List
of the medicines recommended for registration by N 8-1/16 meeting decision of
the Pharmacological Council of MoH of RA dated on August 17, 2016
President___________________E. Amroyan
N
1.
2.
3.
4.
5.
6.
Trade
name
International nonproprietary
(generic) names or
names of active
substances
Methadone
Hydrochlori
de
methadone
(methadone
hydrochloride)
Eslidin
lipoid PPL-400
(phospholipids),
methionine
Eslidin
Diacarb
Tinidazol
Stopress
lipoid PPL-400
(phospholipids),
methionine
acetazolamide
tinidazole
perindopril
(perindopril tertbutylamine)
dosage strength &
output form
(packaging)
Manufacturer
concentrate for
oral solution
25mg/ml; 150ml
glass bottle
Rusan Pharma Ltd., Khasra
No122MI, Central Hope
Town, Selaqui, Dehradun
248 197, Uttarakhand
capsules
300mg+100mg;
(30/3x10/) in
blister
Nizhpharm JSC, 603950,
Nizhny Novgorod, GSP-459,
Salganskaya st., 7
300mg+100mg;
(30/3x10/) in
blister
Makiz-Pharma LLC, 6
Avtomobilny proezd,
buildings 4, 6, 8, 109029,
Moscow
250mg; (30/3x10/)
in blister
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Starogard Gdanski
500mg; (4/1x4/) in
blister, (16/4x4/) in
blister
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Starogard Gdanski
dosage form
capsules
tablets
tablets coated
tablets
4mg; (30/3x10/) in
blister
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
country
License holder
License
holder
country
India
Rusan Pharma Ltd.,
58-D, Govt. Ind. Estate
Charkop, Kandivli
(West) Mumbai-400
067
India
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Starogard Gdanski
Poland
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Starogard Gdanski
Poland
Russia
Russia
Poland
Poland
Poland
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Prescription
status
R
Conclusion
N & date
15875
17.08.2016
15876
OTC
17.08.2016
15877
OTC
17.08.2016
15878
R
17.08.2016
15879
R
17.08.2016
15880
Poland
R
17.08.2016
1
7.
8.
9.
10.
11.
12.
13.
14.
Stopress
Imodium
Sodium
adenosintri
phosphateDarnitsa
PlasmoTech 10
ZimagraODS 50
Kenalog
Kenalog 40
Hexiloc
perindopril
(perindopril tertbutylamine)
tablets
Starogard Gdanski
Starogard Gdanski
8mg; (30/3x10/) in
blister
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Starogard Gdanski
Pharmaceutical Works
Polpharma S.A., ul.
Pelplinska 19, 83-200
Starogard Gdanski
Poland
2mg; (6/1x6/) and
(20/1x20/) in
blister
Janssen-Cilag, Domaine de
Maigremont, 27100 Val De
Reuil
Johnson & Johnson
LLC, 121614, Moscow,
Krylatskaya str., 17,
building 2
Russia
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Boryspilska Str.,13
Ukraine
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
Armenia
R
India
R
Poland
loperamide
(loperamide
hydrochloride)
capsules
adenosintriphosph
ate
(adenosintriphosp
hate disodium)
solution for
injection
10mg/ml;
(10/2x5/)
ampoules 1ml
Darnitsa Pharmaceutical
Firm PrJSC, 02093, Kiev,
Boryspilska Str.,13
Ukraine
solution for
infusion
100mg/ml; 50ml,
100ml, 200ml,
250ml, 400ml,
500ml and 1000ml
plastic pack
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111
Republic of
Armenia
50mg; (4), (10)
sachets
Zim Laboratories Ltd., B21/22, MIDC Area,
Kalmeshwar-441 501, Dist.
Nagpur (M.S.)
hydroxyethyl
starch
sildenafil
(sildenafil citrate)
triamcinolone
films
orodispersible
tablets
4mg; (50) in glass
bottle
KRKA d.d., Novo mesto,
Smarjeska cesta 6, 8501
Novo Mesto
France
India
Zim Laboratories Ltd.,
Ground Floor, Sadoday
Gyan, Nelson Square,
Chhindwara Road,
15881
R
17.08.2016
15882
OTC
17.08.2016
15884
R
17.08.2016
15885
17.08.2016
15886
17.08.2016
Nagpur-440 013
Slovenia
triamcinolone
(triamcinolone
acetonide)
suspension for
injection
40mg/ml; (5)
ampoules 1ml
KRKA d.d., Novo mesto,
Smarjeska cesta 6, 8501
Novo Mesto
Slovenia
chlorhexidine
(chlorhexidine
gel for external
1.2mg/ml; 10ml,
15ml, 25ml and
Arsanit Ltd, 110 Yerevanyan
str., Masis- batch releaser,
Republic of
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia
Arsanit Ltd, 110
Republic of
15887
R
17.08.2016
15888
R
17.08.2016
OTC
15890
2
Denta
15.
16.
17.
18.
Febrofid
Domoseda
n gel
Herpevir
Herpevir
digluconate)
ketoprofen
detomidine
(detomidine
hydrochloride)
aciclovir
aciclovir
use
30ml plastic vial
with pump
dispenser and
plastic or glass
vial with applicator
secondary packager,
PharmaTech CJSC, 111
Raffi str., 0064, Yerevan,
Republic of Armenia-bulk
manufacturer, primary
packager
gel for external
use
25mg/g; 30g
aluminium tube,
50g aluminium
tube
Medana Pharma JSC, 98200 Sieradz, W. Lokietka 10
- batch releaser, Medana
Pharma JSC, str. Polskiej
Organizacji Wojskowej 57,
98-200 Sieradz, Poland-bulk
manufacturer, packager
gel
oromucosal
7,6mg/ml; (1) prefilled syringe 3ml
Orion Corporation, Orionintie
1, 02200 Espoo
tablets
200mg; (20/2x10/)
in blister
Kievmedpreparat PJSC,
01032, Kiev, Saksaganskogo
street, 139
400mg; (10/1x10/)
in blister
Kievmedpreparat PJSC,
01032, Kiev, Saksaganskogo
street, 139
tablets
Armenia
Yerevanyan str., Masis
Armenia
Poland
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10
Poland
Finland
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8
Ukraine
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
Armenia
R
Russia
OTC
Ukraine
Ukraine
19.
Atropine
sulfate
atropine (atropine
sulfate)
solution for
i/m, i/v and s/c
injection
1mg/ml; (10)
ampoules 1ml
Pharmaceutical Company
"Zdorovye" LLC, 61013,
Kharkov, Shevchenko str.,
22
Ukraine
20.
ManniTech 10%
mannitol
solution for
infusion
100mg/ml; 200ml,
250ml, 400ml and
500ml plastic pack
PharmaTech CJSC, 0064,
Yerevan, Raffi str. 111
Republic of
Armenia
Grippferon
interferon alfa-2b
10000IU/ml; 5ml
and 10ml plastic
FIRN M CJSC, 4,
Dzerzhinskogo str.,
Kokoshkino Settlement,
21.
drops nasal
Russia
"FIRN M" CJSC, 15/1,
entrance "B", Borby
square, Moscow,
17.08.2016
15891
R
17.08.2016
15892
OTC
17.08.2016
15894
R
17.08.2016
15895
R
17.08.2016
15896
R
17.08.2016
15897
17.08.2016
15898
3
vial with dropper
22.
23.
24.
Herpferon
Amlodipine
Amlodipine
Cefotaxime
25.
Atb 1g
26.
27.
Mertenil
Mertenil
interferon alfa-2b,
aciclovir, lidocaine
(lidocaine
hydrochloride)
amlodipine
(amlodipine
besilate)
amlodipine
(amlodipine
besilate)
ointment for
external use
tablets
tablets
Naro-Fominsky district,
Moskow region, 143390
20000IU/g+30mg/
g+10mg/g; 5g,
10g and 30g
aluminium tube
FIRN M CJSC, 4,
Dzerzhinskogo str.,
Kokoshkino Settlement,
Naro-Fominsky district,
Moskow region, 143390
5mg; (30/3x10/) in
blister
Open joint stock company
"Borisovskiy zavod
medicinskikh preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
10mg; (30/3x10/)
in blister
Open joint stock company
"Borisovskiy zavod
medicinskikh preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus
Romania
Hungary
cefotaxime
(cefotaxime
sodium)
powder for
solution for
injection/infusi
on
1000mg; (1), (10),
(50) glass vial
Antibiotice S.A., 1 Valea
Lupului str., 707410 lasibatch releaser, Facta
Farmaceutici S.p.A., Nucleo
Industriale S. Atto, 64100
TERAMO (TE), Italy-bulk
manufacturer, packager
rosuvastatin
(rosuvastatin
calcium)
tablets filmcoated
20mg; (30/3x10/)
in blister
Gedeon Richter PLC,
Gyomroi ut 19-21, 1103
Budapest
10mg; (30/3x10/)
in blister
Gedeon Richter PLC,
Gyomroi ut 19-21, 1103
Budapest
rosuvastatin
(rosuvastatin
calcium)
tablets filmcoated
127055
Russia
Belarus
Hungary
17.08.2016
"FIRN M" CJSC, 15/1,
entrance "B", Borby
square, Moscow,
127055
Russia
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus
Antibiotice S.A., 1
Valea Lupului str.,
707410 lasi
Romania
Gedeon Richter PLC,
Gyomroi ut 19-21, 1103
Budapest
Hungary
Gedeon Richter PLC,
Gyomroi ut 19-21, 1103
Budapest
15899
OTC
17.08.2016
15900
R
17.08.2016
15901
R
17.08.2016
15902
R
17.08.2016
15903
R
17.08.2016
15904
Hungary
R
17.08.2016
4
28.
29.
30.
31.
32.
33.
34.
Mertenil
Lortenza
Lortenza
Lortenza
Lortenza
Depakine
enteric 300
Famotidine
rosuvastatin
(rosuvastatin
calcium)
tablets filmcoated
5mg; (30/3x10/) in
blister
Gedeon Richter PLC,
Gyomroi ut 19-21, 1103
Budapest
Hungary
amlodipine
(amlodipine
besilate), losartan
(losartan
potassium)
tablets filmcoated
5mg+50mg;
(30/3x10/) in
blister
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
amlodipine
(amlodipine
besilate), losartan
(losartan
potassium)
tablets filmcoated
10mg+50mg;
(30/3x10/) in
blister
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
amlodipine
(amlodipine
besilate), losartan
(losartan
potassium)
tablets filmcoated
5mg+100mg;
(30/3x10/) in
blister
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
amlodipine
(amlodipine
besilate), losartan
(losartan
potassium)
tablets filmcoated
10mg+100mg;
(30/3x10/) in
blister
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
tablets gastroresistant
300mg;
(100/10x10/) in
blister
Sanofi-Aventis S.A., Ctra.
C35 La Batlloria a Hostalric,
km 63.09,17404 Riells I
Viabrea (Girona)
40mg; (20/2x10/)
in blister
Open joint stock company
"Borisovskiy zavod
medicinskikh preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
valproate sodium
(valproic acid)
famotidine
tablets filmcoated
Spain
Belarus
Gedeon Richter PLC,
Gyomroi ut 19-21, 1103
Budapest
Hungary
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
Krka-RUS LLC, 50
Moskovskaya str., Istra,
Moscow region 143500
Russia
Sanofi Winthrop
Industrie, 1, rue de la
Vierge-Ambares et
Lagreve, 33565 Carbon
Blanc-Cedex
France
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus
15905
R
17.08.2016
15906
R
17.08.2016
15907
R
17.08.2016
15908
R
17.08.2016
15909
R
17.08.2016
15910
R
17.08.2016
15911
R
17.08.2016
5
35.
36.
37.
38.
39.
40.
Famotidine
famotidine
tablets filmcoated
20mg; (20/2x10/)
in blister
Open joint stock company
"Borisovskiy zavod
medicinskikh preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
tablets
10mg; (10/1x10/)
in blister
Hemofarm LLC, 249030,
Obninsk, Kaluga Region, 62
Kievskoye shosse
Belarus
Loratadine
STADA
loratadine
Nolpaza
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets gastroresistant
20mg; (28/2x14/)
in blister
KRKA d.d., Novo mesto,
Smarjeska cesta 6, 8501
Novo Mesto
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets gastroresistant
40mg; (14/1x14/)
in blister,
(28/2x14/) in
blister
KRKA d.d., Novo mesto,
Smarjeska cesta 6, 8501
Novo Mesto
Slovenia
625IU/ml; (1)
ampoule 1ml
Octapharma AB, Lars
Forssells gata 23, Stockholm,
11275-batch releaser,
Octapharma AB, Lars
Forssells gata 23, Stockholm,
11275, Sweden-bulk
manufacturer, primary
packager, Octapharma
Dessau GmbH,Otto-ReuterStr. 3, 06847 Dessau-Roblau,
Germany-secondary packager
Sweden
Nolpaza
Rhesonativ
625IU/ml
Rhesonativ
625IU/ml
human anti-D
immunoglobulin
human anti-D
immunoglobulin
solution for
injection
solution for
injection
625IU/ml; (1) and
(10) ampoules
2ml
Octapharma AB, Lars
Forssells gata 23, Stockholm,
11275-batch releaser,
Octapharma AB, Lars
Forssells gata 23, Stockholm,
11275, Sweden-bulk
manufacturer, primary
packager, Octapharma
Russia
Slovenia
Sweden
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia
Octapharma AB, Lars
Forssells gata 23,
Stockholm, 11275
Sweden
Octapharma AB, Lars
Forssells gata 23,
Stockholm, 11275
Sweden
15912
R
17.08.2016
15913
OTC
17.08.2016
15914
R
17.08.2016
15915
R
17.08.2016
15916
R
17.08.2016
15917
R
17.08.2016
6
Dessau GmbH,Otto-ReuterStr. 3, 06847 Dessau-Roblau,
Germany-secondary packager
41.
42.
43.
44.
45.
46.
47.
Humulin
70/30
insulin human
(recombinant
DNA)
suspension for
injection
100IU/ml; (1)
glass vial 10ml
Eli Lilly and Company,
Indianapolis, IN 46285
USA
Humulin N
insulin human
isophane
(recombinant
DNA)
suspension for
injection
100IU/ml; (1)
glass vial 10ml
Eli Lilly and Company,
Indianapolis, IN 46285
USA
insulin human
regular
(recombinant
DNA)
solution for
injection
100IU/ml; (1)
glass vial 10ml
Eli Lilly and Company,
Indianapolis, IN 46285
USA
vancomycin
(vancomycin
hydrochloride)
powder for
solution for i/v
injection
1000mg; glass
vial
Lek Pharmaceuticals d.d.,
Verovskova Str. 57, 1526
Ljubljana
Slovenia
thiamphenicol
(thiamphenicol
glycinate
acetylcysteinate)
powder
lyophilized for
solution for i/m
injection and
inhalation
500mg; (3) glass
vial and (3)
solvent in
ampoules 4ml
Zambon S.P.A., Via della
Chimica, 9, Vicenza, 36100
Italy
Humulin R
Edicin
Fluimucilantibiotic
IT
Claforan
Infanrix
Hexa
cefotaxime
(cefotaxime
sodium)
powder and
solvent for
solution for
injection
1000mg; glass
vial and 4ml
solvent in
ampoule
Zentiva Saglik Urunleri
San.ve Tic. A.S.,
Kucukkaristiran Mahalessi,
Merkez Sokak No:223/A,
39780 Buyukkaristiran,
Luleburgaz, Kirklareli
diphtheria toxoid,
tetanus toxoid,
pertussis toxoid,
filamentous
powder and
suspension for
suspension for
not less than
30IU/dose+not
less than
40IU/dose+25mcg
GlaxoSmithKline Biologicals
s.a., Rue de l' Institut, 89 B1330 Rixensart-batch
releaser, GlaxoSmithKline
Turkey
Belgium
15918
Eli Lilly and Company,
Indianapolis, IN 46285
USA
Eli Lilly and Company,
Indianapolis, IN 46285
USA
Eli Lilly and Company,
Indianapolis, IN 46285
USA
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia
Zambon S.P.A., Via
Lillo del Duca, 10,
Bresso, 20091
Italy
Sanofi Aventis Ilaclari
Ltd. Sti., Buyukdere
Cad. No:193 Levent
34394 Sisli-Istanbul
Turkey
GlaxoSmithKline
Biologicals s.a., Rue de
l` Institut, 89 B-1330
R
17.08.2016
15919
R
17.08.2016
15920
R
17.08.2016
15921
R
17.08.2016
15922
R
17.08.2016
15924
R
17.08.2016
15925
Belgium
R
17.08.2016
7
haemagglutinin,
pertactin, hepatitis
B surface antigen,
inactivated
poliovirus type 1,
inactivated
poliovirus type 2,
inactivated
poliovirus type 3,
haemophilus
influenzae type b
polysaccharide
(conjugated to
tetanus toxoid)
48.
49.
50.
51.
injection
/dose+25mcg/dos
e+8mcg/dose+10
mcg/dose+40Dantigen
unit/dose+8Dantigen
unit/dose+32Dantigen
unit/dose+10mcg/
dose
(25mcg/dose);
0.5ml/dose glass
vial, pre-filled
syringe and (2)
needles
insulin human
regular
(recombinant
DNA)
solution for
injection
100IU/ml; (5)
cartridges 3ml
Lilly France, Zone
Industrielle, 2 rue du Colonel
Lilly, 67640 Fegersheim
Humulin
70/30
insulin human
(recombinant
DNA)
suspension for
injection
100IU/ml; (5)
cartridges 3ml
Lilly France, Zone
Industrielle, 2 rue du Colonel
Lilly, 67640 Fegersheim
Humulin N
insulin human
isophane
(recombinant
DNA)
suspension for
injection
100IU/ml; (5)
cartridges 3ml
Lilly France, Zone
Industrielle, 2 rue du Colonel
Lilly, 67640 Fegersheim
France
insulin lispro
solution for
injection
100IU/ml
(3,5mg/ml); (5)
cartridges 3ml
Lilly France, Zone
Industrielle, 2 rue du Colonel
Lilly, 67640 Fegersheim
France
Humulin R
Humalog
Biologicals SA, Rue des
Aulnois, 637 59230 SaintAmand-Les-Eaux, Francebulk manufacturer, packager
Rixensart
France
France
Lilly France, Zone
Industrielle, 2 rue du
Colonel Lilly, 67640
Fegersheim
France
Lilly France, Zone
Industrielle, 2 rue du
Colonel Lilly, 67640
Fegersheim
France
Lilly France, Zone
Industrielle, 2 rue du
Colonel Lilly, 67640
Fegersheim
France
Eli Lilly Nederland B.V.,
Papendorpseweg 83,
3528 BJ Utrecht
the Netherlands
15926
R
17.08.2016
15927
R
17.08.2016
15928
R
17.08.2016
15929
R
17.08.2016
8