92521 Neuilly-sur-Seine
France
Romania
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
MONOFER 100 mg/ml
100mg/ml
Denmark
Romania
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
FERINJECT 50 mg fer/ml
50mg/ml
Victor
92521 Neuilly-sur-Seine
France
Slovak
VIFOR France SA
Ferric
Republic
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Slovak
Orion Corporation,
Iron sucrose
Republic
Orionintie 1,
complex
Ferion 20 mg/ml
20mg/ml
Solution for
injection
FI-02200 Espoo,
Concentrate for
Finland
solution for
infusion
27
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Slovak
Fresenius Medical Care
Iron sucrose
Republic
Nephrologica Deutschland
complex
Ferrologic 20 mg/ml
20mg/ml
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
Slovak
VIFOR France SA
Iron sucrose
Republic
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
Solution for
Intravenous use
injection
Victor
92521 Neuilly-sur-Seine
France
Slovenia
Fresenius Medical Care
Iron sucrose
Ferrologic 20 mg/ml raztopina
Nephrologica Deutschland
complex
za injiciranje/ koncentrat za
injection
raztopino za infundiranje
Concentrate for
GmbH
20mg/ml
Solution for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Intravenous use
Germany
Slovenia
VIFOR France SA
carboxymaltose
7-13 Boulevard Paul Emile
Iroprem 50 mg/ml raztopina
50mg/ml
za iniciranje ali infundiranje
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
Slovenia
Lek farmacevtska družba
Iron sucrose
Venofer 20 mg/ml raztopina
d.d.,
complex
za injiciranje/ koncentrat za
injection
raztopino za infundiranje
Concentrate for
Verovškova 57,
20mg/ml
Solution for
1000 Ljubljana
solution for
Slovenia
infusion
28
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
intramuscular use
(in EEA)
Spain
Pharmacosmos A/S
Iron (III) hydroxide
COSMOFER 50 mg/ml
Roervangsvej 30
dextran complex
SOLUCION PARA PERFUSION
injection
E INYECCION
Solution for
Holbaek DK-4300
50mg/ml
Denmark
Spain
Spain
infusion
GUERBET B.P.
Iron sucrose
ENDOREM 11,2 mg FE/ml
57400 ROISSY CdG
complex
CONCENTRADO PARA
11,2mg/ml
suspension for
CEDEX F-95943
SUSPENSION PARA
infusion
France
PERFUSION
20mg/ml
Concentrate for
G.E.S. Genericos
Iron sucrose
FERIV 20mg/ml SOLUCION
Espanoles Laboratorio
complex
INYECTABLE O
injection
S.A.Cólquide, 6 - Portal 2,
CONCENTRADO PARA
Concentrate for
1 Oficina F.Las Rozas
SOLUCION PARA PERFUSION
solution for
28230 MADRID
Solution for
Intravenous use
Intravenous use
infusion
Spain
Spain
Fresenius Medical Care
Iron sucrose
HIERRO SACAROSA FME 20
Nephrologica Deutschland
complex
20mg/ml
Solution for
mg/ml SOLUCION
injection
GmbH
INYECTABLE O
Concentrate for
Else-Kröner-Strasse 1
CONCENTRADO PARA
solution for
61346 Bad Homburg
SOLUCION PARA PERFUSION
infusion
Intravenous use
Germany
Spain
Laboratorios Normon S.A.
Iron sucrose
HIERRO SACAROSA NORMON
Ronda de Valdecarrizo 6
complex
20mg/ml
Solution for
20 mg/ml SOLUCION
injection
28760 Tres Cantos
INYECTABLE O
Concentrate for
Madrid
CONCENTRADO PARA
solution for
Spain
SOLUCION PARA PERFUSION
infusion
29
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Spain
Medice Arzneimittel Pütter
Iron sucrose
FERMED 100 mg/ 5 ml
GmbH & Co KG
complex
100mg/5ml
SOLUCION INYECTABLE O
injection
Kuhloweg 37
CONCENTRADO PARA
Concentrate for
DE-58638 Iserlohn
SOLUCION PARA PERFUSION
solution for
Germany
Spain
infusion
VIFOR France SA
Iron sucrose
VENOFER 20 mg/ml
7-13 Boulevard Paul Emile
complex
20mg/ml
SOLUCION INYECTABLE O
injection
Victor
CONCENTRADO PARA
Concentrate for
92521 Neuilly-sur-Seine
SOLUCION PARA PERFUSION
solution for
France
Spain
Solution for
Intravenous use
infusion
VIFOR France SA
Ferric
FERINJECT 50 mg/ml
7-13 Boulevard Paul Emile
carboxymaltose
SOLUCION INYECTABLE Y
injection
PARA PERFUSION
Solution for
Victor
50mg/ml
92521 Neuilly-sur-Seine
Solution for
Intravenous use
infusion
France
Spain
Pharmacosmos A/S
Iron(III)
MONOFERRO 100 mg/ml
100mg/ml
Roervangsvej 30
isomaltoside
SOLUCIÓN INYECTABLE O
injection
Holbaek DK-4300
complex
PARA PERFUSIÓN
Solution for
Denmark
Sweden
Solution for
Intravenous use
infusion
VIFOR France SA
Iron sucrose
7-13 Boulevard Paul Emile
complex
Venofer®
20mg/ml
Concentrate for
Intravenous use
solution for
Victor
injection
92200 Neuilly-sur-Seine
France
Sweden
Pharmacosmos A/S
Iron (III) hydroxide
Roervangsvej 30
dextran complex
Cosmofer®
50mg/ml
Solution for
injection
Holbaek DK-4300
Denmark
30
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
Sweden
VIFOR France SA
Ferric
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
injection
Victor
92200 Neuilly-sur-Seine
France
Sweden
Fresenius Medical Care
Iron sucrose
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
Concentrate for
Intravenous use
solution for
GmbH
injection
Else-Kröner-Strasse 1
61346 Bad Homburg
Germany
Sweden
Orion Corporation,
Iron sucrose
Orionintie 1,
complex
Ferion
20mg/ml
Concentrate for
Intravenous use
solution for
FI-02200 Espoo,
injection
Finland
Sweden
Pharmacosmos A/S
Iron(III)
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
MonoFer®
100mg/ml
Solution for
Intravenous use
injection
Denmark
The
Pharmamatch B.V.
Iron sucrose
IJzerhydroxide sacharose
Netherlands
Egelenburg 2
complex
complex bevattende 20 mg/ml
injection
Amsterdam GK - 1081
IJzer PHARMAMATCH,
Concentrate for
The Netherlands
oplossing/concentraat voor
solution for
oplossing voor injectie
infusion
31
20mg/ml
Solution for
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
The
Fresenius Medical Care
Iron sucrose
FerroLogic 20 mg/ml,
Netherlands
Nephrologica Deutschland
complex
20mg/ml
oplossing voor injectie of
injection
GmbH
concentraat voor oplossing
Concentrate for
Else-Kröner-Strasse 1
voor infusie
solution for
61352 Bad Homburg
infusion
Germany
The
Pharmacosmos A/S
Iron(III)
MonoFer 100 mg/ml oplossing
Netherlands
Roervangsvej 30
isomaltoside
voor injectie/infusie
Holbaek DK-4300
complex
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
The
VIFOR France SA
Iron sucrose
Venofer 20 mg/ml ijzer (III),
Netherlands
7-13 Boulevard Paul Emile
complex
oplossing voor injectie of
20mg/ml
injection
Victor
concentraat voor oplossing
Concentrate for
92521 Neuilly-sur-Seine
voor intraveneuze infusie
solution for
France
Solution for
Intravenous use
infusion
The
VIFOR France SA
Ferric
FERINJECT 50 mg ijzer/ ml,
Netherlands
7-13 Boulevard Paul Emile
carboxymaltose
oplossing voor injectie/infusie
50mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
The
Pharmacosmos A/S
Iron (III) hydroxide
CosmoFer 50 mg/ml oplossing
Netherlands
Roervangsvej 30
dextran complex
voor infusie en injectie
Holbaek DK-4300
Denmark
32
50mg/ml
Solution for
injection/infusion
Intravenous use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
The
Pharmachemie B.V.
Iron sucrose
IJzerhydroxide sacharose
Netherlands
Haarlem - 2031 GA
complex
complex 20 mg/ml PCH,
injection
oplossing voor
Concentrate for
injectie/concentraat voor
solution for
oplossing voor infusie
infusion
The Netherlands
United
VIFOR France SA
Iron sucrose
Kingdom
7-13 Boulevard Paul Emile
complex
Venofer
20mg/ml
20mg/ml
Solution for
Intravenous use
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
United
Pharmacosmos A/S
Iron(III)
Kingdom
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Monofer
100mg/ml
Solution for
Intravenous use
injection/infusion
Denmark
United
Pharmacosmos A/S
Iron(III)
Kingdom
Roervangsvej 30
isomaltoside
Holbaek DK-4300
complex
Diafer
50mg/ml
Solution for
Intravenous use
injection
Denmark
United
Pharmacosmos A/S
Iron (III) hydroxide
Kingdom
Roervangsvej 30
dextran complex
Cosmofer
50mg/ml
Holbaek DK-4300
Denmark
33
Solution for
Intravenous use
injection/infusion
intramuscular use
Member
Marketing authorisation
State
holder
INN
Invented name
Strength
Pharmaceutical
Route of
form
administration
Solution for
Intravenous use
(in EEA)
United
Fresenius Medical Care
Iron sucrose
Kingdom
Nephrologica Deutschland
complex
Ferrologic
20mg/ml
injection
GmbH
Concentrate for
Else-Kröner-Strasse 1
solution for
61352 Bad Homburg
infusion
Germany
United
VIFOR France SA
Ferric
Kingdom
7-13 Boulevard Paul Emile
carboxymaltose
Ferinject
50mg/ml
Solution for
injection/infusion
Victor
92521 Neuilly-sur-Seine
France
34
Intravenous use