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1554 Emanera
esomeprazole
(esomeprazole
magnesium)
capsules gastro-
resistant
40mg,
in blister (7/1x7/, 14/2x7/,
15/3x5/, 28/4x7/,
30/3x10/, 56/8x7/,
60/6x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia A02BC05 1418506.02.2015
06.02.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1555 Emend
fosaprepitant
(fosaprepitant
dimeglumine)
powder lyophilized
for solution for
infusion
150mg,
10ml glass vial
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem -
secondary packager,
batch releaser (bulk
manufacturer,
primary packager -
Patheon
Manufacturing
Services LLC, 5900
Martin Luther King
Jr. Higway,
Greenville, North
Carolina 27834, USA)
the Netherlands A04AD12 12302/319.08.2016
22.03.2018PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
1556 Emend
fosaprepitant
(fosaprepitant
dimeglumine)
powder lyophilized
for solution for
infusion
150mg,
10ml glass vial (1)
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem -
secondary packager,
batch releaser (bulk
manufacturer,
primary packager -
Patheon
Manufacturing
Services LLC, 5900
Martin Luther King
Jr. Higway,
Greenville, North
Carolina 27834, USA)
the Netherlands A04AD12 1688308.08.2017
08.08.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
341
1557 Emoxypine emoxipine drops eye (solution)10mg/ml,
5ml glass vial
Belmedpreparaty
RUE (220007, Minsk,
Fabritsius St., 30)
Belarus S01XA 1289507.10.2013
07.10.2018PoM
Belmedpreparaty
RUE (220007, Minsk,
Fabritsius St., 30,
Belarus)
1558 Emoxypine emoxipine drops eye (solution)10mg/ml,
5ml vial-dropper
Belmedpreparaty
RUE, 220007, Minsk,
Mayakovskogo St., 1 ,
No 5
Belarus S01XA 1728926.12.2017
26.12.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1559Emoxypine-
Belmedemoxypine solution for injection
10mg/ml,
1ml ampoules,
in blister (10/1x10/,
5/1x5/, 10/2x5/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus N07XX 1423620.02.2015
20.02.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1560Emoxypine-
Belmedemoxypine
solution for i/v and
i/m injection
30mg/ml,
5ml ampoules (5/1x5/,
10/2x5/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus N07XX 1681522.06.2017
22.06.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1561Ena+HCT-Denk
20/12,5
enalapril (enalapril
maleate),
hydrochloro-
thiazide
tablets20mg+12,5mg,
in blister (30/3x10/)
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1,
29439 Luchow
Germany C09BA02 1252801.06.2013
01.06.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1562 Ena-Denk 10enalapril (enalapril
maleate)tablets
10mg,
in blister (30/3x10/)
Denk Pharma GmbH
& Co. KG, Gollstr. 1,
84529 Tittmoning
Germany C09AA02 1264604.07.2013
04.07.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
1563 Ena-Denk 20enalapril (enalapril
maleate)tablets
20mg,
in blister (30/3x10/)
Denk Pharma GmbH
& Co. KG, Gollstr. 1,
84529 Tittmoning
Germany C09AA02 1264704.07.2013
04.07.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
342
1564 Enalaprilenalapril (enalapril
maleate)tablets
5mg,
blisters (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C09AA02 13529/111.07.2016
30.05.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
1565 Enalaprilenalapril (enalapril
maleate)tablets
10mg,
blisters (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C09AA02 13530/111.07.2016
30.05.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
1566 Enalaprilenalapril (enalapril
maleate)tablets
20mg,
blisters (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C09AA02 13531/111.07.2016
30.05.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
1567 Enalaprilenalapril (enalapril
maleate)tablets
5mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus C09AA02 1367708.07.2014
08.07.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1568 Enalaprilenalapril (enalapril
maleate)tablets
10mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus C09AA02 1367808.07.2014
08.07.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1569 Enalaprilenalapril (enalapril
maleate)tablets
20mg,
in blister (20/2x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia C09AA02 1682110.07.2017
10.07.2022PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
343
1570 Enalaprilenalapril (enalapril
maleate)tablets
10mg,
in blister (20/2x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia C09AA02 1682210.07.2017
10.07.2022PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1571 Enalaprilenalapril (enalapril
maleate)tablets
5mg,
in blister (20/2x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia C09AA02 1682310.07.2017
10.07.2022PoM
for Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1572 Enalapril-H
enalapril (enalapril
maleate),
hydrochloro-
thiazide
tablets10mg+25mg,
in blister (20/2x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC09BA02 13966
04.11.2014
04.11.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1573Enalapril-H-
Zdorovye
enalapril (enalapril
maleate),
hydrochlorothia-
zide
tablets
10mg+25mg,
in blister (20/1x20/,
30/1x30/, 40/2x20/,
60/2x30/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C09BA02 1636730.12.2016
30.12.2021PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
1574 Enapenalapril (enalapril
maleate)tablets
2,5mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA02 1303525.11.2013
25.11.2018PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1575 Enapenalapril (enalapril
maleate)tablets
5mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA02 1639210.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1576 Enapenalapril (enalapril
maleate)tablets
20mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA02 1639310.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
344
1577 Enapenalapril (enalapril
maleate)tablets
10mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA02 1639410.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1578 Enap enalaprilat solution for injection
1,25mg/ml,
1ml ampoules, in blister
(5)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia 1694905.09.2017
05.09.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1579 Enap-H
enalapril (enalapril
maleate),
hydrochlorothiazid
e
tablets10mg+25mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA02 1639610.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1580 Enap-HL
enalapril (enalapril
maleate),
hydrochlorothiazid
e
tablets10mg+12,5mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA02 1639510.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1581 Enap-HL 20
enalapril (enalapril
maleate),
hydrochloro-
thiazide
tablets20mg+12,5mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA02 1567008.06.2016
08.06.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1582 Enbrel etanerceptsolution for s/c
injection
50mg/ml,
1ml glass pre-filled
syringes (4),
alcohol swabs (4)
Wyeth
Pharmaceuticals, New
Lane, Havant,
Hampshire PO9 2NG
- secondaryt packager,
batch releaser (dosage
form manufacturer -
Pfizer Ireland
Pharmaceuticals,
Grange Castle
Business Park,
Clondalkin, Dublin
22, Ireland)
UK L04AB01 1257306.06.2013
06.06.2018PoM
Pfizer LTD, Ramsgate
Road, Sandwich,
CT13 9NJ, Kent, UK
345
1583 Enbrel etanerceptsolution for s/c
injection
50mg/ml,
1ml pre-filled glass pen-
syringes (4) and (4)
alcohol swabs
Wyeth
Pharmaceuticals, New
Lane, Havant, PO9
2NG - batch releaser,
secondary packager,
Pfizer Ireland
Pharmaceuticals,
Grange Castle
Business Park,
Clondalkin, Dublin
22, Ireland-bulk
manufacturer, Vetter
Pharma-Fertigung,
Eisenbahnstr. 2-4,
Langenargen, Baden-
Wuerttemberg,
88085, Germany-
primary packager
UK L04AB01 1702826.09.2017
26.09.2022PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York 10017, USA
1584 EnciferIron sucrose
complex
solution for i/v
injection
20mg/ml,
5ml ampoules (5)
Emcure
Pharmaceuticals Ltd.,
Plot NO. J-174, J-168,
J-168/1, MIDC,
Tarapur, Boisar,
Thane 401506,
Maharashtra State
India B03AC 1509715.12.2015
15.12.2020PoM
Emcure
Pharmaceuticals Ltd.,
T-184, M.I.D.C.,
Bhosari, Pune-
411026, Maharashtra,
India
1585 Eneas
enalapril (enalapril
maleate),
nitrendipine
tablets10mg+20mg,
in blister (30/3x10/)
Ferrer International,
S.A., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain C09BB06 1625619.12.2016
19.12.2021PoM
Ferrer International,
S.A., Gran Via Carlos
III, 94, 08028,
Barcelona, Spain
1586 Enerion sulbutiamine tablets coated200mg,
in blister (20/2x10/)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France A11DA02 1683610.07.2017
10.07.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
346
1587 Engerix B Adult
hepatitis B surface
antigene
(recombinant DNA)
suspension for
injection
20mcg/ml,
pre-filled syringe/(1 dose)
and needle
GlaxoSmithKline
Biologicals s.a., Rue
de l' Institut, 89 B-
1330 Rixensart-batch
releaser, bulk
manufacturer, Glaxo
SmithKline
Biologicals NL der
SmithKline Beecham
Pharma GmbH & Co.
K.G., Zirkusstrasse 40,
01069 Dresden
Germany- packager
BelgiumJ07BC01;
vaccine16312
30.12.2016
30.12.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l` Institut, 89 B-
1330 Rixensart,
Belgium
1588 Engerix B Junior
hepatitis B surface
antigene
(recombinant DNA)
suspension for
injection
10mcg/0,5ml,
pre-filled syringe/(1 dose)
and needle
GlaxoSmithKline
Biologicals s.a., Rue
de l' Institut, 89 B-
1330 Rixensart-batch
releaser, bulk
manufacturer, Glaxo
SmithKline
Biologicals NL der
SmithKline Beecham
Pharma GmbH & Co.
K.G., Zirkusstrasse 40,
01069 Dresden
Germany- packager
BelgiumJ07BC01;
vaccine16313
30.12.2016
30.12.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l` Institut, 89 B-
1330 Rixensart,
Belgium
1589 Enroflox enrofloxacin solution for injection50mg/ml,
100ml glass vial
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
Spain
QJ01MA90;
veterinary
drug
1507907.12.2015
07.12.2020PoM
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
347
1590
ENROVETo-20
oral solution
A.U.V.
enrofloxacin solution oral200mg/ml,
1000mll plastic bottle
Laboratories Biove, 3
Rue Lorraine, BP45, F-
62510 Arques-
packager, batch
releaser, Pernix
Pharma
Gyogyszergyarto Kft,
H-8900 Zalaegerszeg,
Eszaki Iparterulet,
Kamilla u.3, Hungary-
bulk manufacturer
France
QJ01MA90;
veterinary
drug
1526822.01.2016
22.01.2021PoM
V.M.D. NV, Hoge
Mauw 900, 2370
Arendonk, Belgium
1591 Enterofuryl nifuroxazide suspension oral
200mg/5ml,
90ml suspension in 125ml
glass bottle and plastic
measuring spoon
(2.5ml/5ml)
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaA07AX03 16380
30.12.2016
30.12.2021PoM
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
1592 Enterofuryl nifuroxazide capsules100mg,
in blister (30/3x10/)
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaA07AX03 16943
05.09.2017
05.09.2022PoM
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
1593 Enterofuryl nifuroxazide capsules200mg,
in blister (16/2x8/)
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaA07AX03 16944
05.09.2017
05.09.2022PoM
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
1594 Enterogermina
spores of
polyantibiotic-
resistant Bacillus
clausii
suspension oral2x10^9/5ml,
5ml plastic vials (10)
Sanofi-Aventis S.p.a.,
Viale Europa 11,
21040 Origgio (VA)
Italy A07FA 1475303.08.2015
03.08.2020OTC
Sanofi-Aventis S.p.a.,
Viale Europa 11,
21040 Origgio (VA),
Italy
348
1595 Enterokind
chamomilla D6,
cina D6, colocynthis
D6, lac defloratum
D6, magnesium
chloratum D6
drops oral (solution)
100mg/g+ 100mg/g+
100mg/g+ 100mg/g+
100mg/g,
20ml glass container
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe
Germany
A03A;
homeopathic
drug
1678922.06.2017
22.06.2022OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
1596 Enterol 250
lyophilized cells of
saccharomyces
boulardii
powder for oral
suspension
250mg,
sachets (10)
Biocodex,1 avenue
Blaise Pascal, 60000
Beauvais
France A07FA02 1230422.03.2013
22.03.2018OTC
Biocodex, 7 avenue
Gallieni 94250
Gentilly, France
1597 Enterol 250
lyophilized cells of
saccharomyces
boulardii
capsules250mg,
in glass bottle (10)
Biocodex,1 avenue
Blaise Pascal, 60000
Beauvais
France A07FA02 1230522.03.2013
22.03.2018OTC
Biocodex, 7 avenue
Gallieni 94250
Gentilly, France
1598 Entoban
holarrhena
antidysenterica,
myrtus communis,
berberis aristata,
aegle marmelos,
quercus infectoria,
butea frondosa
capsules
400mg+400mg+
100mg+100mg+
100mg+100mg,
in plastic container (20,
60)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900
PakistanA07XA;
herbal drug15241
25.12.2015
25.12.2020OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900,
Pakistan
1599 Entrop phenylpiracetam tablets
100mg,
in blister (10/1x10/,
20/2x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX 1690108.08.2017
08.08.2022PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1600 Enzix
I-enalapril
(enalapril maleate),
II-indapamide
tablets and film-
coated tablets
I-10mg, II-2,5mg,
(30/3x10//5-I tablets +5-II
film-coated tablets/) in
blister
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse
Russia C09BA02 1602917.10.2016
17.10.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1601 Enzix Duo
I-enalapril
(enalapril maleate),
II -indapamide
tablets and film-
coated tablets
I-10mg, II-2,5mg,
(45/3x15//10 I tablets + 5
II film-coated tablets/) in
blister
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse
Russia C09BA02 1602817.10.2016
17.10.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
349
1602 Enzix Duo Forte
I-enalapril
(enalapril maleate),
II-indapamide
tablets and film-
coated tablets
I-20mg, II-2,5mg,
(45/3x15/10-I tablets +5 II-
film coated tablets/) in
blister
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse
Russia C09BA02 1603017.10.2016
17.10.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1603 Epiduoadapalene, benzoyl
peroxidegel
1mg/g+25mg/g,
5g, 15g and 30g plastic
tube, 15g and 30g plastic
multidose container with
airless pump
Laboratoires
Galderma Z.I.
Montdesir, 74540
Alby-sur-Cheran
France D10AD53 1665611.05.2017
11.05.2022PoM
Galderma SA,
Zugerstrasse 8, CH-
6330 Cham,
Switzerland
1604 Equoral ciclosporin capsules soft25mg,
in blister (50/5x10/)
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p. 305,
747 70 Opava-
Komarov
Czech Republic L04AD01 1378705.09.2014
05.09.2019PoM
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p.
305, 747 70 Opava-
Komarov, Czech
Republic
1605 Equoral ciclosporin capsules soft50mg,
in blister (50/5x10/)
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p. 305,
747 70 Opava-
Komarov
Czech Republic L04AD01 1378805.09.2014
05.09.2019PoM
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p.
305, 747 70 Opava-
Komarov, Czech
Republic
1606 Equoral ciclosporin capsules soft100mg,
in blister (50/5x10/)
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p. 305,
747 70 Opava-
Komarov
Czech Republic L04AD01 1378905.09.2014
05.09.2019PoM
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p.
305, 747 70 Opava-
Komarov, Czech
Republic
1607 Equoral ciclosporin solution oral
100mg/ml,
a syringe and a dropper in
a plastic container and
50ml glass bottle
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p. 305,
747 70 Opava-
Komarov
Czech Republic L04AD01 1379005.09.2014
05.09.2019PoM
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p.
305, 747 70 Opava-
Komarov, Czech
Republic
350
1608 Ercefuryl nifuroxazide capsules200mg,
in blister (28/2x14/)
Sanofi Winthrop
Industrie, 6,
Boulevard de l Europe
21800 Quetigny
France A07AX03 1524730.12.2015
30.12.2020PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
1609 Erexesilsildenafil (sildenafil
citrate)tablets coated
25mg,
in blister (1/1x1/, 4/1x4/,
8/2x4/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Atlantic Pharma -
Producoes
Farmaceuticas S.A.,
Rua da Tapada
Grande,No 2,
Abrunheira 2710-089
Sintra, Portugal - bulk
manufacturer,
packager)
Hungary G04BE03 1379105.09.2014
05.09.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1610 Erexesilsildenafil (sildenafil
citrate)tablets coated
50mg,
in blister (1/1x1/, 4/1x4/,
8/2x4/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Atlantic Pharma -
Producoes
Farmaceuticas S.A.,
Rua da Tapada
Grande,No 2,
Abrunheira 2710-089
Sintra, Portugal - bulk
manufacturer,
packager)
Hungary G04BE03 1379205.09.2014
05.09.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
351
1611 Erexesilsildenafil (sildenafil
citrate)tablets coated
100mg,
in blister (1/1x1/, 4/1x4/,
8/2x4/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Atlantic Pharma -
Producoes
Farmaceuticas S.A.,
Rua da Tapada
Grande,No 2,
Abrunheira 2710-089
Sintra, Portugal - bulk
manufacturer,
packager)
Hungary G04BE03 1379305.09.2014
05.09.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1612 Erfamectin ivermectin solution for injection10mg/ml,
50ml glass vial
Erfan Darou
Pharmaceutical
Company, 19th street,
Second phase,
Hashtgerd industrial
city, Tehran
Iran
QP54AA01;
veterinary
drug
1686611.07.2017
11.07.2022PoM
Erfan Darou
Pharmaceutical
Company, 19th
street, Second phase,
Hashtgerd industrial
city, Tehran, Iran
1613 Erfamycin LA
oxytetracycline
(oxytetracycline
dihydrate)
solution for injection200mg/ml,
50ml glass vial
Erfan Darou
Pharmaceutical
Company 19th street,
Second phase,
Hashtgerd industrial
city, Tehran
Iran
QS01AA04;
veterinary
drug
13446/107.07.2017
06.05.2019PoM
Erfan Darou
Pharmaceutical
Company 19th street,
Second phase,
Hashtgerd industrial
city, Tehran, Iran
1614Ergocalciferol
(Vitamin D2)ergocalciferol solution oil
1,25mg/ml (50000IU),
10ml glass bottle
Technolog PJSC,
Manuylskogo str. 8,
20300 Uman,
Cherkassy region
Ukraine A11CC01 1236919.04.2013
19.04.2018PoM
Technolog PJSC,
Manuylskogo str. 8,
20300 Uman,
Cherkassy region,
UKRAINE
352
1615 Ergoferon
affinity purified
antibodies to
human interferon
gamma, affinity
purified antibodies
to histamine,
affinity purified
antibodies to CD4
tablets to be sucked
6mg+6mg+6mg,
in blister (20/1x20/,
40/2x20/, 100/5x20/)
NPF Materia Medica
Holding Ltd., 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russia
J05AX; R06A;
homeopathic
drug
12511/121.01.2014
01.06.2018OTC
NPF Materia Medica
Holding Ltd., 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
1616 Ermucin erdosteine capsules
300mg,
in blisters (10/1x10/,
20/2x10/)
Angelini Pharma
Ceska republika s.r.o.,
Paterni 1216/7, 635
00 Brno - packager,
batch releaser,
(Edmond Pharma
S.r.l., Strada Statale
dei Giovi no.131,
20037 Paderno
Dugnano (MI), Italy -
bulk manufacturer)
Czech Republic R05CB15 14476/224.07.2017
30.04.2020PoM
"UAB" MRA Totoriu
st. 20-9, LT-01121
Vilnius, Republic of
Lithuania
1617 Ermucin erdosteinegranules for oral
solution
225mg,
4,425g sachets (20)
Angelini Pharma
Ceska republika s.r.o.,
Paterni 1216/7, 635
00 Brno - packager,
batch releaser,
(Edmond Pharma
S.r.l., Strada Statale
dei Giovi no.131,
20037 Paderno
Dugnano (MI), Italy -
bulk manufacturer)
Czech Republic R05CB15 14477/224.07.2017
30.04.2020PoM
"UAB" MRA Totoriu
st. 20-9, LT-01121
Vilnius, Republic of
Lithuania
353
1618 Ermucin erdosteinegranules for oral
suspension
175mg/5ml,
100ml glass bottle
Angelini Pharma
Ceska republika s.r.o.,
Paterni 1216/7, 635
00 Brno - packager,
batch releaser,
(Edmond Pharma
S.r.l., Strada Statale
dei Giovi no.131,
20037 Paderno
Dugnano (MI), Italy -
bulk manufacturer)
Czech Republic R05CB15 14478/224.07.2017
30.04.2020PoM
"UAB" MRA Totoriu
st. 20-9, LT-01121
Vilnius, Republic of
Lithuania
1619 Erolin loratadine tablets
10mg,
in blister (10/1x10/,
30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary R06AX13 1669323.05.2017
23.05.2022OTC
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1620 Erynit Tatpharmpentaerithrityl
tetranitratetablets
10mg,
blisters (50/5x10/)
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia C01DA05 14334/130.12.2016
25.03.2020PoM
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
1621 Erythromycin
erythromycin
(erythromycin
ethylsuccinate)
tablets200mg,
in blister (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ01FA01 12203
07.03.2013
07.03.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1622 Erythromycin erythromycintablets enteric-
coated
100mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk region
Belarus J01FA01 12374/116.05.2016
19.04.2018PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk
region, Belarus
354
1623 Erythromycin erythromycintablets enteric-
coated
250mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk region
Belarus J01FA01 12375/116.05.2016
19.04.2018PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1624 Erythromycin
erythromycin
(erythromycin
ethylsuccinate)
tablets400mg,
in blister (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ01FA01 12639
25.06.2013
25.06.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
1625 Erythromycin
erythromycin
(erythromycin
ethylsuccinate)
solution for topical
use
20mg/ml,
30ml glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD10AF02 12879
19.09.2013
19.09.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1626 Erythromycin erythromycingranules for oral
suspension
40mg/ml,
40g glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
Armenia
D10AF02,
J01FA01,
S01AA17
1397221.11.2014
21.11.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1627 Erythromycin erythromycin ointment eye10mg/g,
10g aluminium tube
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia S01AA17 1463703.07.2015
03.07.2020PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
1628 Erythromycin erythromycintablets gastro-
resistant coated
200mg,
in blister (16/1x16/)
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw
Poland J01FA01 1555812.05.2016
12.05.2021PoM
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw, Poland
355
1629Erythromycin
ointmenterythromycin ointment
10mg/g,
20g, 25g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD10AF02 14083/1
14.04.2015
16.12.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1630 Escapelle levonorgestrel tablets1,5mg,
in blister (1)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AC03 1446522.04.2015
22.04.2020OTC
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
1631 Escitalopram
escitalopram
(escitalopram
oxalate)
tablets coated10mg,
in blisters (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN06AB10 16873
31.07.2017
31.07.2022PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1632 Esfolenessential
phospholipids
solution for i/v
injection
50mg/ml,
5ml glass vials (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaA05C 14407
16.04.2015
16.04.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1633 Esita
escitalopram
(escitalopram
oxalate)
tablets film-coated5mg,
in blister (20/2x10/)
Healthcare
Pharmaceuticals
Limited, Gazaria Para,
Rajendrapur, Gazipur
Bangladesh N06AB10 1576104.07.2016
04.07.2021PoM
Healthcare
Pharmaceuticals
Limited, Probashi
Kallyan Bhabon 71-
72, Old Elephant
Road, Eskaton
Garden, Dhaka-1000,
Bangladesh
356
1634 Esita
escitalopram
(escitalopram
oxalate)
tablets film-coated10mg,
in blister (20/2x10/)
Healthcare
Pharmaceuticals
Limited, Gazaria Para,
Rajendrapur, Gazipur
Bangladesh N06AB10 1576204.07.2016
04.07.2021PoM
Healthcare
Pharmaceuticals
Limited, Probashi
Kallyan Bhabon 71-
72, Old Elephant
Road, Eskaton
Garden, Dhaka-1000,
Bangladesh
1635 Eslidin
lipoid PPL-400
(phospholipids),
methionine
capsules300mg+100mg,
in blister (30/3x10/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia A05C 15876/115.09.2017
23.08.2021OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1636 Eslidin
lipoid PPL-400
(phospholipids),
methionine
capsules300mg+100mg,
in blister (30/3x10/)
Makiz-Pharma LLC, 6
Avtomobilny proezd,
buildings 4, 6, 8,
109029, Moscow
Russia A05C 15877/115.09.2017
23.08.2021OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1637 Eslidin
lipoid PPL-400
(phospholipids),
methionine
capsules300mg+100mg,
in blister (30/3x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia A05C 1713907.11.2017
07.11.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1638 Esmeron
rocuronium
(rocuronium
bromide)
solution for injection10mg/ml,
5ml glass vial (10)
N.V. Organon,
Molenstraat 110, 5342
CC OSS - secondary
packager, batch
releaser (Hameln
Pharmaceutical
GmbH, Langes Feld
13, 31789 Hameln,
Germany - bulk
manufacturer,
primary packager)
the Netherlands M03AC09 1349830.05.2014
30.05.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
357
1639 Esmeron
rocuronium
(rocuronium
bromide)
solution for injection10mg/ml,
5ml glass vial (10)
N.V. Organon,
Molenstraat 110, 5342
CC OSS
the Netherlands M03AC09 1678322.06.2017
22.06.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
1640 Esmyaulipristal (ulipristal
acetate)tablets
5mg,
in blister (28/2x14/,
84/6x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary
G03AD02;
new
indication
13211/124.02.2014
24.02.2019PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1641 EsoMed-40
esomeprazole
(esomeprazole
magnesium
trihydrate)
tablets gastro-
resistant
40mg,
in strip (100/10x10/)
Perdaman
Pharmaceuticals Pvt.
Ltd., G/5 & G/6
Gorwa B.I.D.C., City
Vadodara-390 016,
dist. Vadodara
India A02BC05 1387806.10.2014
06.10.2019PoM
Perdaman
Pharmaceuticals Pvt.
Ltd., Level-11, A-111,
Himalaya House, KG
Marg, Cannaught
Place, New Delhi-
110001, India
1642Esomeprazol
Sandoz
esomeprazole
(esomeprazole
sodium)
powder for solution
for injection and
infusion
40mg,
glass vial (1, 5, 10)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia A02BC05 1578920.07.2016
20.07.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1643Esomeprazol
SANDOZ 20mg
esomeprazole
(esomeprazole
magnesium
dihydrate)
tablets gastro-
resistant
20mg,
in blister (14/2x7/,
28/4x7/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany A02BC05 1619116.11.2016
16.11.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1644Esomeprazol
SANDOZ 40mg
esomeprazole
(esomeprazole
magnesium
dihydrate)
tablets gastro-
resistant
40mg,
in blister (14/2x7/,
28/4x7/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany A02BC05 1619016.11.2016
16.11.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
358
1645 Espolcapsicum spissum
extract
ointment for
external use
100mg/g,
30g aluminium tube
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
RussiaM02AB;
herbal drug13640/1
21.12.2016
27.06.2019OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1646 Espumisan simethicone capsules soft40mg,
in blister (25/1x25/)
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125,
12489 Berlin-
packager, batch
releaser, Catalent
Germany Eberbach
GmbH,
Gammelsbacherstrass
e 2, D-69412
Eberbach, Germany-
bulk manufacturer
Germany A03AX13 1422120.02.2015
20.02.2020OTC
Berlin-Chemie AG
(Menarini Group),
Glienicker Weg 125,
12489 Berlin,
Germany
1647 Espumisan simethicone capsules soft40mg,
in blister (25/1x25/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, Catalent
Germany Eberbach
GmbH,
Gammelsbacherstrass
e 2, D-69412
Eberbach, Germany-
bulk manufacturer,
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden,
Germany- packager
Germany A03AX13 1551419.04.2016
19.04.2021OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
1648 Espumisan L simethicone emulsion oral40mg/ml,
30ml glass vial-dropper
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125,
12489 Berlin
Germany A03AX13 1422220.02.2015
20.02.2020OTC
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125,
12489 Berlin,
Germany
359
1649 Essentiale forte Nphospholipids
(essential)-EPLcapsules
300mg,
in blister (30/3x10/)
A. Nattermann & Cie.
GmbH,
Nattermannallee 1, D-
50829 Cologne
Germany A05C 1713007.11.2017
07.11.2022OTC
Casella-med GmbH &
Co. KG,
Gereonsmuhlengasse
1, 50670 Cologne,
Germany
1650 Essliver Forte
essential
phospholipids,
thiamine (thiamine
mononitrate),
riboflavin,
pyridoxine
(pyridoxine
hydrochloride),
nicotinamide, alpha-
tocopherol acetate,
cyanocobalamin
capsules
300mg+6mg+6mg+6mg+6
mg+30mg+ 6mcg,
in blister (30/3x10/,
50/5x10/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7-
batch releaser,
secondary packager,
Nabros Pharma Pvt.
Ltd., Survey
No110/A/2 Amit
Farm, Jain Upasrya,
N.H. No. 8 Kajipura,
Kheda, 387411,
Gujarat, India- bulk
manufacturer,
primary packager
Russia A05C 1650117.03.2017
17.03.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1651 Estrinorm estriol suppositories vaginal0,5mg
(15/3x5/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G03CA04 1325424.02.2014
24.02.2019PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
1652 Etacizin ethacizine tablets coated50mg,
in blister (50/5x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia C01BC09 1598815.09.2016
15.09.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1653Ethambutol
Hydrochloride
ethambutol
(ethambutol
hydrochloride)
tablets film-coated400mg,
in blister (672/24x28/)
Macleods
Pharmaceuticals Ltd.,
Plot No 25-27, Sr. No
366, Premier Ind.
Estate, Kachigam,
Daman-396210 (UT)
India J04AK02 1601706.10.2016
06.10.2021PoM
Macleods
Pharmaceuticals Ltd.,
304, Atlanta Arcade,
Marol Church
Road,Andheri (East),
Mumbai-400 059,
India
360
1654Ethambutol
Hydrochloride
ethambutol
(ethambutol
hydrochloride)
tablets film-coated100mg,
in blister (100/10x10/)
Macleods
Pharmaceuticals Ltd.,
Plot No 25-27, Sr. No
366, Premier Ind.
Estate, Kachigam,
Daman-396210 (UT)
India J04AK02 1601806.10.2016
06.10.2021PoM
Macleods
Pharmaceuticals Ltd.,
304, Atlanta Arcade,
Marol Church
Road,Andheri (East),
Mumbai-400 059,
India
1655 Etoposid-Ebewe etoposideconcentrate for
solution for infusion
20mg/ml,
5ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01CB01 1451615.05.2015
15.05.2020PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1656 Etruzil letrozole tablets coated
2,5mg,
in blister (30/3x10/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120-batch releaser,
Synthon Hispaina,
S.L., Castello,
1,Poligono Las
Salines, 08830 Sant
Boi De Llobregat,
Spain-bulk
manufacturer,
primary and
secondary packager
Hungary L02BG04 1506102.12.2015
02.12.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
361
1657 Etruzil letrozole tablets coated
2,5mg,
in blister (30/3x10/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
Synthon Hispaina,
S.L., Castello,
1,Poligono Las
Salines, 08830 Sant
Boi De Llobregat,
Spain - bulk
manufacturer,
Rottendorf Pharma
GmbH, Ostenfelder
Strasse 51-61, 59320
Ennigerloh, Germany-
primary and
secondary packager
Hungary L02BG04 1506202.12.2015
02.12.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1658 Euphyllin aminophylline tablets150mg,
in blister (30/3x10/)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia D10AF02 1281117.09.2013
17.09.2018PoM
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
1659 Euphyllin aminophyllinesolution for i/v
injection
24mg/ml,
5ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaR03DA05 15636
24.05.2016
24.05.2021PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1660 Euphylline aminophylline tablets
150mg,
in blister (30/3x10/,
30/2x15/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R03DA05 1390330.09.2014
30.09.2019PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
362
1661 Euphylline aminophylline tablets
150mg,
in blister (10/1x10/,
30/3x10/, 10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus R03DA05 1562224.05.2016
24.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1662 Euphyllinum aminophylline solution for injection
24mg/ml,
5ml ampoules label
banderol (10), 5ml
ampoules, dividella
(10/2x5/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus R03DA05 1394329.10.2014
29.10.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1663 Eurespal
fenspiride
(fenspiride
hydrochloride)
tablets film-coated80mg,
in blister (30/2x15/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France R03DX03 1604017.10.2016
17.10.2021PoM
Les Laboratoires
Servier, 50, rue
Carnot 92284
Suresnes cedex,
France
1664 Eurespal syrup
fenspiride
(fenspiride
hydrochloride)
syrup2mg/ml,
150ml plastic bottle
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy- batch releaser,
Les Laboratoires
Servier Industrie-
Fleury les Aubrais,
326 rue Marcellin
Berthelot, Fleury les
Aubrais, 45407,
France-bulk
manufacturer,
packager
France R03DX03 1603917.10.2016
17.10.2021PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
363
1665 Eurobiol 25000lipase, amylase,
proteasecapsules hard
25000U+22500U+1250U,
glass bottle (20, 50, 100)
Laboratoires Mayoly
Spindler, 6 avenue de
l`Europe B.P.
5178401 Chatou
Cedex -batch releaser,
Nordmark
Arzneimittel GmbH
& Co. KG,
Pinnauallee 4, 25436
Uetersen, Germany-
bulk manufacturer,
packager
France A09AA02 1465603.07.2015
03.07.2020OTC
Laboratoires Mayoly
Spindler, 6 avenue de
l`Europe B.P.
5178401 Chatou
Cedex, France
1666 Eurofer
iron (III) hydroxide
polymaltose
complex
syrup
10mg/ml,
30ml, 60ml, 120ml glass
bottle
Osoth Inter
Laboratories Co., Ltd.,
600/9 Moo 11,
Sukhaphiban 8 Road,
Nong Kham, Si Racha,
Chonburi 20230
Thailand B03AB05 1469716.07.2015
16.07.2020PoM
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
1667 Euthyrox
levothyroxine
(levothyroxine
sodium)
tablets25mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03AA01 1356010.06.2014
10.06.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1668 Euthyrox
levothyroxine
(levothyroxine
sodium)
tablets50mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03AA01 1356110.06.2014
10.06.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1669 Euthyrox
levothyroxine
(levothyroxine
sodium)
tablets75mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03AA01 1356210.06.2014
10.06.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
364
1670 Euthyrox
levothyroxine
(levothyroxine
sodium)
tablets125mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03AA01 1356310.06.2014
10.06.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1671 Euthyrox
levothyroxine
(levothyroxine
sodium)
tablets150mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03AA01 1356410.06.2014
10.06.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1672 Euthyrox
levothyroxine
(levothyroxine
sodium)
tablets100mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03AA01 1390030.09.2014
30.09.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
1673 Evica
saraca indica,
symplocos
racemosa, valeriana
wallichi, matricaria
chamomilla, vitex
agnus castus, areca
catechu
capsules
150mg+50mg+
50mg+50mg+
50mg+50mg,
in plastic container (20,
60)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900
PakistanG02C
herbal drug 13849
18.09.2014
18.09.2019PoM
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900,
Pakistan
1674 Excedrin
paracetamol,
acetylsalicylic acid,
caffeine
tablets film-coated250mg+250mg+ 65mg,
in blister (10/1x10/)
Novartis Consumer
Health Inc., 10401
Highway 6, Lincoln,
NE 68517
USA N02BE71 1629630.12.2016
30.12.2021OTC
Novartis Consumer
Health S.A., Route de
I`Etraz, Case postale
269, 1260 Nyon,
Switzerland
1675 Exforge
amlodipine
(amlodipine
besilate), valsartan
tablets film-coated
5mg+160mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain C09DB01 1559313.05.2016
13.05.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
365
1676 Exforge
amlodipine
(amlodipine
besilate), valsartan
tablets film-coated
10mg+160mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain C09DB01 1559413.05.2016
13.05.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1677 Exforge
amlodipine
(amlodipine
besilate), valsartan
tablets film-coated
5mg+80mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain C09DB01 1559513.05.2016
13.05.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1678 Exforge H
amlodipine
(amlodipine
besilate), valsartan,
hydrochloro-
thiazide
tablets film-coated
5mg+160mg+ 12,5mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria, 158, 08210
Barbera del Valles,
Barcelona
Spain C09DX01 1317310.01.2014
10.01.2019PoM
Novartis Pharma AG,
56, Lichtstrasse, 4056
Basel, Switzerland
1679 Exforge H
amlodipine
(amlodipine
besilate), valsartan,
hydrochloro-
thiazide
tablets film-coated
10mg+160mg+ 12,5mg,
in blister (14/1x14/,
28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria, 158, 08210
Barbera del Valles,
Barcelona
Spain C09DX01 1317410.01.2014
10.01.2019PoM
Novartis Pharma AG,
56, Lichtstrasse, 4056
Basel, Switzerland
1680
Exforge HCT
10mg/160mg/
25mg
amlodipine
(amlodipine
besilate), valsartan,
hydrochloro-
thiazide
tablets film-coated
10mg+160mg+ 25mg,
in blister (14/1x14,
28/2x14/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland C09DX01 1569206.06.2016
06.06.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
1681
Exforge HCT
10mg/160mg/12.5
mg
amlodipine
(amlodipine
besilate), valsartan,
hydrochloro-
thiazide
tablets film-coated
10mg+160mg+ 12,5mg,
in blister (14/1x14/,
28/2x14/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland C09DX01 1569006.06.2016
06.06.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
366
1682
Exforge HCT
5mg/160mg/
12.5mg
amlodipine
(amlodipine
besilate), valsartan,
hydrochloro-
thiazide
tablets film-coated
5mg+160mg+ 12,5mg,
(14/1x14/), in blister,
(28/2x14/), in blister
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland C09DX01 1568906.06.2016
06.06.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
1683Exforge HCT
5mg/160mg/25mg
amlodipine
(amlodipine
besilate), valsartan,
hydrochloro-
thiazide
tablets film-coated
5mg+160mg+25mg;
(14/1x14/), in blister,
(28/2x14/), in blister
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland C09DX01 1569106.06.2016
06.06.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
1684 Exjade deferasirox tablets dispersible250mg,
in blister (28/4x7/)
Novartis Pharma
Stein AG
(Schaffhauserstrasse,
4332 Stein)
Switzerland V03AC03 1291107.10.2013
07.10.2018PoM
Novartis Pharma AG
(Switzerland 35,
Lichtstrasse, 4056
Basel, Switzerland)
1685 Exjade deferasirox tablets dispersible500mg,
in blister (28/4x7/)
Novartis Pharma
Stein AG
(Schaffhauserstrasse,
4332 Stein)
Switzerland V03AC03 1291207.10.2013
07.10.2018PoM
Novartis Pharma AG
(Switzerland 35,
Lichtstrasse, 4056
Basel, Switzerland)
1686 Exoderilnaftifine (naftifine
hydrochloride)
solution for external
use
10mg/ml,
10ml, 20ml glass vial
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl - batch
releaser (dosage form
manufacturer,
packager -
Globopharm
Pharmazeutische
Produktions-und
Handels GmbH.,
Breitenfurter Strasse
251, 1231 Wien,
Austria)
Austria D01AE22 12673/125.12.2015
04.07.2018OTC
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
367
1687 Exoderilnaftifine (naftifine
hydrochloride)
cream for external
use
10mg/g,
15g aluminium tube
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl - batch
releaser (dosage form
manufacturer,
packager -
Globopharm
Pharmazeutische
Produktions-und
Handels GmbH.,
Breitenfurter Strasse
251, 1231 Wien,
Austria)
Austria D01AE22 1267404.07.2013
04.07.2018OTC
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
1688 Exoderilnaftifine (naftifine
hydrochloride)
cream for external
use
10mg/g,
15g aluminium tube
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl - batch
releaser, Merck KGaA
& Co., Werk Spittal,
Hosslgasse 20, 9800
Spittal an der Drau,
Austria- bulk
manufacturer,
packager
Austria D01AE22 1718628.11.2017
28.11.2022OTC
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
1689 Exoderilnaftifine (naftifine
hydrochloride)
solution for external
use
10mg/ml,
10ml and 20ml glass vial
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl - batch
releaser, Globopharm
Pharmazeutische
Produktions-und
Handels GmbH.,
Breitenfurter Strasse
251, 1230 Wien,
Austria- bulk
manufacturer,
packager
Austria D01AE22 1718728.11.2017
28.11.2022OTC
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
368
1690 Expectorant
guaifenesin,
chlorpheniramine
(chlorpheniramine
maleate),
phenylpropanolami
ne
(phenylpropanolam
ine hydrochloride)
syrup with cherry
flavour
100mg/5ml+
2mg/5ml+5mg/5ml, 60ml
glass bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaR05FB01 16292
21.12.2016
21.12.2021OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1691Extract
Belladonnae extract belladonnae suppositories rectal
15mg,
in blister (10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia A03BA04;
herbal drug 16875
08.08.2017
08.08.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1692Extractum Aloes
fluidumaloe liquid extract solution for injection
360mg/ml,
1ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
Armenia
A16AX10
herbal drug 13861
18.09.2014
18.09.2019PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
1693 Eylea aflibercept solution for injection
40mg/ml,
0.278ml glass vial (1) and
needle
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin- batch
releaser, secondary
packager, Regeneron
Pharmaceuticals, Inc.,
81 Columbia
Turnpike, Rensselaer,
New York 12144,
USA- bulk
manufacturer, Vetter
Pharma-Fertigung
GmbH & Co. KG,
Eisenbahnstr. 2-4,
88085 Langenargen,
Germany- primary
packager
Germany S01LA05 1702326.09.2017
26.09.2022PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353, Berlin,
Germany
369
16945-Fluorouracil
Ebewefluorouracil
concentrate for
solution for infusion
50mg/ml,
5ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BC02 1474903.08.2015
03.08.2020PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
16955-Fluorouracil
Ebewefluorouracil
concentrate for
solution for infusion
50mg/ml,
10ml glass vial
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BC02 1475003.08.2015
03.08.2020PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1696 9 months Folic acid folic acid tablets film-coated0.4mg,
in blister (30/3x10/)
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2
Russia B03BB01 15723/108.11.2017
22.06.2021PoM
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2,
Russia
1697 Falimintacetylaminonitropr
opoxybenzenetablets coated
25mg,
in blister (20)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, packager
(dosage form
manufacturer - Berlin-
Chemie AG,
Tempelhofer Weg 83,
12347 Berlin,
Germany)
Germany R02A 1326510.03.2014
10.03.2019OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
1698 Famotidine famotidine tablets film-coated40mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A02BA03 1591123.08.2016
23.08.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
370
1699 Famotidine famotidine tablets film-coated20mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A02BA03 1591223.08.2016
23.08.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1700 Famvir famciclovir tablets film-coated125mg,
in blister (10/1x10/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain J05AB09 1548331.03.2016
31.03.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1701 Famvir famciclovir tablets film-coated250mg,
in blisters (21/3x7/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain J05AB09 1548431.03.2016
31.03.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1702 Famvir famciclovir tablets film-coated
500mg,
in blisters (14/2x7/,
30/3x10/, 56/8x7)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain J05AB09 1548531.03.2016
31.03.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1703Farmorubicin
Rapid Dissolution
epirubicin
(epirubicin
hydrochloride)
powder lyophilized
for solution for
infusion
10mg,
glass vial, 5ml solvent in
ampoules (1)
Actavis Italy S.p.A.,
Nerviano Plant, Viale
Pasteur 10, 20014
Nerviano (Milan)
Italy L01DB03 1318710.01.2014
10.01.2019PoM
Pfizer Italia S.r.l., via
Isonzo 71-04100
Latina, Italy
371
1704Farmorubicin
Rapid Dissolution
epirubicin
(epirubicin
hydrochloride)
powder lyophilized
for solution for
infusion
50mg,
glass vial (1)
Actavis Italy S.p.A.,
Nerviano Plant, Viale
Pasteur 10, 20014
Nerviano (Milan) for
Pfizer Italia S.r.l., via
Isonzo 71-04100
Latina, Italy
Italy L01DB03 1318810.01.2014
10.01.2019PoM
Pfizer Italia S.r.l., via
Isonzo 71-04100
Latina, Italy
1705 Fasigyn tinidazole tablets film-coated500mg,
in blister (4/1x4/)
Fareva Amboise, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse
France P01AB02 1544202.04.2016
02.04.2021PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
1706 Faspic ibuprofen tablets film- coated
400mg,
in blister (6/1x6, 12/2x6/,
24/4x6/, 30/5x6/)
Zambon S.P.A., Via
della Chimica, 9,
Vicenza, 36100
Italy M01AE01 1726413.12.2017
13.12.2022OTC
Zambon S.P.A., Via
Lillo del Duca, 10,
Bresso, 20091, Italy
1707 Fastum gel ketoprofen gel
25mg/g,
30g, 50g and 100g
aluminium tube
A. Menarini
Manufacturing
Logistics and Services
S.r.l., Via Sette Santi,
3 50131 Firenze
Italy M02AA10 1462503.07.2015
03.07.2020PoM
A. Menarini Industrie
Farmaceutiche
Riunite S.r.l., Via
Sette Santi, 3 50131
Firenze, Italy
1708 Fastum gel ketoprofen gel
25mg/g,
100g plastic tube and
pump dispenser
A. Menarini
Manufacturing
Logistics and Services
S.r.l., Via Sette Santi,
3 50131 Firenze
Italy M02AA10 1462603.07.2015
03.07.2020PoM
A. Menarini Industrie
Farmaceutiche
Riunite S.r.l., Via
Sette Santi, 3 50131
Firenze, Italy
372
1709 Febrofid ketoprofen gel for external use25mg/g,
30g, 50g aluminium tube
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10 - batch
releaser, Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57, 98-200
Sieradz, Poland-bulk
manufacturer,
packager
Poland M02AA10 1589123.08.2016
23.08.2021PoM
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10, Poland
1710 Feiba 25U/mlfactor VIII inhibitor
bypassing activity
powder and solvent
for solution for
infusion
500U (25U/ml), glass vial
with powder (1), glass
vial with 20ml solvent (1),
BaxJect ii Hi-Flow (1),
disposable syringe (1),
disposable needle (1),
butterfly needle with
clamp (1)
Baxalta Innovations
GmbH,
Industriestrasse 67, A-
1221 Vienna
Austria B02BD02 16611/102.06.2017
10.04.2022PoM
Baxalta Innovations
GmbH,
Industriestrasse 67, A-
1221 Vienna, Austria
1711 Feiba 50U/mlfactor VIII inhibitor
bypassing activity
powder and solvent
for solution for
infusion
1000U (50U/ml), glass
vial with powder (1),
glass vial with 20ml
solvent (1), BaxJect ii Hi-
Flow (1), disposable
syringe (1), disposable
needle (1), butterfly
needle with clamp (1)
Baxalta Innovations
GmbH,
Industriestrasse 67, A-
1221 Vienna
Austria B02BD02 16612/102.06.2017
10.04.2022PoM
Baxalta Innovations
GmbH,
Industriestrasse 67, A-
1221 Vienna, Austria
1712 Femaplex letrozole tablets film-coated 2,5mg
Genepharm S.A., 18th
km Marathonos
Avenue, 153 51
Pallini Attiki
Greece L02BG04 1384518.09.2014
18.09.2019PoM
Genepharm S.A.,
18th km Marathonos
Avenue, 153 51
Pallini Attiki, Greece
1713 Femara letrozole tablets film-coated2,5mg,
in bliser (30/3x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L02BG04 1220407.03.2013
07.03.2018PoM
Novartis Pharma AG,
Switzerland 56,
Lichtstrasse, 4056
Basel, Switzerland
373
1714 Femara letrozole tablets film-coated2,5mg,
in blister (30/3x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L02BG04 1661412.04.2017
12.04.2022PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
1715 Femilex lactic acid suppositories vaginal100mg,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia G01AD01 13224/215.09.2017
24.02.2019OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1716 Feminon Ccimicifuga racemosa
rhizomecapsules hard
6,5mg,
in blister (60/6x10/)
Cesra Arzneimittel
GmbH & Co. KG,
Braunmattstr. 20,
Baden-Baden, 76532-
batch releaser,
packager,
intermediate product
manufacturer,
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Germany-capsules
filler
GermanyG02C;
herbal drug16464
06.03.2017
06.03.2022OTC
Cesra Arzneimittel
GmbH & Co. KG,
Braunmattstr. 20,
Baden-Baden, 76532
1717 Femoston 1/10
white tablet -
estradiol, gray
tablet - estradiol,
dydrogesterone
tablets film-coated
1mg+1mg+10mg, (28/ 14
white tablets + 14 gray
tablets) in blister
ABBOTT Biologicals
B.V., Veerweg 12,
8121 AA Olst
the Netherlands G03FB08 1271823.07.2013
23.07.2018PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
NL-1381 CP Weesp,
the Netherlands
1718 Femoston 1/5 conti
estradiol (estradiol
hemihydrate),
dydrogesterone
tablets film-coated1mg+5mg,
in blister (28)
ABBOTT Biologicals
B.V., Veerweg 12,
8121 AA Olst
the Netherlands G03FA14 1227322.03.2013
22.03.2018PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands
374
1719 Femoston 2/10
pink tablet-
estradiol, yellow
tablet- estradiol +
dydrogesterone
tablets film-coated
2mg+2mg+10mg, (28/14
pink tablets + 14 yellow
tablets/) in blister
ABBOTT Biologicals
B.V., Veerweg 12,
8121 AA Olst
the Netherlands G03FB08 1405019.12.2014
19.12.2019PoM
ABBOTT Healthcare
Products B.V., C.J.
van Houtenlaan 36,
NL-1381 CP Weesp,
the Netherlands
1720 Fenistil gel
dimetindene
(dimetindene
maleate)
gel1mg/g,
30g aluminium tube
Novartis Consumer
Health S.A. (Route de
I`Etraz, 1260 Nyon)
Switzerland D04AA13 1299728.10.2013
28.10.2018OTC
Novartis Consumer
Health S.A. (Route de
I`Etraz, 1260 Nyon,
Switzerland)
1721 Fenistil New
dimetindene
(dimetindene
maleate)
drops oral (solution)1mg/ml,
20ml glass bottle
Novartis Consumer
Health S.A., Route de
I`Etraz, Case postale
269, 1260 Nyon
Switzerland R06AB03 1344316.04.2014
16.04.2019OTC
Novartis Consumer
Health S.A., Route de
I`Etraz, Case postale
269, 1260 Nyon,
Switzerland
1722 Fenistil Pencivir penciclovir cream10mg/g,
2g aluminium tube
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr/Baden
Germany D06BB06 1218301.02.2013
01.02.2018OTC
Novartis Consumer
Health S.A., Route de
l Etraz, 1260 Nyon,
Switzerland
1723 Fenkarol
quifenadine
(quifenadine
hydrochloride)
tablets10mg,
in blister (20/2x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia R06AX31 1571522.06.2016
22.06.2021OTC
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1724 Fenkarol
quifenadine
(quifenadine
hydrochloride)
tablets25mg,
in blister (20/2x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia R06AX31 1571622.06.2016
22.06.2021OTC
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1725 Fenkarol
quifenadine
(quifenadine
hydrochloride)
tablets
50mg,
in blister (15/1x15/,
30/2x15/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia R06AX31 1571722.06.2016
22.06.2021OTC
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1726 Fentanyl fentanyl solution for injection
0,05mg/ml,
2ml ampoules, in blister
(100/20x5)
"KPE" Zdorovje
narodu" LLC, 61002,
Kharkov, Melnikova
str. 41
Ukraine N02AB03 1620708.12.2016
08.12.2021PoM/UC
"KPE" Zdorovje
narodu" LLC, 61013,
Kharkov, Sevchenko
str. 22, Ukraine
375
1727 Fentanyl Kalceks fentanylsolution for i/v and
i/m injection
0,05mg/ml,
2ml ampoules, in blister
(10/2x5/)
Kalceks JSC, 53
Krustpils Street, Riga,
LV-1057 - batch
releaser (Sanitas JSC,
134B Veiveriu
street,Kaunas, LT-
46352, Lithuania -
bulk manufacturer,
packager)
Latvia N01AH01 1375425.07.2014
25.07.2019PoM/UC
Kalceks JSC, 53
Krustpils Street, Riga,
LV-1057, Latvia
1728 Fentanyl Kalceksfentanyl (fentanyl
citrate)
solution for i/v and
i/m injection
0,05mg/ml,
2ml ampoules, in blister
(10/2x5/, 100/20x5/)
Kalceks JSC, 53
Krustpils Street, Riga,
LV-1057- batch
releaser, HBM
Pharma s.r.o.,
Sklabinska 30, 03680
Martin, Slovakia-bulk
manufacturer,
packager
Latvia N01AH01 1536626.02.2016
26.02.2021PoM/UC
Kalceks JSC, 53
Krustpils Street, Riga,
LV-1057, Latvia
1729Fentavera 50mcg/h
transdermal patchfentanyl patch transdermal
50mcg/h,
patches (5)
Acino AG, Am
Windfeld 35, 83714
Miesbach
Germany N02AB03 1383418.09.2014
18.09.2019PoM/UC
Acino AG, Am
Windfeld 35, 83714
Miesbach, Germany
1730Fentavera 75mcg/h
transdermal patchfentanyl patch transdermal
75mcg/h,
patches (5)
Acino AG, Am
Windfeld 35, 83714
Miesbach
Germany N02AB03 1383518.09.2014
18.09.2019PoM/UC
Acino AG, Am
Windfeld 35, 83714
Miesbach, Germany
1731 Ferracin IVIron sucrose
complexsolution for injection
20mg/ml,
5ml ampoules (5)
Rafarm S.A., Thesi
Pousi- Hatzi, Agiou
Louka, str. Painania,
Attiki 19002 P.O. Box
37
Greece B03AC02 1357310.06.2014
10.06.2019PoM
Acino AG, Am
Windfeld 35, 83714
Miesbach, Germany
376
1732 Ferro-Folgamma
iron sulfate, folic
acid,
cyanocobalamin
capsules
112,6mg+5mg+ 0,01mg,
in blister (20/2x10/,
50/5x10/)
C.P.M. Contract
Pharma GmbH & Co.
KG, Fruhling str. 7,
83678 Feldkirchen-
Westerham -
packager, batch
releaser (bulk
manufacturer -
Catalent Germany
Eberbach GmbH,
Gammelsbacher str. 2,
69412 Eberbach,
Germany)
Germany B03AE01 12333/106.08.2014
09.04.2018PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
1733 Ferro-Folgamma
iron sulfate, folic
acid,
cyanocobalamin
capsules
112,6mg+5mg+ 0,01mg;
(20/2x10/) and (50/5x10/)
in blister
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723- batch releaser,
packager, Catalent
Germany Eberbach
GmbH,
Gammelsbacher Str.
2, 69412 Eberbach,
Germany-bulk
manufacturer
Czech Republic B03AE01 1725813.12.2017
13.12.2022PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
1734 Ferropoliron (III) hydroxide
with polymaltosedrops oral
50mg/ml,
30ml glass bottle
Medana Pharma JSC,
98-200 Sieradz, W.
Lokietka 10 - batch
releaser, Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57, 98-200
Sieradz, Poland-bulk
manufacturer,
packager
Poland B03AB05 1678522.06.2017
22.06.2022PoM
for Medana Pharma
JSC, 98-200 Sieradz,
W. Lokietka 10,
Poland
1735 Ferrum Lekiron (III)-hydroxide
dextran complex
solution for i/m
injection
50mg/ml,
2ml ampoules (5, 50)
Lek d.d., Verovskova
Str. 57, 1526 LjubljanaSlovenia B03AC 14412
08.04.2015
08.04.2020PoM
Lek d.d., Verovskova
Str. 57, 1526
Ljubljana, Slovenia
377
1736 Ferrum LEK
iron (III) hydroxide
with polymaltose
complex
tablets chewable100mg,
in blister (30/3x10/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia B03AB05 1677027.06.2017
27.06.2022PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
1737 Ferrum LEK
iron (III) hydroxide
with polymaltose
complex
syrup
50mg/5ml,
100ml glass bottle and
measuring spoon
Sandoz Ilac Sanayi ve
Ticaret A.S., Inoenue
Mahallesi, Gebze
Plastikciler Organize
Sanayi Boelgesi
Atatturk Bulvari 9,
Cadde No.2, 41400,
Kocaeli
Turkey B03AB05 1683710.07.2017
10.07.2022PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
1738 Fervex
paracetamol,
ascorbic acid,
pheniramine
(pheniramine
maleate)
powder for oral
solution with lemon
flavour and sugar
500mg+200mg+ 25mg,
13,1g sachets (8)
UPSA SAS, 979,
avenue des Pyrenees,
47520 Le Passage
France N02BE51 12428/1 24.08.2017
07.05.2018OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1739 Fervex
paracetamol,
ascorbic acid,
pheniramine
(pheniramine
maleate)
powder for oral
solution with
raspberry flavour
and sugar
500mg+200mg+ 25mg,
12,75g sachets (8)
UPSA SAS, 979,
avenue des Pyrenees,
47520 Le Passage
France N02BE51 12429/1 24.08.2017
07.05.2018OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1740 Fervex
paracetamol,
ascorbic acid,
pheniramine
(pheniramine
maleate)
powder for oral
solution with lemon,
sugar free
500mg+200mg+ 25mg,
4,95g sachets (8)
UPSA SAS, 979,
avenue des Pyrenees,
47520 Le Passage
France N02BE51 12989/1 17.08.2017
28.10.2018OTC
UPSA SAS, 3, rue
Joseph Monier- 92500
Rueil- Malmaison,
France
1741 Fevarin
fluvoxamine
(fluvoxamine
maleate)
tablets film-coated50mg,
in blister (15/1x15/)
Abbott Healthcare
SAS, Route de
Belleville, Lieu-dit
Maillard, 01400
Chatillon sur
Chalaronne
France N06AB08 1350330.05.2014
30.05.2019PoM
Abbott Healthcare
Products B.V., C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands
378
1742 Fevarin
fluvoxamine
(fluvoxamine
maleate)
tablets film-coated100mg,
in blister (15/1x15/)
Abbott Healthcare
SAS, Route de
Belleville, Lieu-dit
Maillard, 01400
Chatillon sur
Chalaronne
France N06AB08 1350430.05.2014
30.05.2019PoM
Abbott Healthcare
Products B.V., C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands
1743 Fexodine
fexofenadine
(fexofenadine
hydrochloride)
tablets film-coated120mg,
in blister (10/1x10/)
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan- batch
releaser, packager,
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.),
India- bulk
manufacturer
Republic of
ArmeniaR06AX26 16608
10.04.2017
10.04.2022OTC
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan, Republic of
Armenia
1744 Finalgonnonivamide,
nicoboxilointment
4mg/g+25mg/g, 20g
aluminium tube and
applicator
Boehringer Ingelheim
Pharma GmbH & Co.
KG, Binger Strasse
173, D-55216
Ingelheim am Rhein -
batch releaser (dosage
form manufacturer,
packager -
Globopharm
Pharmazeutische
Produktions-und
Handels GmbH.,
Breitenfurter Strasse
251, 1230 Wien,
Austria)
Germany M02AX10 1313610.01.2014
10.01.2019OTC
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
379
1745
Finasteride 5mg
Film-coated
Tablets
finasteride tablets film-coated5mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,
319 Pinner Road, North
Harrow, Middlesex,
HA1 4HF - batch
releaser, Intas
Pharmaceuticals
Limited, Plot No 457 &
458 & 191/218 P,
Sarkhej-Bavla Highway,
Matoda Village, Sanand,
District-Ahmedabad,
382 210, Gujarat, India-
bulk manufacturer,
Accord Healthcare
Limited, Unit C & D,
Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK G04CB01 1599519.09.2016
19.09.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
1746
Finasteride 5mg
Film-coated
Tablets
finasteride tablets film-coated5mg,
in blister (28/2x14/)
Laboratorios Normon
S.A., Ronda de
Valdecarrizo 6, 28760
Tres Cantos, Madrid -
batch releaser, Intas
Pharmaceuticals
Limited, Plot No 457 &
458 & 191/218 P,
Sarkhej-Bavla Highway,
Matoda Village, Sanand,
District-Ahmedabad,
382 210, Gujarat, India-
bulk manufacturer,
Accord Healthcare
Limited, Unit C & D,
Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
Spain G04CB01 1599619.09.2016
19.09.2021PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
380
1747 Finlepsin carbamazepine tablets200mg,
in blister (50/5x10/)
TEVA Operations
Poland Sp. z o.o,
Mogilska str. 80, 31-
546 Krakow
Poland N03AF01 1221007.03.2013
07.03.2018PoM
TEVA
Pharmaceutical
Industries LTD, 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
1748Finlepsin 200
retardcarbamazepine
tablets prolonged-
release
200mg,
in blister (50/5x10/,
100/10x10/, 200/20x10/)
TEVA Operations
Poland Sp. z o.o,
Mogilska str. 80, 31-
546 Krakow
Poland N03AF01 1221107.03.2013
07.03.2018PoM
TEVA
Pharmaceutical
Industries LTD, 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
1749Finlepsin 400
retardcarbamazepine
tablets prolonged-
release
400mg,
in blister (50/5x10/,
100/10x10/, 200/20x10/)
TEVA Operations
Poland Sp. z o.o,
Mogilska str. 80, 31-
546 Krakow
Poland N03AF01 1221207.03.2013
07.03.2018PoM
TEVA
Pharmaceutical
Industries LTD, 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
1750 Finoptin
verapamil
(verapamil
hydrochloride)
tablets film-coated
40mg,
in plastic container (30,
100)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland C08DA01 1474303.08.2015
03.08.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
1751 Finzepine carbamazepine tablets film-coated
200mg,
in blister (10/1x10/,
50/5x10/, 100/10x10/)
Protech Biosystems
Pvt. Ltd., Plot No 145-
146, Pace City-1,
Sector-37, Gurgaon,
Haryana-122001
India N03AF01 13077/121.01.2014
09.12.2018PoM
Protech Biosystems
Pvt. Ltd., Plot No 145-
146, Pace City-1,
Sector-37, Gurgaon,
Haryana-122001,
India
1752Fish oil
vitaminizedfish oil capsules
500mg,
in blister (50/5x10/)
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112
Belarus A11CB 1380005.09.2014
05.09.2019OTC
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112, Belarus
381
1753 Fitolizyn
extractum
compositum ex:
solidaginis virgaureae
herba, equiseti herba,
polygoni avicularis
herba, agropyri
rhizomate, allii cepae
squama, betulae folio,
foenugraeci semine,
petroselini radice,
levistici radice , salvia
sclarea aetheroleum,
menthae piperitae
aetheroleum, pini
sylvestris
aetheroleum, aurantii
dulcis aetheroleum
paste for oral use
67,2g+1g+0,5g+
0,2g+0,15g,
100g aluminium tube
Herbapol Warszawa
Sp. z o.o., 05-800
Pruszkow, ul.
Olowkowa 54
Poland G04BX 12578/130.08.2013
06.06.2018OTC
Herbapol Warszawa
Sp. z o.o., 05-800
Pruszkow, ul.
Olowkowa 54, Poland
1754 Fitolizyn
solidaginis
virgaureae herba,
equiseti herba,
polygoni avicularis
herba, agropyri
rhizomate, allii
cepae squama,
betulae folio,
foenugraeci semine,
petroselini radice,
levistici radice thick
extract, salvia
sclarea
aetheroleum,
menthae piperitae
aetheroleum, pini
sylvestris
aetheroleum,
aurantii dulcis
aetheroleum
paste oral
67,2g/100g+ 1g/100g+
0,5g/100g+ 0,2g/100g+
0,15g/100g,
100g aluminium tube
Herbapol Warszawa
Sp. z o.o., 05-800
Pruszkow, ul.
Olowkowa 54
PolandG04BX;
herbal drug17233
08.12.2017
08.12.2022OTC
Herbapol Warszawa
Sp. z o.o., 05-800
Pruszkow, ul.
Olowkowa 54, Poland
382
1755 Flammegis infliximab
powder lyophilized
for concentrate for
solution for infusion
100mg,
in glass vial (1)
Celltrion Inc., 20,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840, the
Republic of Korea
Korea Sourth L04AB02 13353/107.04.2015
04.04.2019PoM
Celltrion Healthcare
Co., Ltd., 19,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840, the
Republic of Korea
1756 Flammegis infliximab
powder lyophilized
for concentrate for
solution for infusion
100mg,
in glass vial (1)
Celltrion Inc., 20,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840, the
Republic of Korea-
batch releaser;
(Mustafa Nevzat Ilac
Sanayii A.S., Sanayi
Caddesi 13,
Yenibosna, Istanbul,
Turkey-bulk
manufacturer,
primary packager);
(Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120, Hungary-
secondary packager)
Korea Sourth L04AB02 13354/107.04.2015
04.04.2019PoM
Celltrion Healthcare
Co., Ltd., 19,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840, the
Republic of Korea
1757Flavamed cough
solution
ambroxol
(ambroxol
hydrochloride)
solution oral
15mg/5ml,
60ml, 100ml glass bottle
and measuring spoon
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin
Germany R05CB06 1442208.04.2015
08.04.2020OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
383
1758Flavamed cough
tablets
ambroxol
(ambroxol
hydrochloride)
tablets
30mg,
in blister (10/1x10/,
20/2x10/, 50/5x10/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
packager,batch
releaser Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347 Berlin,
Germany-bulk
manufacturer
Germany R05CB06 1449715.05.2015
15.05.2020OTC
Berlin-Chemie A.G.,
Glienicker Weg 125,
D-12489 Berlin,
Germany
1759Flavamed cough
tablets
ambroxol
(ambroxol
hydrochloride)
tablets
30mg,
in blister (10/1x10/,
20/2x10/, 50/5x10/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin -
packager, batch
releaser (bulk
manufacturer -
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden,
Germany)
Germany R05CB06 1485718.09.2015
18.09.2020OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
1760Flavamed
effervescent tablets
ambroxol
(ambroxol
hydrochloride)
tablets effervescent
60mg,
aluminium or plastic
container (10)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin-batch
releaser (bulk
manufacturer,
primary and
secondary packager-
Hermes Arzneimittel
GmbH, Hans-Urmiler
Ring 52, 82515
Wolfratshausen,
Germany)
Germany R05CB06 1478514.08.2015
14.08.2020OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
1761 Flavamed forte
ambroxol
(ambroxol
hydrochloride)
solution oral (with
raspberry flavor)
30mg/5ml,
100ml glass bottle and
measuring spoon
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin
Germany R05CB06 1442308.04.2015
08.04.2020OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
384
1762 Flazon
metronidazole
(metronidazole
benzoate)
suspension oral
25mg/ml,
100ml glass bottle and
measuring cup
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaP01AB01 13862
18.09.2014
18.09.2019PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1763 Flazon metronidazole suppositories vaginal500mg,
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaG01AF01 16689
23.05.2017
23.05.2022PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1764 Flebaven diosmin, hesperidin tablets film-coated
450mg+50mg,
in blister (32/2x16/,
64/4x16/, 96/6x16/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C05CA53 1714107.11.2017
07.11.2022OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1765 Flemoclav Solutab
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets dispersible875mg+125mg,
in blister (14/2x7/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands
J01CR02;
new
indication
14479/130.04.2015
30.04.2020PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1766 Flemoclav Solutab
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets dispersible125mg+31,25mg, in
blister (20/5x4/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CR02 1593529.08.2016
29.08.2021PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1767 Flemoclav Solutab
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets dispersible250mg+62,5mg,
in blister (20/5x4/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CR02 1593629.08.2016
29.08.2021PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
385
1768 Flemoclav Solutab
amoxicillin
(amoxicillin
trihydrate),
clavulanic acid
(potassium
clavulanate)
tablets dispersible500mg+125mg,
in blister (20/5x4/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CR02 1593729.08.2016
29.08.2021PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1769 Flemoxin Solutab
amoxicillin
(amoxicillin
trihydrate)
tablets dispersible1000mg,
in blister (20/4x5/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CA04 13611/112.05.2015
27.06.2019PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1770 Flemoxin Solutab
amoxicillin
(amoxicillin
trihydrate)
tablets dispersible125mg,
in blister (20/4x5/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CA04 1593229.08.2016
29.08.2021PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1771 Flemoxin Solutab
amoxicillin
(amoxicillin
trihydrate)
tablets dispersible250mg,
in blister (20/4x5/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CA04 1593329.08.2016
29.08.2021PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1772 Flemoxin Solutab
amoxicillin
(amoxicillin
trihydrate)
tablets dispersible500mg,
in blister (20/4x5/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands J01CA04 1593429.08.2016
29.08.2021PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
1773 Flexid
levofloxacin
(levofloxacin
hemihydrate)
tablets film-coated
500mg,
in blister (5/1x5/, 7/1x7/,
10/1x10/, 10/2x5/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia J01MA12 15543/107.06.2016
19.04.2021PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
386
1774 Flixonase
fluticasone
(fluticasone
propionate)
spray nasal
(suspension)
50mcg/dose, glass bottle
fitted with a metering,
atomising pump, nasal
adaptor and a dust cover
(120dose)
Glaxo Wellcome
S.A.Avenida de
Extremadura 3 09400
Aranda de Duero
Burgos
Spain R01AD08 1334117.03.2014
17.03.2019PoM
GlaxoSmithKline,
S.A., Severo Ochoa, 2
28760- Tres Cantos
(Madrid), Spain
1775
Flixotide 125
micrograms
Evohaler
fluticasone
(fluticasone
propionate)
suspension,
pressurised
inhalation
125mcg/dose,
120 doses in aluminium
inhaller container
Glaxo Wellcome,
S.A., Avda. de
Extremadura, no 3,
09400- Aranda de
Duero, Burgos, Spain
Spain R01AD08 12407/119.08.2015
23.04.2018PoM
Glaxo Wellcome UK
Limited, Stockley
Park West, Uxbridge,
Middlesex, UB11
1BT, UK
1776
Flixotide 250
micrograms
Evohaler
fluticasone
(fluticasone
propionate)
suspension,
pressurised
inhalation
250mcg/dose,
120 doses in aluminium
inhaller container
Glaxo Wellcome,
S.A., Avda. de
Extremadura, no 3,
09400- Aranda de
Duero, Burgos, Spain
Spain R01AD08 12408/119.08.2015
23.04.2018PoM
Glaxo Wellcome UK
Limited, Stockley
Park West, Uxbridge,
Middlesex, UB11
1BT, UK
1777
Flixotide 50
micrograms
Evohaler
fluticasone
(fluticasone
propionate)
suspension,
pressurised
inhalation
50mcg/dose,
120 doses in aluminium
inhaller container
Glaxo Wellcome,
S.A., Avda. de
Extremadura, no 3,
09400- Aranda de
Duero, Burgos, Spain
Spain R01AD08 12406/119.08.2015
23.04.2018PoM
Glaxo Wellcome UK
Limited, Stockley
Park West, Uxbridge,
Middlesex, UB11
1BT, UK
1778 Flosteron
betamethasone
(betamethasone
dipropionate),
betamethasone
(betamethasone
sodium phosphate)
suspension for
injection
5mg/ml+2mg/ml, 1ml
ampoules (5)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia H02AB01 1652317.03.2017
17.03.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1779 Flotac
diclofenac
cholestyramine
(diclofenac sodium)
capsules145,6mg (75mg), in
blister (20/2x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr/Baden
Germany M01AB05 1237019.04.2013
19.04.2018PoM
Novartis Pharma AG,
56, Lichtstrasse, 4056
Basel, Switzerland
387
1780 Floxadex
ciprofloxacin
(ciprofloxacin
hydrochloride),
dexamethasone
suspension eye/ear3mg/ml+1mg/ml, 10ml
plastic vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS03CA01 14560
09.06.2015
09.06.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1781Floxaval 500mg
film-coated tablets
levofloxacin
(levofloxacin
hemihydrate)
tablets film-coated500mg,
in blister (10/1x10/)
Delorbis
Pharmaceuticals Ltd,
17 Athinon
str.,Ergates Industrial
Area,2643 Ergates,
P.O. Box 28629,2081
Lefkosia
Cyprus J01MA12 1405519.12.2014
19.12.2019PoM
Delorbis
Pharmaceuticals Ltd,
17 Athinon
str.,Ergates Industrial
Area,2643 Ergates,
P.O. Box 28629,2081
Lefkosia, Cyprus
1782 Flucinarfluocinolone
acetonide
ointment for topical
use
0,25mg/g,
15g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AC04 1497618.11.2015
18.11.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1783 Flucinarfluocinolone
acetonidegel for topical use
0,25mg/g,
15g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AC04 1497718.11.2015
18.11.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
1784 Flucinar N
fluocinolone
acetonide,
neomycin
(neomycin
sulphate)
ointment for topical
use
0,25mg/g+5mg/g,
15g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07CC02 1501902.12.2015
02.12.2020PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
388
1785 Fluco fluconazole capsules150mg,
in blister (10/1x10/)
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan- batch
releaser, packager,
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.),
India- bulk
manufacturer
Republic of
ArmeniaJ02AC01 16953
05.09.2017
05.09.2022PoM
Tufenkji Group LLC,
Kochinyan 13/16,
Yerevan, Republic of
Armenia
1786 Flucona-Denk 100 fluconazole capsules100mg,
in blister (10)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany J02AC01 1322824.02.2014
24.02.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1787 Flucona-Denk 150 fluconazole capsules150mg,
in blister (1)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany J02AC01 1322924.02.2014
24.02.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
1788 Fluconazole fluconazole tablets50mg,
in blister (12)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ02AC01 12471
09.12.2013
09.12.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
389
1789 Fluconazole fluconazole capsules150mg,
in blister (1)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J02AC01 1266704.07.2013
04.07.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
1790 Fluconazole fluconazole capsules50mg,
in blister (7)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J02AC01 1266804.07.2013
04.07.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
1791 Fluconazole fluconazole tablets coated150mg,
in blister (2)
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine J02AC01 1327504.03.2014
04.03.2019PoM
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
1792 Fluconazole fluconazole capsules150mg,
in blister (10/1x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaJ02AC01 14319
09.03.2015
09.03.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1793Fluconazole-
Asteria Cap. 50mgfluconazole capsules hard
50mg,
in blister (2/2x1/,
10/1x10/, 100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
Si, Chungcheongbuk-
do
Korea Sourth J02AC01 1535526.02.2016
26.02.2021PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, South Korea
390
1794Fluconazole-
Asteria Cap.150mgfluconazole capsules hard
150mg,
in blister (2/2x1/,
10/1x10/, 100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
Si, Chungcheongbuk-
do
Korea Sourth J02AC01 1535426.02.2016
26.02.2021PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, South Korea
1795Fluconazole-
Biocomfluconazole capsules
150mg,
blister (1, 2/2x1/, 4/4x1/,
8/2x4/, 16/4x4/, 7,
14/2x7/, 28/4x7/, 10,
20/2x10/, 40/4x10/)
Biocom JSC, 54
Chapaevsky Cr.,
Stavropol, 355016
Russia J02AC01 12986/128.06.2016
28.10.2018PoM
Biocom JSC, 54
Chapaevsky Cr.,
Stavropol, 355016,
Russia
1796 Fluconazole-Inta fluconazole capsules50mg,
in blister (30/3x10/)
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka
Bangladesh J02AC01 1447022.04.2015
22.04.2020PoM
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka, Bangladesh
1797 Fluconazole-Inta fluconazole capsules150mg,
in blister (10/1x10/)
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka
Bangladesh J02AC01 1447122.04.2015
22.04.2020PoM
Incepta
Pharmaceuticals
Limited, Dewan Idris
Road, Zirabo, Savar,
Dhaka, Bangladesh
1798Fluconazole-
Zdorovyefluconazole capsules hard
50mg,
in blister (7/1x7/,
10/1x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine J02AC01 1655303.04.2017
03.04.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
1799Fluconazole-
Zdorovyefluconazole capsules hard
100mg,
in blister (7/1x7/,
10/1x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine J02AC01 1655403.04.2017
03.04.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
391
1800Fluconazole-
Zdorovyefluconazole capsules hard
150mg,
in blister (1, 2, 3/1x3/,
3/3x1/, 7)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine J02AC01 1667911.05.2017
11.05.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
1801 Flucopt fluconazole drops eye3mg/ml,
5ml vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01X 14618
03.07.2015
03.07.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1802 Flucostat fluconazole capsules50mg,
in blister (7)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J02AC01 13096/126.12.2017
09.12.2018PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1803 Flucostat fluconazole capsules
150mg,
in blister (2/1x2/, 3/1x3/,
24/4x6/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J02AC01 13097/226.12.2017
09.12.2018PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
1804 Flugarda
fludarabine
(fludarabine
phosphate)
powder lyophilized
for solution for
injection
50mg,
glass vials (5)
Biocad CJSC, Petrovo-
Dalnee, Krasnogorsky
district, Moscow
Region, 143422
Russia L01BB05 1373824.07.2014
24.07.2019PoM
Biocad CJSC, 34 bld.,
lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Petersburg, 198515,
Russia
1805 Fluifort
carbocisteine
lysinate
(carbocisteine
lysinate
monohydrate)
syrup
90mg/ml,
40ml, 120ml glass bottle
and measuring spoon
M & H
Manufacturing Co.
Ltd., 41 Sukhumvit
Road, Paknam,
Muang, Samutprakarn
10270
Thailand R05CB03 1230122.03.2013
22.03.2018OTC
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat ,
Belgium
392
1806 Fluifort
carbocisteine
lysinate
(carbocisteine
lysinate
monohydrate)
powder for solution
for oral use
2700mg,
2,7g sachets
(5, 30, 50)
Polipharm Co., Ltd.,
109 Bangna-Trad
Road, Bang Phli
District, Samut
Prakan 10540
Thailand R05CB03 1255906.06.2013
06.06.2018OTC
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
1807 Fluimucil acetylcysteine tablets effervescent600mg,
in blister (10/5x2/)
Zambon Switzerland
Ltd., Via Industria 13,
CH-6814, Cadempino
Switzerland R05CB01 1459918.06.2015
18.06.2020OTC
Zambon S.P.A., Via
Lillo Del Duca, 10,
Bresso, 20091, Italy
1808 Fluimucil acetylcysteine
solution for i/m and
i/v injection and
inhalation
100mg/ml,
3ml ampoules (5)
Zambon S.P.A., Via
della Chimica, 9,
Vicenza, 36100
Italy R05CB01 1579420.07.2016
20.07.2021PoM
Zambon S.P.A., Via
Lillo del Duca, 10,
Bresso, 20091, Italy
1809 Fluimucil acetylcysteinegranules for oral
solution
200mg,
1g sachet (20, 60)
Zambon Switzerland
Ltd., Via Industria 13,
CH-6814, Cadempino
Switzerland R05CB01 1621608.12.2016
08.12.2021OTC
Zambon S.P.A., Via
Lillo Del Duca, 10,
Bresso, 20091, Italy
1810Fluimucil-
antibiotic IT
thiamphenicol
(thiamphenicol
glycinate
acetylcysteinate)
powder lyophilized
for solution for i/m
injection and
inhalation
500mg,
glass vial (3) and 4ml
solvent in ampoules (3)
Zambon S.P.A., Via
della Chimica, 9,
Vicenza, 36100
Italy J01BA02 1592223.08.2016
23.08.2021PoM
Zambon S.P.A., Via
Lillo del Duca, 10,
Bresso, 20091, Italy
1811 Flumex fluconazole capsules hard150mg,
in blister (2)
ABC Farmaceutici
S.p.A, Via Cantone
Moretti, 29, 10090,
Ivrea
Italy J02AC01 1608610.11.2016
10.11.2021PoM
ABC Farmaceutici
S.p.A, Corso Vittorio
Emanuele II, 72,
Torino, Italy
1812 Fluocinolonefluocinolone
acetonide
ointment for
external use
0,25mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07AC04 16378
30.12.2016
30.12.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
393
1813 Fluracedyl fluorouracil solution for injection50mg/ml,
100ml glass vial
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem
the Netherlands Լ01BC02 1412529.12.2014
29.12.2019PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552, 2003 RN
Haarlem, the
Netherlands
1814 Fluracedyl fluorouracil solution for injection50mg/ml,
10ml glass vial
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem
the Netherlands L01BC02 1412629.12.2014
29.12.2019PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552, 2003 RN
Haarlem, the
Netherlands
1815 Fluracedyl fluorouracil solution for injection50mg/ml,
20ml glass vial
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem
the Netherlands L01BC02 1412729.12.2014
29.12.2019PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552, 2003 RN
Haarlem, the
Netherlands
1816 Fluracedyl fluorouracil solution for injection50mg/ml,
5ml glass vial
Pharmachemie
B.V.,Swensweg 5, NL
2031 GA Haarlem
the Netherlands L01BC02 1412829.12.2014
29.12.2019PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552, 2003 RN
Haarlem, the
Netherlands
1817 Flutamide flutamide tablets250mg,
in blister (84/4x21/)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland L02BB01 1349523.05.2014
23.05.2019PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
394
1818 FlyuremAnvi
capsule A- ascorbic
acid. acetylsalicylic
acid. rutoside
(rutoside
trihydrate), capsule
B- metamizole
(metamizole
sodium
monohydrate),
calcium gluconate
(calcium gluconate
monohydrate),
diphenhydramine
(diphenhydramine
hydrochloride)
capsules
300mg+250mg+
20mg+250mg+
100mg+20mg,
in blister (20/2x10//10
capsules A+10 capsules
B/)
Pharmproject JSC,
bld. 14, lit. A,
Sofiyskaya str., Saint
Petersburg, 192236
Russia R05X 1650517.03.2017
17.03.2022OTC
"AnviLab" LLC,
141302 Sergiev Posad,
Festival street, 10,
Sergiev Posad
municipal district,
urban settlement
Sergiev Posad,
Moscow region,
Russia
1819 Fokusin
tamsulosin
(tamsulosin
hydrochloride)
capsules modified-
release
0,4mg,
in blister (30/3x10/)
Zentiva a.s.
(Nitrianska 100, 920
27 Hlohovec)
Slovakia G04CA02 1290407.10.2013
07.10.2018PoM
Zentiva, k.s. (U
kabelovny 130, 102
37 Praha 10, Dolni
Mecholupy, Czech
Republic)
1820 Folacin folic acid tablets5mg,
in blister (30/3x10/)
JADRAN- GALENSKI
LABORATORIJ d.d.,
Svilno 20, 51000
Rijeka
Croatia B03BB01 1571422.06.2016
22.06.2021PoM
JADRAN- GALENSKI
LABORATORIJ d.d.,
Svilno 20, 51000
Rijeka, Croatia
1821 Folic Acid folic acid tablets1mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaB03BB01 13866
18.09.2014
18.09.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
395
1822 Folic Acid folic acid tablets1mg,
in blister (50/5x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus B03BB01 1428319.03.2015
19.03.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1823 Folic Acid folic acid tablets
5mg,
in blisters (48/2x24/,
50/5x10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaB03BB01 14728/1
25.12.2017
30.07.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1824 Folic Acid folic acid tablets5mg,
in blister (20/2x10/)
Replek Farm Ltd,
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia B03BB01 1500602.12.2015
02.12.2020PoM
Esculap Ltd., 17/2, 1
block, Davidashen,
0054, Yerevan,
Republic of Armenia
1825 Folic Acid folic acid tablets5mg,
in plastic container (50)
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine B03BB01 1505202.12.2015
02.12.2020PoM
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
1826 Folic Acid folic acid tablets1mg,
in plastic container (50)
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine B03BB01 1505302.12.2015
02.12.2020PoM
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
1827 Forlaxmacrogol (macrogol
4000)
powder for oral
solution
10g,
sachets (20)
Beaufour Ipsen
Industrie , Ethe
Virton, 28100 Dreux
France A06AD65 1419506.02.2015
06.02.2020OTC
Ipsen Pharma, 65
quai Georges Gorse,
92100 Boulogne-
Billancourt, France
396
1828 Formetin
metformin
(metformin
hydrochloride)
tablets
1000mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia A10BA02 1419006.02.2015
06.02.2020PoM
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1829 Formetin
metformin
(metformin
hydrochloride)
tablets
850mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia A10BA02 1419106.02.2015
06.02.2020PoM
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1830 Formetin
metformin
(metformin
hydrochloride)
tablets
500mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 212
Russia A10BA02 1419206.02.2015
06.02.2020PoM
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1831 Formetin
metformin
(metformin
hydrochloride)
tablets
500mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A10BA02 1608310.11.2016
10.11.2021PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1832 Formetin
metformin
(metformin
hydrochloride)
tablets
850mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A10BA02 1608410.11.2016
10.11.2021PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
1833 Formetin
metformin
(metformin
hydrochloride)
tablets
1000mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A10BA02 1608510.11.2016
10.11.2021PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
397
1834 Formidron formaldehydesolution for external
use
37mg/ml,
30ml glass bottle
ESCO-PHARM LLC
(Nor-Norq V block,
Mikoyan 13, Yerevan
0079)
Republic of
ArmeniaD08AX 12992
28.10.2013
28.10.2018OTC
ESCO-PHARM LLC
(Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia)
1835 Fortransmacrogol (macrogol
4000)
powder for oral
solution
64g,
73,69g sachets (4)
Beaufour Ipsen
Industrie, rue Ethe
Virton, 28100 Dreux
France A06AD15 1630730.12.2016
30.12.2021OTC
Ipsen Pharma, 65
quai Georges
Gorse,92100
Boulogne-Billancourt,
France
1836 ForTRONN
ceftazidime
(ceftazidime
sodium)
powder for solution
for injection
1000mg,
glass vial
Protech Biosystems
Pvt Ltd.,Plot No 145-
146, Pace City-1,
Sector-37 Gurgaon,
Haryana
India J01DD02 1234009.04.2013
09.04.2018PoM
Protech Biosystems
Pvt Ltd.,Plot No 145-
146, Pace City-1,
Sector-37 Gurgaon,
Haryana, India
1837 Fortum
ceftazidime
(ceftazidime
pentahydrate)
powder for solution
for injection/infusion
500mg,
glass vial
GlaxoSmithKline
Manufacturing S.p.A.,
Via A. Fleming 2,
37135, Verona
Italy J01DD02 1310810.12.2013
10.12.2018PoM
GlaxoSmithKline
Manufacturing S.p.A.,
Via A. Fleming 2,
37135, Verona, Italy
1838 Fortum
ceftazidime
(ceftazidime
pentahydrate)
powder for solution
for injection/infusion
1000mg,
glass vial
GlaxoSmithKline
Manufacturing S.p.A.,
Via A. Fleming 2,
37135, Verona
Italy J01DD02 1310910.12.2013
10.12.2018PoM
GlaxoSmithKline
Manufacturing S.p.A.,
Via A. Fleming 2,
37135, Verona, Italy
1839 Fotil
pilocarpine
(pilocarpine
hydrochloride),
timolol (timolol
maleate)
drops eye20mg/ml+5mg/ml, 5ml
plastic vial
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01ED51 1245207.05.2013
07.05.2018PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
398
1840 Fotil forte
pilocarpine
(pilocarpine
hydrochloride),
timolol (timolol
maleate)
drops eye40mg/ml+5mg/ml, 5ml
plastic vial
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01ED51 1245307.05.2013
07.05.2018PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
1841 Frangulax
aloe capensis,
frangulae corticis
extractum siccum
tablets coated35mg+42mg,
in blister (20/2x10/)
Poznan Plant of
Medicinal herbs
"Herbapol" S.A. 47/51,
Towarowa str., 61-896
Poznan
PolandA06AB
herbal drug 12169
01.02.2013
01.02.2018OTC
Poznan Plant of
Medicinal herbs
"Herbapol" S.A.
47/51, Towarowa str.,
61-896 Poznan,
POLAND
1842Fraxiparine 2850IU
AXa/0,3mlnadroparin calcium solution for injection
2850IU AXa/0,3ml,
0,3ml pre-filled syringes
(10)
Aspen Notre Dame de
Bondeville, 1 rue de
l’Abbaye, 76960
Notre Dame de
Bondeville, France
France B01AB06 14076/131.07.2015
16.12.2019PoM
Aspen Pharma
Trading Limited,
3016 Lake Drive,
Citywest Business
Campus, Dublin 24,
Ireland
1843Fraxiparine 5700IU
AXa/0,6mlnadroparin calcium solution for injection
5700IU AXa/0,6ml,
0,6ml pre-filled syringes
(2, 10)
Aspen Notre Dame de
Bondeville, 1 rue de
l’Abbaye, 76960
Notre Dame de
Bondeville, France
France B01AB06 14077/131.07.2015
16.12.2019PoM
Aspen Pharma
Trading Limited,
3016 Lake Drive,
Citywest Business
Campus, Dublin 24,
Ireland
1844 Fromilid clarithromycin tablets film-coated250mg,
in blister (14/2x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01FA09 1303325.11.2013
25.11.2018PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1845 Fromilid clarithromycin tablets film-coated500mg,
in blister (14/2x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01FA09 1303425.11.2013
25.11.2018PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
399
1846 Fromilid uno clarithromycintablets prolonged-
release
500mg,
in blister (7/1x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01FA09 1628819.12.2016
19.12.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1847 Ftorafur tegafur capsules400mg,
in plastic container (100)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia L01BC03 1626619.12.2016
19.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
1848 Ftorocort
triamcinolone
(triamcinolone
acetonide)
ointment1mg/g,
15g aluminium tube
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary D07AB09 1445204.05.2015
04.05.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
1849 Fungazolemiconazole
(miconazole nitrate)
cream for external
use
20mg/g,
15g aluminium tube
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine D01AC02 1718828.11.2017
28.11.2022OTC
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
1850Fungicide-acaricide
ointment Yam
birch liquid tar,
turpentine oil,
sulfur, salicylic acid,
zinc oxide, lysol
ointment
100mg/g+70mg/g+100mg/
g+20mg/g+100mg/g+60mg
/g, 20g, 50g, 90g, 250g, in
plastic container or 20g,
50g, 90g, 250g, in tube
"Brovafarma" Ltd,18-
a, Nezalezhnosti
blvd., Brovary, Kiev
region, 07400
Ukraine
QD10AB;
veterinary
drug
14380/120.05.2015
16.04.2020PoM
"Brovafarma" Ltd,18-
a, Nezalezhnosti
blvd., Brovary, Kiev
region, 07400,
Ukraine
1851 Fungolon fluconazole capsules hard50mg,
in blister (4/1x4/, 8/1x8/)
Balkanpharma-
Razgrad AD, 68
Aprilsko Vastanie
Blvd, 7200 Razgrad
Bulgaria J02AC01 1410329.12.2014
29.12.2019PoM
Balkanpharma-
Razgrad
AD(ACTAVIS
GROUP), 68 Aprilsko
Vastanie Blvd, 7200
Razgrad, Bulgaria
400
1852 Fungoterbin
terbinafine
(terbinafine
hydrochloride)
cream for external
use
10mg/g,
15g aluminium or plastic
laminated tube
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia D01AE15 1446404.05.2015
04.05.2020OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1853 Fungoterbin NEO
terbinafine
(terbinafine
hydrochloride),
urea
gel for external use
10mg+100mg,
15g aluminium or plastic
tube
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia D01AE 12813/130.06.2016
17.09.2018OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1854 Fungoterbine
terbinafine
(terbinafine
hydrochloride)
spray10mg/g,
30g plastic container
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia D01AE15 1354330.05.2014
30.05.2019OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
1855Furacilin ointment
0,2%nitrofural ointment
2mg/g,
25g aluminium tube
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaD08AF01 12523
01.06.2013
01.06.2018OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Armenia
1856 Furacilin Tatpharm nitrofuraltablets for solution
for local use
20mg,
strip (10),
blister (10)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia D08AF01 12779/213.03.2017
14.08.2018OTC
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
1857 Furadonin
nitrofurantoin
(nitrofurantoin
monohydrate)
tablets50mg,
in blister (10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia J01XE01 1283717.09.2013
17.09.2018PoM
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
401
1858 Furadonin nitrofurantoin tablets50mg,
in strip (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus J01XE01 1552419.04.2016
19.04.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1859 Furagin furazidin tablets50mg,
in blister (30/3x10/)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01XE03 1380405.09.2014
05.09.2019PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
1860 Furagin furazidin tablets50mg,
in blister (30/3x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia J01XE03 1649217.03.2017
17.03.2022PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1861Furaginum
Adamedfurazidin tablets
50mg,
in blister (30/1x30/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland J01XE03 1727713.12.2017
13.12.2022PoM
Adamed Sp. z o.o.,
Pienkow 149, 05-152
Czosnow, Poland
1862 Furalgin
phenazone,
tetracaine
(tetracaine
hydrochloride),
nitrofural
drops ear70mg/g+25mg/g+ 2mg/g,
5g plastic vial
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaS02DA30 12524
01.06.2013
01.06.2018OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Armenia
1863 Furamagfurazidin (furazidin
potassium)capsules hard
25mg,
in blister (30/3x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia J01XE03 1623219.12.2016
19.12.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
402
1864 Furamagfurazidin (furazidin
potassium)capsules hard
50mg,
in blister (30/3x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia J01XE03 1623319.12.2016
19.12.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1865 Furasolfurazidin (furazidin
potassium)
powder for solution
for external use
100mg,
1g sachets (15)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia D06BX 1600106.10.2016
06.10.2021OTC
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
1866 Furazolidon furazolidone tablets50mg,
in blister (10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia G01AX06 1319810.01.2014
10.01.2019PoM
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
1867 Furazolidone furazolidone tablets50mg,
in strip (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus G01AX06 1568308.06.2016
08.06.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1868 Furosemide furosemide solution for injection10mg/ml,
2ml ampoules (10)
Experimental plant
GNCLS LLC, 61057,
Kharkov, Vorobeva
str., 8
Ukraine C03CA01 1309809.12.2013
09.12.2018PoM
Experimental plant
GNCLS LLC, 61057,
Kharkov, Vorobeva
str., 8, Ukraine
1869 Furosemide furosemide tablets
40mg,
in blister (50/5x10/,
50/2x25/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus C03CA01 1410829.12.2014
29.12.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
403
1870 Furosemide furosemide tablets40mg,
in blister (40/1x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC03CA01 14882
24.09.2015
24.09.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1871 Furosemide furosemide solution for injection
10mg/ml,
2ml ampoules (10), 2ml
ampoules label banderol
(10), 2ml ampoules
dividella (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus C03CA01 1568508.06.2016
08.06.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1872 Furosemide furosemide solution for injection
10mg/ml,
2ml ampoules (10,
10/1x10/) and 2ml
ampoules, in blister
(10/2x5/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C03CA01 1643106.03.2017
06.03.2022PoM
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8, Ukraine
1873 Furosemide furosemide tablets
40mg,
in blister (50/5x10,
100/4x25/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben-
batch releaser,
packager, Sandoz
Private Limited,
MIDC Plot No. 8-A/2
,8-B, T.T.C. Industrial
Area, Kalwe Block,
Village-Digha, Opp.
Thane-Belapur Road,
Mumbai, 400 708,
India-bulk
manufacturer
Germany C03CA01 1656503.04.2017
03.04.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
404
1874 Furosemide furosemide tablets40mg,
in blister (50/5x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C03CA01 1662625.04.2017
25.04.2022PoM
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8, Ukraine
1875
Furotalgin
2.5mg/31.25mg/87.
5mg/ml ear drops,
solution
nitrofural,
tetracaine
(tetracaine
hydrochloride),
phenazone
drops ear (solution)
2,5mg/ml+ 31,25mg/ml+
87,5mg/ml,
glass (1) or 5ml plastic
vial with dropper
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria S02DA30 1545902.04.2016
02.04.2021PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
1876 Furoxitonus
cefuroxime
(cefuroxime
sodium)
powder for solution
for injection
750mg,
glass vials (25)
Panpharma Z.I., du
Clairay-Luitre 35133,
Fougeres
France J01DC02 1275914.08.2013
14.08.2018PoM
Panpharma Z.I., du
Clairay-Luitre 35133,
Fougeres, France
1877 Fusarpi sodium fusidateointment for topical
use
20mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD06AX01 14078
16.12.2014
16.12.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1878
5% Glucose
solution for
injection
glucose anhydrous solution for infusion
50mg/ml,
100ml, 200ml, 250ml,
400ml, 500ml, 1000ml,
2000ml and 3000ml
plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaB05CX01 14865
24.09.2015
24.09.2020PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
1879
10% Glucose
solution for
injection
glucose anhydrous solution for infusion
100mg/ml,
100ml, 200ml, 250ml,
500ml, 1000ml, 2000ml
and 3000ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaB05CX01 14866
24.09.2015
24.09.2020PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
405
1880 Gabagamma gabapentin capsules hard
400mg,
in blister (20/2x10/,
50/5x10/)
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723- batch releaser,
packager,
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Germany-bulk
manufacturer
Czech Republic N03AX12 1542602.04.2016
02.04.2021PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
1881 Gabagamma gabapentin capsules hard
300mg,
in blister (20/2x10/,
50/5x10/)
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723- batch releaser,
packager,
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Germany-bulk
manufacturer
Czech Republic N03AX12 1542702.04.2016
02.04.2021PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
1882 Gabagamma gabapentin capsules hard100mg,
(20/2x10/, 50/5x10/)
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723- batch releaser,
packager,
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Germany-bulk
manufacturer
Czech Republic N03AX12 1542802.04.2016
02.04.2021PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
406
1883Gabagamma
100mggabapentin capsules hard
100mg,
in blister (20/2x10/,
50/5x10/)
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723 - packager,
batch releaser
(Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1und
2, 73614, Schorndorf,
Germany - bulk
manufacturer)
Czech Republic N03AX12 1345706.05.2014
06.05.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
1884Gabagamma
300mggabapentin capsules hard
300mg,
in blister (20/2x10/,
50/5x10/)
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723 - packager,
batch releaser
(Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1und
2, 73614, Schorndorf,
Germany - bulk
manufacturer)
Czech Republic N03AX12 1345806.05.2014
06.05.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
1885Gabagamma
400mggabapentin capsules hard
400mg,
in blister (20/2x10/,
50/5x10/)
Medis International
a.s., Prumyslova
961/16, Bolatice,
74723 - packager,
batch releaser
(Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1und
2, 73614, Schorndorf,
Germany - bulk
manufacturer)
Czech Republic N03AX12 1345906.05.2014
06.05.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
407
1886 Gabapentin gabapentin capsules300mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN03AX12 16293
21.12.2016
21.12.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1887
Galantamine
Pharmathen 16mg
prolonged-release
capsules hard
galantamine
(galantamine
hydrobromide)
capsules prolonged-
release, hard
16mg,
in blister (28/2x14/)
Pharmaten
International S.A.
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5, Rodopi
69300
Greece N06DA04 1333317.03.2014
17.03.2019PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini Attiki, Greece
1888
Galantamine
Pharmathen 8mg
prolonged-release
capsules hard
galantamine
(galantamine
hydrobromide)
capsules prolonged-
release, hard
8mg,
in blister (28/2x14/)
Pharmaten
International S.A.
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5, Rodopi
69300
Greece N06DA04 1333217.03.2014
17.03.2019PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini Attiki, Greece
1889Galazolin Polfa
0,05%
xylometazoline
(xylometazoline
hydrochloride)
drops nasal (solution)0,5mg/ml,
10ml plastic vial
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland R01AA07 13046/102.02.2017
25.11.2018OTC
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
1890Galazolin Polfa
0,05%
xylometazoline
(xylometazoline
hydrochloride)
drops nasal, solution0,5mg/ml,
10ml plastic vial-dropper
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland R01AA07 1727313.12.2017
13.12.2022OTC
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
408
1891Galazolin Polfa
0,1%
xylometazoline
(xylometazoline
hydrochloride)
drops nasal (solution)1mg/ml,
10ml plastic vial
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland R01AA07 13047/102.02.2017
25.11.2018OTC
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
1892Galazolin Polfa
0,1%
xylometazoline
(xylometazoline
hydrochloride)
drops nasal, solution1mg/ml,
10ml plastic vial-dropper
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland R01AA07 1727413.12.2017
13.12.2022OTC
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
1893 Galoziloc
xylometazoline
(xylometazoline
hydrochloride)
drops nasal0.5mg/ml,
5ml, 10ml plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch
releaser,packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaR01AA07 15181
30.12.2015
30.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
1894 Galoziloc
xylometazoline
(xylometazoline
hydrochloride)
drops nasal1mg/ml,
5ml, 10ml plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch
releaser,packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaR01AA07 15182
30.12.2015
30.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
409
1895 Galoziloc
xylometazoline
(xylometazoline
hydrochloride)
spray nasal0.5mg/ml,
10ml plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch
releaser,packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaR01AA07 15183
30.12.2015
30.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
1896 Galoziloc
xylometazoline
(xylometazoline
hydrochloride)
spray nasal1mg/ml,
10ml plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch
releaser,packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaR01AA07 15184
30.12.2015
30.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
1897 Galvus vildagliptin tablets
50mg,
in blister (7/1x7/,
28/2x14/, 56/4x14/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland A10BH02 1543001.04.2016
01.04.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
1898 Galvus vildagliptin tablets
50mg,
in blister (28/2x14/,
56/4x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona
Spain A10BH02 1618723.11.2016
23.11.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1899 GalvusMET
vildagliptin,
metformin
(metformin
hydrochloride)
tablets film-coated
50mg+500mg,
in blister (30/3x10/,
60/6x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr (Baden
Wurttemberg)
Germany A10BD08 1314410.01.2014
10.01.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
410
1900 GalvusMET
vildagliptin,
metformin
(metformin
hydrochloride)
tablets film-coated
50mg+850mg
in blister (30/3x10/,
60/6x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr (Baden
Wurttemberg)
Germany A10BD08 1314510.01.2014
10.01.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1901 GalvusMET
vildagliptin,
metformin
(metformin
hydrochloride)
tablets film-coated
50mg+1000mg,
in blister (30/3x10/,
60/6x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr (Baden
Wurttemberg)
Germany A10BD08 1314610.01.2014
10.01.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1902 GalvusMet
vildagliptin,
metformin
(metformin
hydrochloride)
tablets film-coated
50mg+850mg,
in blister (30/3x10/,
60/6x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr (Baden
Wurttemberg) -batch
releaser, packager,
Novartis Singapore
Pharmaceutical
Manufacturing Pte.
Ltd., 10 Tuas Bay
Lane, 637461
Singapore-bulk
manufacturer
Germany A10BD08 1633630.12.2016
30.12.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1903 GalvusMet
vildagliptin,
metformin
(metformin
hydrochloride)
tablets film-coated50mg+1000mg,
in blister (60/6x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr (Baden
Wurttemberg) -batch
releaser, packager,
Novartis Singapore
Pharmaceutical
Manufacturing Pte.
Ltd., 10 Tuas Bay
Lane, 637461
Singapore-bulk
manufacturer
Germany A10BD08 1633730.12.2016
30.12.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
411
1904 Gamalate B6
magnesium
glutamate
hydrobromide,
gamma-
aminobutyric acid,
gamma-amino-beta-
hydroxybutyric
acid, vitamin B6
tablets coated
75mg+75mg+
37mg+37mg,
in blister (20/2x10/)
Ferrer International,
S.A., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain N06BX 1477903.08.2015
03.08.2020PoM
Laboratorios Novag,
S.A., Gran Via Carlos
III, 94 08028,
Barcelona, Spain
1905 Gamalate B6
magnesium
glutamate
hydrobromide,
gamma-
aminobutyric acid,
gamma-amino-beta-
hydroxybutyric
acid, vitamin B6
solution oral
20mg/ml+ 20mg/ml+
10mg/ml+10mg/ml, 80ml
glass bottle
Ferrer International,
S.A., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain N05BX 1494920.10.2015
20.10.2020PoM
Ferrer International,
S.A., Joan Gran Via
Carlos III, 94 08028,
Barcelona, Spain
1906 Gangleron ganglefene capsules
40mg,
in blister (60/5x12/), in
plastic container (30)
the Scientific
Technological Center
of Organic and
Pharmaceutical
Chemistry,A.L.
Mndjoyan Institute of
Fine Organic
Chemistry NAS RA ,
Yerevan, Azatutyun
avenue 26 - batch
releaser (Arpimed
LLC, Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia -
bulk manufacturer,
packager)
Republic of
ArmeniaA03AB, C02B 13683
08.07.2014
08.07.2019PoM
the Scientific
Technological Center
of Organic and
Pharmaceutical
Chemistry,A.L.
Mndjoyan Institute of
Fine Organic
Chemistry NAS RA ,
Yerevan, Azatutyun
avenue 26, Republic
of Armenia
412
1907 Gangleron ganglefene solution for injection15mg/ml,
2ml ampoules (10)
the Scientific
Technological Center
of Organic and
Pharmaceutical
Chemistry,A.L.
Mndjoyan Institute of
Fine Organic
Chemistry NAS RA ,
Yerevan, Azatutyun
avenue 26 - batch
releaser (Arpimed
LLC, Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia -
bulk manufacturer,
packager)
Republic of
ArmeniaA03AB, C02B 13684
08.07.2014
08.07.2019PoM
the Scientific
Technological Center
of Organic and
Pharmaceutical
Chemistry,A.L.
Mndjoyan Institute of
Fine Organic
Chemistry NAS RA ,
Yerevan, Azatutyun
avenue 26, Republic
of Armenia
1908 Gardasil
human
papillomavirus type
6 L1 protein,
human
papillomavirus type
11 L1 protein,
human
papillomavirus type
16 L1 protein,
human
papillomavirus type
18 L1 protein
suspension for i/m
injection
20mcg/dose+
40mcg/dose+
40mcg/dose+ 20mcg/dose,
0,5ml/dose glass vial
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, secondary
packager, Merck
Sharp & Dohme
Corp., 770
Sumneytown
Pike,West Point,
19486, USA- bulk
manufacturer,
primary packager
the NetherlandsJ07BM01;
vaccine15703
22.06.2016
22.06.2021PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
413
1909 Gardasil
human
papillomavirus type
6 L1 protein,
human
papillomavirus type
11 L1 protein,
human
papillomavirus type
16 L1 protein,
human
papillomavirus type
18 L1 protein
suspension for i/m
injection
20mcg/dose+
40mcg/dose+
40mcg/dose+ 20mcg/dose,
0,5ml/dose pre-filled
syringe, (1) or (2) needles
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, secondary
packager, Merck
Sharp & Dohme
Corp., 770
Sumneytown
Pike,West Point,
19486, USA- bulk
manufacturer,
primary packager
the NetherlandsJ07BM01;
vaccine15704
22.06.2016
22.06.2021PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
1910 Gastritol
anserinae herba,
matricariae flos,
liquiritiae radix,
angelicae radix,
cnici benedicti
herba, absinthii
herba
drops oral
0.35ml/ml+ 0.2ml/ml+
0.15ml/ml+ 0.05ml/ml+
0.05ml/ml+ 0.05ml/ml,
20ml, 50ml, 100ml glass
vial
Dr. Gustav Klein
GmbH & Co. KG,
Steinenfeld 3, 77736
Zell am Harmersbach
GermanyA03AX
herbal drug13511
30.05.2014
30.05.2019OTC
Dr. Gustav Klein
GmbH & Co. KG,
Steinenfeld 3, 77736
Zell am Harmersbach,
Germany
1911 Gaviscon
sodium alginate,
sodium bicarbonate,
calcium carbonate
suspension oral with
peppermint flavour
50mg/ml+ 26,7mg/ml+
16mg/ml,
100ml, 150ml, 300ml
glass bottle
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS
UK A02BX 1369124.07.2014
24.07.2019OTC
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS,
UK
414
1912 Gaviscon
sodium alginate,
sodium bicarbonate,
calcium carbonate
tablets chewable
with peppermint
flavor
250mg+133.5mg+ 80mg,
in blister (12/2x6/,
16/2x8/, 24/3x8, 32/4x8/,
48/6x8)
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS-
bulk manufacturer,
primary packager,
batch releaser,
Pharmapac Limited,
Unit 20, Valley Road
Business Park,
Bidston, Wirral,
Merseyside, CH41
7EL,UK-secondary
packager
UK A02BX 14761/126.12.2017
03.08.2020OTC
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS,
UK
1913 Gaviscon Forte
sodium alginate,
potassium hydrogen
carbonate
suspension oral with
peppermint flavour
100mg/ml+ 20mg/ml,
80ml, 150ml, 200ml,
250ml, 300ml glass bottle
and 10ml sachets (4, 8,
12, 16, 20)
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS
UK A02BX 1369224.07.2014
24.07.2019OTC
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS,
UK
1914 Gazyva obinutuzumabconcentrate for
solution for infusion
1000mg/40ml,
40ml glass vial (1)
F. Hoffmann-La
Roche Ltd. 4303
Kaiseraugst- batch
releaser, secondary
packager, Roche
Diagnostics GmbH,
Sandhofer Strasse 116,
68305 Mannheim,
Germany- bulk
manufacturer,
primary packager
Switzerland L01XC15 1702626.09.2017
26.09.2022PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
415
1915 Gelmicidoxyclozanide,
albendazoletablets
175mg+360mg,
in blister (100/4x25/)
NVT
Agrovetzashchita S-P
Ltd. ('AVZ S-P'),
Moscow Region,
Sergiyev Posad, 1,
Tsentralnaya Str.,
141300
Russia
QP52AC11
veterinary
drug
1387323.09.2014
23.09.2019PoM
LLC 'Scientific and
Implamentation
Center
Agrovetzaschita',
Kolskaya str. 1, bldg.
1, Moscow, 129329,
Russia
1916 Gelofusine
gelatin
succinylated,
sodium chloride
solution for infusion40mg/ml+ 7,01mg/ml,
500ml plastic bottle (10)
B.Braun Medical AG,
Route de Sorge, 9 CH-
1023 Crissier
Switzerland B05AA06 1636830.12.2016
30.12.2021PoM
B.Braun Melsungen
AG, Carl-Braun-
Strasse 1, 34212
Melsungen, Germany
1917 Gembio
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for
injection
200mg,
glass vial
Bioprofarma S.A.,
Terrada 1270, Ciudad
Autonoma de Buenos
Aires - packager,
batch releaser (dosage
form manufacturer -
Quality Pharma
S.A.Gral. Villegas
1320/1510, San Justo,
Provinicia de Buenos
Aires, Argentina)
Argentina L01BC05 1270223.07.2013
23.07.2018PoM
Bioprofarma S.A.,
Terrada 1270, Ciudad
Autonoma de Buenos
Aires, Argentina
1918 Gembio
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for
injection
1000mg,
glass vial
Bioprofarma S.A.,
Terrada 1270, Ciudad
Autonoma de Buenos
Aires - packager,
batch releaser (dosage
form manufacturer -
Quality Pharma
S.A.Gral. Villegas
1320/1510, San Justo,
Provinicia de Buenos
Aires, Argentina)
Argentina L01BC05 1270323.07.2013
23.07.2018PoM
Bioprofarma S.A.,
Terrada 1270, Ciudad
Autonoma de Buenos
Aires, Argentina
416
1919 Gemcitabin Ebewe
gemcitabine
(gemcitabine
hydrochloride)
concentrate for
solution for i/v
infusion
10mg/ml,
20ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BC05 1605417.10.2016
17.10.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1920 Gemcitabin Ebewe
gemcitabine
(gemcitabine
hydrochloride)
concentrate for
solution for i/v
infusion
10mg/ml,
100ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BC05 1605517.10.2016
17.10.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
1921 Gemcitabine
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for
infusion
200mg,
10ml glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BC05 1510915.12.2015
15.12.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
1922 Gemcitabine
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for
infusion
1000mg,
50ml glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BC05 1511015.12.2015
15.12.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
417
1923
Gemcitabine
100mg/ml
concentrate for
solution for
infusion
gemcitabine
(gemcitabine
hydrochloride)
concentrate for
solution for i/v
infusion
100mg/ml,
2ml glass vial (1)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01BC05 1490702.10.2015
02.10.2020PoM
Accord Healthcare
Limited, Sage House,
319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF,
UK
1924
Gemcitabine
100mg/ml
concentrate for
solution for
infusion
gemcitabine
(gemcitabine
hydrochloride)
concentrate for
solution for i/v
infusion
100mg/ml,
10ml glass vial (1)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01BC05 1490802.10.2015
02.10.2020PoM
Accord Healthcare
Limited, Sage House,
319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF,
UK
418
1925
Gemcitabine
100mg/ml
concentrate for
solution for
infusion
gemcitabine
(gemcitabine
hydrochloride)
concentrate for
solution for i/v
infusion
100mg/ml,
20ml glass vial (1)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01BC05 1490902.10.2015
02.10.2020PoM
Accord Healthcare
Limited, Sage House,
319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF,
UK
1926
Gemcitabine
100mg/ml
concentrate for
solution for
infusion
gemcitabine
(gemcitabine
hydrochloride)
concentrate for
solution for i/v
infusion
100mg/ml,
15ml glass vial (1)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF-batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India-bulk
manufacturer, primary
packager, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
secondary packager
UK L01BC05 1491002.10.2015
02.10.2020PoM
Accord Healthcare
Limited, Sage House,
319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF,
UK
1927Gemcitabine for
injection
gemcitabine
(gemcitabine
hydrochloride)
powder for solution
for infusion
1000mg,
glass vial (1)
Atlanta Bioligical
PVT Ltd, Vill. Kotla,
Barotiwala, Distt.
Solan, Himachal
Pradesh
India L01BC05 1394129.10.2014
29.10.2019PoM
Atlanta Biological
PVT Ltd, Poddar
Court 9th floor, Gate
No.1, 18 Rabindra
Sarani, Kolkata- 700
001, India
419
1928 Gemcitabine PCH
gemcitabine
(gemcitabine
hydrochloride)
powder for solution
for infusion
200mg,
10ml glass vials
Pharmachemie B.V.,
Swensweg 5, P.O. Box
552 2003 RN Haarlem
the Netherlands L01BC05 1227422.03.2013
22.03.2018PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552 2003 RN
Haarlem, the
Netherlands
1929 Gemcitabine PCH
gemcitabine
(gemcitabine
hydrochloride)
powder for solution
for infusion
1000mg,
50ml glass vial
Pharmachemie B.V.,
Swensweg 5, P.O. Box
552 2003 RN Haarlem
the Netherlands L01BC05 1227522.03.2013
22.03.2018PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552 2003 RN
Haarlem, the
Netherlands
1930 Gemcitabine PCH
gemcitabine
(gemcitabine
hydrochloride)
powder for solution
for infusion
2000mg,
100ml glass vial
Pharmachemie B.V.,
Swensweg 5, P.O. Box
552 2003 RN Haarlem
the Netherlands L01BC05 1227622.03.2013
22.03.2018PoM
Pharmachemie B.V.,
Swensweg 5, P.O.
Box 552 2003 RN
Haarlem, the
Netherlands
1931Gemozol corn
ointmentsalicylic acid
ointment for
external use
500mg/g,
10g plastic container
Pharmaceutical
Manufacturing
Enterprise "GEMI", 05-
480 Karczew,
Mickiewicza 36 str.
Poland D02AF 1708005.10.2017
05.10.2022OTC
Pharmaceutical
Manufacturing
Enterprise "GEMI",
05-480 Karczew,
Mickiewicza 36 str.,
Poland
1932 Gemzar
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for i/v
injection
1000mg,
glass vial (1)
Eli Lilly and
Company,
Indianapolis, IN
46285
USA L01BC05 1649517.03.2017
17.03.2022PoM
Eli Lilly and
Company,
Indianapolis, IN
46285, USA
1933 Gemzar
gemcitabine
(gemcitabine
hydrochloride)
powder lyophilized
for solution for i/v
injection
200mg,
glass vial (1)
Eli Lilly and
Company,
Indianapolis, IN
46285
USA L01BC05 1649617.03.2017
17.03.2022PoM
Eli Lilly and
Company,
Indianapolis, IN
46285, USA
420
1934 Genferon lightinterferon alfa-2b,
taurine
suppositories vaginal
and rectal
250000IU+5mg,
in blister (5, 10/2x5/)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L03AB05 1532704.02.2016
04.02.2021PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Petersburg, 198515,
Russia
1935 Genferon lightinterferon alfa-2b,
taurine
suppositories vaginal
and rectal
125000IU+5mg,
in blister (5, 10/2x5/)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L03AB05 1532904.02.2016
04.02.2021PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Petersburg, 198515,
Russia
1936 Gentamicingentamicin
(gentamicin sulfate)
ointment for
external use
1mg/g,
15g aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus D06AX07 1385118.09.2014
18.09.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1937 Gentamicingentamicin
(gentamicin sulfate)drops eye
3mg/ml,
5ml plastic bottle
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland S01AA11 1437325.03.2015
25.03.2020PoM
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
1938 Gentamicin-Kgentamicin
(gentamicin sulfate)solution for injection
80mg/2ml,
2ml ampoules (10/2x5/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01GB03 1665811.05.2017
11.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
421
1939 Gentamicin-Kgentamicin
(gentamicin sulfate)solution for injection
40mg/ml,
1ml ampoules (10/2x5/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01GB03 1665911.05.2017
11.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
1940Gentamicin-
Zdorovye
gentamicin
(gentamicin sulfate)solution for injection
40mg/ml,
2ml ampoules (10), 2ml
ampoules, in blister
(10/2x5/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine J01GB03 1642906.03.2017
06.03.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
1941 Gentos oral drops
populus D1, sabal
D6, conium D6,
potassium iodide
D12, ferrum
picrinicum D12
drops oral
7ml/100ml+ 10ml/100ml+
10ml/100ml+
10ml/100ml+
10ml/100ml,
20ml and 50ml glass
bottle
Richard Bittner AG,
Ossiacherstrasse 7, A-
9560 Feldkirchen
Austria
G04;
homeopathic
drug
1669623.05.2017
23.05.2022OTC
Richard Bittner AG,
Reisnerstrasse 55-57,
A-1030 Wien, Austria
1942Gentos sublingual
tablets
populus D1, sabal
D6, conium D6,
potassium iodide
D12, ferrum
picrinicum D12
tablets sublingual
25mg+37,2mg+
37,2mg+37,2mg+ 37,2mg,
in blister (20/1x20/)
Richard Bittner AG,
Ossiacherstrasse 7, A-
9560 Feldkirchen
Austria
G04;
homeopathic
drug
1669523.05.2017
23.05.2022OTC
Richard Bittner AG,
Reisnerstrasse 55-57,
A-1030 Wien, Austria
1943 Geral ornidazole tablets coated500mg,
in blister (10)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia P01AB03 1249401.06.2013
01.06.2018PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
422
1944 Geucamen
levomenthol,
racemic camphor,
eucalyptus oil,
clove oil
ointment for
external use
180mg/g+ 100mg/g+
100mg/g+10mg/g, 25g
aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
BelarusM02AX10;
herbal drug 14339
25.03.2015
25.03.2020OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1945 Gexosept-Rn chlorhexidine suppositories vaginal 16mg,
(10/2x5/)
"Rubicon" LLC, 62B,
M. Gorky street,
210002, Vitebsk
Belarus G01AX 1571322.06.2016
22.06.2021OTC
"Rubicon" LLC, 62B,
M. Gorky street,
210002, Vitebsk,
Belarus
1946Ginkgo Biloba-
Astrapharm
ginkgo biloba dry
extractcapsules
40mg,
in blister (30/3x10/)
'ASTRAFARM' LLC,
6 Kyivska St,
Vyshneve, Kyivo-
Sviatoshynskyi
district, Kyiv region,
08132
UkraineN06DX02
herbal drug13536
30.05.2014
30.05.2019OTC
ASTRAFARM' LLC, 6
Kyivska St, Vyshneve,
Kyivo-Sviatoshynskyi
district, Kyiv region,
08132, Ukraine
1947 Ginkofar Forteginkgo biloba
extracttablets coated
80mg,
in blister (20/2x10/,
60/6x10/)
Biofarm Sp. z.o.o., 13,
Walbrzyska Str., 60-
198, Poznan
PolandN06DX02;
herbal drug14998
02.12.2015
02.12.2020OTC
Biofarm Sp. z.o.o., 13,
Walbrzyska Str., 60-
198, Poznan, Poland
1948 Ginkor Fort
ginkgo biloba
extract, troxerutin,
heptaminol
hydrochloride
capsules14mg+300mg+ 300mg,
in blister (30/3x10/)
Beaufour Ipsen
Industrie, rue Ethe
Virton, 28100 Dreux
France C05CA54 1545802.04.2016
02.04.2021OTC
Ipsen Pharma, 65
quai Georges
Gorse,92100
Boulogne-Billancourt,
France
1949 Glaoxbetaxolol (betaxolol
hydrochloride)drops eye
5mg/ml,
5ml plastic vial
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01ED02 12384
19.04.2013
19.04.2018PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
423
1950 Glaveral omeprazolecapsules gastro-
resistant hard
20mg,
in plastic container (14,
28)
Help S.A., Pedini
Ioanninon, Ioannina,
45500 for Help S.A.,
10 Valaoritou str., GR
14452
Metamorphosis,
Attica, Greece
Greece A02BC01 1710823.10.2017
23.10.2022PoM
Help S.A., 10
Valaoritou str., GR
14452
Metamorphosis,
Attica, Greece
1951 Glempid glimepiride tablets6mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
packager, Specifar SA,
1, 28 Octovriou str.,
Agia Varvara, 12351,
Greece- bulk
manufacturer
Hungary A10BB12 1710223.10.2017
23.10.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1952 Glempid glimepiride tablets4mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
packager, Specifar SA,
1, 28 Octovriou str.,
Agia Varvara, 12351,
Greece- bulk
manufacturer
Hungary A10BB12 1710323.10.2017
23.10.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1953 Glempid glimepiride tablets3mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
packager, Specifar SA,
1, 28 Octovriou str.,
Agia Varvara, 12351,
Greece- bulk
manufacturer
Hungary A10BB12 1710423.10.2017
23.10.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
424
1954 Glempid glimepiride tablets2mg,
in blister (30/3x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
packager, Specifar SA,
1, 28 Octovriou str.,
Agia Varvara, 12351,
Greece- bulk
manufacturer
Hungary A10BB12 1710523.10.2017
23.10.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
1955 Gliatilin choline alfosceratesolution for i/v & i/m
injection
250mg/ml,
4ml ampoules (3)
Italfarmaco S.p.A.,
Viale Fulvio Testi,
330-20126 Milan
Italy N07AX02 1321724.02.2014
24.02.2019PoM
Italfarmaco S.p.A.,
Viale Fulvio Testi,
330-20126 Milan,
Italy
1956 Gliatilin choline alfoscerate capsules400mg,
in blister (14)
Italfarmaco S.p.A.,
Viale Fulvio Testi,
330-20126 Milan -
batch releaser,
packager (bulk
manufacturer -
Catalent Italy S.p.A.,
Via Nettunense Km.
20, 100-Aprilia (LT),
Italy)
Italy N07AX02 1321824.02.2014
24.02.2019PoM
Italfarmaco S.p.A.,
Viale Fulvio Testi,
330-20126 Milan,
Italy
1957 Glibenclamide glibenclamide tablets5mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA10BB01 13348
13.03.2014
13.03.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1958Glibenclamid-
Zdorovyeglibenclamide tablets
5mg,
in blister (50/5x10/,
120/6x20/),
in plastic container (50,
50/1x50/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine A10BB01 1631430.12.2016
30.12.2021PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
425
1959 Glicised glycine tablets100mg,
in blister (50/5x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine N07XX 1715607.11.2017
07.11.2022OTC
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
1960 Gliclazide gliclazidetablets modified-
release
30mg,
in blister (60/6x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus A10BB09 1363527.06.2014
27.06.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
1961 Gliclazide Canon gliclazidetablets prolonged-
release
60mg,
in blister (30/3x10/,
30/2x15/)
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo
Russia A10BB09 1728513.12.2017
13.12.2022PoM
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo,
Russia
1962 Glimepiride glimepiride tablets4mg,
in blister (30/3x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A10BB12 1411829.12.2014
29.12.2019PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
1963Glimepiride 1mg
tabletsglimepiride tablets
1mg,
in blister (30/3x10/)
Lek S.A., ul.
Domaniewska 50C,
Warszawa, 02-672-
batch releaser,
packager, Lek S.A.,16
Podlipie Str., 95-010
Strykow, Poland-bulk
manufacturer
Poland A10BB12 1669723.05.2017
23.05.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
426
1964Glimepiride 2mg
tabletsglimepiride tablets
2mg,
in blister (90/9x10/)
Lek S.A., ul.
Domaniewska 50C,
Warszawa, 02-672-
batch releaser,
packager, Lek S.A.,16
Podlipie Str., 95-010
Strykow, Poland-bulk
manufacturer
Poland A10BB12 1669823.05.2017
23.05.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1965Glimepiride 4mg
tabletsglimepiride tablets
4mg,
in blister (90/9x10/)
Lek S.A., ul.
Domaniewska 50C,
Warszawa, 02-672-
batch releaser,
packager, Lek S.A.,16
Podlipie Str., 95-010
Strykow, Poland-bulk
manufacturer
Poland A10BB12 1669923.05.2017
23.05.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
1966 Glivecimatinib (imatinib
mesylate)tablets film-coated
100mg,
in blister (60/6x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr/Baden
Germany
L01XE01,
new
indication
13072/109.12.2013
09.12.2018PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1967 Glivecimatinib (imatinib
mesylate)tablets film-coated
400mg,
in blister (30/3x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE01 1523323.12.2015
23.12.2020PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1968 Glivecimatinib (imatinib
mesylate)tablets film-coated
400mg,
in blister (30/3x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr
Germany L01XE01 1697605.09.2017
05.09.2022PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
1969Glucantime
1,5g/5ml
meglumine
antimoniatesolution for injection
300mg/ml,
5ml ampouls (5)
Famar Health Care
Services Madrid,
S.A.U., Avenida de
Leganes, 62, 28923
Alcorcon(Madrid)
Spain P01CB01 12793/107.03.2014
14.08.2018PoM
Sanofi-Aventis
France, 1-13
boulevard Romain
Rolland 75014 Paris,
France
427
1970 Glucophage
metformin
(metformin
hydrochloride)
tablets film-coated
1000mg,
in blister (30/2x15/,
30/3x10/, 60/6x10/,
60/4x15/)
Merck Sante s.a.s., 2
rue du Pressoir Vert,
45400 Semoy
France A10BA02 1507407.12.2015
07.12.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
1971 Glucophage
metformin
(metformin
hydrochloride)
tablets film-coated
500mg,
in blister (30/2x15/,
30/3x10/, 60/3x20/)
Merck Sante s.a.s., 2
rue du Pressoir Vert,
45400 Semoy
France A10BA02 1507507.12.2015
07.12.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
1972 Glucophage
metformin
(metformin
hydrochloride)
tablets film-coated
850mg,
in blister (30/2x15/,
60/3x20/)
Merck Sante s.a.s., 2
rue du Pressoir Vert,
45400 Semoy
France A10BA02 1507607.12.2015
07.12.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
1973 Glucosamine Plus
glucosamine
(glucosamine
hydrochloride),
chondroitin sulfate
(chondroitin sulfate
sodium)
tablets film-coated
500mg+400mg,
in plastic container (30,
60, 100)
IBN AL-Haytham
Pharma Industries
Co., P.O.Box 16232,
Al Mansoura-Aleppo
SyriaM01AX05,
M01AX2513731
24.07.2014
24.07.2019OTC
IBN AL-Haytham
Pharma Industries
Co., P.O.Box 16232,
Al Mansoura-Aleppo,
Syria
1974 Glucose dextrosesolution for i/v
injection
400mg/ml,
5ml ampoules label
banderol (10),
5ml ampoules,
in blister (10/2x5/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus V06DC01 1625419.12.2016
19.12.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
1975 Glucose glucose anhydrous solution for infusion
50mg/ml,
100ml, 200ml, 250ml,
400ml and 500ml plastic
vial
Kelun-Kazpharm
LLP, Almaty region,
Karasai area, Eltay
rural district, the
village of Kokozek
Kazakhstan B05CX01 1651817.03.2017
17.03.2022PoM
Kelun-Kazpharm
LLP, Almaty region,
Karasai area, Eltay
rural district, the
village of Kokozek,
Kazakhstan
428
1976 Glucose glucose anhydrous solution for infusion
100mg/ml,
100ml, 200ml, 250ml,
400ml and 500ml plastic
vial
Kelun-Kazpharm
LLP, Almaty region,
Karasai area, Eltay
rural district, the
village of Kokozek
Kazakhstan B05CX01 1651917.03.2017
17.03.2022PoM
Kelun-Kazpharm
LLP, Almaty region,
Karasai area, Eltay
rural district, the
village of Kokozek,
Kazakhstan
1977 Glucosedextrose (dextrose
monohydrate)solution for infusion
50mg/ml,
50ml,100ml, 200ml,
250ml, 500ml and 3000ml
plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB05CX01 17112
23.10.2017
23.10.2022PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1978 Glucoton MR gliclazidetablets modified-
release
30mg,
in blister (30/3x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia A10BB09 1638216.01.2017
16.12.2021PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
1979 Glucovance
glibenclamide,
metformin
(metformin
hydrochloride)
tablets film-coated5mg+500mg,
in blister (30/2x15/)
Merck Sante s.a.s., 2
rue du Pressoir Vert,
45400 Semoy
France A10BD02 1507207.12.2015
07.12.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
1980 Glucovance
glibenclamide,
metformin
(metformin
hydrochloride)
tablets film-coated2,5mg+500mg,
in blister (30/2x15/)
Merck Sante s.a.s., 2
rue du Pressoir Vert,
45400 Semoy
France A10BD02 1507307.12.2015
07.12.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
1981 Glurenorm gliquidone tablets30mg,
in blister (60/6x10/)
Boehringer Ingelheim
Ellas A.E. (5th km,
Paiania-Markopoulo,
194 00 Koropi, Attiki)
Greece A10BB08 1293307.10.2013
07.10.2018PoM
Boehringer Ingelheim
International GmbH
(Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany)
429
1982 Glycelax glycerol suppositories rectal750mg
(10/2x5/)
Moscow
Pharmaceutical
factory JSC, 125239,
Pharmaceutical
passage 1, Moscow
Russia A06AX01 1329704.03.2014
04.03.2019OTC
Moscow
Pharmaceutical
factory JSC, 125239,
Pharmaceutical
passage 1, Moscow,
Russia
1983 Glycelax glycerol suppositories rectal1500mg
(10/2x5/)
Moscow
Pharmaceutical
factory JSC, 125239,
Pharmaceutical
passage 1, Moscow
Russia A06AX01 1329804.03.2014
04.03.2019OTC
Moscow
Pharmaceutical
factory JSC, 125239,
Pharmaceutical
passage 1, Moscow,
Russia
1984 Glycerin glycerolsolution for external
use
900mg/g,
30ml, 100ml glass or
plastic vial, 10ml plastic
container
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan
Republic of
ArmeniaD11AX 13439
14.04.2014
14.04.2019OTC
Esco-Pharm LLC, Nor-
Norq, Mikoyan 13,
Yerevan, Republic of
Armenia
1985 Glycerin glycerol suppositories rectal1000mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaA06AX01 13475
06.05.2014
06.05.2019OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1986 Glycerin glycerol suppositories rectal2110mg
(10/2x5/)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaA06AX01 13476
06.05.2014
06.05.2019OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
1987 Glycerin glycerol suppositories rectal1,24g,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia A06AG04 15475/103.03.2017
02.04.2021OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
430
1988 Glycerin glycerol suppositories rectal2.11g,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia A06AG04 16356/122.03.2017
30.12.2021OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1989 Glycerin glycerol suppositories rectal1,24g,
in blister (10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia A06AG04 1703526.09.2017
26.09.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1990 Glycerin glycerol suppositories rectal2.11g,
in blister (10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia A06AG04 1703626.09.2017
26.09.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
1991
Glycerin
Suppositories BP 4g
Adult Size
glycerol suppositories rectal2,8g
(12)
LCM Ltd.,
Linthwaite,
Huddersfield, West
Yorkshire, HD7 5QH
UK A06AX01 1280527.08.2013
27.08.2018OTC
Thornton & Ross Ltd.,
Huddersfield, HD7
5QH, UK
1992 Glycine glycine tablets sublingual100mg,
in blister (50/1x50/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaB05CX03 13641
27.06.2014
27.06.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
1993 Glycine glycine tablets sublingual100mg,
in blister (50/1x50/)
"Limited Liability
Company "Medical
Scientific and
Production Complex"
BIOTIKI", 6-ya
Radialnaya str. 24, b.
14, 115404, Moscow
Russia N06BX 1701326.09.2017
26.09.2022OTC
"Limited Liability
Company "Medical
Scientific and
Production Complex"
BIOTIKI", 6-ya
Radialnaya str. 24, b.
14, 115404, Moscow,
Russia
431
1994 Glycine glycinesolution for
irrigation
15mg/ml,
3000ml plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB05CX03 17083
05.10.2017
05.10.2022PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
1995 Glycofor 850mg
metformin
(metformin
hydrochloride)
tablets film-coated850mg,
in blister (30/3x10/)
Medopharm Private
Limited (34-B,
Industrial Area,
Malur-563 130,
Karnataka)
India A10BA02 1294828.10.2013
28.10.2018PoM
Troge Medical GmbH
(Milchstrasse 19, D-
20148 Hamburg,
Germany)
1996 Glycyron Tablets
monoammonium
glycyrrhizinate
(glycyrrhizic acid),
glycine, DL-
methionine
tablets coated35mg+25mg+ 25mg,
in blister (100/10x10/)
Minophagen
Pharmaceutical Co.,
Ltd,. 2-3,
Komatsubara 2-
chome, Zama-shi,
Kanagawa-batch
releaser, secondary
packager, Akiyama
Jozai Co. Ltd., 2-4-21
Hiratsuka, Shinagawa-
ku,Tokyo, Japan-bulk
manufacturer,
primary packager
Japan A05B 1566408.06.2016
08.06.2021PoM
Minophagen
Pharmaceutical Co.,
Ltd., Shinjuku Mitsui
Building #2, 3-2-11,
Nishi-Shinjuku,
Shinjuku-ku,
Tokyo,160-0023,
Japan
1997 Golden Star Balsam
crystallic menthol,
camphor, menthae
oil, eucalypt oil,
cloves oil, cassia oil
pencil inhalation
658mg+124mg+
258mg+65mg+ 5mg+6mg,
1,3g plastic container
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Danang city
Vietnam R05X 1245807.05.2013
07.05.2018OTC
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Danang city,
Vietnam
1998 Golden Star Balsam
crystallic menthol,
camphor, menthae
oil, eucalypt oil,
cloves oil, cassia oil
liquid balsam
280mg/ml+ 88,8mg/ml+
229mg/ml+
1mg/ml+4,6mg/ml+3,8mg
/ml,
5ml glass bottle
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Danang city
Vietnam R05X 1245907.05.2013
07.05.2018OTC
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Danang city,
Vietnam
432
1999 Golden Star Balsam
crystallic menthol,
camphor, oil
menthae piperitae,
eucalyptus leaf oil,
cloves flowers oil,
chinese cassia oil
balsam
113,75mg/g+ 227,5mg/g+
174,5mg/g+
35mg/g+57mg/g+
13,25mg/g,
4g metallic container
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Danang city
Vietnam R05X 1246007.05.2013
07.05.2018OTC
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Danang city,
Vietnam
2000Gonadotropin
chorionic
gonadotropin
chorionic
powder lyophilized
for solution for i/m
injection
500U,
glass vial (5) and 1ml
solvent in ampoule (5)
"Moscow Endocrine
Plant FSUE", 25,
Novokhokhlovskaya
st., Moscow 109052
Russia G03GA01 1473130.07.2015
30.07.2020PoM
"Moscow Endocrine
Plant FSUE", 25,
Novokhokhlovskaya
st., Moscow 109052,
Russia
2001Gonadotropin
chorionic
gonadotropin
chorionic
powder lyophilized
for solution for i/m
injection
1000IU,
glass vial (5) and 1ml
solvent in ampoule (5)
"Moscow Endocrine
Plant FSUE", 25,
Novokhokhlovskaya
st., Moscow 109052
Russia G03GA01 1473230.07.2015
30.07.2020PoM
"Moscow Endocrine
Plant FSUE", 25,
Novokhokhlovskaya
st., Moscow 109052,
Russia
2002 Gonal-F follitropin alfapowder for solution
for injection
5,5mcg (75IU),
3ml glass vial, 1ml solvent
in pre-filled syringe,
sterill needles (2)
Merck Serono S.A.
(Succursale d
Aubonne, Zone
Industrielle de l
Ouriettaz, 1170
Aubonne)
Switzerland G03GA05 1298828.10.2013
28.10.2018PoM
Merck Serono Europe
Limited (56 Marsh
Wall, E14 9TP
London, UK)
2003 GONAL-f follitropin alfasolution for s/c
injection
450IU(33mcg)/ 0,75ml,
0.75ml pre-filled pen-
syringe (1) and needles
(12)
Merck Serono S.p.A.,
Via delle Magnolie
15, 70026 Modugno
(BA)
Italy G03GA05 1630230.12.2016
30.12.2021PoM
Merck Serono Europe
Ltd., Marsh Wall 56,
London E14 9TP, UK
2004 GONAL-f follitropin alfasolution for s/c
injection
300IU(22mcg)/ 0,5ml,
0.5ml glass pre-filled
syringe (1) and needles (8)
Merck Serono S.p.A.,
Via delle Magnolie
15, 70026 Modugno
(BA)
Italy G03GA05 1630330.12.2016
30.12.2021PoM
Merck Serono Europe
Ltd., Marsh Wall 56,
London E14 9TP, UK
433
2005 GONAL-f follitropin alfasolution for s/c
injection
900IU(66mcg)/ 1,5ml,
1.5ml glass pre-filled pen-
syringe (1) and needles
(20)
Merck Serono S.p.A.,
Via delle Magnolie
15, 70026 Modugno
(BA)
Italy G03GA05 1630430.12.2016
30.12.2021PoM
Merck Serono Europe
Ltd., Marsh Wall 56,
London E14 9TP, UK
2006 Grammidin neo
gramicidin S
(gramicidin S
dihydrochloride),
cetylpyridinium
chloride
(cetylpyridinium
chloride
monohydrate)
tablets to be sucked3mg+1mg,
in blister (18/2x9/)
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2
Russia R02A 15770/108.12.2017
04.07.2021OTC
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2,
Russia
2007Grammidin with
anesthetic neo
gramicidin S
(gramicidin S
dihydrochloride),
oxybuprocaine
(oxybuprocaine
hydrochloride),
cetylpyridinium
chloride
(cetylpyridinium
chloride
monohydrate)
tablets to be sucked3mg+0.2mg+1mg, in
blister (18/2x9/)
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2
Russia R02A 15769/108.12.2017
04.07.2021OTC
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2,
Russia
2008 Grandaxin tofisopam tablets
50mg,
in blister (20/2x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65 -
batch releaser,
packager, Egis
Pharmaceuticals PLC,
1165 Budapest,
Bokenyfoldi st. 118-
120, Hungary-bulk
manufacturer
Hungary N05BA23 1644206.03.2017
06.03.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2009 Grandaxin tofisopam tablets
50mg,
in blister (20/2x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05BA23 1644306.03.2017
06.03.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
434
2010Grani-Denk
1mg/ml
granisetron
(granisetron
hydrochloride)
concentrate for
solution for
injection/infusion
1mg/ml,
3ml ampoules (5)
Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789
Germany A04AA02 1383818.09.2014
18.09.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2011Grani-Denk
1mg/ml
granisetron
(granisetron
hydrochloride)
concentrate for
solution for
injection/infusion
1mg/ml,
1ml ampoules (5)
Hameln
Pharmaceuticals
GmbH, Langes Feld
13, Hameln,
Niedersachsen, 31789
Germany A04AA02 1399126.11.2014
26.11.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2012 Graphites Cream graphites cream6x9%,
30g aluminum tube
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH
UK
D11AX
homeopathic
drug
1352230.05.2014
30.05.2019PoM
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH,
UK
2013Grinterol capsules
250mg
ursodeoxycholic
acidcapsules
250mg,
in blister (50/5x10/,
100/10x10/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia A05AA02 1652017.03.2017
17.03.2022PoM
Grindeks Rus LLC,
5th floor, corpus 3,
74, Varshavskoe
shosse, Moscow,
117556, Russia
2014 Grippferon interferon alfa-2b drops nasal
10000IU/ml,
5ml,10ml plastic vial with
dropper
FIRN M CJSC, 4,
Dzerzhinskogo str.,
Kokoshkino
Settlement, Naro-
Fominsky district,
Moskow region,
143390
Russia L03AB01 1589823.08.2016
23.08.2021OTC
"FIRN M" CJSC, 15/1,
entrance "B", Borby
square, Moscow,
127055, Russia
435
2015GrippoFlu cold and
flu
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid
powder for oral
solution with
raspberry flavour
325mg+10mg+
20mg+50mg,
13g sachets (10)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia N02BE51 1451015.05.2015
15.05.2020OTC
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
2016GrippoFlu cold and
flu
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid
powder for oral
solution with
cranberry flavour
325mg+10mg+
20mg+50mg,
13g sachet (10)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia N02BE51 1712324.10.2017
24.10.2022OTC
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
2017GrippoFlu Extra
cold and flu
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid
powder for oral
solution with black-
currant flavour
0,65g+0,01g+ 0,02g+0,05g,
13g sachets (3, 8)
Marbiopharm JSC,
424006,Republic Mari
El,Yoshkar-Ola, st.
Karl Marx 121
Russia N02BE51 1389506.10.2014
06.10.2019OTC
Marbiopharm JSC,
424006,Republic Mari
El,Yoshkar-Ola, st.
Karl Marx 121, Russia
2018GrippoFlu Extra
cold and flu
paracetamol,
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid
powder for oral
solution with lemon
flavour
0,65g+0,01g+ 0,02g+0,05g,
13g sachets (3, 8)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia N02BE51 1440616.04.2015
16.04.2020OTC
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
436
2019 Grippostadparacetamol,
ascorbic acid
powder for oral
solution
600mg+50mg,
5g sachets (5)
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel-
batch releaser,
allphamed PHARBIL
Arzneimittel GmbH,
Hildebrandstr. 10-12,
37081 Gottingen,
Niedersachsen,
Germany-bulk
manufacturer,
packager
Germany N02BE51 1697305.09.2017
05.09.2022OTC
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel,
Germany
2020 Grippostad C
paracetamol,
ascorbic acid,
caffeine,
chlorphenamine
(chlorphenamine
maleate)
capsules
200mg+150mg+
25mg+2,5mg,
in blister (10/1x10/)
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel
Germany N02BA71 1697205.09.2017
05.09.2022OTC
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel,
Germany
2021Grippostad Rhino
0,1% nasal drops
xylometazoline
(xylometazoline
hydrochloride)
drops nasal1mg/ml,
10ml glass bottle (1)
STADA Arzneimittel
AG, Stadastrasse 2-18
D-61118 Bad Vilbel
Germany R01AA07 1214001.02.2013
01.02.2018OTC
STADA Arzneimittel
AG, Stadastrasse 2-18
D-61118 Bad Vilbel,
Germany
2022 Grippoton
xylometazoline
(xylometazoline
hydrochloride)
spray nasal
1mg/ml,
10ml plastic bottle with
pump dispenser
Pharmtechnology
LLC, Korzhenevskogo
str., 22, 220024,
Minsk
Belarus R01AA07 1672605.06.2017
05.06.2022OTC
Giga Farm LLC,
Gogunca str.3/5,
Gyumri, Republic of
Armenia
2023 Grippoton
xylometazoline
(xylometazoline
hydrochloride)
spray nasal
0.5mg/ml,
10ml plastic bottle with
pump dispenser
Pharmtechnology
LLC, Korzhenevskogo
str., 22, 220024,
Minsk
Belarus R01AA07 1672705.06.2017
05.06.2022OTC
Giga Farm LLC,
Gogunca str.3/5,
Gyumri, Republic of
Armenia
2024 Grippoton Sashe
paracetamol,
pheniramine
(pheniramine
maleate), ascorbic
acid
powder for oral
solution
325mg+25mg+ 220mg,
sachet (10)
Pharmtechnology
LLC, Korzhenevskogo
str., 22, 220024,
Minsk
Belarus N02BE51 1680522.06.2017
22.06.2022OTC
Giga Farm LLC,
Gogunca str.3/5,
Gyumri, Republic of
Armenia
437
2025 Groprinosin inosine pranobex syrup
50mg/ml,
120ml glass bottle and
measuring cup
Gedeon Richter
Polska Sp. z o.o. 5, ks.
J. Poniatowskiego Str.,
05-825 Grodzisk
Mazowiecki - batch
releaser (S.C. Gedeon
Richter Romania S.A.,
99-105 Guza Voda
street, 540306, Targu-
Mures, Romania -
bulk manufacturer,
packager)
Poland J05AX05 1342114.04.2014
14.04.2019PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2026 Groprinosin inosine pranobex tablets
500mg,
in blister (20/2x10/,
50/5x10/)
Gedeon Richter
Polska Sp. z o.o. 5, ks.
J. Poniatowskiego Str.,
05-825 Grodzisk
Mazowiecki
Poland J05AX05 1494320.10.2015
20.10.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2027Groprinosin-
Richterinosine pranobex syrup
50mg/ml,
150ml glass bottle and
plastic syringe 0.5ml-5ml
Gedeon Richter
Polska Sp. z o.o., ul.
Ks. J. Poniatowskiego
5, Grodzisk
Mazowiecki, 05-825-
batch releaser,
Gedeon Richter
Romania S.A., 99-105
Guza Voda str.,
540306, Targu-Mures,
Romania-bulk
manufacturer,
packager
Poland J05AX05 1570922.06.2016
22.06.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2028 Guttalax sodium picosulfate drops oral
7,5mg/ml,
15ml and 30ml plastic
bottle
Istituto de Angeli
S.R.L. Loc. Prulli,
103/C 50066 Reggello,
Firenze
Italy A06AB08 1673405.06.2017
05.06.2022OTC
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
438
2029 Gynepriston mifepristone tablets10mg,
in blister (1)
Obninsk Chemical
Pharmaceutical
Company CJSC,
249036, 4 Koroleva
str., Obninsk, Kaluga
region
Russia G03XB01 1625119.12.2016
19.12.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2030 Gynocaps
miconazole
(miconazole
nitrate),
metronidazole
capsules vaginal 100mg+100mg, (10/2x5/)
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112
Belarus G01AF20 1306225.11.2013
25.11.2018PoM
Minskintercaps UE,
220075-Minsk, 26
Inzhenernaya St,
P.B.112, Belarus
2031 Gynofort
butoconazole
(butoconazole
nitrate)
cream vaginal20mg/g,
5g plastic applicator
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G01AF15 1483204.09.2015
04.09.2020PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2032 Gyno-Tardyferoniron sulfate, folic
acid
tablets prolonged-
release
80mg+0.35mg,
in blister (30/3x10/)
Pierre Fabre
Medicament
Production,
Etablissement
Progipharm, Rue du
Lycee, 45500 Gien
France B03AD 1425020.02.2015
20.02.2020PoM
Pierre Fabre
Medicament
Production, 45, place
Abel Gance, 92100
Boulogne, France
2033 Gynotril letrozole tablets film-coated2,5mg,
in blister (30/3x10/)
Douglas
Manufacturing Ltd,
Corner Te Pai Place
and Central Park
Drive, Lincoln
Auckland
New Zealand L02BG04 1498518.11.2015
18.11.2020PoM
Eris Pharmaceuticals
(Australia) Pty Ltd, 6
Eastern Road, South
Melbourne, Victoria,
3205, Australia
2034 H+care
aesculus
hippocastanum
tincture, calendula
officinalis tincture,
hamamelis virginica
tincture, paeonia
officinalis tincture
cream
1/10 2.4%+ 1/10 2.4%+
1/10 2.4%+ 1/10 2.4%,
30g aluminum tube
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH
UK
C05AX
homeopathic
drug
1352130.05.2014
30.05.2019PoM
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH,
UK
439
2035 Haemate P 1000
human blood
coagulation factor
VIII, human Von
Willebrand Factor
(VWF:RCo)
powder and solvent
for solution for
injection/ infusion
1000IU+2400IU, glass vial
(1), 15ml glass vial with
solvent, transfer/filter
device 20/20 (1), alcohol
swabs (2)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg
Germany B02BD06 1480604.09.2015
04.09.2020PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
2036 Haemate P 250
human blood
coagulation factor
VIII, human Von
Willebrand Factor
(VWF:RCo)
powder and solvent
for solution for
injection/ infusion
250IU+600IU, glass vial
(1), 5ml glass vial with
solvent, transfer/filter
device 20/20 (1), alcohol
swabs (2)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg
Germany B02BD06 1480404.09.2015
04.09.2020PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
2037 Haemate P 500
human blood
coagulation factor
VIII, human Von
Willebrand Factor
(VWF:RCo)
powder and solvent
for solution for
injection/ infusion
500IU+1200IU, glass vial
(1), 10ml glass vial with
solvent, transfer/filter
device 20/20 (1), alcohol
swabs (2)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg
Germany B02BD06 1480504.09.2015
04.09.2020PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
2038Haemodesum-
PharmaTech
polyvinylpyrrolidon
e, sodium chloride,
potassium chloride,
calcium chloride
(calcium chloride
dihydrate),
magnesium
chloride
(magnesium
chloride
hexahydrate),
sodium
hydrocarbonate
solution for infusion
60mg/ml+ 5,5mg/ml+
0,42mg/ml+ 0,375mg/ml+
0,005mg/ml+ 0,23mg/ml,
100ml, 200ml, 250ml,
400ml, 500ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaB05AA 15718
22.06.2016
22.06.2021PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
440
2039 Hairgaine for Men minoxidil solution50mg/g,
60ml plastic bottle
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD11AX01 13666
08.07.2014
08.07.2019PoM
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
2040Hairgaine for
Womenminoxidil solution
20mg/g,
60ml plastic bottle
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD11AX01 13665
08.07.2014
08.07.2019PoM
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
2041 Hairgaine Gel minoxidil gel20mg/g,
30g aluminium tube
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
EmiratesD11AX01 13667
08.07.2014
08.07.2019PoM
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
2042 H-AL therapeutic
I-.pollen - 1, 10, 100, 1000, 10000
JSK / 1, 10, 100, 1000, 10000 PNU
(1-grass pollen mixture I (1-
10000JSK/ml) - Arrhenatherum
elatius, Dactylis glomerata, Festuca
sp., Lolium sp., Phleum pratense,
Secale cereale, 2-Spring trees (1-
10000 JSK/ml) - Alnus glutinosa,
Betula pendula, Carpinus betulus,
Corylus avellana, 3-Autumn pollen
mixture (1-10000 PNU/ml) -
Artemisia absinthium, Artemisia
vulgaris, Solidago canadensis, 4-
ambrosia (1-10000JSK/ml) -
Ambrosia artemisiifolia, 5-ambrosia
(1-10000PNU/ml) - Ambrosia
artemisiifolia), II-mites - 1, 10, 100,
1000, 10000 PNU (mixture of mites
(1-10000PNU/ml) - Acarus siro,
Dermatophagoides farinae,
Dermatophagoides pteronyssinus),
III-moulds - 0.1, 1, 10, 100, 1000
PNU (1-outdoor mould mixture (0.1-
1000PNU/ml) - Alternaria sp..
Botrytis cinerea, Cladosporium sp.,
Fusarium sp., Chrysonilia sitophila, 2-
indoor mould mixture (0.1-
1000PNU/ml) - Aspergillus
fumigatus, Aspergillus niger,
Penicillium sp., Mucor sp., Rhizopus
sp.)
drops oral
I-pollen (1 JSK/ml, 10 JSK/ml, 100
JSK/ml, 1000 JSK/ml, 10000 JSK/ml
/ 1 PNU/ml, 10 PNU/ml, 100
PNU/ml, 1000 PNU/ml, 10000
PNU/ml)+ II-mites (1 PNU/ml, 10
PNU/ml, 100 PNU/ml, 1000
PNU/ml, 10000 PNU/ml) + III-
moulds (0.1 PNU/ml, 1 PNU/ml, 10
PNU/ml, 100 PNU/ml, 1000
PNU/ml); (1) glass vial 9ml:
1000PNU/ml or 10000PNU/ml or
10000JSK/ml and (1) sterile dosator;
(6) glass vial 9ml: 0,1PNU/ml,
1PNU/ml, 10PNU/ml, 100PNU/ml,
1000PNU/ml (N2) or 1PNU/ml,
10PNU/ml, 100PNU/ml,
1000PNU/ml, 10000PNU/ml (N2)
or 1JSK/ml, 10JSK/ml, 100JSK/ml,
1000JSK/ml, 10000JSK/ml (N2) and
(6) sterile dosator
Sevapharma a.s.,
Vitavska 53, 252 63
Roztoky, building 101
and 102 for
Czech Republic V01AA 1398426.11.2014
26.11.2019PoM
Sevapharma a.s.,
Prumyslova 1472/11,
102 19 Praha 10,
Czech Republic
441
2043 Halidor
bencyclane
(bencyclane
fumarate)
solution for injection
25mg/ml,
2ml ampoules, in blister
(10/2x5/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C04AX11 1555912.05.2016
12.05.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2044 Halidor
bencyclane
(bencyclane
fumarate)
tablets100mg,
in glass container (50)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary C04AX11 1556012.05.2016
12.05.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2045 Halixol
ambroxol
(ambroxol
hydrochloride)
tablets30mg,
blisters (20/2x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary R05CB06 1595515.09.2016
15.09.2021OTC
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2046 Halixol
ambroxol
(ambroxol
hydrochloride)
syrup
3mg/ml,
100ml glass bottle and
measuring cup
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary R05CB06 1595615.09.2016
15.09.2021OTC
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2047 Haloperidol haloperidol tablets5mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05AD01 12470
04.12.2013
04.12.2018PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2048 Haloperidol haloperidol tablets1,5mg,
in blister (48/2x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05AD01 14318
09.03.2015
09.03.2020PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2049Haloperidol-
Richterhaloperidol tablets
5mg,
in blister (50/2x25/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N05AD01 1478003.08.2015
03.08.2020PoM/UC
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
442
2050Haloperidol-
Richterhaloperidol
solution for i/m
injection
5mg/ml,
1ml ampoules (5)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N05AD01 1488924.09.2015
24.09.2020PoM/UC
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2051 Halopril haloperidol solution for injection
5mg/ml,
1ml ampoules,
in blister (10, 10/2x5/)
KPE Zdorovye
narodu" LLC,
Melnikova str., 41,
Kharkov, 61002
Ukraine N05AD01 1237319.04.2013
19.04.2018PoM/UC
"KPE" Zdorovye
narodu" LLC, 61013,
Kharkov,Sevchenko
str. 22, Ukraine
2052 Halothane halothane liquid for inhalation100%,
250ml glass bottle
Piramal Enterprises
Limited, Sy.No.7-70,
70/1 & 70/2, Digwal
Village, Kohir
Mandal, Sangareddy
District - 502 321,
Telangana
India N01AB01 1677522.06.2017
22.06.2022PoM
Piramal Enterprises
Limited, Piramal
Towers, Ganpatrao
Kadam Marg, Lower
Parel, Mumbai-
400013, India
2053 Hamamelis hamamelis D1 suppositories rectal57mg,
in blister (10/2x5/)
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow
Russiahomeopathic
drug12199
07.03.2013
07.03.2018OTC
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow,
RUSSIA
2054 Hamamelis hamamelis D1 ointment100mg/g,
30g aluminium tube
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow
Russiahomeopathic
drug12200
07.03.2013
07.03.2018OTC
Moscow
Pharmaceutical
Works CJSC, 125239,
Pharmaceutical
driveway 1, Moscow,
RUSSIA
2055 Hartil ramipril tablets
5mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09AA05 1361927.06.2014
27.06.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
443
2056 Hartil ramipril tablets
10mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
121
Hungary C09AA05 1362027.06.2014
27.06.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2057 Hartil ramipril tablets
5mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120- batch releaser,
Actavis Ltd., BLB 015,
BLB 016, Bulebel
Industrial Estate,
Zejtun, ZTN 3000,
Malta-bulk
manufacturer,
packager
Hungary C09AA05 1506802.12.2015
02.12.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2058 Hartil ramipril tablets
10mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120- batch releaser,
Actavis Ltd., BLB 015,
BLB 016, Bulebel
Industrial Estate,
Zejtun, ZTN 3000,
Malta-bulk
manufacturer,
packager
Hungary C09AA05 1506902.12.2015
02.12.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2059 Hartil ramipril tablets
2,5mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120- batch releaser,
Actavis Ltd., BLB 015,
BLB 016, Bulebel
Industrial Estate,
Zejtun, ZTN 3000,
Malta-bulk
manufacturer,
packager
Hungary C09AA05 1507002.12.2015
02.12.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
444
2060 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
5mg+5mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary C09BB07 1558212.05.2016
12.05.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2061 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
10mg+5mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary C09BB07 1558312.05.2016
12.05.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2062 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
10mg+10mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary C09BB07 1558412.05.2016
12.05.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2063 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
10mg+10mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09BB07 1659110.04.2017
10.04.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2064 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
5mg+10mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09BB07 1659210.04.2017
10.04.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2065 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
10mg+5mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09BB07 1659310.04.2017
10.04.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
445
2066 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
5mg+5mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09BB07 1659410.04.2017
10.04.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2067 Hartil Amlo
ramipril,
amlodipine
(amlodipine
besilate)
capsules
2,5mg+2,5mg,
in blister (28/4x7/,
30/3x10/, 56/8x7/,
90/9x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary C09BB07 1659510.04.2017
10.04.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2068 Hartil-D
ramipril,
hydrochlorothiazid
e
tablets2,5mg+12,5mg,
in blister (28/2x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120-batch releaser,
Allphamed Pharbil
Arzneimittel GmbH,
Hildebrandstr. 12,
37081 Gottingen,
Germany-bulk
manufacturer,
packager
Hungary C09BA05 1644706.03.2017
06.03.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
2069 Hartil-D
ramipril,
hydrochlorothiazid
e
tablets5mg+25mg,
in blister (28/2x14/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120-batch releaser,
Allphamed Pharbil
Arzneimittel GmbH,
Hildebrandstr. 12,
37081 Gottingen,
Germany-bulk
manufacturer,
packager
Hungary C09BA05 1644806.03.2017
06.03.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
446
2070 Havrix 1440hepatitis A vaccine
inactivated
suspension for
injection
1440 ELISA U/ml, 1ml
glass vial
GlaxoSmithKline
Biologicals s.a., Rue
de l' Institut, 89 B-
1330 Rixensart-batch
releaser,
GlaxoSmithkline
Biologicals SA, Parc
de la Noire Epine -
Rue Fleming 20,
Wavre, 1300, Belgium-
bulk manufacturer,
packager
BelgiumJ07BC02;
vaccine16311
30.12.2016
30.12.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l` Institut, 89 B-
1330 Rixensart,
Belgium
2071 Hedelix ivy leaves extract drops oral40mg/ml,
50ml glass bottle
Krewel Meuselbach
GmbH, Krewel str. 2,
53783 Eitorf -batch
releaser (dosage fom
manufacturer,
packager - Krewel
Meuselbach GmbH,
Xavier-Vorbruggen
str. 6, 98708 Gehren,
Germany)
GermanyR05CP;
herbal drug12824
17.09.2013
17.09.2018OTC
Krewel Meuselbach
GmbH, Krewel str. 2,
53783 Eitorf,
Germany
2072 Hedelix ivy leaves extract syrup
8mg/ml,
100ml glass bottle and
measuring spoon
Krewel Meuselbach
GmbH, Krewel str. 2,
53783 Eitorf
GermanyR05CA;
herbal drug15759
04.07.2016
04.07.2021OTC
Krewel Meuselbach
GmbH, Krewel str. 2,
53783 Eitorf,
Germany
2073 Helmintox 125mgpyrantel (pyrantel
embonate)tablets film-coated
125mg,
in blister (6)
Innothera Chouzy,
Rue Rene Chantereau
"Lisle Vert", 41150
Chouzy-Sur-Cisse
France P02CC01 1410018.12.2014
18.12.2019PoM
Laboratoire Innotech
International, 22,
Avenue Aristide
Briand, 94110
Arcueil, France
2074Helmintox
125mg/2,5ml
pyrantel (pyrantel
embonate)suspension oral
125mg/2,5ml,
15ml glass bottle
Innothera Chouzy,
Rue Rene Chantereau
"Lisle Vert", 41150
Chouzy-Sur-Cisse
France P02CC01 1409918.12.2014
18.12.2019PoM
Laboratoire Innotech
International, 22,
Avenue Aristide
Briand, 94110
Arcueil, France
447
2075 Helmintox 250mgpyrantel (pyrantel
embonate)tablets film-coated
250mg,
in blister (3)
Innothera Chouzy,
Rue Rene Chantereau
"Lisle Vert", 41150
Chouzy-Sur-Cisse
France P02CC01 1409818.12.2014
18.12.2019PoM
Laboratoire Innotech
International, 22,
Avenue Aristide
Briand, 94110
Arcueil, France
2076 Hemomycin
azithromycin
(azithromycin
dihydrate)
tablets film-coated500mg,
in blister (3)
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb
Serbia J01FA10 1512511.12.2015
11.12.2020PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
2077 Hemomycin
azithromycin
(azithromycin
dihydrate)
powder for oral
suspension
200mg/ml,
60ml glass bottle with 10g
powder and measuring
spoon 5ml
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia J01FA10 1628919.12.2016
19.12.2021PoM
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
2078 Hemomycin
azithromycin
(azithromycin
dihydrate)
capsules250mg,
in blister (6/1x6/)
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia J01FA10 1629019.12.2016
19.12.2021PoM
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
448
2079 HemoSol
sodium chloride,
potassium chloride,
magnesium
chloride, sodium
acetate, sodium
gluconate
solution for infusion
5,26mg/ml+ 0,37mg/ml+
0,3mg/ml+ 2,22mg/ml+
5,02mg/ml,
250ml, 500ml, 1000ml
plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB05BB 12856
17.09.2013
17.09.2018PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2080 Hepabel cynarae dry extract tablets film-coated200mg,
in plastic container (60)
Brupharmexport
SPRL (Rue de la
Grotte, 14, Brussels,
1020)
Belgium A05AX 1299028.10.2013
28.10.2018OTC
Brupharmexport
SPRL (Rue de la
Grotte, 14, Brussels,
1020, Belgium)
2081 Hepabene
extractum fumaria
officinalis,
extractum silybum
marianum
capsules275,10mg+ 83,10mg,
in blister (30/3x10/)
Merckle GmbH,
89143, Blaubeuren-
Weiler, Ludwig-
Merckle-Str.3
Germany A05B 1218401.02.2013
01.02.2018PoM
Ratiopharm GmbH,
89079, Ulm, Graf-
Arco-Str. 3, Germany
2082 Heparinheparin (heparin
sodium)gel for external use
1000IU/g,
30g aluminium tube
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia C05BA03 1575304.07.2016
04.07.2021OTC
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
2083 Heparin ointment
heparin (heparin
sodium),
benzocaine, benzyl
nicotinate
ointment for
external use
100IU/g+40mg/g+0,8mg/g
; 25g aluminium or plastic
tube
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia C05BA53 1665111.05.2017
11.05.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
2084 Heparin-Belmedheparin (heparin
sodium)
solution for i/v and
s/c injection
5000UU/ml,
5ml vials (1, 5)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus B01AB01 1402526.11.2014
26.11.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
449
2085 Heparin-Indar heparin sodium solution for injection5000 IU/ml,
5ml glass vial (5)
PrJSC "On the
production of insulin
"INDAR", 02099,
Kyiv, 5 Zroshuvalna st
Ukraine B01AB01 1685510.07.2017
10.07.2022PoM
PrJSC "On the
production of insulin
"INDAR", 02099,
Kyiv, 5 Zroshuvalna
st, Ukraine
2086 Heparin-Liqvoheparin (heparin
sodium)
solution for i/v and
s/c injection
5000IU/ml,
5ml glass vial (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB01AB01 17208
08.12.2017
08.12.2022PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2087 Hepasol-Neo
L-valine, L-
isoleucine, L-
leucine, L-lysine (L-
lysine
monoacetate), L-
methionine, L-
threonine, L-
phenylalanine, L-
tryptophan, L-
alanine, L-arginine,
glicine, L-histidine,
L-proline, L-serine,
L-cysteine (L-
cysteine
acetylcysteine)
solution for infusion
10,08mg/ml+ 10,4mg/ml+
13,09mg/ml+ 6,88mg/ml+
1.1mg/ml+ 4.4mg/ml+
0.88mg/ml+ 0.7mg/ml+
4.64mg/ml+ 10.72mg/ml+
5.82mg/ml+ 2.8mg/ml+
5.73mg/ml+ 2.24mg/ml+
0.52mg/ml,
500ml glass vial
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemomont d.o.o.,
81000,Podgorica, Ilije
Plamenca str. bb,
Montenegro-bulk
manufacturere,
packager
Serbia B05BA01 1626019.12.2016
19.12.2021PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
2088 Hepathrombin
heparin sodium,
allantoin,
dexpanthenol
gel for external use
300IU/g+2,5mg/g+2,5mg/
g,
40g aluminium tube
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia C05BA53 1631630.12.2016
30.12.2021OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
450
2089 Hepathrombin
heparin sodium,
allantoin,
dexpanthenol
cream for external
use
300IU/g+3mg/g+ 4mg/g,
40g aluminium tube
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia C05BA53 16437/110.10.2017
06.03.2022OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
2090 Hepathrombin H
heparin sodium,
prednisolone
(prednisolone
acetate),
polidocanol
ointment for rectal
and external use
65IU/g+ 2,233mg/g+
30mg/g,
20g aluminium tube
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia C05BA53 1637130.12.2016
30.12.2021OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
2091 Hepathrombin H
heparin sodium,
prednisolone
(prednisolone
acetate),
polidocanol
suppositories rectal120IU+1,675mg+ 30mg,
(10/2x5/)
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.
Vrsac, branch plant
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb, Serbia-bulk
manufacturer,
packager
Serbia C05BA53 1637230.12.2016
30.12.2021OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
2092
Hepatitis B
Vaccine (rDNA)
(Adult)
hepatitis B surface
antigene
suspension for
injection
20mcg/dose,
1ml glass vial
(1 dose) (50)
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028
India J07BC01;
vaccine 15208/1
30.08.2017
30.12.2020PoM
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028, India
451
2093
Hepatitis B
Vaccine (rDNA)
(Adult)
hepatitis B surface
antigene
suspension for
injection
20mcg/dose,
1ml ampoules
(1 dose) (50)
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028
India J07BC01;
vaccine 15209/1
30.08.2017
30.12.2020PoM
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028, India
2094
Hepatitis B
Vaccine (rDNA)
(Adult)
hepatitis B surface
antigene
suspension for
injection
20mcg/dose,
10ml glass vial
(10 doses) (25)
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028
India J07BC01;
vaccine 15210/1
30.08.2017
30.12.2020PoM
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028, India
2095
Hepatitis B
Vaccine (rDNA)
(Paediatric)
hepatitis B surface
antigene
suspension for
injection
10mcg/dose,
5ml glass vial,
(10 doses) (50)
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028
India J07BC01;
vaccine 15206/1
30.08.2017
30.12.2020PoM
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028, India
2096
Hepatitis B
Vaccine (rDNA)
(Paediatric)
hepatitis B surface
antigene
suspension for
injection
10mcg/dose; (50)
ampoules 0.5ml (1 dose)
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028
India J07BC01;
vaccine 15207/1
30.08.2017
30.12.2020PoM
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028, India
2097
Hepatitis B
Vaccine (rDNA)
(Paediatric)
hepatitis B surface
antigene
suspension for
injection
10mcg/dose,
0.5ml glass vial
(1 dose) (50)
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028
India J07BC01;
vaccine 15211/1
30.08.2017
30.12.2020PoM
Serum Institute of
India Pvt Ltd., 212/2,
Hadapsar, Pune
411028, India
2098 Hepatoprimornithine (ornithine
aspartate)
concentrate for
solution for injection
500mg/ml,
20ml glass vial
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaA05BA 12484
15.05.2013
15.05.2018PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2099 Heptral ademetioninetablets gastro-
resistant
400mg,
in blister (20/2x10/)
AbbVie S.r.l., S.R. 148
Pontina KM 52, SNC -
Campoverde di
Aprilia (loc. Aprilia)-
04011 Aprilia (LT)
Italy A16AA02 1587011.08.2016
11.08.2021PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
452
2100 Heptral ademetionine
powder lyophilized
for solution for
injection
400mg,
glass vials (5) and 5ml
solvent in ampoules (5)
Famar L'Aigle, Usine
de Saint Remy, rue de
l'Isle, 28380, Saint
Remy Sur Avre
(Famar A.V.E. Alimos
Plant 63, Ag.
Dimitriou Str., Agiou
Dimitriou 63, Alimos
Attiki, 17456, Greece-
solvent manufacturer
and primary
packager)
France A16AA02 15871/102.06.2017
11.08.2021PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2101Herbion cowslip
syrup
liquid aqueous
cowslip root
extract, liquid
aqueous garden
thyme herb extract
syrup
1030mg/5ml+
2060mg/5ml,
150ml glass bottle and
measuring spoon
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
KRKA, tovarna
zdravil, d.d., Novo
mesto, Povhova ulica
5, 8501 Novo Mesto,
Slovenia-bulk
manufacturer,
packager
SloveniaR05C;
herbal drug16498
17.03.2017
17.03.2022OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2102Herbion Iceland
moss syrup
iceland moss thick
extractsyrup
6mg/ml,
150ml glass bottle and
measuring spoon
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
SloveniaR05D;
herbal drug15784
20.07.2016
20.07.2021OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2103 Herbion ivy syrup ivy leaf dry extract syrup
7mg/ml,
150ml glass bottle and
measuring spoon
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
SloveniaR05C
herbal drug 13372
04.04.2014
04.04.2019OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
453
2104Herbion plantain
syrup
liquid aqueous
extract of the
narrowleaf plantain
leaves, liquid
aqueous extract of
the common
mallow flower,
ascorbic acid
syrup
1250mg/5ml+
1250mg/5ml+ 65mg/5ml,
150ml glass bottle and
measuring spoon
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
KRKA, tovarna
zdravil, d.d., Novo
mesto, Povhova ulica
5, 8501 Novo Mesto,
Slovenia-bulk
manufacturer,
packager
SloveniaR05D;
herbal drug16497
17.03.2017
17.03.2022OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2105 Herbion Zen Sen
panax ginseng
radicis extractum
siccum
capsules350mg,
in glass container (24)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
SloveniaHN06WA;
herbal drug 12857
17.09.2013
17.09.2018OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2106 Herceptin trastuzumab
powder for
concentrate for
solution for infusion
440mg,
glass vial (1) and 20ml
solvent in vial
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel-
batch releaser, F.
Hoffmann-La Roche
Ltd., Wurmisweg, CH-
4303, Kaiseraugst,
Switzerland -primary
and secondary
packager, Genentech
Inc., DNA Way 1,
South San Francisco,
CA 94080, USA-bulk
manufacturer
Switzerland
L01XC03;
new
indication
14693/102.07.2015
02.07.2020PoM
Hoffmann-La Roche
Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
454
2107 Herceptin trastuzumab
powder for
concentrate for
solution for infusion
440mg,
glass vial (1) and 20ml
solvent in vial
F. Hoffmann-La
Roche Ltd.,
Wurmisweg, CH-
4303, Kaiseraugst-
packager, batch
releaser (Genentech
Inc., 4625 NW
Brookwood Parkway,
Hillsboro, Oregon,
OR 97124-9332, USA-
bulk manufacturer)
Switzerland L01XC03 1586528.07.2016
28.07.2021PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070,
Switzerland
2108 Herpevir aciclovir tablets200mg,
in blister (20/2x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J05AB01 1589423.08.2016
23.08.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
2109 Herpevir aciclovir tablets400mg,
in blister (10/1x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J05AB01 1589523.08.2016
23.08.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
2110 Herpevir aciclovir ointment
25mg/g,
5g and 15g aluminium
tube
Kievmedpreparat
PJSC, 03115, Kyiv,
Peremogy avenue,
120
Ukraine D06BB03 1638610.02.2017
10.02.2022OTC
Kievmedpreparat
PJSC, 01032, Kyiv,
Saksaganskogo street,
139, Ukraine
2111 Herpferon
interferon alfa-2b,
aciclovir, lidocaine
(lidocaine
hydrochloride)
ointment for
external use
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
Russia D06BB53 1589923.08.2016
23.08.2021OTC
"FIRN M" CJSC, 15/1,
entrance "B", Borby
square, Moscow,
127055, Russia
455
2112 Hexalyse
biclotymol,
lysozyme (lysozyme
hydrochloride),
enoxolone
tablets orodispersible5mg+5mg+5mg, blisters
(30/3x10/)
Laboratoires Bouchara-
Recordati, Parc
Mecatronic 03410
Saint Victor
France R02AX 14591/107.06.2016
08.06.2020OTC
Laboratoires
Bouchara-Recordati,
Immeuble le Wilson,
70 avenue du General
de Gaulle, 92800
Puteaux, France
2113 Hexaspray biclotymol aerosol for local use
750mg/30g,
30g glass bottle with
pump dispenser
Laboratoires Bouchara-
Recordati, Parc
Mecatronic 03410
Saint Victor
France R02AA20 1486724.09.2015
24.09.2020OTC
Laboratoires
Bouchara-Recordati,
Immeuble le Wilson,
70 avenue du General
de Gaulle 92800
Puteaux
2114 Hexaxim
diphtheria toxoid,
tetanus toxoid,
pertussis
toxoid/filamentous
haemagglutinin,
poliovirus types
1/2/3, hepatitis B
surface antigen,
haemophilus
infuenzae type b
polysaccharide,
haemophilus
infuenzae type b
polysaccharide
conjugated to
tetanus protein
suspension for
injection
20IU/0.5ml+ 40IU/0.5ml+
25/25mcg/0.5ml+
40/8/32DU/0.5ml+10mcg/
0.5ml+ 12mcg/0.5ml+22-
36mcg/0.5ml, 0.5ml glass
vial (10)
Sanofi Pasteur SA,
Parc Industriel
d'Incarville, 27100
Val de Reuil
France
J07CA09;
vaccine, new
indication
15225/130.12.2015
30.12.2020PoM
Sanofi Pasteur SA, 2
avenue Pont Pasteur,
69007 Lyon, France
456
2115 Hexaxim
diphtheria toxoid,
tetanus toxoid,
pertussis
toxoid/filamentous
haemagglutinin,
poliovirus types
1/2/3, hepatitis B
surface antigen,
haemophilus
infuenzae type b
polysaccharide,
haemophilus
infuenzae type b
polysaccharide
conjugated to
tetanus protein
suspension for
injection
20IU/0.5ml+ 40IU/0.5ml+
25/25mcg/0.5ml+
40/8/32DU/0.5ml+
10mcg/0.5ml+
12mcg/0.5ml+22-
36mcg/0.5ml, 0.5ml pre-
filled syringe (1) and
needles (2)
Sanofi Pasteur SA,
Parc Industriel
d'Incarville, 27100
Val de Reuil
France
J07CA09;
vaccine, new
indication
15350/126.02.2016
26.02.2021PoM
Sanofi Pasteur SA, 2
avenue Pont Pasteur,
69007 Lyon, France
2116 Hexicon
chlorhexidine
(chlorhexidine
bigluconate)
suppositories vaginal 16mg, (1, 10)
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia G01AX 1257202.10.2013
02.10.2018OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2117 Hexicon
chlorhexidine
(chlorhexidine
bigluconate)
solution for topical
use
0,5mg/ml,
100ml plastic bottle
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia D08AC02 1287619.09.2013
19.09.2018OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2118 Hexiloc
chlorhexidine
(chlorhexidine
digluconate)
solution for external
use
0.5mg/ml,
100ml and 250ml glass or
plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14872
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
457
2119 Hexiloc
chlorhexidine
(chlorhexidine
digluconate)
solution for external
use
2mg/ml,
50ml, 100ml, 250ml
plastic or glass vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14873
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2120 Hexiloc
chlorhexidine
(chlorhexidine
digluconate)
spray
2mg/ml,
15ml, 25ml and 60ml
glass or plastic vial with
pump dispenser
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14875
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2121 Hexiloc
chlorhexidine
(chlorhexidine
digluconate)
solution for external
use
10mg/ml,
100ml, 250ml, 1000ml
and 5000ml glass or
plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch
releaser,packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer
Republic of
ArmeniaD08AC02 15402
09.03.2016
09.03.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
458
2122 Hexiloc
chlorhexidine
(chlorhexidine
digluconate)
gel for external use
2mg/ml,
10ml, 15ml, 25ml and
30ml plastic vial with
pump dispenser or glass
vial with applicator
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 16360
30.12.2016
30.12.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2123 Hexiloc Denta
chlorhexidine
(chlorhexidine
digluconate)
solution for external
use
1.2mg/ml,
50ml, 100ml, 250ml glass
or plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14874
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2124 Hexiloc Denta
chlorhexidine
(chlorhexidine
digluconate)
spray
1.2mg/ml,
15ml, 25ml and 60ml
glass or plastic vial with
pump dispenser
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14880
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
459
2125 Hexiloc Denta
chlorhexidine
(chlorhexidine
digluconate)
gel for external use
1.2mg/ml,
10ml, 15ml, 25ml and
30ml plastic vial with
pump dispenser and
plastic or glass vial with
applicator
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 15890
23.08.2016
23.08.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2126Hexiloc Denta
Menthol
chlorhexidine
(chlorhexidine
digluconate)
spray
1.2mg/ml,
15ml, 25ml, 60ml glass or
plastic vial with pump
disnenser
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14877
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2127Hexiloc Denta
Menthol
chlorhexidine
(chlorhexidine
digluconate)
solution for external
use
1.2mg/ml,
50ml, 100ml and 250ml
glass or plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14879
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
460
2128Hexiloc Denta
Menthol
chlorhexidine
(chlorhexidine
digluconate)
gel for external use
1.2mg/ml,
10ml, 15ml, 25ml and
30ml plastic vial with
pump dispenser and
plastic or glass vial with
applicator
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 16359
30.12.2016
30.12.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2129 Hexiloc Menthol
chlorhexidine
(chlorhexidine
digluconate)
solution for external
use
2mg/ml,
50ml, 100ml, 250ml glass
or plastic vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14876
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2130 Hexiloc Menthol
chlorhexidine
(chlorhexidine
digluconate)
spray
2mg/ml,
15ml, 25ml and 60ml
glass or plastic vial with
pump dispenser
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 14878
24.09.2015
24.09.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2131 Hexiloc Menthol
chlorhexidine
(chlorhexidine
digluconate)
gel for external use
2mg/ml,
10ml, 15ml, 25ml and
30ml plastic vial with
pump dispenser and
plastic or glass vial with
applicator
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaD08AC02 16361
30.12.2016
30.12.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
461
2132 Hexoral hexetidinepressurised
inhalation solution
2mg/ml,
40ml aluminium
container with pump
dispenser
Famar Orleans, 5
avenue de Concyr,
45071 Orleans, Cedex
2
France A01AB12 1720908.12.2017
08.12.2022OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
2133 Hialurom Tendon
hyaluronic acid
(sodium
hyaluronate)
solution for injection20mg/ml,
2ml pre-filled syringe (1)
S.C. Rompharm
Company S.R.L.,
075100, Str. Drumul
Garii Nr.52,Otopeni
Romania M09AX01 1480304.09.2015
04.09.2020PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
2134 Hiconcil
amoxicillin
(amoxicillin
trihydrate)
powder for oral
suspension
250mg/5ml,
100ml glass bottle and
measuring spoon
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
packager, Sandoz
GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria- bulk
manufacturer
Slovenia J01CA04 12705/115.03.2016
23.07.2018PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2135 Hiconcil
amoxicillin
(amoxicillin
trihydrate)
capsules hard500mg,
in blister (16/2x8/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01CA04 1595815.09.2016
15.09.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2136 Hiconcil
amoxicillin
(amoxicillin
trihydrate)
capsules hard250mg,
in blister (16/2x8/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01CA04 1595915.09.2016
15.09.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2137 Hidrasec racecadotrilgranules for oral
suspension
10mg,
1g sachets (16)
Sophartex, 28500,
Vernouillet, 21 rue du
Pressoir
France A07XA04 1383118.09.2014
18.09.2019PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
462
2138 Hidrasec racecadotrilgranules for oral
suspension
30mg,
3g sachets (16)
Sophartex, 28500,
Vernouillet, 21 rue du
Pressoir
France A07XA04 1383218.09.2014
18.09.2019PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2139 Hidrasec racecadotril capsules hard100mg,
in blister (10/1x10/)
Sophartex, 28500,
Vernouillet, 21 rue du
Pressoir
France A07XA04 1383318.09.2014
18.09.2019PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2140 Hierrodexina
iron polysaccharide,
cobalt chloride,
vitamin B12
solution for injection
100mg/ml+ 4mcg/ml+
25mcg/ml, 50ml, 100ml
glass vial
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
Spain
QB03AC;
veterinary
drug
1431310.03.2015
10.03.2020PoM
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19, Spain
2141 Hi-Flex Inj.
hyaluronic acid
(sodium
hyaluronate)
solution for injection20mg/2ml,
2ml pre-filled syringe (3)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South M09AX01 1652117.03.2017
17.03.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
2142 Hippopheae oil hippopheae oil suppositories rectal500mg,
(10/2x5/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova C05AX 1282217.09.2013
17.09.2018OTC
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
2143 Hippopheae oil hippopheae oil suppositories rectal500mg
(10/2x5/)
Nizhpharm OJSC
(603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7)
Russia C05AX 1289907.10.2013
07.10.2018OTC
Nizhpharm OJSC
(603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia)
463
2144 Hippopheae oil hippopheae oil suppositories350mg,
in blister (10/2x5/)
Lekhim-Kharkiv JSC,
36,Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv
UkraineA16AX;
herbal drug17099
23.10.2017
23.10.2022OTC
Lekhim-Kharkiv JSC,
36,Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv,
Ukraine
2145 Holosas rose extract syrup
400mg/g,
140g glass vial or glass
bottle,
300g glass vial
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.
RussiaA05AX;
herbal drug13059
25.11.2013
25.11.2018OTC
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.,
Russia
2146 Hondroxid
chondroitin sulfate
(chondroitin sulfate
sodium)
ointment50mg/g,
30g aluminium tube
Nizhpharm JSC,
Salganskaya str., 7,
GSP-459, Nizhniy
Novgorod 603950
Russia M01AX25 1337504.04.2014
04.04.2019OTC
Nizhpharm JSC,
Salganskaya str., 7,
GSP-459, Nizhniy
Novgorod 603950,
Russia
2147 Hotgra 100sildenafil (sildenafil
citrate)tablets film-coated
100mg,
in blister (4)
Akriti
Pharmaceuticals Pvt.
Ltd., Plot No. D-10, D-
11, M.I.D.C. Indl.
Estate, Nira Road,
Jejuri, Tal. Purandhar
(Saswad), Dist. Pune-
412 303, Maharashtra
India G04BE03 1353330.05.2014
30.05.2019PoM
Akriti
Pharmaceuticals Pvt.
Ltd., 117, Block No. 2,
Emerald Plaza,
Hiranandai Meadows,
Barrister Nath Pai
Road, Thane (West)
400 610, India
2148 Hotgra 50sildenafil (sildenafil
citrate)tablets film-coated
50mg,
in blister (4)
Akriti
Pharmaceuticals Pvt.
Ltd., Plot No. D-10, D-
11, M.I.D.C. Indl.
Estate, Nira Road,
Jejuri, Tal. Purandhar
(Saswad), Dist. Pune-
412 303, Maharashtra
India G04BE03 1353230.05.2014
30.05.2019PoM
Akriti
Pharmaceuticals Pvt.
Ltd., 117, Block No. 2,
Emerald Plaza,
Hiranandai Meadows,
Barrister Nath Pai
Road, Thane (West)
400 610, India
464
2149 Humalog insulin lispro solution for injection100IU/ml (3,5mg/ml),
3ml cartridges (5)
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim
France A10AB04 1592923.08.2016
23.08.2021PoM
Eli Lilly Nederland
B.V.,
Papendorpseweg 83,
3528 BJ Utrecht, the
Netherlands
2150 Humalog Mix 25
insulin lispro
solution and insulin
lispro protamine
suspension
suspension for
injection
100IU/ml (3,5mg/ml),
3ml cartridges (5)
Lilly France S.A.S., 2,
rue du Colonel Lilly,
67640 Fegersheim
France A10AB04 1235409.04.2013
09.04.2018PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991, RA Houten,
the Netherlands
2151 Humalog Mix 50
50% insulin lispro
solution and 50%
insulin lispro
protamine
suspension
(recombinant DNA)
suspension for s/c
injection
100IU/ml (3.5mg/ml),
3ml glass cartridges (5)
Lilly France S.A.S., 2,
rue du Colonel Lilly,
67640 Fegersheim
France A10AB04 1407219.12.2014
19.12.2019PoM
Eli Lilly Nederland
B.V., Grootslag 1-5,
NL-3991, RA Houten,
the Netherlands
2152 Humulin 70/30insulin human
(recombinant DNA)
suspension for
injection
100IU/ml,
10ml glass vial (1)
Eli Lilly and
Company,
Indianapolis, IN
46285
USA A10AD01 1591823.08.2016
23.08.2021PoM
Eli Lilly and
Company,
Indianapolis, IN
46285, USA
2153 Humulin 70/30insulin human
(recombinant DNA)
suspension for
injection
100IU/ml,
3ml cartridges (5)
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim
France A10AD01 1592723.08.2016
23.08.2021PoM
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim,
France
2154 Humulin N
insulin human
isophane
(recombinant DNA)
suspension for
injection
100IU/ml,
10ml glass vial (1)
Eli Lilly and
Company,
Indianapolis, IN
46285
USA A10AC01 1591923.08.2016
23.08.2021PoM
Eli Lilly and
Company,
Indianapolis, IN
46285, USA
465
2155 Humulin N
insulin human
isophane
(recombinant DNA)
suspension for
injection
100IU/ml,
3ml cartridges (5)
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim
France A10AC01 1592823.08.2016
23.08.2021PoM
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim,
France
2156 Humulin R
insulin human
regular
(recombinant DNA)
solution for injection100IU/ml,
10ml glass vial (1)
Eli Lilly and
Company,
Indianapolis, IN
46285
USA A10AB01 1592023.08.2016
23.08.2021PoM
Eli Lilly and
Company,
Indianapolis, IN
46285, USA
2157 Humulin R
insulin human
regular
(recombinant DNA)
solution for injection100IU/ml,
3ml cartridges (5)
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim
France A10AB01 1592623.08.2016
23.08.2021PoM
Lilly France S.A.S.,
Zone Industrielle, 2
rue du Colonel Lilly,
67640 Fegersheim,
France
2158 Hyalurom
hyaluronic acid
(sodium
hyaluronate)
solution for injection15mg/ml,
2ml pre-filled syring (1,3)
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A
Romania M09AX01 1320510.01.2014
10.01.2019PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A,
Romania
2159Hydrochloro-
thiazide
hydrochloro-
thiazidetablets
25mg,
in blister (100/4x25/)
Salutas Pharma
GmbH, Otto-von-
Guericke-Alle-1,
39179 Barleben
Germany C03AA03 1650017.03.2017
17.03.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
2160Hydrochloro-
thiazide
hydrochloro-
thiazidetablets
25mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64, No3,
ul. Chapaeva, Borisov,
Minsk region
Belarus C03AA03 1718130.11.2017
30.11.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
466
2161Hydrochlorthia-
zide
hydrochlorothia-
zidetablets
25mg,
in blister (20/2x10/)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus C03AA03 1243811.08.2013
11.08.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
2162 Hydrocortisone
hydrocortisone
(hydrocortisone
acetate)
ointment for topical
use
10mg/g,
10g, 15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD07AA02 12467/1
16.01.2017
02.10.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2163 Hydrocortisone
hydrocortisone
(hydrocortisone
acetate)
ointment eye5mg/g,
3g, 5g aluminium tube
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia S01BA02 1466303.07.2015
03.07.2020PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
2164 Hydrocortisone
hydrocortisone
(hydrocortisone
acetate)
ointment eye5mg/g,
3g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland S01BA02 1533726.02.2016
26.02.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2165Hydrocortisone
eye ointment
hydrocortisone
(hydrocortisone
acetate)
ointment eye5mg/g,
3g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaS01BA02 15866
28.07.2016
28.07.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2166Hydrocortison-
Richter
hydrocortisone
(hydrocortisone
acetate), lidocaine
(lidocaine
hydrochloride)
suspension for
injection
25mg/ml+5mg/ml, 5ml
glass vial (1)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary H02AB09 1506302.12.2015
02.12.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
467
2167Hydroxycarba-
mide medachydroxycarbamide capsules
500mg,
blisters
(50/5x10/)(100/10x10/)
blisters
Medac GmbH,
Theaterstrasse 6,
22880 Wedel - batch
releaser, (Haupt
Pharma Amareg
GmbH, Donaustaufer
Strasse 378, 93055
Regensburg, Germany
- bulk manufacturer,
packager)
Germany L01XX05 13414/106.12.2016
14.04.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
2168Hymecromone
Sopharmahymecromone tablets
400mg,
in blister (20/2x10/)
Unipharm JSC, 3
Traiko Stanoev Str.,
Sofia 1797
Bulgaria A05AX02 1482104.09.2015
04.09.2020PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2169 Hyoxyson
hydrocortisone
(hydrocortisone
acetate),
oxytetracycline
(oxytetracycline
hydrochloride)
ointment for
external use
10mg/g+30mg/g, 10g
aluminium tube
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29
Russia D07CA01 1523223.12.2015
23.12.2020PoM
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29, Russia
2170 Hypomed
amlodipine
(amlodipine
besilate), lisinopril
(lisinopril
dihydrate)
tablets5mg+10mg,
in blister (40/1x40/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC09BB 13642
27.06.2014
27.06.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2171 Hypothiazidhydrochlorothia-
zidetablets
25mg,
in blister (20/1x20/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary C03AA03 1489324.09.2015
24.09.2020PoM
Sanofi-Aventis
Private Co. Ltd.,1045
Budapest, To u. 1-5,
Hungary
468
2172 Hypothiazidhydrochlorothia-
zidetablets
100mg,
in blister (20/1x20/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary C03AA03 1489424.09.2015
24.09.2020PoM
Sanofi-Aventis
Private Co. Ltd.,1045
Budapest, To u. 1-5,
Hungary
2173
Iasibon 6mg
concetrate for
solution for
infusion
ibandronic acid
(ibandronic acid
sodium
monohydrate)
concentrate for
solution for infusion
6mg/6ml,
6ml glass vial
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki
Greece M05BA06 1274824.07.2013
24.07.2018PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki, Greece
2174 Ibufene ibuprofen suspension oral
20mg/ml,
100ml glass bottle and
measuring cup
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaM01AE01 13545
30.05.2014
30.05.2019OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
2175 Ibunok ibuprofen cream50mg/g,
50g aluminium tube
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaM02AA13 15314
04.02.2016
04.02.2021OTC
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
2176 Ibupar Forte ibuprofen tablets film-coated400mg,
in blister (10/1x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland M01AE01 1630530.12.2016
30.12.2021OTC
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
469
2177 Ibuprofen ibuprofen tablets coated
200mg,
in blisters (10, 50/5x10/,
5000/500x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus M01AE01 1684410.07.2017
10.07.2022OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2178 Ibuprofen AKTIV ibuprofen syrup
20mg/ml,
100ml glass bottle and
measuring spoon
Replek Farm Ltd,
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia M01AE01 1357710.06.2014
10.06.2019OTC
Esculap Ltd., 17/2, 1
block, Davidashen,
0054, Yerevan,
Republic of Armenia
2179 Ibuprofen AKTIV ibuprofen tablets film-coated200mg,
in blister (30/3x10/)
Replek Farm Ltd,
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia M01AE01 1357810.06.2014
10.06.2019OTC
Esculap Ltd., 17/2, 1
block, Davidashen,
0054, Yerevan,
Republic of Armenia
2180 Ibuprofen AKTIV ibuprofen tablets film-coated400mg,
in blister (30/3x10/)
Replek Farm Ltd,
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia M01AE01 1357910.06.2014
10.06.2019OTC
Esculap Ltd., 17/2, 1
block, Davidashen,
0054, Yerevan,
Republic of Armenia
2181 Ibuprofen Medana ibuprofensuspension oral with
strawberry flavour
20mg/ml,
100ml and 120ml plastic
container and measuring
syringe
Medana Pharma JSC,
98-200 Sierad., W.
Lokietka 10 - batch
releaser, Medana
Pharma JSC, str.
Polskiej Organizacji
Wojskowej 57, 98-200
Sieradz, Poland-bulk
manufacturer,
packager
Poland M01AE01 1455709.06.2015
09.06.2020OTC
Medana Pharma JSC,
98-200 Sierad., W.
Lokietka 10, Poland
470
2182 Ibuprofen Sandoz ibuprofen tablets film-coated800mg,
in blister (20/2x10/)
Salutas Pharma
GmbH, Dieselstrasse
5, 70839 Gerlingen -
batch releaser, Salutas
Pharma GmbH, Otto-
von-Guericke-Alle-1,
39179 Barleben,
Germany-packager,
Sandoz Grup Saglik
Ueruenleri Ilaclari
San. ve Tic. A. S.,
Ihsan Dede Cadde No.
900. Sokak, Gebze-
Kocaeli, TR-41480,
Turkey-bulk
manufacturer
Germany M01AE01 1420106.02.2015
06.02.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verevskova 57, SI-
1526 Ljubljana,
Slovenia
2183 Ibuprofen Sandoz ibuprofen tablets film-coated600mg,
in blister (20/2x10/)
Salutas Pharma
GmbH, Dieselstrasse
5, 70839 Gerlingen -
batch releaser, Salutas
Pharma GmbH, Otto-
von-Guericke-Alle-1,
39179 Barleben,
Germany-packager,
Sandoz Grup Saglik
Ueruenleri Ilaclari
San. ve Tic. A. S.,
Ihsan Dede Cadde No.
900. Sokak, Gebze-
Kocaeli, TR-41480,
Turkey-bulk
manufacturer
Germany M01AE01 1420206.02.2015
06.02.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verevskova 57, SI-
1526 Ljubljana,
Slovenia
471
2184Ibuprofen Sandoz
600mgibuprofen tablets film-coated
600mg,
in blister (20/2x10/)
Lek S.A.,16 Podlipie
Str., 95-010 Strykow-
batch releaser,
packager, Sandoz
Grup Saglik
Ueruenleri Ilaclari
San. ve A.S., Gebze
Organized Industrial
Region Ihsan Dede,
Cadde No. 900 Sokak,
TR-41480, Gebze-
Kocaeli, Turkey-bulk
manufacturer
Poland M01AE01 1610410.11.2016
10.11.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1526 Ljubljana,
Slovenia
2185Ibuprofen Sandoz
800mgibuprofen tablets film-coated
800mg,
in blister (20/2x10/)
Lek S.A.,16 Podlipie
Str., 95-010 Strykow-
batch releaser,
packager, Sandoz
Grup Saglik
Ueruenleri Ilaclari
San. ve A.S., Gebze
Organized Industrial
Region Ihsan Dede,
Cadde No. 900 Sokak,
TR-41480, Gebze-
Kocaeli, Turkey-bulk
manufacturer
Poland M01AE01 1610510.11.2016
10.11.2021PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1526 Ljubljana,
Slovenia
2186 Ibuprofen-Asteria ibuprofen tablets film-coated
400mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth M01AE01 14420/128.10.2015
08.04.2020OTC
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
472
2187Ibuprofen-
Hemofarmibuprofen tablets film-coated
400mg,
in blister (30/3x10/)
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm d.o.o.,
78000, Banja-Luka,
Novakovici bb, Bosnia
and Herzegovina-bulk
manufacturere,
packager
Serbia M01AE01 1624219.12.2016
19.12.2021OTC
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
2188 Ichthiol ichthammolointment for
external use
100mg/g,
25g aluminium tube
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaD10BX01 15283
04.02.2016
04.02.2021OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
2189 Ichthiol ichthammolointment for
external use
200mg/g,
25g aluminium tube
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaD10BX01 15284
04.02.2016
04.02.2021OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
2190 Ichtyol ichtyol suppositories rectal200mg
(10/2x5/)
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia D10BX01 1267004.07.2013
04.07.2018OTC
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
473
2191 Ilon
larch turpentine,
turpentine oil,
eucalyptus oil
ointment54mg/g+72mg/g+ 12mg/g,
25g aluminium tube
Cesra Arzneimittel
GmbH & Co. KG,
Braunmattstr. 20,
Baden-Baden, 76532-
batch releaser,
packager, etol
Gesundheitspflege-
und Pharmaprodukte
GmbH, Konrad-
Adenauer-Str.3,
Oberkirch, 77704,
Germany- bulk
manufacturer,
packager
GermanyD08;
herbal drug16426
06.03.2017
06.03.2022OTC
Cesra Arzneimittel
GmbH & Co. KG,
Braunmattstr. 20,
Baden-Baden, 76532,
Germany
2192 Immunate
human blood
coagulation factor
VIII, Von
Willebrand
Factor(VWF:RCo)
powder and solvent
for solution for
injection
1000IU+750IU,
(1) glass vial, 10ml glass
vial with solvent, (1)
transfer/filter set, (1)
disposable syringe (10ml),
(1) disposable needle, (1)
winged infusion set
Baxter AG,
Industriestrasse 67, A-
1221 Vienna-batch
releaser, secondary
packager, Baxter AG,
Lange Allee 24, A-
1221 Vienna, Austria-
bulk manufacturer,
primary packager
Austria B02BD06 1472216.07.2015
16.07.2020PoM
Baxter AG,
Industriestrasse 67, A-
1221 Vienna, Austria
2193 Immunate
human blood
coagulation factor
VIII, Von
Willebrand
Factor(VWF:RCo)
powder and solvent
for solution for
injection
250IU+190IU,
(1) glass vial, 5ml glass
vial with solvent, (1)
transfer/filter set, (1)
disposable syringe (5ml),
(1) disposable needle, (1)
winged infusion set
Baxter AG,
Industriestrasse 67, A-
1221 Vienna-batch
releaser, secondary
packager, Baxter AG,
Lange Allee 24, A-
1221 Vienna, Austria-
bulk manufacturer,
primary packager
Austria B02BD06 1472316.07.2015
16.07.2020PoM
Baxter AG,
Industriestrasse 67, A-
1221 Vienna, Austria
474
2194 Immunate
human blood
coagulation factor
VIII, Von
Willebrand
Factor(VWF:RCo)
powder and solvent
for solution for
injection
500IU+375IU,
(1) glass vial, 5ml glass
vial with solvent, (1)
transfer/filter set, (1)
disposable syringe (5ml),
(1) disposable needle, (1)
winged infusion set
Baxter AG,
Industriestrasse 67, A-
1221 Vienna-batch
releaser, secondary
packager, Baxter AG,
Lange Allee 24, A-
1221 Vienna, Austria-
bulk manufacturer,
primary packager
Austria B02BD06 1472416.07.2015
16.07.2020PoM
Baxter AG,
Industriestrasse 67, A-
1221 Vienna, Austria
2195 Immunokind
calcium
carbonicum
Hahnemanni D6,
calcium fluoratum
D6, calcium
phosphoricum D6,
sulfur jodatum D12
tablets
20mg+20mg+
20mg+20mg,
in glass container (150)
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe
Germany
L03A;
homeopathic
drug
1678822.06.2017
22.06.2022OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
2196IMMUNOMAX
BIOpeptidoglycan
powder lyophilized
for solution for i/m
injection
200IU,
glass vial (3)
IMMAPHARMA
LLC, 18/11, st.
Gamaleya, Moscow,
123098
Russia L03 1607326.10.2016
26.10.2021PoM
IMMAPHARMA
LLC, 18/11, st.
Gamaleya, Moscow,
123098, Russia
2197 Imodium
loperamide
(loperamide
hydrochloride)
capsules
2mg,
in blister (6/1x6/,
20/1x20/)
Janssen-Cilag,
Domaine de
Maigremont, 27100
Val De Reuil
France A07DA03 1588223.08.2016
23.08.2021OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
475
2198 Imodium
loperamide
(loperamide
hydrochloride)
tablets orodispersible
2mg,
in blister (6/1x6/,
10/1x10/)
Janssen-Cilag,
Domaine de
Maigremont, 27100
Val de Reuil-
secondary packager,
batch releaser,
Catalent UK Swindon
Zydis Ltd., Frankland
Road, Blagrove,
Swindon, Wiltshire,
SN5 8RU, UK-bulk
manufacturer,
primary packager
France A07DA03 1712123.10.2017
23.10.2022OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
2199 Impaza
affinity purified
antibodies to
endothelial NO
synthase
tablets to be sucked
not more than 10^-
15ng/g,
in blister (20/1x20/)
NPF Materia Medica
Holding LLC, 54,
Buguruslanskaya st.,
Chelyabinsk 454139
Russia
G04BE;
homeopathic
drug
1569922.06.2016
22.06.2021OTC
NPF Materia Medica
Holding LLC, 9 bld.,
3rd Samotyochny
per., Moscow 127473,
Russia
2200Implicor
50mg/5mg
metoprolol
(metoprolol
tartrate), ivabradine
(ivabradine
hydrochloride)
tablets film-coated
50mg+5mg,
in blister (28/2x14/,
56/4x14)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France 1600306.10.2016
06.10.2021PoM
Les Laboratoires
Servier, 50, Rue
Carnot 92284
Suresnes cedex,
France
2201Implicor
50mg/7.5mg
metoprolol
(metoprolol
tartrate), ivabradine
(ivabradine
hydrochloride)
tablets film-coated
50mg+7,5mg,
in blister (28/2x14/,
56/4x14/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France 1600206.10.2016
06.10.2021PoM
Les Laboratoires
Servier, 50, Rue
Carnot 92284
Suresnes cedex,
France
2202 Imunobex inosine pranobex capsules
500mg,
in blister (30/3x10/,
50/5x10/)
Minskintercaps U.V.,
26, Inzhenernaya str.,
220075, Minsk
Belarus J05AX05 1728113.12.2017
13.12.2022PoM
Minskintercaps U.V.,
26, Inzhenernaya str.,
220075, Minsk,
Belarus
476
2203 Imunorix pidotimod solution oral400mg/7ml,
glass vials (10)
Doppel Farmaceutici
S.R.L., Via Martiri
delle Foibe, 1-29016
Cortemaggiore (PC)
Italy L03AX05 1280630.08.2013
30.08.2018PoM
Polichem S.A., 50,
Val Fleuri, L-1526,
Luxembourg,
Luxembourg
2204 Incruse Ellipta
umeclidinium
(umeclidinium
bromide)
powder for
inhalation
62.5mcg/dose, powder in
strip (30 doses) in plastic
inhaler
Glaxo Operations UK
Ltd, Priory Street,
Ware, Hertfordshire
SG12 0DJ
UK R03BB07 1624319.12.2016
19.12.2021PoM
Glaxo Group Limited,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
2205 Indabru 2,5mg indapamide tablets coated2,5mg,
in blister (30/2x15/)
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels -
batch releaser
(Farmalabor Produtos
Farmaceuticos, S.A,
Zona Industrial de
Condeixa-a-Nova,
Sebal Grande 3150-
194 Condeixa-a-Nova,
Portugal - bulk
manufacturer,
packager)
Belgium C03BA11 1341914.04.2014
14.04.2019PoM
Brupharmexport sprl,
Rue de la Grotte, 14,
B-1020, Brussels,
Belgium
2206 Indapafon indapamide tablets coated2,5mg,
in blister (30/3x10/)
Open Joint Stock
Company , 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus C03BA11 1283817.09.2013
17.09.2018PoM
Open Joint Stock
Company , 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
2207 Indapamid SR indapamidetablets prolonged-
release film-coated
1,5mg,
in blister (28/2x14/,
30/2x15/, 56/4x14/,
60/4x15/)
Pharmaceutical
Works Polpharma
S.A., ul. Pelplinska 19,
83-200 Starogard
Gdanski
Poland C03BA11 1583620.07.2016
20.07.2021PoM
Pharmaceutical
Works Polpharma
S.A., ul. Pelplinska
19, 83-200 Starogard
Gdanski, Poland
477
2208Indapamide MR
STADAindapamide
tablets prolonged-
release film-coated
1,5mg,
blisters (30/3x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye highway
Russia C03BA11 14150/125.07.2016
29.12.2019PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2209Indapamide MR
STADAindapamide
tablets prolonged-
release film-coated
1,5mg,
in blister (30/3x10/)
Makiz-Pharma LLC, 6
Avtomobilny proezd,
buildings 4, 6, 8,
109029, Moscow
Russia C03BA11 1597615.09.2016
15.09.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2210 Indometacin indometacin suppositories rectal50mg,
(6/1x6/, 10/2x5/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829
Moldova M01AB01 1250601.06.2013
01.06.2018PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829,
Moldova
2211 Indometacin indometacin suppositories rectal100mg
(6/1x6/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829
Moldova M01AB01 1250701.06.2013
01.06.2018PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis.,MD-4829,
Moldova
2212 Indometacin indometacin ointment100mg/g,
40g aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus M02AA23 1367608.07.2014
08.07.2019OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
2213Indometacin
Sopharmaindometacin suppositories
50mg,
(6/1x6/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria M01AB01 1713107.11.2017
07.11.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
478
2214
Indometacin
Sopharma 10%
ointment
indometacin ointment100mg/g,
40g aluminium tube
Sopharma JSC (str.
Iliensko shosse 16,
1220 Sofia) - batch
releaser (dosage form
manufacturer -
Sopharma JSC
/Vrabevo vlg. 5660,
district of Lovetch,
Bulgaria/)
Bulgaria M02AA23 1299528.10.2013
28.10.2018OTC
Sopharma JSC (str.
Iliensko shosse 16,
1220 Sofia, Bulgaria)
2215
Indometacin
Sopharma 25mg
gastro-resistant
tablets
indometacintablets gastro-
resistant
25mg,
in blister (30/1x30/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria M01AB01 1649317.03.2017
17.03.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2216 Indopres indapamide tablets film-coated2,5mg,
in blister (30/3x10/)
SIC Borshchahivskiy
chemical-
pharmaceutical plant
PJSC 17, Mira St, Kiev
03134
Ukraine C03BA11 1285017.09.2013
17.09.2018PoM
SIC Borshchahivskiy
chemical-
pharmaceutical plant
PJSC 17, Mira St, Kiev
03134, Ukraine
2217 Indovasinindometacin,
troxerutingel for external use
30mg/g+20mg/g,
45g aluminium tube
Balkanpharma-
Troyan AD,
Krayrechna Str. N1,
5600, Troyan
Bulgaria M01AB51 1683410.07.2017
10.07.2022OTC
Balkanpharma-
Troyan AD,
(ACTAVIS GROUP)
Krayrechna Str. N1,
5600, Troyan,
Bulgaria
2218 Inestom levocarnitine solution oral100mg/ml,
10ml glass vial (10)
Help S.A., Pedini
Ioanninon, Ioannina,
45500
Greece A16AA01 1682910.07.2017
10.07.2022PoM
Help S.A., 10
Valaoritou str., GR
14452
Metamorphosis,
Attica, Greece
479
2219 Inestom levocarnitine solution for injection200mg/ml,
5ml ampoules (5)
Help S.A., Pedini
Ioanninon, Ioannina,
45500
Greece A16AA01 1683010.07.2017
10.07.2022PoM
Help S.A., 10
Valaoritou str., GR
14452
Metamorphosis,
Attica, Greece
2220 Infanrix
diphtheria toxoid,
tetanus toxoid,
pertussis toxoid,
filamentous
haemagglutinin,
pertactin
suspenion for
injection
not less than
30IU/dose+not less than
40IU/dose+ 25mcg/dose+
25mcg/dose+ 8mcg/dose,
0.5ml/dose pre-filled glass
syringe and needle
GlaxoSmithKline
Biologicals s.a., Rue
de l Institut, 89 B-
1330 Rixensart- batch
releaser,
GlaxoSmithKline
Biologicals SA, Rue
des Aulnois, 637
59230 Saint-Amand-
Les-Eaux, France-
bulk manufacturer,
packager
Belgium
J07AJ52;
պատվաստ
անյութ
1565508.06.2016
08.06.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l Institut, 89 B-
1330 Rixensart,
Belgium
2221 Infanrix Hexa
diphtheria toxoid,
tetanus toxoid,
pertussis toxoid,
filamentous
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)
powder and
suspension for
suspension for
injection
not less than
30IU/dose+not less than
40IU/dose+ 25mcg/dose+
25mcg/dose+ 8mcg/dose+
10mcg/dose+40D-antigen
unit/dose+8D-antigen
unit/dose+32D-antigen
unit/dose+ 10mcg/dose
(25mcg/dose), 0.5ml/dose
glass vial, pre-filled
syringe and (2) needles
GlaxoSmithKline
Biologicals s.a., Rue
de l' Institut, 89 B-
1330 Rixensart-batch
releaser,
GlaxoSmithKline
Biologicals SA, Rue
des Aulnois, 637
59230 Saint-Amand-
Les-Eaux, France-
bulk manufacturer,
packager
BelgiumJ07CA09;
vaccine15925
23.08.2016
23.08.2021PoM
GlaxoSmithKline
Biologicals s.a., Rue
de l` Institut, 89 B-
1330 Rixensart,
Belgium
480
2222 Inflectra infliximab
powder lyophilized
for concentrate for
solution for infusion
100mg,
glass vial (1)
Hospira Enterprises
B.V., Randstad 22-11,
1316 BN Almere -
batch releaser,
Mustafa Nevzat Ilac
Sanayii A.S., Sanayi
Caddesi 13,
Yenibosna, Istanbul,
Turkey -bulk
manufacturer,
primary packager,
Hospira Zagreb d.o.o.,
10000, Prilaz baruna
Filipovica 27/D and
10291, Prigorje
Brdovecko, Prudnicka
cesta 60, Zagreb,
Republic of Croatia-
secondary packager
the Netherlands L04AB02 1426920.02.2015
20.02.2020PoM
Celltrion Healthcare
Co., Ltd., 19,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840,
Republic of Korea
2223 Inflectra infliximab
powder lyophilized
for concentrate for
solution for infusion
100mg,
glass vial (1)
Celltrion, Inc., 20,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840
Korea Sourth L04AB02 1428219.03.2015
19.03.2020PoM
Celltrion Healthcare
Co., Ltd., 19,
Academy-ro 51beon-
gil, Yeonsu-gu,
Incheon, 406-840,
Republic of Korea
2224 Influcid
aconitum trit.D3,
gelsemium trit.D3,
ipecacuanha
trit.D3,phosphorus
trit.D5, bryonia trit.
D2, eupatorium
perfoliatum trit.D1
tablets
25mg+25mg+
25mg+25mg+2
5mg+25mg,
in blister (60/3x20/)
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24 76227
Karlsruhe-batch
releaser, Dr. Willmar
Schwabe GmbH &
Co. KG, Willmar-
Schwabe-Str. 4, 76227
Karlsruhe, Germany-
bulk manufacturer,
packager
Germany
R05X;
homeopathic
drug
1427419.03.2015
19.03.2020OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
481
2225Influvac (season
2015/2016)
influenza vaccine
inactivated (surface
antigen):
A/California/7/2009
/H1N1/pdm09 - like
strain
A/California/7/2009
/NYMC X-181;
A/Switzerland/9715
293/2013/H3N2 -
like strain
A/Switzerland/9715
293/2013, NIB-88;
B/Phuket/3073/201
3
suspension for i/m
and s/c injection
15mcg haemagglutinin/
dose+15mcg
haemagglutinin/
dose+15mcg
haemagglutinin/ dose,
0,5ml pre-filled syringe
(1)
ABBOTT Biologicals
B.V. Veerweg 12,
8121 AA Olst -
packager, batch
releaser (ABBOTT
Biologicals B.V. C.J.
van Houtenlaan 36,
1381 CP Weesp, the
Netherlands - bulk
manufacturer)
the NetherlandsJ07BB02;
vaccine13913/1
31.07.2015
29.10.2019PoM
ABBOTT Biologicals
B.V. C.J. van
Houtenlaan 36, 1381
CP Weesp, the
Netherlands
2226 Ingavirin
pentanedioic acid
(pentanedioic acid
imidazolyl
ethanamide)
capsules90mg,
in blister (7/1x7/)
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2
Russia J05AX 15652/225.12.2017
07.06.2021OTC
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 3
2227 Ingavirin
pentanedioic acid
(pentanedioic acid
imidazolyl
ethanamide)
capsules60mg,
in blister (7/1x7/)
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2
Russia J05AX 16255/125.12.2017
19.12.2021OTC
Valenta Pharm PJSC,
141101, Moscow
Region, Shchelkovo,
Fabrichnaya St., 2
2228 Inlyta axitinib tablets film-coated1mg,
in blister (56/4x14/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany L01XE17 1439316.04.2015
16.04.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
482
2229 Inlyta axitinib tablets film-coated5mg,
in blister (56/4x14/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany L01XE17 1439416.04.2015
16.04.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
2230 Inspra eplerenone tablets film-coated25mg,
in blister (30/3x10/)
Pfizer PGM, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse-
packager, batch
releaser, Pfizer
Pharmaceuticals LLC,
1.9 km Road 689,
Vega Baja, Puerto
Rico 00693, USA-
bulk manufacturer
France C03DA04 1461103.07.2015
03.07.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York, 10017, USA
2231 Inspra eplerenone tablets film-coated50mg,
in blister (30/3x10/)
Pfizer PGM, Zone
Industrielle, 29 route
des Industries, 37530
Poce-sur-Cisse-
packager, batch
releaser, Pfizer
Pharmaceuticals LLC,
1.9 km Road 689,
Vega Baja, Puerto
Rico 00693, USA-
bulk manufacturer
France C03DA04 1461203.07.2015
03.07.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York, 10017, USA
2232 Insty sugar free
salix alba,adhatoda
vasica,viola
odorata,glycyrrhiza
glabra,thea
sinensis,foeniculum
vulgare,eucalyptus
globulus,valeriana
officinalis
granules
750mg+300mg+
100mg+550mg+
125mg+75mg+
35mg+100mg, sachets (5)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900
Pakistan RO5X 1267912.07.2013
12.07.2018OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900,
Pakistan
483
2233 Insulatardinsulin human
(recombinant DNA)
suspension for
injection
100IU/ml,
10ml glass vial (1)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AC01 1370024.07.2014
24.07.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2234 Insulatardinsulin human
(recombinant DNA)
suspension for
injection
100IU/ml,
10ml glass vial (1)
Novo Nordisk
Production SAS, 45
avenue d`Orleans, F-
28000, Chartres
France A10AC01 1716007.11.2017
07.11.2022PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2235 Insulatard Penfill insulin humansuspension for
injection
100IU/ml,
3ml glass cartridges (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AC01 13508/102.07.2014
30.05.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2236 Integrilin eptifibatide solution for infusion0,75mg/ml,
100ml glass vial
Glaxo Operations UK
Ltd., Harmire Road
Barnard Castle Co
Durham, DL12 8DT
UK B01AC16 1431110.03.2015
10.03.2020PoM
Glaxo Group Ltd, 980
Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
2237 Integrilin eptifibatide solution for injection2mg/ml,
10ml glass vial (1)
Glaxo Operations UK
Ltd., Harmire Road
Barnard Castle Co
Durham, DL12 8DT
UK B01AC16 1431210.03.2015
10.03.2020PoM
Glaxo Group Ltd,
980 Great West Road,
Brentford, Middlesex,
TW8 9GS, UK
2238 Intellan
ginkgo biloba,
centella asiatica,
herpestis monniera,
coriandrum
sativum, amomum
subulatum, emblica
officinalis
capsules
50mg+500mg+
125mg+200mg+
200mg+400mg,
in plastic container (20,
60)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900
PakistanHN06DX
herbal drug 13942
29.10.2014
29.10.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial area,
Karachi-74900,
Pakistan
484
2239 Intellan
ginkgo biloba,
centella asiatica,
herpestis monniera,
coriandrum
sativum, amomum
subulatum, emblica
officinalis
syrup
5mg/ml+50mg/ml+5mg/m
l+15mg/ml+15mg/ml+20
mg/ml, 90ml, 120ml,
150ml glass vial
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900
PakistanHN06DX;
herbal drug14189
06.02.2015
06.02.2020OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900,
Pakistan
2240 Interflox-100 enrofloxacinsolution for i/m or
s/c injection
100mg/ml,
100ml glass bottle
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray-
secondary packager,
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county,
Estonia- bulk
manufacturer,
primary packager,
batch releaser
the Netherlands
QJ01MA90;
veterinary
drug
1527404.02.2016
04.02.2021PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2241 Intermectin ivermectin solution for injection10mg/ml,
50ml, 100ml glass bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray-batch
releaser, packager,
Interchemie werken
'De Adelaar' Eesti As
ltd, Estonia Vanapre
str. 14, Puunsi,
Viimsi, Harju country-
bulk manufacturer,
primary packager
the Netherlands
QP54AA01;
veterinary
drug
1414129.12.2014
29.12.2019PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
485
2242 Intermectin Superivermectin,
clorsulon
solution for s/c
injection
10mg/ml+ 100mg/ml,
50ml and 100ml plastic
vial
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county-
bulk manufacturer,
primary packager,
batch releaser,
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands-
secondary packager
Estonia
QP54AA51;
veterinary
drug
1520330.12.2015
30.12.2020PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2243 Interspectin-L
spectinomycin
(spectinomycin
hydrochloride),
lincomycin
(lincomycin
hydrochloride)
solution for i/m
injection
100mg/ml+ 50mg/ml,
100ml glass bottle
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county-
bulk manufacturer,
primary packager,
batch releaser,
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands-
secondary packager
Estonia
QJ51RF03;
veterinary
drug
1528804.02.2016
04.02.2021PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2244 Intertrim LAsulfadoxine,
trimethoprim
solution for i/m
injection
200mg/ml+ 40mg/ml,
100ml glass vial
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray-
secondary packager,
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county,
Estonia- bulk
manufacturer,
primary packager,
batch releaser
the Netherlands
QJ01EW13;
veterinary
drug
1479004.09.2015
04.09.2020PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
486
2245 Intertrim-480 Oraltrimethoprim,
sulfadiazinesuspenion oral
80mg/ml+ 400mg/ml,
1000ml plasstic bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
the Netherlands
QP01EW10;
veterinary
drug
1479104.09.2015
04.09.2020PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2246 Intetrix
tiliquinol, tiliquinol-
N-dodecyl sulfate,
tilbroquinol
capsules50mg+50mg+ 200mg,
in blister (20/2x10/)
Beaufour Ipsen
Industrie , Ethe
Virton, 28100 Dreux
France P01A 1422620.02.2015
20.02.2020PoM
Ipsen Pharma, 65
quai Georges Gorse,
92100 Boulogne-
Billancourt, France
2247 Intracox Oral toltrazuril solution oral
25mg/ml,
100ml, 1000ml plastic
bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray
the Netherlands
QP51AJ01;
veterinary
drug
1579320.07.2016
20.07.2021PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2248 Intrafer-200 B12iron,
cyanocobalaminsolution for injection
(200mg+ 200mcg)/ml,
100ml glass bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray-batch
releaser, packager,
Interchemie werken
'De Adelaar' Eesti As
ltd, Estonia Vanapre
str. 14, Puunsi,
Viimsi, Harju country-
bulk manufacturer,
primary packager
the Netherlands
QB03AC90;
veterinary
drug
1413929.12.2014
29.12.2019PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
487
2249 Introvit
vitaminA,
vitaminD3,
vitaminE,
vitaminB1,
vitaminB2,
vitaminB6,
vitaminB12, D-
panthenol,
nicotinamide, folic
acid, biotin, choline
chloride, DL-
methionine, L-
lysine
hydrochloride
solution for injection
15000IU/ml+
7500IU+20mg/ml+10mg/
ml+5mg/mg+3mg/ml+
60mcg/ml+ 25mg/ml+
50mg/ml+ 150mcg/ml+
125mcg/ml+ 12.5mg/ml+
5mg/ml+7mg/ml,
50ml,100ml glass bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray-batch
releaser, packager,
Interchemie werken
'De Adelaar' Eesti As
ltd, Estonia Vanapre
str. 14, Puunsi,
Viimsi, Harju country-
bulk manufacturer,
primary packager
the Netherlands
QA11AB;
veterinary
drug
1414029.12.2014
29.12.2019PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2250 Invega paliperidonetablets prolonged-
release
6mg,
in blister (28/4x7/)
Janssen-Cilag S.p.A.,
Via C. Janssen, 04100
Borgo San Michele,
Latina-batch releaser,
packager, Janssen
Cilag Manufacturing
LLC., State Road 933-
km 0.1, Mamey
Ward, Gurabo, Puerto
Rico 00778, USA-bulk
manufacturer
Italy N05AX13 1618916.11.2016
16.11.2021PoM
Janssen- Cilag
International NV,
Turnhoutseweg 30, B-
2340 Beerse, Belgium
2251Iodine 5%
alcoholic solutioniodine
solution for external
use
50mg/ml,
10ml, 15ml, 30ml and
250ml glass bottle
Alfa-Pharm CJSC,
Khrimyan Hayrik 62,
Gyumri
Republic of
ArmeniaD08AG03 15931
24.08.2016
24.08.2021OTC
Alfa-Pharm CJSC,
Khrimyan Hayrik 62,
Gyumri, Republic of
Armenia
2252 Iodinol iodinesolution for external
use
1mg/ml,
100ml glass or plastic
bottle
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaD08AG03 14945
20.10.2015
20.10.2020OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
488
2253 Iodogel povidone-iodine gel for external use50mg/g,
15g aluminium tube
"LMP" Ltd., 1,
Vietalvas street, Riga,
LV-1009
Latvia D08AG02 1559103.05.2016
03.05.2021OTC
"LMP" Ltd., 1,
Vietalvas street, Riga,
LV-1009, Latvia
2254 Iodomarin 200 potassium iodide tablets200mcg,
in blister (100/4x25/),
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, Menarini-
Von Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden,
Germany-bulk
manufacturer,
primary and
secondary packager
Germany H03C 1528204.02.2016
04.02.2021PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
2255 Iodomarin 200 potassium iodide tablets200mcg,
in blister (100/4x25/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin-batch
releaser, packager,
Berlin-Chemie AG,
Tempelhofer Weg 83,
12347
Berlin,Germany- bulk
manufacturer
Germany H03C 1622208.12.2016
08.12.2021PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
2256 Iono-Tech
sodium acetate
(sodium acetate
trihydrate), sodium
chloride, potassium
chloride, calcium
chloride (calcium
chloride dihydrate),
magnesium
chloride
(magnesium
chloride
hexahydrate)
solution for infusion
5mg/ml+ 5,85mg/ml+
0,302mg/ml+ 0,36mg/ml+
0,25mg/ml,
50ml, 100ml, 200ml,
250ml, 400ml, 500ml,
1000ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaB05BB01 15094
15.12.2015
15.12.2020PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
489
2257 Ipigrix
ipidacrine
(ipidacrine
hydrochloride)
tablets20mg,
in blister (50/2x25/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia N06DA05 1709123.10.2017
23.10.2022PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2258 Ipigrix 15mg/ml
ipidacrine
(ipidacrine
hydrochloride)
solution for injection 15mg/ml,
1ml ampoules (10/2x5/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga - batch
releaser, HBM
Pharma s.r.o.,
Sklabinska 30, 03680,
Martin, Slovak
Republic - bulk
manufacturer,
packager
Latvia N06DA05 1689508.08.2017
08.08.2022PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2259 Ipigrix 5mg/ml
ipidacrine
(ipidacrine
hydrochloride)
solution for injection 5mg/ml,
1ml ampoules (10/2x5/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga - batch
releaser, HBM
Pharma s.r.o.,
Sklabinska 30, 03680,
Martin, Slovak
Republic - bulk
manufacturer,
packager
Latvia N06DA05 1689608.08.2017
08.08.2022PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2260 Irinotecan
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for infusion
20mg/ml,
5ml glass vial (1)
BIOCAD CJSC,
Petrovo-Dalnee,
Krasnogorsky district,
Moscow Region,
143422
Russia L01XX19 1388606.10.2014
06.10.2019PoM
BIOCAD CJSC, 34
bld., lit. A, Svyazi
st.,Strelna,
Petrodvortsoviy
district, Saint
Petersburg, 198515,
Russia
490
2261
Irinotecan
Moosmann
20mg/ml
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for infusion
20mg/ml,
2ml glass vial
Actavis Italy S.p.A.,
Viale Pasteur, 10,
20014 Nerviano,
Milan
Italy L01XX19 1711423.10.2017
23.10.2022PoM
Moosmann
Pharmaceuticals LLC,
Vanahovit 8,
Proshyan v., Ashtarak
Ave., Kotayk Marz
2413, Republic of
Armenia
2262
Irinotecan
Moosmann
20mg/ml
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for infusion
20mg/ml,
5ml glass vial
Actavis Italy S.p.A.,
Viale Pasteur, 10,
20014 Nerviano,
Milan
Italy L01XX19 1711523.10.2017
23.10.2022PoM
Moosmann
Pharmaceuticals LLC,
Vanahovit 8,
Proshyan v., Ashtarak
Ave., Kotayk Marz
2413, Republic of
Armenia
2263
Irinotecan
Moosmann
20mg/ml
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for infusion
20mg/ml,
15ml glass vial
Actavis Italy S.p.A.,
Viale Pasteur, 10,
20014 Nerviano,
Milan
Italy L01XX19 1711623.10.2017
23.10.2022PoM
Moosmann
Pharmaceuticals LLC,
Vanahovit 8,
Proshyan v., Ashtarak
Ave., Kotayk Marz
2413, Republic of
Armenia
2264
Irinotecan
Moosmann
20mg/ml
irinotecan
(irinotecan
hydrochloride
trihydrate)
concentrate for
solution for infusion
20mg/ml,
25ml glass vial
Actavis Italy S.p.A.,
Viale Pasteur, 10,
20014 Nerviano,
Milan
Italy L01XX19 1711723.10.2017
23.10.2022PoM
Moosmann
Pharmaceuticals LLC,
Vanahovit 8,
Proshyan v., Ashtarak
Ave., Kotayk Marz
2413, Republic of
Armenia
491
2265 Isla-Mint iceland moos pastilles100mg,
in blister (30/3x10/)
Engelhard
Arzneimittel GmbH&
Co. KG,
Herzbergstrasse 3,
61138
Niederdorfelden-
batch releaser,
primary and
secondary packager,
Bolder Arzneimittel
GmbH & Co. KG,
Rheinische Allee 11,
50858 Koln, Germany-
bulk manufacturer
Germany herbal drug 1520230.12.2015
30.12.2020OTC
Engelhard
Arzneimittel GmbH&
Co. KG,
Herzbergstrasse 3,
61138
Niederdorfelden,
Germany
2266 Isla-Moos iceland moos pastilles80mg,
in blister (30/3x10/)
Engelhard
Arzneimittel GmbH&
Co. KG,
Herzbergstrasse 3,
61138
Niederdorfelden-
batch releaser,
primary and
secondary packager,
Bolder Arzneimittel
GmbH & Co. KG,
Rheinische Allee 11,
50858 Koln, Germany-
bulk manufacturer
Germany herbal drug 1520130.12.2015
30.12.2020OTC
Engelhard
Arzneimittel GmbH&
Co. KG,
Herzbergstrasse 3,
61138
Niederdorfelden,
Germany
2267 Ismigenlyophilized
bacterial lysatetablets sublingual
50mg,
in blister (10/1x10/,
30/3x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi 0165 -
secondary packager,
batch releaser (dosage
form manufacturer,
primary packager -
Bruschettini S.r.l., Via
Isonzo 6, 16147
Genova, Italy)
Georgia L03AX 13026/107.03.2014
25.11.2018PoM
Lallemand Pharm
AG, Via Selva, 2, CH-
6900 Massagno,
Switzerland
492
2268 Isoflurane isoflurane liquid for inhalation100%,
250ml glass bottle
Piramal Enterprises
Limited, Sy.No.7-70,
70/1 & 70/2, Digwal
Village, Kohir
Mandal, Sangareddy
District - 502 321,
Telangana
India N01AB06 1678122.06.2017
22.06.2022PoM
Piramal Enterprises
Limited, Piramal
Towers, Ganpatrao
Kadam Marg, Lower
Parel, Mumbai-
400013, India
2269 Isofraframycetin
(framycetin sulfate)spray nasal
8000U/ml,
15ml plastic vial with
pump dispenser
Sophartex, 21 rue du
Pressoir, 28500
Vernouillet
France R01AX08 1626519.12.2016
19.12.2021PoM
Laboratoires
Bouchara-Recordati,
Immeuble "le
Wilson", 70 avenue
du General de Gaulle,
92800 Puteaux,
France
2270 Isoniazid isoniazid tablets100mg,
in blister (100/10x10)
Macleods
Pharmaceuticals Ltd.,
Plot No 25-27, Sr. No
366, Premier Ind.
Estate, Kachigam,
Daman-396210 (UT)
India J04AC01 1601506.10.2016
06.10.2021PoM
Macleods
Pharmaceuticals Ltd.,
304, Atlanta Arcade,
Marol Church
Road,Andheri (East),
Mumbai-400 059,
India
2271 Isoniazid isoniazid tablets300mg,
in blister (672/24x28/)
Macleods
Pharmaceuticals Ltd.,
Plot No 25-27, Sr. No
366, Premier Ind.
Estate, Kachigam,
Daman-396210 (UT)
India J04AC01 1601606.10.2016
06.10.2021PoM
Macleods
Pharmaceuticals Ltd.,
304, Atlanta Arcade,
Marol Church
Road,Andheri (East),
Mumbai-400 059,
India
493
2272
Isosorbide
mononitrate 20mg
Tablets
isosorbide
mononitratetablets
20mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C01DA14 1522822.12.2015
22.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2273
Isosorbide
mononitrate 40mg
Tablets
isosorbide
mononitratetablets
40mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK C01DA14 1522922.12.2015
22.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
494
2274 Itracim itraconazole capsules100mg,
in blister (15/3x5/)
Acino Pharma AG,
Birsweg 2, 4253
Liesberg-packager,
batch releaser, bulk-
manufacturer- Intas
Pharmaceuticals
Limited, Plot No 457
& 458 Sarkhej-Bavla
Highway, Matoda
Village, Sanand,
Taluka, District-
Ahmedabad, 382 210,
Gujarat, India
Switzerland J02AC02 1414329.12.2014
29.12.2019PoM
Acino Pharma AG,
Birsweg 2, 4253
Liesberg, Switzerland
2275
Ivermectin
injection 1% w/v
(Vet.)
ivermectin solution for injection
10mg/ml,
10ml, 20ml, 50ml and
100ml vial
Intracin
Pharmaceutical Pvt
Ltd, C-1/B-53,
G.I.D.C., city: Nadiad,
Dist:Kheda, Gujarat
state
India
QP54AA01;
veterinary
drug
1539609.03.2016
09.03.2021PoM
Veejay
Pharmaceuticals Pvt.
Ltd., D. No 9-
34/6,Plot 8A/P,
Survey No. 302 &
303, Nagaram,
Hyderabad-500083,
India
2276 IVERVETo-1 ivermectin solution for injection10mg/ml,
50ml, 100ml plastic bottle
Laboratoires Biove,
Rue de Lorraine 3,
62510 Arques
France
QP54AA01
veterinary
drug
1325624.02.2014
24.02.2019PoM
V.M.D. n.v., Hoge
Mauw 900, B-2370
Arendonk, Belgium
2277Ivotek Super
Injection
ivermectin,
clorsulon
solution for s/c
injection
10mg/ml+ 100mg/ml,
50ml, 100ml glass vial
Chongqing Bull
Animal
Pharmaceutical Co.
Ltd., Banqiao
Industrial Park,
Rongchang,
Chongqing
China
QP54AA51;
veterinary
drug
1439716.04.2015
16.04.2020PoM
Chongqing Bull
Animal
Pharmaceutical Co.
Ltd., Banqiao
Industrial Park,
Rongchang,
Chongqing, China
2278 Izigel ibuprofen gel for external use50mg/g,
60g aluminium tube
Arafarma Group, S.A.
(C/Fray Gabriel de
San Antonio, 6-10,
Pol. Ind. Del Henares,
19180, Marchamalo,
Guadalajara)
Spain M02AA13 1295128.10.2013
28.10.2018OTC
GM Pharmaceuticals
Ltd (PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia)
495
2279 Izoconazol-Misoconazole
(isoconazole nitrate)suppositories vaginal
600mg,
(1)
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaG01AF07 17190
28.11.2017
28.11.2022PoM
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
2280 Jakavi
ruxolitinib
(ruxolitinib
phosphate)
tablets5mg,
in blister (56/4x14/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE18 1397726.11.2014
26.11.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
2281 Jakavi
ruxolitinib
(ruxolitinib
phosphate)
tablets15mg,
in blister (56/4x14/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE18 1397826.11.2014
26.11.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
2282 Jakavi
ruxolitinib
(ruxolitinib
phosphate)
tablets20mg,
in blister (56/4x14/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L01XE18 1397926.11.2014
26.11.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
2283 Janumet
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+850mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Aesica Queenborough
Limited,
Queenborough Kent
ME 11 5EL, UK-bulk
manufacturer
the Netherlands A10BD07 1558012.05.2016
12.05.2021PoM
Schering-Plough
Central East Ag,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
496
2284 Janumet
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+1000mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Aesica Queenborough
Limited,
Queenborough Kent
ME 11 5EL, UK-bulk
manufacturer
the Netherlands A10BD07 1558112.05.2016
12.05.2021PoM
Schering-Plough
Central East Ag,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
2285 Janumet
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+1000mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Patheon Puerto Rico,
Inc., State Road 670
Km. 2,7 Manati,
Puerto Rico, 00674,
USA- bulk
manufacturer
the Netherlands A10BD07 1706905.10.2017
05.10.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
2286 Janumet
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+500mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Patheon Puerto Rico,
Inc., State Road 670
Km. 2,7 Manati,
Puerto Rico, 00674,
USA- bulk
manufacturer
the Netherlands A10BD07 1707005.10.2017
05.10.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
497
2287 Janumet
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+850mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.
Waarderweg 39, 2031
BN Haarlem-batch
releaser, packager,
Patheon Puerto Rico,
Inc., State Road 670
Km. 2,7 Manati,
Puerto Rico, 00674,
USA- bulk
manufacturer
the Netherlands A10BD07 1707105.10.2017
05.10.2022PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
2288Janumet
50mg+1000mg
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+1000mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem -
packager, batch
releaser (bulk
manufacturer -
Patheon Puerto Rico,
Inc., State Road 670
Km. 2,7 Manati,
Puerto Rico, 00674,
USA)
the Netherlands A10BD07 12436/103.04.2015
07.05.2018PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
2289Janumet
50mg+500mg
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+500mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem -
packager, batch
releaser (bulk
manufacturer -
Patheon Puerto Rico,
Inc., State Road 670
Km. 2,7 Manati,
Puerto Rico, 00674,
USA)
the Netherlands A10BD07 12434/103.04.2015
07.05.2018PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
498
2290Janumet
50mg+850mg
sitagliptin
(sitagliptin
phosphate
monohydrate),
metformin
(metformin
hydrochloride)
tablets film-coated50mg+850mg,
in blister (56/4x14/)
Merck Sharp &
Dohme B.V.,
Waarderweg 39, 2031
BN Haarlem -
packager, batch
releaser (bulk
manufacturer -
Patheon Puerto Rico,
Inc., State Road 670
Km. 2,7 Manati,
Puerto Rico, 00674,
USA)
the Netherlands A10BD07 12435/103.04.2015
07.05.2018PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
2291 Januvia
sitagliptin
(sitagliptin
phosphate hydrate)
tablets film-coated100mg,
in blister (28/2x14/)
Merck Sharp &
Dohme Ltd., Shotton
Lane, Cramlington,
Northumberland
NE23 3JU
UK A10BH01 1411729.12.2014
29.12.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
2292 Jeanineethinylestradiol,
dienogesttablets coated
0.03mg+2mg,
in blister (21/1x21/)
Bayer Weimar GmbH
& Co. KG,
Dobereinerstrasse 20,
99427 Weimar
Germany G03AA 1476903.08.2015
03.08.2020PoM
Bayer Pharma AG,
Mullerstrasse 178,
13353 Berlin,
Germany
499
2293 Jene-35 ED
I tablet-cyproterone
(cyproterone
acetate),
ethinylestradiol, II
tablet-inactive
tablets film-coated
2mg+0.035mg, (28/1x28/
21 (I) tablets+ 7(II)
tablets/), in blister
Eris Pharmaceuticals
(Australia) Pty Ltd, 6
Eastern Road, South
Melbourne, Victoria,
3205-batch releaser,
Douglas
Manufacturing Ltd,
Corner Te Pai Place
and Central Park
Drive, Lincoln
Auckland, New
Zealand-bulk
manufacturer,
Douglas
Manufacturing Fiji
Ltd, Brewers Road
Martintar Nadi, Fiji-
primary and
secondary packager
Australia G03HB01 1534226.02.2016
26.02.2021PoM
Eris Pharmaceuticals
(Australia) Pty Ltd, 6
Eastern Road, South
Melbourne, Victoria,
3205, Australia
2294 Jocet
salbutamol
(salbutamol sulfate),
bromhexine
hydrochloride,
guaifenesin,
menthol
(levomenthol)
syrup
1mg/5ml+ 2mg/5ml+
50mg/5ml+ 0,5mg/5ml,
100ml and 200ml plastic
container and measuring
cup 15ml
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.),
Plot No. 128/1,
G.I.D.C. Indastrial
area, Ankleshwar. 393
002: Gujarat State
India R05C 14898/109.10.2015
24.09.2020PoM
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals
Ltd.), Worli, Mumbai-
400 030, India
2295 Jodbalance potassium iodide tablets100mcg,
in blisters (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03CA 13901/123.03.2017
30.09.2019OTC
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
500
2296 Jodbalance potassium iodide tablets200mcg,
in blister (100/4x25/)
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt
Germany H03CA 1390230.09.2014
30.09.2019PoM
Merck KGaA
Frankfurter Strasse
250, 64 293
Darmstadt, Germany
2297 Joxpovidone-iodine,
allantoinspray
85mg/ml+ 1mg/ml,
30ml plastic bottle and
dosator
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p. 305,
747 70 Opava-
Komarov
Czech Republic R02AA20 1224707.03.2013
07.03.2018OTC
TEVA Czech
Industries s.r.o.,
Ostravska 29, c.p.
305, 747 70 Opava-
Komarov, Czech
Republic
2298 Kadcylatrastuzumab
emtansine
powder for
concentrate for
solution for infusion
160mg,
20ml glass vial (1)
F. Hoffmann-La
Roche Ltd. 4303
Kaiseraugst
Switzerland L01XC14 1710923.10.2017
23.10.2022PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
2299 Kadcylatrastuzumab
emtansine
powder for
concentrate for
solution for infusion
100mg,
15ml glass vial (1)
F. Hoffmann-La
Roche Ltd. 4303
Kaiseraugst
Switzerland L01XC14 1711023.10.2017
23.10.2022PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
2300 Kafra ofloxacin tablets film-coated400mg,
in blister (5)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia J01MA01 1301625.11.2013
25.11.2018PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
2301 Kagocel kagocel tablets12mg,
blister (10/1x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse St.
Russia J05AX 13433/207.12.2016
14.04.2019OTC
NEARMEDIC PLUS
LLC,
Aviakonstruktora
Mikoyana St., 12,
Moscow, 125252,
Russia
501
2302 Kagocel kagocel tablets
12mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
NEARMEDIC
PHARMA LLC , 6
Kiev highway, near
the village Malagnino,
Borovsky district
249008, Kaluga region
Russia J05AX 1716630.11.2017
30.11.2022OTC
NEARMEDIC PLUS
LLC,
Aviakonstruktora
Mikoyana St., 12,
Moscow, 125252,
Russia
2303 Kalcinova
vitamin A, vitamin
D3, vitamin B6,
vitamin C, calcium,
phosphorus
tablets
1000IU+100IU+
0,4mg+15mg+
100mg+77mg,
in blister (27/3x9/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto - batch
releaser, KRKA d.d.,
Novo mesto, Ulica
Rada Pusenjaka 10,
Ljutomer, 9240,
Slovenia-bulk
manufacturer,
packager
Slovenia A11AA03 1678422.06.2017
22.06.2022OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2304 Kaletra lopinavir, ritonavir solution oral
80mg/ml+20mg/ml, 60ml
plastic bottle (5) and 5ml
dispenser (5)
Aesica Queenborough
Limited,
Queenborough Kent
ME 11 5EL
UK J05AR10 1623619.12.2016
19.12.2021PoM
AbbVie
Biopharmaceuticals
GmbH, Neuhofstrasse
23, Postfach 6341
Baar, Switzerland
2305 Kalium chloride potassium chloridesolution for i/v
infusion
40mg/ml,
200ml plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaA12BA01 15658
08.06.2016
08.06.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
502
2306 Kalymin 60Npyridostigmine
bromidetablets
60mg,
in glass bottle (100)
Merckle GmbH,
Ludwig-Merckle-
Strasse 3, 89143
Blaubeuren - batch
releaser (Klocke
Pharma-Service
GmbH, Strassburger
Str. 77, Appenweier,
77767, Germany -
bulk manufacturer,
packager)
Germany N07AA02 1369824.07.2014
24.07.2019PoM
TEVA
Pharmaceutical
Industries Ltd., 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
2307 Kameton
chlorobutanol
(chlorobutanol
hydrate), camphora,
L-menthol,
eucalyptus oil
aerosol for local use
6,67mg/g+ 6,67mg/g+
6,67mg/g+ 6,67mg/g,
30g and 45g bottle
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R02AA20 13556/102.07.2014
06.06.2019OTC
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
2308 Kamiren
doxazosin
(doxazosin
mesylate)
tablets4mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C02CA04 1333017.03.2014
17.03.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2309 Kamistad
matricaria
chamomilla,
lidocaine (lidocaine
hydrochloride)
gel for local
application
185mg/g+20mg/g, 10g
aluminium tube
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel
GermanyA01AD11;
herbal drug14069
19.12.2014
19.12.2019OTC
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel
2310 Kanamycinkanamycin
(kanamycin sulfate)
powder for solution
for i/m injection
1000mg,
glass vial (1)
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01GB04 1402326.11.2014
26.11.2019PoM
Kievmedpreparat
OJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
503
2311 Kapetral capecitabine tablets film-coated150mg,
in blister (60/6x10/)
Remedica Ltd,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus L01BC06 1468229.06.2015
29.06.2020PoM
Remedica Ltd.,
Limassol Industrial
Estate, Aharnon
street, P.O. Box
51706, 3508 Limassol,
Cyprus
2312 Kapetral capecitabine tablets film-coated500mg,
in blister (120/12x10/)
Remedica Ltd,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus L01BC06 1468329.06.2015
29.06.2020PoM
Remedica Ltd.,
Limassol Industrial
Estate, Aharnon
street, P.O. Box
51706, 3508 Limassol,
Cyprus
2313 Kapikor
meldonium
(meldonium
dihydrate), gamma-
butyrobetaine
(gamma-
butyrobetaine
dihydrate)
capsules
180mg+60mg,
in blister (20/2x10/,
60/6x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia C01EX 1666411.05.2017
11.05.2022PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
2314 Kapron tranexamic acidsolution for
injection/infusion
100mg/ml,
5ml ampoules (6)
Amoun
Pharmaceutical
Company, El-Obour
City, Cairo
Egypt B02AA02 1238119.04.2013
19.04.2018PoM
Amoun
Pharmaceutical
Company, El-Obour
City, Cairo, EGYPT
2315 Kapron tranexamic acid tablets film-coated500mg,
in blister (20/2x10/)
Amoun
Pharmaceutical
Company, El-Obour
City, Cairo
Egypt B02AA02 1238219.04.2013
19.04.2018PoM
Amoun
Pharmaceutical
Company, El-Obour
City, Cairo, EGYPT
2316 Kaptopril captopril tablets25mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA01 12929/109.12.2013
07.10.2018PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2317 Kaptopril captopril tablets50mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA01 1639010.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
504
2318 Kaptopril captopril tablets12,5mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09AA01 1639110.02.2017
10.02.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2319 Kardiket isosorbide dinitratetablets prolonged-
release
20mg,
in blister (20/2x10/,
50/5x10/)
Aesica
Pharmaceuticals
GmbH, Alfred-Nobel-
Strasse 10, 40789
Monheim - batch
releaser (dosage form
manufacturer - Aesica
Pharmaceuticals
GmbH, Galileistrasse
6, 08056 Zwickau,
Germany) (packager -
Aesica
Pharmaceuticals
GmbH, Mittelstrasse
15, 40789 Monheim,
Germany)
Germany C01DA08 1216101.02.2013
01.02.2018PoM
UCB Pharma GmbH,
Alfred-Nobel-Strasse
10, 40789 Monheim,
Germany
2320 Kardiket isosorbide dinitratetablets prolonged-
release
40mg,
in blister (20/2x10/,
50/5x10/)
Aesica
Pharmaceuticals
GmbH, Alfred-Nobel-
Strasse 10, 40789
Monheim - batch
releaser (dosage form
manufacturer - Aesica
Pharmaceuticals
GmbH, Galileistrasse
6, 08056 Zwickau,
Germany) (packager -
Aesica
Pharmaceuticals
GmbH, Mittelstrasse
15, 40789 Monheim,
Germany)
Germany C01DA08 1216201.02.2013
01.02.2018PoM
UCB Pharma GmbH,
Alfred-Nobel-Strasse
10, 40789 Monheim,
Germany
505
2321 Kardiotex
meldonium
(meldonium
dihydrate)
solution for i/v and
parabulbar injection
100mg/ml,
5ml ampoules, blister
(5/1x5/, 10/2x5/)
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia C01EB22 13323/113.05.2016
17.03.2019PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
2322 Karvidil carvedilol tablets25mg,
in blister (28/2x14/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia C07AG02 1623819.12.2016
19.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2323 Karvidil carvedilol tablets12,5mg,
in blister (28/2x14/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia C07AG02 1623919.12.2016
19.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2324 Karvidil carvedilol tablets6,25mg,
in blister (28/2x14/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia C07AG02 1624019.12.2016
19.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2325 Katarax
azapentacene
(azapentacene
polysulfonate
sodium)
drops eye0,15mg/ml,
15ml plastic vial
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01XA 1646106.03.2017
06.03.2022PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
2326 Katarel tenoxicam
powder lyophilized
and solvent for
solution for i/m/i/v
injection
20mg,
glass vial (1) and 2ml
solvent in ampoule
Anfarm Hellas S.A.,
61st Km National
Road Athens-Lamia,
Sximatari Viotias,
32009
Greece M01AC02 1597115.09.2016
15.09.2021PoM
J&P Pharma UK Ltd,
Ashcombe House, 5
The Crescent,
Leatherhead, Surrey,
KT22 8DY, UK
506
2327 Kefentech plaster ketoprofen plaster transdermal 30mg,
in pack (7)
Jeil Pharmaceutical
Co., Ltd., 7
Cheongganggachang-
ro, Baegam-myeon,
Cheoin-gu, Yongin-si,
Gyeonggi-do
Korea South M01AE03 1690408.08.2017
08.08.2022PoM
Jeil Pharmaceutical
Co., Ltd., 343,
Sapyeong-daero,
Seocho-gu, Seul,
Republic of Korea
2328 Kenalog triamcinolone tablets4mg,
in glass bottle (50)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia H02AB08 1588723.08.2016
23.08.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2329 Kenalog 40
triamcinolone
(triamcinolone
acetonide)
suspension for
injection
40mg/ml,
1ml ampoules (5)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia H02AB08 1588823.08.2016
23.08.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2330 Keppra levetiracetam tablets film-coated500mg,
in blister (30/3x10/)
UCB Pharma S.A.,
Chemin du Foriest, B-
1420 Braine-l'Alleud
Belgium N03AX14 1497018.11.2015
18.11.2020PoM
UCB Pharma S.A.,
Allee de la Recherche
60, B-1070 Bruxelles,
Belgium
2331 Keppra levetiracetam tablets film-coated250mg,
in blister (30/3x10/)
UCB Pharma S.A.,
Chemin du Foriest, B-
1420 Braine-l'Alleud
Belgium N03AX14 1497118.11.2015
18.11.2020PoM
UCB Pharma S.A.,
Allee de la Recherche
60, B-1070 Bruxelles,
Belgium
2332Kepromec Super
Inj.
ivermectin,
clorsulonsolution for injection
10mg/ml+ 100mg/ml,
10ml, 50ml, 100ml and
250ml plastic container
Kepro BV,
Maagdenburgstraat
17, 7421 ZA Deventer-
secondary packager,
batch releaser, Kepro
BV, Forellenweg 16,
4941SJ
Raamsdonksveer, the
Netherlands- bulk
manufacturer,
primary packager
the Netherlands
QP54AA51;
veterinary
drug
1460603.07.2015
03.07.2020PoM
Kepro BV,
Maagdenburgstra-at
17, 7421 ZA
Deventer, the
Netherlands
507
2333 Kepxan Oral
levamisole
(levamisole
hydrochloride),
oxyclozanide
suspension oral
30mg/ml+60mg/ml,
100ml and 1000ml plastic
container
Kepro BV,
Maagdenburgstraat
17, 7421 ZA Deventer-
secondary packager,
batch releaser, Kepro
BV, Forellenweg 16,
4941SJ
Raamsdonksveer, the
Netherlands- bulk
manufacturer,
primary packager
the Netherlands
QP52AE51;
veterinary
drug
1458009.06.2015
09.06.2020PoM
Kepro BV,
Maagdenburgstraat
17, 7421 ZA
Deventer, the
Netherlands
2334 Kestine ebastine tablets film-coated
10mg,
in blister, (5/1x5/,
10/1x10/)
Industrias
Farmaceuticas
Almirall S.A., Ctra.
Nacional II, Km. 593,
Sant Andreu de la
Barca, Barcelona,
08740
Spain R06AX22 13660/110.10.2017
08.07.2019OTC
Almirall, S.A., Ronda
General Mitre, 151,
08022 Barcelona,
Spain
2335 Kestine ebastine tablets film-coated20mg,
in blister (10/1x10/)
Industrias
Farmaceuticas
Almirall S.A., Ctra.
Nacional II, Km. 593,
08740 Sant Andreu de
la Barca, Barcelona
Spain R06AX22 1699205.09.2017
05.09.2022OTC
for Almirall, S.A.,
Ronda General Mitre,
151, 08022 Barcelona,
Spain
2336 Ketalgin longketorolac (ketorolac
tromethamine)solution for injection
30mg/ml,
1ml ampoules, in blister
(10)(10/2x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine M01AB15 1528504.02.2016
04.02.2021PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
2337 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated25mg,
in blister (30/3x10/)
Pharmaceutical
Works Polpharma
S.A., str. Pelplinska19,
83-200 Starogard
Gdanski
Poland N05AH04 1215201.02.2013
01.02.2018PoM
Pharmaceutical
Works Polpharma
S.A., str.
Pelplinska19, 83-200
Starogard Gdanski,
Poland
508
2338 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated
100mg,
in blister (60/6x10/,
90/9x10/)
Pharmaceutical
Works Polpharma
S.A., str. Pelplinska19,
83-200 Starogard
Gdanski
Poland N05AH04 1215301.02.2013
01.02.2018PoM
Pharmaceutical
Works Polpharma
S.A., str.
Pelplinska19, 83-200
Starogard Gdanski,
Poland
2339 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated
200mg,
in blister (60/6x10/,
90/9x10/)
Pharmaceutical
Works Polpharma
S.A., str. Pelplinska19,
83-200 Starogard
Gdanski
Poland N05AH04 1215401.02.2013
01.02.2018PoM
Pharmaceutical
Works Polpharma
S.A., str.
Pelplinska19, 83-200
Starogard Gdanski,
Poland
2340 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated
300mg,
in blister (60/6x10/,
90/9x10/)
Pharmaceutical
Works Polpharma
S.A., str. Pelplinska19,
83-200 Starogard
Gdanski
Poland N05AH04 1215501.02.2013
01.02.2018PoM
Pharmaceutical
Works Polpharma
S.A., str.
Pelplinska19, 83-200
Starogard Gdanski,
Poland
2341 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated25mg,
in blister (30/3x10/)
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski
Poland N05AH04 1696505.09.2017
05.09.2022PoM
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski, Poland
2342 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated
100mg,
in blister (60/6x10/,
90/9x10/)
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski
Poland N05AH04 1696605.09.2017
05.09.2022PoM
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski, Poland
2343 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated
200mg,
in blister (60/6x10/,
90/9x10/)
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski
Poland N05AH04 1696705.09.2017
05.09.2022PoM
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski, Poland
509
2344 Ketiap
quetiapine
(quetiapine
fumarate)
tablets film-coated
300mg,
in blister (60/6x10/,
90/9x10/)
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski
Poland N05AH04 1696805.09.2017
05.09.2022PoM
Pharmaceutical
Works Polpharma
S.A., 19 Pelplinska
Str., 83-200 Starogard
Gdanski, Poland
2345 Ketilept
quetiapine
(quetiapine
fumarate)
tablets coated
25mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 12376/119.08.2015
19.04.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2346 Ketilept
quetiapine
(quetiapine
fumarate)
tablets coated
100mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 12377/119.08.2015
19.04.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2347 Ketilept
quetiapine
(quetiapine
fumarate)
tablets coated
150mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 12378/119.08.2015
19.04.2018PoM
Egis Pharmaceuticals
PLC 1106 Budapest,
Kereszturi st 30-38,
Hungary
2348 Ketilept
quetiapine
(quetiapine
fumarate)
tablets coated
200mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 12379/119.08.2015
19.04.2018PoM
Egis Pharmaceuticals
PLC 1106 Budapest,
Kereszturi st 30-38,
Hungary
2349 Ketilept
quetiapine
(quetiapine
fumarate)
tablets coated
300mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 12380/119.08.2015
19.04.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
510
2350 Ketilept
quetiapine
(quetiapine
fumarate)
tablets film-coated
100mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 1726813.12.2017
13.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2351 Ketilept
quetiapine
(quetiapine
fumarate)
tablets film-coated
150mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 1726913.12.2017
13.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2352 Ketilept
quetiapine
(quetiapine
fumarate)
tablets film-coated
200mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 1727013.12.2017
13.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2353 Ketilept
quetiapine
(quetiapine
fumarate)
tablets film-coated
300mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 1727113.12.2017
13.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2354 Ketilept
quetiapine
(quetiapine
fumarate)
tablets film-coated
25mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N05AH04 1727213.12.2017
13.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2355 Ketoconazole ketoconazole cream20mg/g,
10g aluminium tube
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova D01AC08 1315910.01.2014
10.01.2019OTC
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
2356 Ketoconazole ketoconazole shampoo20mg/ml,
100ml plastic container
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD01AC08 14871
24.09.2015
24.09.2020OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
511
2357 Ketoconazole ketoconazolecream for external
use
20mg/g,
15g, 25g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD01AC08 15779
11.07.2016
11.07.2021OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2358 Ketonal ketoprofen gel for external use25mg/g,
50g aluminium tube
Salutas Pharma
GmbH, Lange
Goehren 3, 39171
Osterweddingen
Germany M02AA10 1497418.11.2015
18.11.2020PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
2359 Ketonal ketoprofencream for external
use
50mg/g,
30g aluminium tube
Salutas Pharma
GmbH, Lange
Goehren 3, 39171
Osterweddingen
Germany M02AA10 1497518.11.2015
18.11.2020PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
2360Ketonal 100mg
suppositoriesketoprofen suppositories
100mg,
in strip (12/2x6/)
Sandoz Ilac Sanayi ve
Ticaret A.S., Gebze
Plastikciler Organize
Sanayi Boelgesi
Atatturk Bulvari 9,
Cadde No.1, 41400,
Kocaeli
Turkey M01AE03 1414429.12.2014
29.12.2019PoM
Lek d.d., Verovskova
str. 57,1526 Ljubljana,
Slovenia
2361
Ketonal
100mg/2ml
solution for
injection
ketoprofen solution for injection50mg/ml,
2ml ampoules (10/2x5/)
Sandoz
Pharmaceuticals d.d.
Verevskova 57, SI-
1526 Ljubljana
Slovenia M01AE03 1395728.10.2014
28.10.2019PoM
Sandoz
Pharmaceuticals d.d.
Verevskova 57, SI-
1526 Ljubljana,
Slovenia
2362Ketonal 50mg
capsulesketoprofen capsules
50mg,
glass container (25)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia M01AE03 14168/127.04.2017
24.12.2019PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
512
2363 Ketonal DUO ketoprofencapsules modified-
release
150mg,
in blister (20/2x10/,
30/3x10/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia M01AE03 1523523.12.2015
23.12.2020PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
2364
Ketonal Forte
100mg film-coated
tablets
ketoprofen tablets film-coated100mg,
in glass container (20)
Sandoz
Pharmaceuticals d.d.
Verevskova 57, SI-
1526 Ljubljana
Slovenia M01AE03 1416724.12.2014
24.12.2019PoM
Sandoz
Pharmaceuticals d.d.
Verevskova 57, SI-
1526 Ljubljana
2365 Ketonal retard ketoprofentablets prolonged-
release
150mg,
in glass container (20)
Sandoz
Pharmaceuticals d.d.
Verevskova 57, SI-
1526 Ljubljana
Slovenia M01AE03 1395828.10.2014
28.10.2019PoM
Sandoz
Pharmaceuticals d.d.
Verevskova 57, SI-
1526 Ljubljana,
Slovenia
2366 Ketoprofen ketoprofen gel for external use25mg/g,
30g aluminum tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus M02AA10 1628019.12.2016
19.12.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
2367Ketoprofen
Rompharmketoprofen
solution for i/v and
i/m injection
50mg/ml,
2ml ampoules,
in blister (5/1x5/, 10/2x5/)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania M01AE03 1562324.05.2016
24.05.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
2368 Ketorol ketorolac tablets film-coated10mg,
in blister (10)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia M01AB15 1253704.12.2013
04.12.2018PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
513
2369 Ketorolacketorolac (ketorolac
trometamol)solution for injection
30mg/ml,
1ml ampoules (10), 1ml
ampoules label banderol
(10),
1ml ampoules dividella
(10)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus M01AB15 1243902.09.2013
02.09.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
2370 Ketorolacketorolac (ketorolac
trometamol)tablets film-coated
10mg,
in blister (10, 20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus M01AB15 1598715.09.2016
15.09.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2371Ketorolac
Rompharm
ketorolac (ketorolac
trometamol)
solution for i/v and
i/m injection
30mg/ml,
1ml ampoules,
in blister (5/1x5/, 10/2x5/)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania M01AB15 1557512.05.2016
12.05.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
2372 Ketotifenketotifen (ketotifen
fumarate)tablets
1mg,
in blister (10/1x10/,
30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus R06AX17 1363627.06.2014
27.06.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
2373 Ketotifenketotifen (ketotifen
fumarate)tablets
1mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus R06AX17 13850/122.01.2015
18.09.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
514
2374
Ketotifen
Sopharma 1mg
tablets
ketotifen (ketotifen
hydrofumarate)tablets
1mg,
in blister (30/3x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria R06AX17 1664425.04.2017
25.04.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2375 KHONDRA-JECT
chondroitin sulfate
(chondroitin sulfate
sodium)
solution for injection100mg/ml,
1ml ampoules (10/2x5/)
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia M01AX25 13161/111.08.2016
10.01.2019PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
2376 Kindinorm
chamomilla D12,
kalium
phosphoricum D6,
staphisagria D12,
valeriana D6
granules
25mg+25mg+
25mg+25mg,
glass container
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe
Germany
N06B;
homeopathic
drug
1689308.08.2017
08.08.2022OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
2377 Kivexaabacavir (abacavir
sulfate), lamivudinetablets film-coated
600mg+300mg,
in blister (30/3x10/)
Glaxo Wellcome S.A.,
Avenida
Extremadura, 3,
09400 Aranda de
Duero, Burgos- batch
releaser, packager,
GlaxoSmithKline
Pharmaceuticals S.A.,
189 Grunwaldzka
street, 60-322 Poznan,
Poland-bulk
manufacturer
Spain J05AR02 1557812.05.2016
12.05.2021PoM
ViiV Healthcare UK
Ltd., 980 Great West
Road, Brentford,
Middlesex, TW8 9GS,
UK
515
2378 Klacid clarithromycingranules for oral
suspension
125mg/5ml,
100ml plastic container
and measuring syringe or
measuring spoon
AbbVie S.r.l., S.R. 148
Pontina KM 52, SNC -
Campoverde di
Aprilia (loc. Aprilia)-
04011 Aprilia (LT)
Italy J01FA09 1461503.07.2015
03.07.2020PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2379 Klacid clarithromycingranules for oral
suspension
250mg/5ml,
100ml plastic container
and measuring syringe or
measuring spoon
AbbVie S.r.l., S.R. 148
Pontina KM 52, SNC -
Campoverde di
Aprilia (loc. Aprilia)-
04011 Aprilia (LT)
Italy J01FA09 1461603.07.2015
03.07.2020PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2380 Klacid SR clarithromycintablets modified-
release film-coated
500mg,
in bliister (5/1x5/,
14/1x14/)
Aesica Queenborough
Limited,
Queenborough Kent
ME 11 5 EL
UK J01FA09 1492220.10.2015
20.10.2020PoM
for Abbott
Laboratories GmbH,
Freundallee 9A,
30173 Hannover,
Germany
2381 Klarisens loratadine tablets
10mg,
in blister (7/1x7/,
10/1x10/, 30/3x10/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R06AX13 14934/121.04.2016
20.10.2020OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2382 Klerimed clarithromycin tablets film-coated500mg,
in blister (14/2x7/)
Medochemie Ltd
(Factory AZ), 2
Michael Erakleous
street, Agios
Athanassios Industrial
Area, 4101 Agios
Athanassios, Limassol
Cyprus J01FA09 1673905.06.2017
05.06.2022PoM
Medochemie Ltd., 1-
10
Constantinoupoleos
street, 3011 Limassol,
Cyprus
516
2383 Klerimed clarithromycin tablets film-coated250mg,
in blister (14/2x7/)
Medochemie Ltd
(Factory AZ), 2
Michael Erakleous
street, Agios
Athanassios Industrial
Area, 4101 Agios
Athanassios, Limassol
Cyprus J01FA09 1674005.06.2017
05.06.2022PoM
Medochemie Ltd., 1-
10
Constantinoupoleos
street, 3011 Limassol,
Cyprus
2384 Klimaktoplan K
ignatia D3 trit,
cimicifuga D2 trit,
sepia D2 trit,
sanguinaria D6 trit
tablets
25mg+25mg+
25mg+25mg,
in blister (100/5x20/)
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24 76227
Karlsruhe-batch
releaser, Dr. Willmar
Schwabe GmbH &
Co. KG, Willmar-
Schwabe str. 4, 76227
Karlsruhe, Germany-
bulk manufacturer,
packager
Germany
G02C;
homeopathic
drug
1425720.02.2015
20.02.2020OTC
Deutsche
Homoopathie-Union
DHU-Arzneimittel
GmbH & Co. KG,
Ottostrasse 24, 76227
Karlsruhe, Germany
2385 Klimalanin beta-alanine tablets
400mg,
blisters (30/3x10/,
30/2x15/)
Laboratoires Bouchara-
Recordati, Parc
Mecatronic 03410
Saint Victor
France G02CX 14000/102.09.2016
26.11.2019OTC
Laboratoires
Bouchara-Recordati,
Immeuble le Wilson,
70 avenue du General
de Gaulle, 92800
Puteaux, France
517
2386 Klimonorm
yellow dragee -
estradiol valerate,
brown dragee -
estradiol valerate,
levonorgestrel
dragee (tablets sugar-
coated)
2mg+2mg+0,15mg, (21/ 9
yellow dragee+12 brown
dragee/) in blister
Jenapharm GmbH &
Co. KG, Otto-Schott-
Strasse 15, D-07745,
Jena - batch relaser
(dosage form
manufacturer - Bayer
Weimar GmbH & Co.
KG, Dobereinerstrasse
20, 99427 Weimar,
Thuringia, Germany)
Germany G03CA53 1261421.06.2013
21.06.2018PoM
Jenapharm GmbH &
Co. KG, Otto-Schott-
Strasse 15, D-07745,
Jena, Germany
2387 Klindacin T
clindamycin
(clindamycin
phosphate)
gel10mg/g,
30g aluminium tube
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw
Poland D10AF01 1623719.12.2016
19.12.2021PoM
Tarchomin
Pharmaceutical
Works "Polfa" S.A.,
2,A. Fleminga str.,03-
176 Warsaw, Poland
2388 Klindamicin
clindamycin
(clindamycin
hydrochloride)
capsules150mg,
in blister (16/2x8/)
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb
Serbia J01FF01 1360320.06.2014
20.06.2019PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
2389 Klion-D 100
metronidazole,
miconazole
(miconazole nitrate)
tablets vaginal100mg+100mg,
in blister (10/1x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G01AF20 1445504.05.2015
04.05.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2390 Klopidogrel AKTIV
clopidogrel
(clopidogrel
bisulfate)
tablets film-coated
75mg,
in blister (30/3x10/,
90/9x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia B01AC04 1362327.06.2014
27.06.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
2391 Kodelak Neobutamirate
(butamirate citrate)syrup
7.5mg/5ml,
100ml glass bottle and
measuring spoon
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05DB13 1620908.12.2016
08.12.2021OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
518
2392 Kodelak Neobutamirate
(butamirate citrate)drops oral
5mg/ml,
20ml glass vial-dropper
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia R05DB13 1621008.12.2016
08.12.2021OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2393Kofetamin-
Tatpharm
caffeine (caffeine
anhydrous),
ergotamine
(ergotamine
tartrate)
tablets coated(91,5mg+1mg), blisters
(10/1x10/, 20/2x10/)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 261
Russia N02CA52 13682/108.06.2017
08.07.2019PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
2394Konakion MM
paediatric phytomenadione
solution for
injection/oral
2mg/0,2ml,
0,2ml ampoules (5) and
dispenser
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse 124
Basel, CH-4070-batch
releaser, Cenexi SAS,
52 rue Marcel et
Jacques Gaucher,
Fontenay Sous Bois,
94120, France- bulk
manufacturer,
packager
Switzerland B02BA01 1692716.08.2017
16.08.2022PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse 124
Basel, CH-4070,
Switzerland
2395 Korold-Asteria
paracetamol,
pseudoephedrine
(pseudoephedrine
hydrochloride),
chlorphenamine
(chlorphenamine
maleate)
tablets film-coated
500mg+30mg+ 2mg,
in blister (20/2x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth N02BE51 15234/103.02.2016
23.12.2020OTC
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
2396 Kreon 10000
pancreatin (lipase
10000PhEU,
amylase 8000
PhEU, protease 600
PhEU)
capsules gastro-
resistant
150mg,
in blister (20/2x10/) and
in plastic container (20)
Abbott Laboratories
GmbH, Justus-von-
Liebig-Strasse 33,
31535 Neustadt
Germany A09AA02 1498918.11.2015
18.11.2020OTC
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
519
2397 Kreon 25000
pancreatin (lipase
25000PhEU,
amylase 18000
PhEU, protease
1000 PhEU)
capsules gastro-
resistant
300mg; (20/2x10/), in
blister and (20) in plastic
container
Abbott Laboratories
GmbH, Justus-von-
Liebig-Strasse 33,
31535 Neustadt
Germany A09AA02 1499018.11.2015
18.11.2020OTC
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2398 Kreon 40000
pancreatin (lipase
40000PhEU,
amylase 25000
PhEU, protease
1600 PhEU)
capsules gastro-
resistant
400mg,
in blister (20/2x10/) and
in plastic container (20)
Abbott Laboratories
GmbH, Justus-von-
Liebig-Strasse 33,
31535 Neustadt
Germany A09AA02 1498818.11.2015
18.11.2020OTC
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
2399 Ksalatamax latanoprost drops eye0,05mg/ml,
2,5ml plastic vial, (1,3)
Jadran Galenski
Laboratorij d.d.,
51000 Rijeka, Pulac
b.b. - batch releaser
(dosage form
manufacturer - Jadran
Galenski Laboratorij
d.d., Svilno
bb,Cavle,51219,
Croatia)
Croatia S01EE01 1243207.05.2013
07.05.2018PoM
Jadran Galenski
Laboratorij d.d.,
51000 Rijeka, Pulac
b.b., Croatia
2400 Lacipil lacidipine tablets film-coated4mg,
in blister (14/2x7/)
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan
Poland C08CA09 1274423.07.2013
23.07.2018PoM
GlaxoSmithKline
Export Ltd, 980 Great
West Road,
Brentford, Middlesex,
TW8 9GS, UK
2401 Lactinette desogestrel tablets film-coated
0,075mg,
in blister (28/1x28/,
84(3x28)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AC09 1456509.06.2015
09.06.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
520
2402 Lacto-G
lactobacillus
acidophilus,
bifidobacterium
longum,
bifidobacterium
bifidum,
bifidobacterium
infantis
capsules10x10^9 CFU/g,
in blister (10)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia A07FA01 1247902.10.2013
02.10.2018OTC
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
2403 Laevomycetin chloramphenicolpowder for solution
for injection
1000mg,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01BA01 1597915.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
2404 Laevomycetin chloramphenicolpowder for solution
for injection
500mg,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01BA01 1598015.09.2016
15.09.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
2405 Laevomycetin chloramphenicol tablets500mg,
in blister (10, 500/50x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01BA01 1606617.10.2016
17.10.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
2406 Laevomycetin chloramphenicol tablets250mg,
in blister (10, 500/50x10/)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01BA01 1606717.10.2016
17.10.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139, Ukraine
2407 Laferobion interferon alfa-2b
powder lyophilized
for intranasal
solution
100000IU/ml, ampoules
(10)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine L03AB05 1223307.03.2013
07.03.2018PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
2408 Laferobion interferon alfa-2b suppositories rectal 1000000IU, (5)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine L03AB01 1228322.03.2013
22.03.2018PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
521
2409 Laferobion interferon alfa-2b suppositories rectal 150000IU, (5)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine L03AB01 1228422.03.2013
22.03.2018PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
2410 Laferobion interferon alfa-2b suppositories rectal 3000000IU, (5)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine L03AB01 1228522.03.2013
22.03.2018PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
2411 Laferobion interferon alfa-2b suppositories rectal 500000IU, (5)
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9
Ukraine L03AB01 1228622.03.2013
22.03.2018PoM
Biopharma PJSC,
03680, Kiev, N.
Amosova str. 9,
Ukraine
2412 Laferobion interferon alfa-2b
powder lyophilized
for intranasal
solution
100000IU/ml, glass vial in
blister (10/2x5/)
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region
Ukraine L03AB05 1699105.09.2017
05.09.2022PoM
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region, Ukraine
2413 Lamal lamotrigine tablets25mg,
in blister (30/3x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N03AX09 1714907.11.2017
07.11.2022PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
2414 Lamal lamotrigine tablets50mg,
in blister (30/3x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N03AX09 1715007.11.2017
07.11.2022PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
2415 Lamal lamotrigine tablets100mg,
in blister (30/2x15/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N03AX09 1715107.11.2017
07.11.2022PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
522
2416 Lamal lamotrigine tablets200mg,
in blister (30/2x15/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N03AX09 1715207.11.2017
07.11.2022PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
2417Lamal 100mg
tabletslamotrigine tablets
100mg,
in blister (30/2x15/)
dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia;
batch releaser -
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
Slovenia N03AX09 12413/121.06.2013
23.04.2018PoM
Alkaloid Ltd,
Motopista 2, 2
"Ricardo Vakarini"
str., fl. 3, ap. 10 Sofia
1404, Bulgaria
2418Lamal 200mg
tabletslamotrigine tablets
200mg,
in blister (30/2x15/)
dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia;
batch releaser -
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
Slovenia N03AX09 12414/121.06.2013
23.04.2018PoM
Alkaloid Ltd,
Motopista 2, 2
"Ricardo Vakarini"
str., fl. 3, ap. 10 Sofia
1404, Bulgaria
523
2419 Lamal 25mg tablets lamotrigine tablets25mg,
in blister (30/3x10/)
dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia;
batch releaser -
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
Slovenia N03AX09 12411/121.06.2013
23.04.2018PoM
Alkaloid Ltd,
Motopista 2, 2
"Ricardo Vakarini"
str., fl. 3, ap. 10 Sofia
1404, Bulgaria
2420 Lamal 50mg tablets lamotrigine tablets50mg,
in blister (30/3x10/)
dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia;
batch releaser -
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
Slovenia N03AX09 12412/121.06.2013
23.04.2018PoM
Alkaloid Ltd,
Motopista 2, 2
"Ricardo Vakarini"
str., fl. 3, ap. 10 Sofia
1404, Bulgaria
2421 Lamictal lamotrigine tablets100mg,
blisters (30/3x10/)
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan
Poland N03AX09 13680/101.09.2016
08.07.2019PoM
GlaxoSmithKline
Trading CJSC,
119180, Moscow,
Yakimanskaya nab.,
2, Russia
524
2422 Lamictal lamotriginetablets chewable/
dispersible
2mg,
in plastic bottle (30)
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan-
packager, batch
releaser (bulk
manufacturer-
GlaxoSmithKline
LLC, 1011 North
Arendell Ave,
Zebulon, North
Carolina 27597, USA)
Poland N03AX09 1586327.07.2016
27.07.2021PoM
The Wellcome
Foundation Ltd, 980
Great West Road
Brentford Middlesex
TW8 9GS UK trading
as GlaxoSmithKline
UK, Stockley Park
West Uxbridge,
Middlesex UB11 1BT,
UK
2423 Lamictal lamotriginetablets chewable/
dispersible
5mg,
in blister (28/2x14/)
GlaxoSmithKline
Pharmaceuticals
S.A.,189 Grunwaldzka
street, 60-322 Poznan-
packager, batch
releaser (bulk
manufacturer-
GlaxoSmithKline
LLC, 1011 North
Arendell Ave,
Zebulon, North
Carolina 27597, USA)
Poland N03AX09 1586427.07.2016
27.07.2021PoM
The Wellcome
Foundation Ltd, 980
Great West Road
Brentford Middlesex
TW8 9GS UK trading
as GlaxoSmithKline
UK, Stockley Park
West Uxbridge,
Middlesex UB11 1BT,
UK
2424 Lamifast
terbinafine
(terbinafine
hydrochloride)
tablets250mg,
in blister (14/2x7/)
Birzeit
Pharmaceutical
Company (BPC),
Ramallah,Industrial
Zone
Palestine D01BA02 1381705.09.2014
05.09.2019PoM
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
2425 Lamisil
terbinafine
(terbinafine
hydrochloride)
tablets250mg,
in blister (14)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr/Baden
Germany D01BA02 1302325.11.2013
25.11.2018PoM
Novartis Pharma AG,
56, Lichtstrasse, 4056
Basel, Switzerland
525
2426 Lamisil
terbinafine
(terbinafine
hydrochloride)
cream
10mg/g,
15g aluminium tube, 15g
laminated tube
Novartis Consumer
Health S.A., Route de
I`Etraz, Case postale
269, 1260 Nyon
Switzerland D01AE15 1665311.05.2017
11.05.2022OTC
Novartis Consumer
Health S.A., Route de
I`Etraz, Case postale
269, 1260 Nyon,
Switzerland
2427 Lamisil DermGel terbinafine gel10mg/g,
15g aluminium tube
Novartis Consumer
Health S.A., Route de
I`Etraz, 1260 Nyon
Switzerland D01AE15 1305125.11.2013
25.11.2018OTC
Novartis Consumer
Health S.A., Route de
I`Etraz, 1260 Nyon,
Switzerland
2428 Lamolep lamotrigine tablets25mg,
in blister (30/3x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N03AX09 1311524.12.2013
24.12.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2429 Lamolep lamotrigine tablets50mg,
in blister (30/3x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N03AX09 1311624.12.2013
24.12.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2430 Lamolep lamotrigine tablets100mg,
in blister (30/3x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary N03AX09 1311724.12.2013
24.12.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
526
2431
Lamotrigine
Accord 100mg
Tablets
lamotrigine tablets100mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N03AX09 1515917.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2432
Lamotrigine
Accord 200mg
Tablets
lamotrigine tablets200mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N03AX09 1515817.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
527
2433
Lamotrigine
Accord 25mg
Tablets
lamotrigine tablets25mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N03AX09 1515717.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2434
Lamotrigine
Accord 50mg
Tablets
lamotrigine tablets50mg,
in blister (56/4x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK N03AX09 1516017.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2435 Lansoptol lansoprazole capsules30mg,
in blister (14/2x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia A02BC03 1230922.03.2013
22.03.2018PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
528
2436 Lantus insulin glarginesolution for s/c
injection
100U/ml,
3ml cartridges (5)
Sanofi-Aventis
Deutschland GmbH,
Industriepark
Hoechst,
Bruningstrasse 50, D-
65926 , Frankfurt am
Main
Germany
A10AE04;
new
indication
12393/119.04.2013
19.04.2018PoM
Sanofi-Aventis
Deutschland GmbH,
Industriepark
Hoechst,
Bruningstrasse 50, D-
65926 , Frankfurt am
Main, Germany
2437 Lantus insulin glarginesolution for s/c
injection
100U/ml, 3ml
cartridges(5), in SoloStar
pen-syringes
Sanofi-Aventis
Deutschland GmbH,
Industriepark
Hoechst,
Bruningstrasse 50, D-
65926 , Frankfurt am
Main
Germany
A10AE04;
new
indication
13119/124.12.2013
24.12.2018PoM
Sanofi-Aventis
Deutschland GmbH,
Industriepark
Hoechst,
Bruningstrasse 50, D-
65926 , Frankfurt am
Main, Germany
2438 Lasix furosemide tablets40mg,
in strip (45/3x15/)
Sanofi India Limited,
Plot No.-3501, 3503-
15, 6310B-14,
G.I.D.C. ESTATE,
Post Box No 136,
Ankleshwar, Bharuch
India C03CA01 1718928.11.2017
28.11.2022PoM
Sanofi India Limited,
54/A, Sir Mathuradas
Vasanji Road,
Andheri (East)
Mumbai 400093,
India
2439 Lasolvan
ambroxol
(ambroxol
hydrochloride)
solution for
inhalation
7,5mg/ml,
100ml glass bottle and
measuring cup
Istituto de Angeli
S.R.L. Loc. Prulli,
103/C 50066 Reggello,
Firenze
Italy R05CB06 12132/107.06.2016
01.02.2018OTC
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
2440 Lasolvan
ambroxol
(ambroxol
hydrochloride)
tablets
30mg,
in blister (20/2x10/,
50/5x10/)
Boehringer Ingelheim
Ellas A.E., 5th km,
Paiania-Markopoulo,
194 00 Koropi
Greece R05CB06 1308609.12.2013
09.12.2018OTC
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
529
2441Lasolvan syrup
15mg/5ml
ambroxol
(ambroxol
hydrochloride)
syrup
15mg/5ml,
100ml glass bottle and
measuring cup
Boehringer Ingelheim
Espana S.A., Prat de la
Riba, 50, 08174 Sant
Cugat del Valles,
Barcelona
Spain R05CB06 1675005.06.2017
05.06.2022OTC
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
2442Lasolvan syrup
30mg/5ml
ambroxol
(ambroxol
hydrochloride)
syrup
30mg/5ml,
100ml glass bottle and
measuring cup
Boehringer Ingelheim
Espana S.A., Prat de la
Riba, 50, 08174 Sant
Cugat del Valles,
Barcelona
Spain R05CB06 1674905.06.2017
05.06.2022OTC
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
2443 La-Son
hydroxyzine
(hydroxyzine
hyrochloride)
tablets film-coated25mg,
in blister (20/2x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05BB01 12709
23.07.2013
23.07.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
2444 Lasoprol lansoprazole capsules30mg,
in blister (14/2x7/)
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia
Cyprus A02BC03 12683/102.12.2014
17.07.2018PoM
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia, Cyprus
2445 Laticort
hydrocortisone
(hydrocortisone 17-
n-butyrate)
ointment for
external use
1mg/g,
15g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AB02 1611210.11.2016
10.11.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2446 Laticort
hydrocortisone
(hydrocortisone 17-
n-butyrate)
solution for external
use
1mg/ml,
20ml plastic vial
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AB02 1611310.11.2016
10.11.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
530
2447 Lavmox 0.6
amoxicillin
(amoxicillin
sodium), clavulanic
acid (potassium
clavulanate)
powder for solution
for injection
500mg+100mg, 10ml
glass vial (1)
Reyoung
Pharmaceutical Co.
Ltd., No 6 Erlangshan
Road, Yiyuan County,
Shandong Province
China J01CR02 1529704.02.2016
04.02.2021PoM
Veejay
Pharmaceuticals Pvt.
Ltd., D. No 9-34/6,
Plot 8A, SV Nagar,
Kessara (M), Nagaram
(V), SV Road No 6,
OPP To Gayatri
Nivas, Near Vijaya
Hospitals Ecil X
Roads, Secunderabaad
AP, 500083, India
2448 Lavmox 1.2
amoxicillin
(amoxicillin
sodium), clavulanic
acid (potassium
clavulanate)
powder for solution
for injection
1000mg+200mg, 20ml
glass vial (1)
Reyoung
Pharmaceutical Co.
Ltd., No 6 Erlangshan
Road, Yiyuan County,
Shandong Province
China J01CR02 1529804.02.2016
04.02.2021PoM
Veejay
Pharmaceuticals Pvt.
Ltd., D. No 9-34/6,
Plot 8A, SV Nagar,
Kessara (M), Nagaram
(V), SV Road No 6,
OPP To Gayatri
Nivas, Near Vijaya
Hospitals Ecil X
Roads, Secunderabaad
AP, 500083, India
2449 Lavomaxtilorone (tilorone
dihydrochloride)tablets coated
125mg,
blister (6, 10)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia J05AX 13071/127.01.2017
09.12.2018OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
2450 Laxalac lactulose solution oral
670mg/ml,
100ml glass bottle and
measuring cup, 200ml,
250ml plastic bottle and
measuring cup
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22
Republic of
ArmeniaA06AD11 13472
06.05.2014
06.05.2019OTC
Medical Horizon Ltd,
Ararat province,
Masis city, Masis
station, Gortsaranain
22, Republic of
Armenia
531
2451 Lecrolyn
cromoglicic acid
(sodium
cromoglicate)
drops eye40mg/ml,
5ml plastic vial
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01GX01 1243123.07.2013
23.07.2018OTC
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
2452 Lecrolyn
cromoglicic acid
(sodium
cromoglicate)
drops eye40mg/ml,
5ml plastic vial (1)
Santen Oy,
Niittyhaankatu 20,
33720 Tampere-
batch releaser,
secondary packager,
Santen
Pharmaceutical
(China) Co., Ltd., No.
169 Tinglan Road,
Suzhou Industrial
Park, Suzhou, Jiangsu
Province, China- bulk
manufacturer,
primary packager
Finland S01GX01 1726613.12.2017
13.12.2022OTC
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
2453Lefluonia 20mg
film-coated tabletsleflunomide tablets film-coated
20mg,
in blister (30/3x10/)
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki
Greece L04AA13 1307609.12.2013
09.12.2018PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki, Greece
2454 Legalon 140 silymarin capsules
140mg,
in blister (20/2x10/,
30/3x10/, 60/6x10/)
Madaus GmbH,
Luetticher Strasse
5,Troisdorf, 53842
Germany A05BA03 1715507.11.2017
07.11.2022OTC
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg,
Germany
532
2455 Legalon SIL silibininpowder for solution
for infusion
350mg,
glass vials (4)
Madaus GmbH, 51101
Cologne - secondary
packager, batch
releaser (primary
packager, bulk
manufacturer - BAG
Health Care GmbH,
Amtsgerichtsstrasse 1-
5, 35423 Lich,
Germany)
Germany
V03AX
new
indication
1324424.02.2014
24.02.2019PoM
Madaus GmbH,
51101 Cologne,
Germany
2456 Lekoklar 500mg clarithromycin tablets film-coated500mg,
in blister (14/2x7/)
S.C. Sandoz S.R.L., str.
Livezeni nr. 7A,
540472, Targu Mures
Romania J01FA09 1379505.09.2014
05.09.2019PoM
Sandoz d.d.,
Verovskova 57, SI-
1526 Ljubljana,
Slovenia
2457 Lekoklar XL clarithromycintablets prolonged-
release film-coated
500mg,
in blister (7/1x7/)
S.C. Sandoz S.R.L., str.
Livezeni nr. 7A,
540472, Targu Mures
Romania J01FA09 14965/115.12.2015
18.11.2020PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1526 Ljubljana,
Slovenia
2458 Lemoks
levofloxacin
(levofloxacin
hemihydrate)
tablets film-coated
500mg,
in blister (5/1x5/,
10/1x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi-secondary
packager, batch
releaser (Arafarma
Group, S.A., C/Fray
Gabriel de San
Antonio, 6-10, Pol.
Ind. Del Henares,
19180, Marchamalo
(Guadalajara), Spain-
bulk manufacturer,
primary packager)
Georgia J01MA12 1585320.07.2016
20.07.2021PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
533
2459 Lendacin
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection/infusion
1000mg,
glass vials (1, 5)
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl
Austria J01DD04 1441308.04.2015
08.04.2020PoM
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria
2460 Lerkamen 10
lercanidipine
(lercanidipine
hydrochloride)
tablets film-coated
10mg,
in blister (7/1x7/,
14/1x14/, 28/2x14,
60/4x15, 90/6x15)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany C08CA13 1534926.02.2016
26.02.2021PoM
Menarini
International O. L.
S.A., 1, Avenue de la
Gare, 1611,
Luxembourg
2461 Leron
furosemide,
amiloride
(amiloride
hydrochloride)
tablets40mg+5mg,
in blister (50/5x10/)
Aversi-Rational Ltd,
(0198 Tbilisi,
Chirnakhuli str. 14) -
batch releaser,
packager (dosage form
manufacturer - Geno
Pharmaceuticals Ltd
/Karaswada Mapusa,
Goa 403526, India/)
Georgia C03EB01 1292707.10.2013
07.10.2018PoM
Aversi-Rational Ltd
(0198 Tbilisi,
Chirnakhuli str. 14,
Georgia)
2462 Lescol XLfluvastatin
(fluvastatin sodium)tablets film-coated
80mg,
blisters (28/2x14/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria, 158, 08210
Barbera del Valles,
Barcelona
Spain C10AA04 12580/113.06.2016
23.06.2018PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
534
2463 Lespefril lespedeza bicolor solution oral
708mg/ml,
100ml glass or plastic
bottle
VIFITEH CJSC,
SCRAM, Obolensk v.,
corp. 84, corp. 87,
build. 90, Serpukhov
district, Moscow
region,142279
Russia G04BX 1508515.12.2015
15.12.2020OTC
VIFITEH CJSC,
SCRAM, Obolensk v.,
Serpukhov district,
Moscow
region,142279, Russia
2464 Letiram levetiracetam tablets coated
500mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
Rontis Hellas S.A.,
P.O. Box 3012, Larisa
Industrial Area, 41004
Larisa, Greece-bulk
manufacturer,
packager
Hungary N03AX14 1530704.02.2016
04.02.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2465 Letiram levetiracetam tablets coated
250mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
Rontis Hellas S.A.,
P.O. Box 3012, Larisa
Industrial Area, 41004
Larisa, Greece-bulk
manufacturer,
packager
Hungary N03AX14 1530804.02.2016
04.02.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2466 Letiram levetiracetam tablets coated
750mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
Rontis Hellas S.A.,
P.O. Box 3012, Larisa
Industrial Area, 41004
Larisa, Greece-bulk
manufacturer,
packager
Hungary N03AX14 1530904.02.2016
04.02.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
535
2467 Letiram levetiracetam tablets coated
1000mg,
in blister (30/3x10/,
60/6x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
Rontis Hellas S.A.,
P.O. Box 3012, Larisa
Industrial Area, 41004
Larisa, Greece-bulk
manufacturer,
packager
Hungary N03AX14 1531004.02.2016
04.02.2021PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2468 Letizencetirizine (cetirizine
dihydrochloride)tablets film-coated
10mg,
in blister (10/1x10/,
20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia R06AE07 1477803.08.2015
03.08.2020OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2469 Letromara letrozole tablets film-coated2,5mg,
in blister (30/3x10/)
PJSC "Farmak", 74
Frunze str., Kiev,
04080
Ukraine L02BG04 1619208.12.2016
08.12.2021PoM
PJSC "Farmak", 63
Frunze str., Kiev,
04080, Ukraine
536
2470
Letrozole 2.5mg
Film-coated
Tablets
letrozole tablets film-coated2,5mg,
in blister (28/2x14/)
Wessling BRS Hungary
Limited, 1047 Budapest,
Foti ut. 56 - batch
releaser, Intas
Pharmaceuticals
Limited, Plot No 457 &
458 & 191/218 P,
Sarkhej-Bavla Highway,
Matoda Village, Sanand,
District-Ahmedabad,
382 210, Gujarat, India-
bulk manufacturer,
Accord Healthcare
Limited, Unit C & D,
Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
Hungary L02BG04 1516117.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2471
Letrozole 2.5mg
Film-coated
Tablets
letrozole tablets film-coated2,5mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK L02BG04 1516217.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2472 Letrozole Denk 2.5 letrozole tablets film-coated2,5mg,
in blister (30/3x10/)
Haupt Pharma
Munster GmbH,
Schleebruggenkamp
15, 48159 Munster
Germany L02BG04 1577304.07.2016
04.07.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
537
2473 Leukeran chlorambucil tablets film-coated2mg,
glass bottle (25)
EXCELLA GmbH &
Co.KG, Nuernberger
st. 12, 90537 Feucht
Germany L01AA02 13320/224.07.2017
04.03.2019PoM
Aspen Pharma
Trading Limited,
3016 Lake Drive,
Citywest Business
Campus, Dublin 24,
Ireland
2474 Levemir FlexPeninsulin detemir
(recombinant)solution for injection
100IU/ml,
3ml pre-filled syringe-
pen (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AE05 1287117.09.2013
17.09.2018PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2475 Levemir Penfillinsulin detemir
(recombinant)solution for injection
100IU/ml,
3ml cartridges (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AE05 1287017.09.2013
17.09.2018PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2476 Levitra
vardenafil
(vardenafil
hydrochloride
trihydrate)
tablets film-coated20mg,
in blister (1,4)
Bayer Pharma AG, D-
51368 Leverkusen Germany G04BE09 13124
10.01.2014
10.01.2019PoM
Bayer Pharma AG, D-
13342, Berlin,
Germany
2477LeViTRONN oral
solution
levofloxacin
(levofloxacin
hemihydrate)
solution oral25mg/ml,
100ml glass bottle
Incepta
Pharmaceuticals Ltd.,
Dewan Idris Road,
Zirabo, Sevar Dhaka
Bangladesh J01MA12 1286017.09.2013
17.09.2018PoM
Incepta
Pharmaceuticals Ltd.,
Dewan Idris Road,
Zirabo, Sevar Dhaka,
Bangladesh
2478
LeViTRONN
solution for i/v
infusion
levofloxacin
(levofloxacin
hemihydrate)
solution for i/v
infusion
5mg/ml,
100ml plastic pack
Incepta
Pharmaceuticals Ltd.,
Dewan Idris Road,
Zirabo, Sevar Dhaka
Bangladesh J01MA12 1286117.09.2013
17.09.2018PoM
Incepta
Pharmaceuticals Ltd.,
Dewan Idris Road,
Zirabo, Sevar Dhaka,
Bangladesh
2479 Levo-Denk 250
levofloxacin
(levofloxacin
hemihydrate)
tablets film-coated250mg,
in blister (10)
Rottendorf Pharma
GmbH, Ostenfelder
Strasse 51-61, 59320
Ennigerloh
Germany J01MA12 1223907.03.2013
07.03.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
538
2480 Levo-Denk 500
levofloxacin
(levofloxacin
hemihydrate)
tablets film-coated500mg,
in blister (10)
Rottendorf Pharma
GmbH, Ostenfelder
Strasse 51-61, 59320
Ennigerloh
Germany J01MA12 1224007.03.2013
07.03.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
2481 Levofloxacin 0.5%
levofloxacin
(levofloxacin
hemihydrate)
solution for infusion 5mg/ml
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaJ01MA12 14713
16.07.2015
16.07.2020PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
2482Levofloxacin-
Asterialevofloxacin tablets film-coated
500mg,
in blister (10/1x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth J01MA12 1525429.12.2015
29.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
2483 Levomecolchloramphenicol,
methyluracilointment
7,5mg/g+40mg/g, 30g, 40g
aluminium tube
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17, Mira St,
Kiev 03134
UkraineD03AX,
D06AX0212792
14.08.2013
14.08.2018OTC
SIC Borshchahivskiy
Chemical-
Pharmaceutical Plant
PJSC, 17, Mira St,
Kiev 03134, Ukraine
2484 Levomecol
chloramphenicol,
dioxomethyltetrahy
dropyramidine
ointment for
external use
7.5mg/g+40mg/g, 25g
aluminium tube
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaD06C 14110
29.12.2014
29.12.2019OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
2485 Levomecolchloramphenicol,
methyluracil
ointment for
external use
7,5mg/g+40mg/g, 25g
aluminium tube
'Lubnypharm' PJSC,
37500, Poltava region,
Lubny, Petrovskogo
str. 16
Ukraine D03AX 1548102.04.2016
02.04.2021OTC
'Lubnypharm' PJSC,
37500, Poltava region,
Lubny, Petrovskogo
str. 16
539
2486 Levomecolchloramphenicol,
methyluracil
ointment for
external use
7,5mg/g+40mg/g, 40g
aluminium tube
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia D06C 1719608.12.2017
08.12.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
2487 Levomepromazine
levomepromazine
(levomepromazine
maleate)
tablets coated25mg,
in blister (50/5x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05AA02 16771
27.06.2017
27.06.2022PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2488Levomicetin-
Darnitsachloramphenicol tablets
250mg,
in blister (10)
Darnitsa
Pharmaceutical Firm
CJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine J01BA01 1234809.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
2489Levomicetin-
Darnitsachloramphenicol tablets
500mg,
in blister (10)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine J01BA01 1234909.04.2013
09.04.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
2490 Levomycetin chloramphenicol tablets500mg,
in blister (10)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia J01BA01 1270823.07.2013
23.07.2018PoM
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
2491 Levomycetin chloramphenicol tablets
500mg,
strip (10),
blister (10)
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia J01BA01 14153/108.06.2017
08.06.2022PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
540
2492Levomycetin
Tatpharmchloramphenicol drops eye
2,5mg/ml,
5ml glass vial-dropper,
5ml plastic vial-dropper,
10ml plastic vial-dropper
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260
Russia S01AA01 13812/125.07.2017
05.09.2019PoM
Tatchempharmpre-
paraty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
2493 Libexin
prenoxdiazine
(prenoxdiazine
hydrochloride)
tablets100mg,
in blister (20/1x20/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary R05DB18 1712224.10.2017
24.10.2022OTC
Sanofi-Aventis
Private Co. Ltd.,1045
Budapest, To u. 1-5,
Hungary
2494 Licopidglucosamine
muramyl dipeptidetablets
1mg,
in blister (10)
Peptek JSC, 16/10
Miklukho-Maklaya
St., Moscow, 117997
Russia L03A 12355/125.12.2017
09.04.2018PoM
Peptek JSC, 16/10
Miklukho-Maklaya
St., Moscow, 117997,
Russia
2495 Licopidglucosamine
muramyl dipeptidetablets
10mg,
in blister (10)
Peptek JSC, 16/10
Miklukho-Maklaya
St., Moscow, 117997
Russia L03A 12392/125.12.2017
19.04.2018PoM
Peptek JSC, 16/10
Miklukho-Maklaya
St., Moscow, 117997,
Russia
2496 Lidasa-Belmed hyaluronidase
powder lyophilized
for solution for i/m
and s/c injection
725IU; (5) glass vial
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus B06AA03 1585020.07.2016
20.07.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
2497 Lidocain lidocaineaerosol for external
use
4.6mg/dose,
38g glass vial with
measuring pump
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary D04AB01 1639710.02.2017
10.02.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi ut 30-38,
Hungary
541
2498Lidocain
hydrochlorid
lidocaine (lidocaine
hydrochloride)solution for injection
10mg/ml,
5ml ampoules (10), 5ml
ampoules, label-banderol
(10), 5ml ampoules,
dividella (10)
Open Joint Stock
Company
"Borisovskiy zavod
medicinskikh
preparatov" (64/27,
Chapayev str., Borisov
222120, Minsk oblast)
Belarus N01BB02 1295428.10.2013
28.10.2018PoM
Open Joint Stock
Company
"Borisovskiy zavod
medicinskikh
preparatov" (64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus)
2499 Lidocaine lidocaine spray50mg/ml,
15ml plastic bottle
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN01BB02 12461
13.05.2013
13.05.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2500Lidocaine 5%
ointmentlidocaine ointment
50mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN01BB02 14484
18.05.2015
18.05.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2501Lidocaine
hydrochloride
lidocaine (lidocaine
hydrochloride)solution for injection
20mg/ml,
2ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaN01BB02 16685
31.05.2017
31.05.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
2502 Lidocaine-Liqvolidocaine (lidocaine
hydrochloride)solution for injection
10mg/ml; (1) and (10)
glass vials 20ml
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaN01BB02 12800/1
28.11.2014
23.08.2018PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2503 Lidocaine-Liqvolidocaine (lidocaine
hydrochloride)solution for injection
20mg/ml; (1) and (10)
glass vials 20ml
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaN01BB02 12801/1
28.11.2014
23.08.2018PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
542
2504Lidocaine-Liqvo
with epinephrine
lidocaine (lidocaine
hydrochloride),
epinephrine
solution for injection20mg/ml+0.01mg/ml; (1)
and (10) glass vials 20ml
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaN01BB52 13383/1
28.11.2014
04.04.2019PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2505Lidocaine-
Zdorovye
lidocaine (lidocaine
hydrochloride)solution for injection
20mg/ml,
2ml ampoules (10), 2ml
ampoules,
in blister (10/2x5/,
10/1x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine N01BB02 1636630.12.2016
30.12.2021PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
2506Lidocaine-
Zdorovye
lidocaine (lidocaine
hydrochloride)solution for injection
100mg/ml; (10) ampoules
2ml, (5/1x5/), (10/2x5/)
and (10/1x10/) ampoules
2ml, in blister
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine C01BB01 1642806.03.2017
06.03.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
2507 Lignospan special
lidocaine (lidocaine
hydrochloride),
adrenaline
(adrenaline tartrate)
solution for injection
20mg/ml+ 12,5mcg/ml,
1,8ml cartridges
(50/5x10/)
Septodont, 58 rue du
Pont de Creteil,
94100 Saint- Maur-
des- Fosses
France N01BB52 1417716.01.2015
16.01.2020PoM
Septodont, 58 rue du
Pont de Creteil,
94100 Saint- Maur-
des- Fosses, France
2508 Limoxin-200LA
oxytetracycline
(oxytetracycline
dihydrate)
solution for injection200mg/ml,
50ml, 100ml glass bottle
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray-batch
releaser, packager,
Interchemie werken
'De Adelaar' Eesti As
ltd, Estonia Vanapre
str. 14, Puunsi,
Viimsi, Harju country-
bulk manufacturer,
primary packager
the Netherlands
QJ01AA06;
veterinary
drug
1414629.12.2014
29.12.2019PoM
Interchemie werken
'De Adelaar' B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
543
2509
Lincomycine-
Spectinomycine
5/10
lincomycin
(lincomycin
hydrochloride),
spectinomycin
(spectinomycin
hydrochloride)
solution for injection50mg/ml+ 100mg/ml,
100ml glass vials (12)
Alfasan International
B.V., Kuipersweg 9-
3449 JA Woerden
the Netherlands
QJ51RF03;
veterinary
drug
1469416.07.2015
16.07.2020PoM
Alfasan International
B.V., Kuipersweg 9-
3449 JA Woerden,
the Netherlands
2510 Lindynette 20ethinylestradiol,
gestodenetablets coated
0.02mg+0.075mg, in
blister
(21, 63/3x21/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AA10 1277114.08.2013
14.08.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2511 Lindynette 30ethinylestradiol,
gestodenetablets coated
0.03mg+0.075mg, in
blister
(21, 63/3x21/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AA10 1277214.08.2013
14.08.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2512 Linex
lyophilized viable
lactic acid bacterias
(Lactobacillus
acidophilus,
Bifidobacterium
infantis,
Enterococcus
faecium)
capsules hard
1,2x10^7,
in glass container (16),
in blister (16/2x8/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser, Lek
Pharmaceuticals d.d.,
Kolodvorska cesta 27,
Menges, 1234,
Slovenia-bulk
manufacturer,
packager
Slovenia A07FA01 1458509.06.2015
09.06.2020OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
2513 Linex forte
lyophilized viable
lactic acid bacterias
(Lactobacillus
acidophilus,
Bifidobacterium
animalis subsp.
lactis)
capsules
2x10^9,
in blister (14/2x7/,
28/4x7/),
in glass container (28)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser, Lek
Pharmaceuticals d.d.,
Kolodvorska cesta 27,
Menges, 1234,
Slovenia-bulk
manufacturer,
packager
Slovenia A07FA01 1460018.06.2015
18.06.2020OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
544
2514Liniment balsamic
(by Vishnevsky)birch tar, xeroform liniment
30mg/g+30mg/g, 30g
aluminium tube
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.
Russia D08AX 1305825.11.2013
25.11.2018OTC
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.,
Russia
2515 Linkus
adhadota vasica,
glycyrrhiza glabra,
piper longum, viola
odorata, hyssopus
officinalis, alpinia
galangal, cordial
latifolia, altaea
officinalis, zizyphus
jujube, onosma
bracteata
syrup sugar free
60mg/ml+ 7,5mg/ml+
10mg/ml+ 2,5mg/ml+
5mg/ml+5mg/ml+
10mg/ml+ 10mg/ml+
10mg/ml+10mg/ml,
90ml,120ml, 150ml glass
bottle
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900
Pakistan R05CA10 1322224.02.2014
24.02.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900,
Pakistan
2516 Linkus
adhadota vasica,
glycyrrhiza glabra,
piper longum, viola
odorata, hyssopus
officinalis, alpinia
galangal, cordial
latifolia, altaea
officinalis, zizyphus
jujube, onosma
bracteata
syrup
60mg/ml+ 7,5mg/ml+
10mg/ml+ 2,5mg/ml+
5mg/ml+5mg/ml+
10mg/ml+ 10mg/ml+
10mg/ml+10mg/ml,
90ml,120ml, 150ml glass
bottle
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900
Pakistan R05CA10 1322324.02.2014
24.02.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900,
Pakistan
2517 Linkus balsam
menthol, eucaliptus
oil, camphor,
turpentine oil,
clove oil
ointment
200mg+60mg+
70mg+20mg+ 40mg,
25g in plastic bottle
Herbion Pakistan Pvt.
Ltd., Plot 30, Sector
28,Korangi Industrial
Area,Karachi-74900
Pakistan R05CA10 1262921.06.2013
21.06.2018OTC
Herbion Pakistan Pvt.
Ltd., Plot 30, Sector
28,Korangi Industrial
Area,Karachi-74900,
Pakistan
2518 Linkus lozenges
adhadota vasica,
glycyrrhiza glabra,
piper longum, viola
odorata, hyssopus
officinalis, alpinia
galanga
lozenges with lemon-
honey flavour
30mg+7mg+6mg+2mg+3
mg+3mg,
in blister (16/2x8/)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900
Pakistan R05CA10 1321924.02.2014
24.02.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900,
Pakistan
545
2519 Linkus lozenges
adhadota vasica,
glycyrrhiza glabra,
piper longum, viola
odorata, hyssopus
officinalis, alpinia
galanga
lozenges with mint
flavour
30mg+7mg+6mg+2mg+3
mg+3mg,
in blister (16/2x8/)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900
Pakistan R05CA10 1322024.02.2014
24.02.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900,
Pakistan
2520 Linkus lozenges
adhadota
vasica,glycyrrhiza
glabra,piper
longum,viola
odorata,hyssopus
officinalis,alpinia
galanga
lozenges with orange
flavour
30mg+7mg+6mg+2mg+3
mg+3mg,
in blister (16/2x8/)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900
Pakistan R05CA10 1322124.02.2014
24.02.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial
Area,Karachi-74900,
Pakistan
2521Linkus ORVI
granules
salix alba, adhatoda
vasika, glycyrrhiza
glabra, viola
odorata, valeriana
officinalis,
foeniculum vulgare,
eucalyptus
globulus, thea
sinensis
granules
750mg+300mg+
550mg+100mg+
100mg+75mg+
35mg+125mg,
5,6g sachets (5, 10)
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900
Pakistan A02AD04 13315/108.07.2014
04.03.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900,
Pakistan
2522Linkus ORVI
granules
salix alba, adhatoda
vasika, glycyrrhiza
glabra, viola
odorata, valeriana
officinalis,
foeniculum vulgare,
eucalyptus
globulus, thea
sinensis
granules with lemon
flavour
750mg+300mg+
550mg+100mg+
100mg+75mg+
35mg+125mg, sachets
5,6g (5, 10)
Herbion Pakistan Pvt.
Ltd., Plot 30, Sector
28,Korangi Industrial
Area, Karachi-74900
Pakistan A02AD04 13316/108.07.2014
04.03.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900,
Pakistan
546
2523Linkus Plus
Expectorant
solanum
xanthocarpum,
adhatoda vasica,
glycyrrhiza glabra,
ocimum basilicum,
cordia latifolia,
piper longum,
althaea officinalis,
illicium verum
syrup
30mg+70mg+
15mg+30mg+
10mg+10mg+
15mg+50mg,
120ml glass bottle and
measuring cup
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900
PakistanR05CA10
herbal drug13730
24.07.2014
24.07.2019OTC
Herbion Pakistan Pvt.
Ltd., 30/28, Korangi
Industrial Area,
Karachi-74900,
Pakistan
2524 Lioton 1000 heparin sodium gel for external use
1000IU/g,
30g, 50g and100g
aluminium tube
A. Menarini
Manufacturing
Logistics and Services
S.r.l., Via Sette Santi,
3 50131 Firenze
Italy C05BA03 1606817.10.2016
17.10.2021OTC
A. Menarini Industrie
Farmaceutiche
Riunite S.r.l.
(Menarini Group),
Via Sette Santi, 3
50131 Firenze, Italy
2525 Lipertance
atorvastatin
(atorvastatin
calcium trihydrate),
perindopril
arginine,
amlodipine
(amlodipine
besilate)
tablets film-coated10mg+5mg+5mg, in
plastic container (30, 100)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C10BX 1582420.07.2016
20.07.2021PoM
Les Laboratoires
Servier, 50,rue
Carnot, 92284
Suresnes cedex,
France
2526 Lipertance
atorvastatin
(atorvastatin
calcium trihydrate),
perindopril
arginine,
amlodipine
(amlodipine
besilate)
tablets film-coated20mg+5mg+5mg, in
plastic container (30, 100)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C10BX 1582520.07.2016
20.07.2021PoM
Les Laboratoires
Servier, 50,rue
Carnot, 92284
Suresnes cedex,
France
547
2527 Lipertance
atorvastatin
(atorvastatin
calcium trihydrate),
perindopril
arginine,
amlodipine
(amlodipine
besilate)
tablets film-coated20mg+10mg+5mg, in
plastic container (30, 100)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C10BX 1582620.07.2016
20.07.2021PoM
Les Laboratoires
Servier, 50,rue
Carnot, 92284
Suresnes cedex,
France
2528 Lipertance
atorvastatin
(atorvastatin
calcium trihydrate),
perindopril
arginine,
amlodipine
(amlodipine
besilate)
tablets film-coated
20mg+10mg+ 10mg,
in plastic container (30,
100)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C10BX 1582720.07.2016
20.07.2021PoM
Les Laboratoires
Servier, 50,rue
Carnot, 92284
Suresnes cedex,
France
2529 Lipertance
atorvastatin
(atorvastatin
calcium trihydrate),
perindopril
arginine,
amlodipine
(amlodipine
besilate)
tablets film-coated
40mg+10mg+ 10mg,
in plastic container (30,
100)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C10BX 1582820.07.2016
20.07.2021PoM
Les Laboratoires
Servier, 50,rue
Carnot, 92284
Suresnes cedex,
France
2530 Liprazid 10
lisinopril (lisinopril
dihydrate),
hydrochlorothiazid
e
tablets10mg+12,5mg,
in blister (30/3x10/)
SIC "Borshchahivskiy
Chemical-
Pharmaceutical Plant"
PJSC, 17, Mira St,
Kyiv, 03134
Ukraine C09BA03 1648909.03.2017
09.03.2022PoM
SIC "Borshchahivskiy
Chemical-
Pharmaceutical
Plant" PJSC, 17, Mira
St, Kyiv, 03134,
Ukraine
548
2531 Liprazid 20
lisinopril (lisinopril
dihydrate),
hydrochlorothiazid
e
tablets20mg+12,5mg,
in blister (30/3x10/)
SIC "Borshchahivskiy
Chemical-
Pharmaceutical Plant"
PJSC, 17, Mira St,
Kyiv, 03134
Ukraine C09BA03 1648809.03.2017
09.03.2022PoM
SIC "Borshchahivskiy
Chemical-
Pharmaceutical
Plant" PJSC, 17, Mira
St, Kyiv, 03134,
Ukraine
2532 Liprimar atorvastatin tablets film-coated10mg,
blisters (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mosswaldalee 1,
79090 Frieburg -
packager (dosage form
manufacturer - Pfizer
Pharmaceuticals
LLC,Km 1.9,Road 689
Vega Baja,PR 00693
Puerto Rico, USA)
Germany C10AA05 12253/111.08.2016
07.03.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
2533 Liprimar atorvastatin tablets film-coated20mg,
blisters (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mosswaldalee 1,
79090 Frieburg -
packager (dosage form
manufacturer - Pfizer
Pharmaceuticals
LLC,Km 1.9,Road 689
Vega Baja,PR 00693
Puerto Rico, USA)
Germany C10AA05 12254/111.08.2016
07.03.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
549
2534 Liprimar atorvastatin tablets film-coated40mg,
blisters (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mosswaldalee 1,
79090 Frieburg -
packager (dosage form
manufacturer - Pfizer
Pharmaceuticals
LLC,Km 1.9,Road 689
Vega Baja,PR 00693
Puerto Rico, USA)
Germany C10AA05 12255/111.08.2016
07.03.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street, New
York 10017, USA
2535 Liprimar atorvastatin tablets film-coated80mg,
blisters (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mosswaldalee 1,
79090 Frieburg -
packager (dosage form
manufacturer - Pfizer
Pharmaceuticals
LLC,Km 1.9,Road 689
Vega Baja,PR 00693
Puerto Rico, USA)
Germany C10AA05 12256/111.08.2016
07.03.2018PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd street,
New York 10017,
USA
2536 Lirra pregabalin capsules75mg,
in blister (30/3x10/)
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208
Bangladesh N03AX16 1367208.07.2014
08.07.2019PoM
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208,
Bangladesh
2537 Lisinocorlisinopril (lisinopril
dihydrate)tablets coated
5mg,
in blister (20/2x10/)
GM Pharmaceuticals
Ltd, Phonichala 65,
0165 Tbilisi
Georgia C09AA03 1659610.04.2017
10.04.2022PoM
GM Pharmaceuticals
Ltd, Phonichala 65,
0165 Tbilisi, Georgia
550
2538 Lisinocorlisinopril (lisinopril
dihydrate)tablets coated
10mg,
in blister (20/2x10/)
GM Pharmaceuticals
Ltd, Phonichala 65,
0165 Tbilisi
Georgia C09AA03 1659710.04.2017
10.04.2022PoM
GM Pharmaceuticals
Ltd, Phonichala 65,
0165 Tbilisi, Georgia
2539 Lisinoprillisinopril (lisinopril
dihydrate)tablets
10mg,
in blister (24/1x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC09AA03 13436
14.04.2014
14.04.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2540 Lisinoprillisinopril (lisinopril
dihydrate)tablets
5mg,
in blister (24/1x24/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC09AA03 14869
24.09.2015
24.09.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2541 Lisinopril lisinopril tablets5mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus C09AA03 1633430.12.2016
30.12.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
2542 Lisinopril lisinopril tablets10mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus C09AA03 1633530.12.2016
30.12.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
551
2543 Liv-52
capparis spinosa,
cichorium intybus,
ferric oxide,
solanum nigrum,
terminalia arjuna,
cassia occidentalis,
achillea
millefolium,
tamarix gallica
tablets
65mg+65mg+
33mg+32mg+
32mg+16mg+
16mg+16mg,
in plastic container (100)
Himalaya Drug
Company, N11,
Makali Grama
Dasanapura Hobli,
Nelamangala Taluk,
Bangalore 562 123
India A05C 1261821.06.2013
21.06.2018PoM
Himalaya Drug
Company, N11,
Makali Grama
Dasanapura Hobli,
Nelamangala Taluk,
Bangalore 562 123,
India
2544 Livarole ketoconazole suppositories vaginal400mg,
(5/1x5/, 10/2x5/)
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia G01AF11 1538126.02.2016
26.02.2021PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2545 Lizinoprillisinopril (lisinopril
dihydrate)tablets
5mg,
in blister (20/2x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C09АA03 1335604.04.2014
04.04.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
2546 Lizinoprillisinopril (lisinopril
dihydrate)tablets
10mg,
in blister (20/2x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C09АA03 1335704.04.2014
04.04.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
2547 Lizinoprillisinopril (lisinopril
dihydrate)tablets
20mg,
in blister (20/2x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia C09АA03 1335804.04.2014
04.04.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
2548 L-lysine aescinat l-lysine aescinate solution for injection
1mg/ml,
5ml ampoules, in blister
(10/2x5/)
Halychpharm JSC,
79024, city of Lviv, st.
Opryshkovskaya, 6/8
Ukraine C05CX 1373224.07.2014
24.07.2019PoM
Halychpharm JSC,
79024, city of Lviv, st.
Opryshkovskaya, 6/8,
Ukraine
552
2549 Locoid
hydrocortisone
(hydrocortisone 17-
butyrate)
ointment for topical
use
1mg/g,
30g aluminium tube
Temmler Italia S.r.L.,
Via delle Industrie 2,
20061 Carugate (MI)
Italy D07AB02 14333/108.06.2017
25.03.2020OTC
LEO Pharma A/S,
Industriparken 55,
DK-2750 Ballerup,
Denmark
2550 Locoid
hydrocortisone
(hydrocortisone 17-
butyrate)
cream for topical use1mg/g,
30g aluminium tube
Temmler Italia S.r.L.,
Via delle Industrie 2,
20061 Carugate (MI)
Italy D07AB02 14341/108.06.2017
25.03.2020OTC
LEO Pharma A/S,
Industriparken 55,
DK-2750 Ballerup,
Denmark
2551 Locoid Crelo
hydrocortisone
(hydrocortisone 17-
butyrate)
emulsion cutaneous
1mg/g,
30g plastic vial with
dropper
Temmler Italia S.r.L.,
Via delle Industrie 2,
20061 Carugate (MI)
Italy D07AB02 1446304.05.2015
04.05.2020OTC
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
2552 Locoid Lipocream
hydrocortisone
(hydrocortisone 17-
butyrate)
cream for topical use1mg/g,
30g aluminium tube
Temmler Italia S.r.L.,
Via delle Industrie 2,
20061 Carugate (MI)
Italy D07AB02 14340/108.06.2017
25.03.2020OTC
LEO Pharma A/S,
Industriparken 55,
DK-2750 Ballerup,
Denmark
2553 Lodigrel
clopidogrel
(clopidogrel
hydrosulfate)
tablets film-coated
75mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary B01AC04 13661/120.02.2015
08.07.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2554 Lodoz
bisoprolol
(bisoprolol
fumarate),
hydrochlorothia-
zide
tablets film-coated5mg+6,25mg,
in blister (30/3x10/)
Merck KGaA,
Frankfurter Strasse
250, 64 293
Darmstadt
Germany C07BB07 1445004.05.2015
04.05.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
2555 Lodoz
bisoprolol
(bisoprolol
fumarate),
hydrochlorothia-
zide
tablets film-coated2,5mg+6,25mg,
in blister (30/3x10/)
Merck KGaA,
Frankfurter Strasse
250, 64 293
Darmstadt
Germany C07BB07 1445104.05.2015
04.05.2020PoM
Merck Sante s.a.s., 37
rue Saint Romain -
69379 Lyon Cedex
08, France
553
2556 Lomexin
fenticonazole
(fenticonazole
nitrate)
capsules vaginal200mg,
in blister (6)
Catalent Italy S.p.A.,
Via Nettunense km.
20,100, Aprilia, 04011
Italy G01AF12 1469002.07.2015
02.07.2020PoM
Recordati Ireland
Ltd., Raheens East,
Ringaskiddy, Co
Cork, Ireland
2557 Lomexin
fenticonazole
(fenticonazole
nitrate)
capsules vaginal600mg,
in blister (1, 2)
Catalent Italy S.p.A.,
Via Nettunense km.
20,100, Aprilia, 04011
Italy G01AF12 1469102.07.2015
02.07.2020PoM
Recordati Ireland
Ltd., Raheens East,
Ringaskiddy, Co
Cork, Ireland
2558 Lomexin
fenticonazole
(fenticonazole
nitrate)
capsules vaginal1000mg,
in blister (1, 2)
Catalent Italy S.p.A.,
Via Nettunense km.
20,100, Aprilia, 04011
Italy G01AF12 1469202.07.2015
02.07.2020PoM
Recordati Ireland
Ltd., Raheens East,
Ringaskiddy, Co
Cork, Ireland
2559 Lomexin
fenticonazole
(fenticonazole
nitrate)
cream for vaginal
and external use
20mg/g; 30g aluminium
tube, 78g aluminium tube
and dispenser
Recordati Industria
Chimica e
Farmaceutica S.p.A.,
Via Civitali, 1-20148
Milano
Italy
G01AC12,
D01AF12;
new
indication
14858/118.09.2015
18.09.2020PoM
Recordati Ireland
Ltd., Raheens East,
Ringaskiddy, Co
Cork, Ireland
2560 Lomilan loratadine tablets10mg,
in blister (10/1x10/)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana
Slovenia R06AX13 1676809.06.2017
09.06.2022OTC
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
2561 Loperamide loperamide capsules
2mg,
in blister (10/1x10/,
20/2x10/)
Biocom JSC (54
Chapaevsky Cr.,
Stavropol, 355016)
Russia A07DA03 1298728.10.2013
28.10.2018OTC
Biocom JSC (54
Chapaevsky Cr.,
Stavropol, 355016,
Russia)
2562 Loperamide
loperamide
(loperamide
hydrochloride)
capsules2mg,
in blister (10/1x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA07DA03 13865
18.09.2014
18.09.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
554
2563Loperamide
Grindeks
loperamide
(loperamide
hydrochloride)
capsules2mg,
in blister (10/1x10/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia A07DA03 1640710.02.2017
10.02.2022OTC
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2564Loperamide
hydrochloride
loperamide
(loperamide
hydrochloride)
capsules
2mg,
in blister (10/1x10/,
20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A07DA03 13854/116.05.2016
18.09.2019OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2565Loperamide-
Zdorovye
loperamide
(loperamide
hydrochloride)
tablets
2mg,
in blister (10/1x10/,
20/2x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine A07DA03 1675205.06.2017
05.06.2022OTC
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
2566 Lopirel
clopidogrel
(clopidogrel
bisulfate)
tablets film-coated
75mg,
in blister (14/2x7/,
28/4x7/, 90/9x10/)
Actavis Ltd., BLB 015,
BLB 016, Bulebel
Industrial Estate,
Zejtun, ZTN 3000
Malta B01AC04 1696405.09.2017
05.09.2022PoM
"Actavis Group PTC
ehf",
Reykjavikurvegur 76-
78, IS-220
Hafnarfjordur,
Iceland
2567 Lopraxer
citalopram
(citalopram
hydrochloride)
drops oral (solution)40mg/ml; 15ml glass
bottle
Help S.A., Pedini
Ioanninon, Ioannina,
45500
Greece N06AB04 1704928.09.2017
28.09.2022PoM
Help S.A., 10
Valaoritou str., GR
14452
Metamorphosis,
Attica, Greece
2568L-Optic
Rompharmlevofloxacin drops eye
5mg/ml,
5ml bottle-dropper
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01AE05 1432925.03.2015
25.03.2020PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
555
2569 Loranex desloratadine solution oral
0,5mg/ml,
150ml glass vial and
measuring device
Laboratorios Basi-
Industria
Farmaceutica, S.A.,
Parque Industrial
Manuel Lourenco
Ferreira, lote 15, 3450-
232 Mortagua
Portugal R06AX27 1663225.04.2017
25.04.2022OTC
GM Pharmaceuticals
Ltd, 65,Phonichala
str., Tbilisi, Georgia
2570 Loratadine loratadine tablets10mg,
in blister (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaR06AX13 12848
17.09.2013
17.09.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2571 Loratadine loratadine tablets10mg,
in blister (10/1x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64a No4,
ul. Chapaeva, Borisov,
Minsk region
Belarus R06AX13 1662825.04.2017
25.04.2022OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
2572 Loratadine STADA loratadine tablets10mg,
in blister (10/1x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse
Russia R06AX13 1591323.08.2016
23.08.2021OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2573Loratadine-
Zdorovyeloratadine tablets
10mg,
in blister (10/1x10/,
20/2x10/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine R06AX13 1643006.03.2017
06.03.2022OTC
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
556
2574 Lorazepam lorazepam tablets2mg,
in blister (24)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05BA06 12717
23.07.2013
23.07.2018PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
2575 Lorazepam lorazepam tablets1mg,
in blister (24)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05BA06 12724
23.07.2013
23.07.2018PoM/UC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
2576 Lordestin
desloratadine
(desloratadine
hemisulfate)
tablets film-coated
5mg,
in blister (10/1x10/,
30/3x10/)
Gedeon Richter-RUS
JSC, Lesnaya st. 40,
Shuvoye, Moscow
region, Yegoriyevsky
district, 140342
Russia R06AX27 1671823.05.2017
23.05.2022OTC
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2577 Lorinden A
flumetasone
(flumetasone
pivalate), salicylic
acid
ointment for
external use
0,2mg/g+30mg/g, 15g
aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07XB01 1627319.12.2016
19.12.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2578 Lorinden C
flumetasone
(flumetasone
pivalate), clioquinol
ointment for
external use
0,2mg/g+30mg/g, 15g
aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07BB01 1599115.09.2016
15.09.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2579 Loristalosartan (losartan
potassium)tablets film-coated
25mg,
in blister (28/2x14/,
28/4x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09DA01 1393529.10.2014
29.10.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
557
2580 Loristalosartan (losartan
potassium)tablets film-coated
50mg,
in blister (28/2x14/,
28/4x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09DA01 1393629.10.2014
29.10.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2581 Loristalosartan (losartan
potassium)tablets film-coated
100mg; (28/2x14/) in
blister
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09CA01 1694205.09.2017
05.09.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
2582 Lorista H
losartan (losartan
potassium),
hydrochloro-
thiazide
tablets film-coated
50mg+12,5mg,
in blister (28/2x14/,
28/4x7/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09DA01 1393429.10.2014
29.10.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2583 Lorista H 100
losartan (losartan
potassium),
hydrochlorothia-
zide
tablets film-coated100mg+12,5mg,
in blister (28/2x14/)
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto)
Slovenia C09DA01 1291807.10.2013
07.10.2018PoM
KRKA d.d., Novo
mesto (Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia)
2584 Lorista HD
losartan (losartan
potassium),
hydrochlorothia-
zide
tablets film-coated100mg+25mg,
in blister (28/2x14/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09DA01 14781/119.05.2016
03.08.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2585 Lortenza
amlodipine
(amlodipine
besilate), losartan
(losartan potassium)
tablets film-coated5mg+50mg,
in blister (30/3x10/)
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500
Russia C09DB06 1590623.08.2016
23.08.2021PoM
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500, Russia
2586 Lortenza
amlodipine
(amlodipine
besilate), losartan
(losartan potassium)
tablets film-coated10mg+50mg,
in blister (30/3x10/)
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500
Russia C09DB06 1590723.08.2016
23.08.2021PoM
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500, Russia
558
2587 Lortenza
amlodipine
(amlodipine
besilate), losartan
(losartan potassium)
tablets film-coated5mg+100mg,
in blister (30/3x10/)
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500
Russia C09DB06 1590823.08.2016
23.08.2021PoM
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500, Russia
2588 Lortenza
amlodipine
(amlodipine
besilate), losartan
(losartan potassium)
tablets film-coated10mg+100mg,
in blister (30/3x10/)
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500
Russia C09DB06 1590923.08.2016
23.08.2021PoM
Krka-RUS LLC, 50
Moskovskaya str.,
Istra, Moscow region
143500, Russia
2589 Losar-Denk 100losartan (losartan
potassium)tablets film-coated
100mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09CA01 1613910.11.2016
10.11.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2590 Losar-Denk 25losartan (losartan
potassium)tablets film-coated
25mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09CA01 1320110.01.2014
10.01.2019PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2591 Losar-Denk 50losartan (losartan
potassium)tablets film-coated
50mg,
in blister (28/2x14/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany C09CA01 1614010.11.2016
10.11.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2592 Losartanlosartan (losartan
potassium)tablets coated
50mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus C09CA01 1385618.09.2014
18.09.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
559
2593 Lotarlosartan (losartan
potassium)tablets film-coated
50mg,
in blister (30/3x10/)
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce - batch
releaser (dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia)
Slovenia C09DA01 1242529.04.2013
29.04.2018PoM
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
2594 Lotarlosartan (losartan
potassium)tablets film-coated
100mg,
in blister (30/2x15/)
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce - batch
releaser (dosage form
manufacturer,
packager - Alkaloid
AD-Skopje, bul.
Aleksandar
Makedonski 12, 1000,
Skopje, Macedonia)
Slovenia C09DA01 1242629.04.2013
29.04.2018PoM
Alkaloid-INT d.o.o.,
Slandrova ulica 4,
1231 Ljubljana-
Crnuce, Slovenia
2595 Lotarlosartan (losartan
potassium)tablets film-coated
100mg,
in blister (30/2x15/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia C09CA01 1722508.12.2017
08.12.2022PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
2596 Lotarlosartan (losartan
potassium)tablets film-coated
50mg,
in blister (30/3x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia C09CA01 1722608.12.2017
08.12.2022PoM
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
560
2597 Lotosonic
Rhizmata
Dioscoreae, Semina
Nelumbinis,
Plumula
Nelumbinis, Semina
Biotae, Semina
Ziziphi jujubae,
Folia mori, Folia
Erythrinae, Fructus
Euphoria longanae
tablets coated
183mg+175mg+
15mg+91,25mg+
91,25mg+ 91,25mg+
91,25mg+ 91,25mg,
in blister
(10, 20/2x10/)
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Thanh Khe
Dist., Da Nang city
VietnamN05CM
herbal drug12758
14.08.2013
14.08.2018OTC
Danapha
Pharmaceutical JSC,
253 Dung Si Thanh
Khe str., Thanh Khe
Dist., Da Nang city,
Vietnam
2598 Lozaplosartan (losartan
potassium)tablets film-coated
50mg,
in blister (30/3x10/)
Saneca
Pharmaceuticals. a.s.,
Nitrianska 100, 920 27
Hlohovec
Slovak Republic C09CA01 1683910.07.2017
10.07.2022PoM
Zentiva a.s.,
Einsteinova 24, 851
01 Bratislava, Slovak
Republic
2599 Lozaplosartan (losartan
potassium)tablets film-coated
100mg,
in blister (30/3x10/)
Saneca
Pharmaceuticals. a.s.,
Nitrianska 100, 920 27
Hlohovec
Slovak Republic C09CA01 1684010.07.2017
10.07.2022PoM
Zentiva a.s.,
Einsteinova 24, 851
01 Bratislava, Slovak
Republic
2600 Lozap Plus
losartan (losartan
potassium),
hydrochlorothia-
zide
tablets film-coated50mg+12,5mg,
in blister (30/3x10/)
Zentiva, k.s., U
kabelovny 130, 102 37
Praha 10, Dolni
Mecholupy
Czech Republic C09DA01 1243307.05.2013
07.05.2018PoM
Zentiva, k.s., U
kabelovny 130, 102
37 Praha 10, Dolni
Mecholupy, Czech
Republic
2601L-Thyroxin 100
Berlin-Chemie
levothyroxine
sodiumtablets
100mcg,
in blisters (50/2x25/,
100/4x25/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany H03AA01 15391/106.04.2016
26.02.2021PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
561
2602L-Thyroxin 125
Berlin-Chemie
levothyroxine
sodiumtablets
125mcg,
in blister (50/2x25/) and
(100/4x25/)
Berlin-Chemie A.G.,
Glienicker Weg 125 D-
12489 Berlin
Germany H03AA01 1719808.12.2017
08.12.2022PoM
Berlin-Chemie A.G.,
Glienicker Weg 125
D-12489 Berlin,
Germany
2603L-Thyroxin 150
Berlin-Chemie
levothyroxine
sodiumtablets
150mcg,
in blister (50/2x25,
100/4x25/)
Berlin-Chemie A.G.,
Glienicker Weg 125 D-
12489 Berlin
Germany H03AA01 1719708.12.2017
08.12.2022PoM
Berlin-Chemie A.G.,
Glienicker Weg 125
D-12489 Berlin,
Germany
2604L-Thyroxin 50
Berlin-Chemie
levothyroxine
(levothyroxine
sodium)
tablets
50mcg,
in blister (25/1x25/,
50/2x25/, 100/4x25/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, packager
(dosage form
manufacturer - Berlin-
Chemie AG,
Tempelhofer Weg 83,
12347 Berlin,
Germany)
Germany H03AA01 1340009.04.2014
09.04.2019PoM
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
2605L-Thyroxin 75
Berlin-Chemie
levothyroxine
sodiumtablets
75mcg,
in blister (50/2x25/) and
(100/4x25/)
Berlin-Chemie A.G.,
Glienicker Weg 125 D-
12489 Berlin
Germany H03AA01 1719908.12.2017
08.12.2022PoM
Berlin-Chemie A.G.,
Glienicker Weg 125
D-12489 Berlin,
Germany
2606 Lucentis ranibizumab solution for injection
10mg/ml,
0.23ml glass vial (1),
syringe (1) and needle (2)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland S01LA04 1659003.04.2017
03.04.2022PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
2607 Lucetam piracetam film-coated tablets800mg,
glass container (30)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas kiraly st. 65
Hungary N06BX03 12563/225.04.2017
06.06.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
562
2608 Lucetam piracetam film tablets coated1200mg,
glass container (20)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas kiraly st. 65
Hungary N06BX03 12564/225.04.2017
06.06.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2609 Lucetam piracetam solution for injection
200mg/ml,
15ml ampoules,
in blister, (4/1x4/,
20/5x4/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N06BX03 1723508.12.2017
08.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2610 Lucetam piracetam solution for injection
200mg/ml,
5ml ampoules, in blister
(10/2x5/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary N06BX03 1723608.12.2017
08.12.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2611 Lydasa-Biopharma hyaluronidasepowder for solution
for injection
64IU,
glass vial, in blister
(10/2x5/)
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region
Ukraine B06AA03 1680922.06.2017
22.06.2022PoM
"BIOFARMA" "PP"
LLC, 37, Kyivska Str.,
Bila Tserkva, 09100,
Kyiv region, Ukraine
2612 Lyrica pregabalin capsules hard
75mg,
in blister (14/1x14/,
56/4x14/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany N03AX16 1463203.07.2015
03.07.2020PoM/UC
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
2613 Lyrica pregabalin capsules hard
150mg,
in blister (14/1x14/,
56/4x14/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany N03AX16 1463303.07.2015
03.07.2020PoM/UC
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
563
2614 Lyrica pregabalin capsules hard300mg,
in blister (14, 56/4x14/)
Pfizer Manufacturing
Deutschland GmbH,
Betriebsstatte
Freiburg,
Mooswaldallee 1,
79090 Frieburg
Germany N03AX16 1463403.07.2015
03.07.2020PoM/UC
Pfizer H.C.P.
Corporation, 235,
East 42nd street New
York 10017, USA
2615 Lysobact
lysozyme (lysozyme
hydrochloride),
pyridoxine
(pyridoxine
hydrochloride)
lozenges compressed
20mg+10mg,
in blister (10/1x10/,
30/3x10/)
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo
Bosnia And
HerzegovinaA01AD11 17078
05.10.2017
05.10.2022OTC
Bosnalijek d.d.,
Jukiceva 53, 71000
Sarajevo, Bosnia And
Herzegovina
2616 Maalox
aluminium
hydroxide,
magnesium
hydroxide
suspension oral35mg/ml+40mg/ml,
250ml glass bottle
Sanofi-Aventis S.p.a.,
Viale Europa 11,
21040 Origgio (VA)
Italy A02AX 1524830.12.2015
30.12.2020OTC
Sanofi-Aventis
France, 1-13
boulevard Romain
Rolland, 75014 Paris,
France
2617 Maalox
aluminium
hydroxide,
magnesium
hydroxide
suspension oral
525mg/15ml+
600mg/15ml,
15ml sachets (30)
Pharmatis, Zone
dactivites Est No.1,
BP 60190 Estress Saint
Denis
France A02AX 1539526.02.2016
26.02.2021OTC
Sanofi-Aventis
France, 1-13
boulevard Romain
Rolland, 75014 Paris,
France
2618 Maalox
aluminium
hydroxide,
magnesium
hydroxide
tablets chewable400mg+400mg,
in blister (40/4x10/)
Sanofi-Aventis S.p.A.,
Strada Statale N17-
km22, 67019 Scoppito
Italy A02AX 1554712.04.2016
12.04.2021OTC
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
564
2619 MabThera rituximabconcentrate for
solution for infusion
100mg/10ml,
10ml glass vials (2)
F. Hoffmann-La
Roche Ltd.
Wurmisweg CH-4303
Kaiseraugst-batch
releaser, secondary
packager, Roche
Diagnostics GmbH,
Sandhofer Strasse 116,
D-68305 Mannheim,
Germany-bulk
manufacturer,
primary packager
Switzerland L01XC02 1407516.12.2014
16.12.2019PoM
F. Hoffmann La
Roche Ltd.,
Grenzacherstrasse 124
Basel, CH-4070,
Switzerland
2620 Macmiror nifuratel tablets coated200mg,
in blister (20/2x10/)
Doppel Farmaceutici
S.R.L., Via Volturno,
48-Quinto de` Stampi-
20089 Rozzano Milan
(MI)
Italy G01AX05 1524630.12.2015
30.12.2020PoM
Polichem S.r.l., Via
Giuseppe Marcora, 11-
20121 Milan (MI),
Italy
2621 Macmiror complex nifuratel, nystatine cream vaginal
10g/100g+
4000000IU/100g, 30g
aluminium tube and
dosing syringe applicator
Doppel Farmaceutici
S.R.L., Via Martiri
delle Foibe, 1-29016
Cortemaggiore (PC)
Italy G01AX05 1524430.12.2015
30.12.2020PoM
Polichem S.r.l., Via
Giuseppe Marcora, 11-
20121 Milan (MI),
Italy
2622 Macmiror complex nifuratel, nystatin suppositories vaginal500mg+200000IU,
in blister (8/1x8/)
Doppel Farmaceutici
S.R.L., Via Volturno,
48-Quinto de` Stampi-
20089 Rozzano Milan
(MI)
Italy G01AX05 1524530.12.2015
30.12.2020PoM
Polichem S.r.l., Via
Giuseppe Marcora, 11-
20121 Milan (MI),
Italy
565
2623 Macrolan-200tylosin (tylosin
tartrate)solution for injection
200mg/ml,
100ml glass bottle
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray-
secondary packager,
Interchemie werken
De Adelaar Eesti AS,
Vanapere tee 14,
Viimsi, Harju county,
Estonia- bulk
manufacturer,
primary packager,
batch releaser
the Netherlands
QJ01FA90;
veterinary
drug
1419906.02.2015
06.02.2020PoM
Interchemie werken
De Adelaar B.V.,
Metaalweg 8, 5804
CG Venray, the
Netherlands
2624 Macropen midecamycin tablets film-coated400mg,
in blister (16/2x8/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
Merck KGaA & Co.,
Werk Spittal,
Hosslgasse 20, 9800
Spittal an der Drau,
Austria- bulk
manufacturer,
packager
Slovenia J01FA03 1720608.12.2017
08.12.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2625 Macropen
midecamycin
(midecamycin
acetate)
granules for oral
suspension
175mg/5ml,
115ml glass bottle and
measuring spoon
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto - batch
releaser, KRKA d.d.,
Novo mesto, Ulica
Rada Pusenjaka 10,
Ljutomer, 9240,
Slovenia-bulk
manufacturer,
packager
Slovenia J01FA03 1689408.08.2017
08.08.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
566
2626 Madopar
levodopa,
benserazide
(benserazide
hydrochloride)
capsules hard100mg+25mg,
in glass bottle (100)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel-
batch releaser (Roche
S.p.A., Via Morelli 2,
Segrate, 20090, Milan,
Italy-bulk
manufacturer) (F.
Hoffmann-La Roche
Ltd., Wurmisweg, CH-
4303, Kaiseraugst,
Switzerland-primary
and secondary
packager)
Switzerland N04BA02 1478814.08.2015
14.08.2020PoM
F. Hoffmann-La
Roche Ltd.,
Greenzacherstrasse,
124, CH-4070, Basel,
Switzerland
2627 Madopar
levodopa,
benserazide
(benserazide
hydrochloride)
tablets200mg+50mg,
in glass bottle (100)
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel-
batch releaser, Roche
S.p.A., Via Morelli 2,
Segrate, 20090, Milan,
Italy- bulk
manufacturer, F.
Hoffmann-La Roche
Ltd., Wurmisweg, CH-
4303, Kaiseraugst,
Switzerland-packager
Switzerland N04BA02 1517617.12.2015
17.12.2020PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse,
124, CH-4070, Basel,
Switzerland
2628 Magne B6
magnesium lactate
dihydrate,
pyridoxine
hydrochloride
tablets coated 470mg+5mg,
in blister (50/5x10/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary A12 1690608.08.2017
08.08.2022OTC
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5, Hungary
567
2629 Magne-B6
magnesium lactate
dihydrate,
pyridoxine
hydrochloride
tablets coated470mg+5mg,
in blister (50/5x10/)
Sanofi Winthrop
Industrie, 6,
Boulevard de l Europe
21800 Quetigny
France A12 1478430.07.2015
30.07.2020OTC
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014 Paris,
France
2630 Magnefar B6
magnesium
hydroaspartate(mag
nesium
hydroasparaginate
tetrahydrate),
pyridoxine
(pyridoxine
hydrochloride)
tablets500mg+5mg,
in blister (60/6x10/)
Biofarm Sp. z o.o., 13,
Walbrzyska Str., 60-
198, Poznan
Poland A12CC05 1549405.04.2016
05.04.2021OTC
Biofarm Sp. z o.o., 13,
Walbrzyska Str., 60-
198, Poznan, Poland
2631 Magnelis B6
magnesium
(magnesium
lactate), pyridoxine
(pyridoxine
hydrochloride)
tablets coated
48mg+5mg,
in plastic container (90),
in blister (50/5x10/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A12C 15199/102.05.2016
30.12.2020OTC
Otcpharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2632 Magnerot
magnesium orotate
(magnesium orotate
dihydrate)
tablets
500mg,
in blister (20/2x10/,
50/5x10/)
Mauermann
Arzneimittel KG,
Heinrich-Knote str. 2,
82343 Pocking,
Bavaria
Germany A12CC09 1257406.06.2013
06.06.2018OTC
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
2633 Magnesium sulfate magnesium sulfate solution for injection250mg/ml,
5ml ampoules (10)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk region
Belarus B05XA05 1419706.02.2015
06.02.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222120, Minsk
region, Belarus
568
2634 Magnesium sulfate magnesium sulfate solution for injection250mg/ml,
5ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaB05XA05 17048
25.09.2017
25.09.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
2635Magnesium sulfate-
Darnitsamagnesium sulfate solution for injection
250mg/ml,
5ml ampoules,
in blister (10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine B05XA05 1245407.05.2013
07.05.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
2636Magnesium sulfate-
Darnitsamagnesium sulfate solution for injection
250mg/ml,
10ml ampoules,
in blister (10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya Str.,13
Ukraine B05XA05 1245507.05.2013
07.05.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borisopolskaya
Str.,13, Ukraine
2637Magnesium
sulphatemagnesium sulfate
powder for oral
solution
25g,
25g sachets
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaA06AD04 13947
29.10.2014
29.10.2019OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
2638 Magnetolux
gadopentetic acid
(gadopentetate
dimeglumine)
solution for injection
469mg/ml
(500micromol/ml), 20ml
glass vial (1)
Sanochemia
Pharmazeutika AG,
Landeggerstrasse 7, A-
2491 Neufeld/Leitha-
batch releaser, bulk
manufacturer,
primary packager,
Sanochemia
Pharmazeutika AG,
Landeggerstrasse 33,
A-2491
Neufeld/Leitha,
Austria-secondary
packager
Austria V08CA01 1426520.02.2015
20.02.2020PoM
Sanochemia
Pharmazeutika AG,
Boltzmanngasse 9-11,
A-1090 Vienna,
Austria
569
2639 Magnevist
gadopentetic acid
(gadopentetate
dimeglumine)
solution for injection469mg/ml,
20ml glass vials (10)
Bayer Schering
Pharma AG, D-13342
Berlin
Germany V08CA01 1248023.07.2013
23.07.2018PoM
Bayer Vital GmbH,
51368 Leverkusen,
Germany
2640 Manni-Tech 10% mannitol solution for infusion
100mg/ml,
200ml, 250ml, 400ml and
500ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaB05BC01 15897
23.08.2016
23.08.2021PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
2641 Mannitol mannitol solution for infusion100mg/ml,
500ml plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaB05BC01 13437
14.04.2014
14.04.2019PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2642 Maraslavin
artemisia pontica,
satureja hortensis,
syzygium
aromaticum, piper
nigrum, zingiber
officinale
solution for local use
41,96mg/ml+ 7,28mg/ml+
36,46mg/ml+
11,99mg/ml+
41,96mg/ml,
100ml glass bottle
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia-batch
releaser, Sopharma
JSC, Vrabevo vlg.
5660, district of
Lovetch, Bulgaria-
bulk manufacturer,
primary and
secondary packager
BulgariaA01AD11;
herbal drug15034
02.12.2015
02.12.2020OTC
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2643 Marion
ceftriaxone
(ceftriaxone
sodium)
powder and solvent
for solution for i/m
injection
1000mg,
glass vial (1) and 3.5ml
solvent in ampoule
Anfarm Hellas S.A.,
61st Km National
Road Athens-Lamia,
Sximatari Viotias,
32009
Greece J01DD04 1606217.10.2016
17.10.2021PoM
J&P Pharma UK Ltd,
Ashcombe House, 5
The Crescent,
Leatherhead, Surrey,
KT22 8DY, UK
2644 Marion
ceftriaxone
(ceftriaxone
sodium)
powder for solution
for injection/infusion
1000mg,
glass vial (1)
Anfarm Hellas S.A.,
61st Km National
Road Athens-Lamia,
Sximatari Viotias,
32009
Greece J01DD04 1606317.10.2016
17.10.2021PoM
J&P Pharma UK Ltd,
Ashcombe House, 5
The Crescent,
Leatherhead, Surrey,
KT22 8DY, UK
570
2645 Mastilex
cephalexin
(cephalexin
monohydrate),
gentamicin
(gentamicin sulfate)
suspension oily
350mg/10ml+
35mg/10ml,
10ml syringes
(4, 24)
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19
Spain
QJ1RD01
veterinary
drug
1257706.06.2013
06.06.2018PoM
Invesa Industrial
Veterinaria, S.A.,
08950 Esplugues de
Llobregat, Barcelona,
Esmeralda 19, Spain
2646 Mastodynon
agnus castus,
caulophyllum
thalictroides D4,
cyclamen D4,
ignatia D6, iris D2,
lilium tigrinum D3
tablets
162mg+81mg+
81mg+81mg+
162mg+81mg,
in blister (60/3x20/)
Bionorica SE,
Kerschensteinerstr. 11-
15, 92318 Neumarkt
Germany
G02CX;
homeopathic
drug
1540509.03.2016
09.03.2021PoM
Bionorica SE,
Kerschensteinerstr.
11-15, 92318
Neumarkt, Germany
2647 Mastomycin
gentamicin
(gentamicin
sulfate),
clindamycin
(clindamycin
phosphate),
lidocaine (lidocaine
hydrochloride)
gel
15mg/ml+20mg/ml+50mg
/ml,
10ml pre-filled syringes
(20)
Nita-Farm LLC,
410010, Saratov,
Osipova st.1
Russia
QN01BB52;
veterinary
drug
12401/106.02.2015
19.04.2018PoM
Nita-Farm LLC,
410010, Saratov,
Osipova st.1, Russia
2648 Mataren Plus
meloxicam, peper
siliculose fruits
tincture
cream
(30mg/g+100mg/g)
15g aluminum or plastic
tube
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia M02AX 13589/107.07.2017
10.06.2019PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2649Matever 250mg
film-coated tabletslevetiracetam tablets film-coated
250mg,
in blister (30/3x10/)
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki
Greece N03AX14 1307409.12.2013
09.12.2018PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki, Greece
2650Matever 500mg
film-coated tabletslevetiracetam tablets film-coated
500mg,
in blister (30/3x10/)
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki
Greece N03AX14 1307509.12.2013
09.12.2018PoM
Pharmathen S.A.,
Dervenakion 6, 15351
Pallini, Attiki, Greece
571
2651 Maxibiotic
neomycin
(neomycin sulfate),
polymyxin B
(polymyxin B
sulfate), bacitracin
zinc
ointment
5mg/g+5000IU/g+400IU/g
,
3g, 5g, 15g aluminium
tube
Emo-Farm Sp.z o.o.,
52 Lodzka St., 95-054
Ksawerow
Poland D06A 14070/123.12.2016
19.12.2019OTC
Valeant LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2652 Maxicold Rhino
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid, paracetamol
powder for oral
solution with orange
flavour
10mg+20mg+50mg+325m
g,
15g sachets (5, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BE51 13740/111.08.2016
24.07.2019OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2653 Maxicold Rhino
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid, paracetamol
powder for oral
solution with lemon
flavour
10mg+20mg+50mg+325m
g,
15g sachets (5, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BE51 13741/111.08.2016
24.07.2019OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2654 Maxicold Rhino
phenylephrine
(phenylephrine
hydrochloride),
pheniramine
(pheniramine
maleate), ascorbic
acid, paracetamol
powder for oral
solution with
raspberry flavour
10mg+20mg+50mg+325m
g,
15g sachets (5, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BE51 13742/111.08.2016
24.07.2019OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2655 Maxidex dexamethasonedrops eye
(suspension)
1mg/ml,
5ml plastic dropper-vial
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs
Belgium S01BA01 1388406.10.2014
06.10.2019PoM
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs, Belgium
572
2656 Maxitrol
dexamethasone,
neomycin
(neomycin sulfate),
polymyxin B
(polymyxin B
sulfate)
drops eye
(suspension)
1mg/ml+3,5IU/ml+6IU/m
l.
5ml vial
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs
Belgium S01CA01 1355306.06.2014
06.06.2019PoM
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs, Belgium
2657 Mebendazole mebendazole tablets100mg,
in blister (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaP02CA01 12872
17.09.2013
17.09.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2658 Mebendazole mebendazole tablets500mg,
in plastic container (1)
Arpimed LLC (Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building)
Republic of
ArmeniaP02CA01 12961
28.10.2013
28.10.2018PoM
Arpimed LLC
(Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia)
2659 Mecolchloramphenicol,
methyluracil
ointment for
external use
7.5mg/g+40mg/g, 40g
aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus D06C 1578320.07.2016
20.07.2021OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2660 Medacomb Cream
triamcinolone
(triamcinolone
acetonide),
nystatin,
gramicidin,
neomycin
(neomycin sulfate)
cream
1mg/g+ 100000IU/g+
0,25mg/g+ 2,5mg/g,
30g aluminium tube
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235
United Arab
Emirates
D01AA01,
D07AB09,
D06AX04,
R02AB30
1381305.09.2014
05.09.2019PoM
Medpharma Pharm .
& Chem. Inds LLC,
Sharjah, Industrial
Area 13, P.O. Box:
25235, United Arab
Emirates
573
2661 Medical Alcohol ethanol solution
40%,
50ml, 100ml, 250ml,
500ml, 1000ml, 5000ml,
10000ml plastic bottle
Alex-Grig LLC,
Arshakunyac 127/21,
Yerevan
Republic of
ArmeniaD08AX08 13063
25.11.2013
25.11.2018OTC
Natali Pharm LLC,
Tichina str. Lane 3,
2/2, 0065, Yerevan,
Republic of Armenia
2662 Medical Alcohol ethanol solution
70%,
50ml, 100ml, 250ml,
500ml, 1000ml, 5000ml,
10000ml plastic bottle
Alex-Grig LLC,
Arshakunyac 127/21,
Yerevan
Republic of
ArmeniaD08AX08 13064
25.11.2013
25.11.2018OTC
Natali Pharm LLC,
Tichina str. Lane 3,
2/2, 0065, Yerevan,
Republic of Armenia
2663 Medical Alcohol ethanol solution
96%,
50ml, 100ml, 250ml,
500ml, 1000ml, 5000ml,
10000ml plastic bottle
Alex-Grig LLC,
Arshakunyac 127/21,
Yerevan
Republic of
ArmeniaD08AX08 13065
25.11.2013
25.11.2018OTC
Natali Pharm LLC,
Tichina str. Lane 3,
2/2, 0065, Yerevan,
Republic of Armenia
2664 Medomexiethylmethylhydrox
ypiridine succinate
solution for i/v and
i/m injection
50mg/ml,
2ml ampoules, in blister
(10/2x5/)
FSUE Moscow
Endocrine Plant, 25,
Novokhokhlovskaya
st., Moscow, 109052
Russia N07XX 1483904.09.2015
04.09.2020PoM
PROMOMED
HOLDINGS
(CYPRUS) LIMITED,
Themistokli Dervi,
15, MARGARITA
HOUSE, 5th floor,
Flat/Office 502, 1066
Nicosia, Cyprus
2665 Medomexiethylmethylhydrox
ypiridine succinate
solution for i/v and
i/m injection
50mg/ml,
5ml ampoules, in blister
(5/1x5/)
FSUE Moscow
Endocrine Plant, 25,
Novokhokhlovskaya
st., Moscow, 109052
Russia N07XX 1484004.09.2015
04.09.2020PoM
PROMOMED
HOLDINGS
(CYPRUS) LIMITED,
Themistokli Dervi,
15, MARGARITA
HOUSE, 5th floor,
Flat/Office 502, 1066
Nicosia, Cyprus
574
2666 Medomexiethylmethylhydrox
ypyridine succinatetablets film-coated
125mg,
in blister (30/3x10/)
Ozon LLC, build. 6,
Gidrostroiteley str.,
Zhigulevsk town,
Samara region,
445351
Russia N07XX 1505402.12.2015
02.12.2020PoM
PROMOMED
HOLDINGS
(CYPRUS) LIMITED,
Themistokli Dervi,
15, MARGARITA
HOUSE, 5th floor,
Flat/Office 502, 1066
Nicosia, Cyprus
2667 Medrolmethylpredni-
solonetablets
4mg,
in blister (30/3x10/)
Pfizer Italia S.R.L.,
Localita Marino del
Tronto 63100 Ascoli
Piceno
Italy H02AB04 1240419.04.2013
19.04.2018PoM
Pfizer Italia s.r.l., Via
Isonzo, 71-04100
Lataina, Italy
2668 Megaplatin carboplatinsolution for i/v
infusion
10mg/ml,
15ml glass vial
Genepharm S.A., 18th
km Marathonos
Avenue, 153 51
Pallini Attiki
Greece L01XA02 1372224.07.2014
24.07.2019PoM
Genepharm S.A.,
18th km Marathonos
Avenue, 153 51
Pallini Attiki, Greece
2669 Megaray Inj.
gadopentetic acid
(meglumine
gadopentetate)
solution for injection469,01mg/ml,
20ml glass vial
DongKook
Pharmaceutical Co.,
Ltd., 488-5, Jukhyeon-
ri, Gwanghyewon-
myeon, Jincheon-gun,
Choongcheongbuk-
do, Korea
Korea Sourth V08CA01 1252501.06.2013
01.06.2018PoM
DongKook
Pharmaceutical Co.,
Ltd., 488-5, Jukhyeon-
ri, Gwanghyewon-
myeon, Jincheon-
gun,
Choongcheongbuk-
do, Korea
2670 Melaxen melatonin tablets coated
3mg,
in blister (12/1x12/,
24/2x12/)
Unipharm Inc. 200
Hick str., Westbury,
New York 11590
USA N05CH01 1349630.05.2014
30.05.2019OTC
Unipharm Inc., 350,
5th avenue, suite
6701, New York, N.Y.
10118, USA
575
2671 Melfor
meldonium
(meldonuim
dihydrate)
capsules250mg,
in blister (40/4x10/)
Ozon LLC, build. 6,
Gidrostroiteley str.,
Zhigulevsk town,
Samara region,
445351
Russia C01EB22 1505602.12.2015
02.12.2020PoM
PROMOMED
HOLDINGS
(CYPRUS) LIMITED,
Themistokli Dervi,
15, MARGARITA
HOUSE, 5th floor,
Flat/Office 502, 1066
Nicosia, Cyprus
2672 Melitor agomelatine tablets film-coated25mg,
in blister (28/2x14/)
Les Laboratoires
Servier Industrie, 905,
route de Saran, 45520
Gidy
France N06AX22 1495623.10.2015
23.10.2020PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
2673 Melitor agomelatine tablets film-coated25mg,
in blister (28/2x14/)
Servier (Ireland)
Industries Ltd, Gorey
Road, Arklow-Co
Wicklow
Ireland N06AX22 1495723.10.2015
23.10.2020PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
2674 Meloflam meloxicam tablets
7,5mg,
in blister (10/1x10/,
20/2x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - packager, batch
releaser (bulk
manufacturer - Egis
Pharmaceuticals PLC,
9900, Kormend,
Matyas kiraly st. 65,
Hungary)
Hungary M01AC06 12258/128.10.2015
07.03.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
576
2675 Meloflam meloxicam tablets
15mg,
in blister (10/1x10/,
20/2x10/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
packager, Egis
Pharmaceuticals PLC,
9900, Kormend,
Matyas Kiraly u. 65,
Hungary- bulk
manufacturer
Hungary M01AC06 1714007.11.2017
07.11.2022PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
2676 Meloflex meloxicamsolution for i/m
injection
10mg/ml,
1,5ml ampoules, (3, 5)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania M01AC06 1581920.07.2016
20.07.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
2677 Melon
ambroxol
(ambroxol
hydrochloride),
salbutamol
(salbutamol sulfate),
guaifenesin
syrup
15mg/5ml+ 1mg/5ml+
50mg/5ml,
100ml plastic bottle
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14
Georgia R03CK 1219001.02.2013
01.02.2018PoM
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14,
GEORGIA
2678 Melon
ambroxol
(ambroxol
hydrochloride),
salbutamol
(salbutamol sulfate),
guaifenesin
tablets15mg+2mg+ 100mg,
in blister (30/3x10/)
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14
Georgia R03CK 1219101.02.2013
01.02.2018PoM
Aversi-Rational Ltd,
0198 Tbilisi,
Chirnakhuli str. 14,
GEORGIA
577
2679 Melotex meloxicamsolution for i/m
injection
10mg/ml,
1.5ml ampoules (3, 5)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia M01AC06 1680322.06.2017
22.06.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
2680 Melotex meloxicam tablets15mg,
in blister (20/2x10/)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345- secondary
packager, batch
releaser, Replek Farm
Ltd.-Skopje, 188 str.
Kozle, 1000 Skopje,
Macedonia- bulk
manufacturer,
primary packager
Russia M01AC06 1710723.10.2017
23.10.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
2681 Meloxicam meloxicam tablets7,5mg,
in blister (20/2x10/)
Chanelle Medical,
Loughrea, Co. Galway-
packager, batch
releaser, Cipla Ltd,,
Manufacturing
Division, Plot No D-7,
MIDC Industrial
Area, Kurkumbh
Village, Taluka
Daund, District-Pune
(Maharashtra), India-
bulk manufacturer
Ireland M01AC06 1333917.03.2014
17.03.2019PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Republic of
Armenia
578
2682 Meloxicam meloxicam tablets15mg,
in blister (20/2x10/)
Chanelle Medical,
Loughrea, Co. Galway-
packager, batch
releaser, Cipla Ltd,,
Manufacturing
Division, Plot No D-7,
MIDC Industrial
Area, Kurkumbh
Village, Taluka
Daund, District-Pune
(Maharashtra), India-
bulk manufacturer
Ireland M01AC06 1334017.03.2014
17.03.2019PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Republic of
Armenia
2683 Meloxicam meloxicam tablets7,5mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus M01AC06 1449915.05.2015
15.05.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2684 Meloxicam meloxicam tablets15mg,
in blister (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus M01AC06 1450015.05.2015
15.05.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2685 Meloxicam meloxicamsolution for i/m
injection
10mg/ml,
1.5ml ampoules, in blister
(3/1x3/)
FSUE "State Plant of
Medical
Preparations", 111024,
23, Enthusiasts
highway, Moscow
Russia M01AC06 1558912.05.2016
12.05.2021PoM
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo,
Russia
579
2686 Meloxicam meloxicamsolution for i/m
injection
10mg/ml,
1.5ml ampoules (5)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus M01AC06 1715807.11.2017
07.11.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
2687 Meloxicam DC meloxicam tablets
7,5mg,
in blister (10/1x10/),
(20/2x10/)
Mekophar Chemical-
Pharmaceutical JSC,
297/5 Ly Thuong
Kiet, Dist. 11, Ho Chi
Minh
Vietnam M01AC06 1393929.10.2014
29.10.2019PoM
Mekophar Chemical-
Pharmaceutical JSC,
297/5 Ly Thuong
Kiet, Dist. 11, Ho Chi
Minh, Vietnam
2688 Meloxicam DC meloxicam tablets
15mg,
in blister (10/1x10/),
(20/2x10/)
Mekophar Chemical-
Pharmaceutical JSC,
297/5 Ly Thuong
Kiet, Dist. 11, Ho Chi
Minh
Vietnam M01AC06 1394029.10.2014
29.10.2019PoM
Mekophar Chemical-
Pharmaceutical JSC,
297/5 Ly Thuong
Kiet, Dist. 11, Ho Chi
Minh, Vietnam
2689 Meloxicam DC meloxicam solution for injection10mg/ml,
1.5ml ampoules (3)
Zhangjiakou Kaiwei
Pharmaceutical Co.
Ltd., No 27, Lingyuan
Road, Zhangjiakou,
Heibei Province
China M01AC06 1432625.03.2015
25.03.2020PoM
Dahnson Trading
Pharmaceutical
Company Limited,
HoChiMinh city, 44A
Dang Dung street,
Tan Dinh ward,
District 1, Vietnam
2690Meloxicam STADA
tablets 15mgmeloxicam tablets
15mg,
in blister (20/2x10/)
Makiz-Pharma LLC,
109029, Moscow, 6
Avtomobilny proezd
Russia M01AC06 1260521.06.2013
21.06.2018PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
580
2691Meloxicam STADA
tablets 15mgmeloxicam tablets
15mg,
in blister (20/2x10/)
Hemofarm LLC,
249030, Obninsk,
Kaluga Region, 62
Kievskoye shosse St.
Russia M01AC06 1279014.08.2013
14.08.2018PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2692 Memantine Canon
memantine
(memantine
hydrochloride)
tablets film-coated
10mg,
in blister (30/3x10/,
30/1x30/)
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo
Russia N06DX01 15993/107.07.2017
15.09.2021PoM
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo,
Russia
2693 Menogon menohropin
powder lyophilized
for solution for
injecton
75IU,
ampoules (10), 1ml
solvent in ampoules(10)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel -
powder dosage form
manufacturer, primary
packager, batch releaser
(solvent dosage form
manufacturer, primary
packager - Haupt
PharmaWulfing GmbH,
Bethelner Landstr. 18,
31028 Gronau/Leine,
Germany) (secondary
packager - Ferring
International Center
SA, Chemin de la
Vergognausaz 50, 1162
Saint-Prex, Switzerland)
Germany G03GA02 1319210.01.2014
10.01.2019PoM
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel,
Germany
581
2694 Menopur menotropin
powder lyophilized
for solution for
injection
75IU,
glass vials (10), 1ml
solvent in ampoules (10)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel -
batch releaser (solvent
bulk manufacturer,
primary packager -
Haupt Pharma
Wulfing GmbH
Bethelner Landstr. 18,
31028 Gronau/Leine,
Germany) (powder
bulk manufacturer,
primary packager -
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel,
Germany) secondary
packager - Ferring
International Center
SA, Chemin de la
Vergognausaz 50,
1162 Saint-Prex,
Switzerland
Germany G03GA02 13078/102.06.2015
09.12.2018PoM
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel,
Germany
2695 Menovazine
menthol racemic,
procaine (procaine
hydrochloride),
benzocaine
solution for external
use
25mg/ml+
10mg/ml+10mg/ml, 30ml
glass vial (1)
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079
Republic of
ArmeniaM02AX10 14960
18.11.2015
18.11.2020OTC
ESCO-PHARM LLC,
Nor-Norq V block,
Mikoyan 13, Yerevan
0079, Republic of
Armenia
2696 Mepivastesin
mepivacaine
(mepivacaine
hydrochloride)
solution for injection30mg/ml,
1,7ml cartridges (50)
3M Deutschland
GmbH (ESPE Platz
82229 Seefeld)
Germany N01BB03 1294321.10.2013
21.10.2018PoM
3M Deutschland
GmbH (Carl-Schurz
Strasse 1, 42453
Neuss, Germany)
582
2697Mercazolyl-
Zdorovyethiamazole tablets
5mg,
in blister (50/5x10/,
100/10x10/),
in plastic container (50,
100)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine H03BB02 1643406.03.2017
06.03.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
2698Meropenem-
Asteriameropenem
powder for solution
for i/v
injection/infusion
500mg,
glass vials (1, 5, 10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth J01DH02 1517817.12.2015
17.12.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
2699 Mertenil
rosuvastatin
(rosuvastatin
calcium)
tablets film-coated20mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C10AA07 1590323.08.2016
23.08.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2700 Mertenil
rosuvastatin
(rosuvastatin
calcium)
tablets film-coated10mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C10AA07 1590423.08.2016
23.08.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2701 Mertenil
rosuvastatin
(rosuvastatin
calcium)
tablets film-coated5mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C10AA07 1590523.08.2016
23.08.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2702 Mesatone
phenylephrine
(phenylephrine
hydrochloride)
solution for i/m, i/v
and s/c injection
10mg/ml,
1ml ampoules (10/1x10/,
10/2x5/)
Pharmaceutical
Company "Zdorovye"
LLC, str. Shevchenko,
22, Kharkov
Ukraine C01CA06 15774/109.08.2016
04.07.2021PoM
Experimental Plant
"GNCLS" LLC, 61075,
Kharkov, Vorobyov
str., 8, Ukraine
583
2703 Metabet SR
metformin
(metformin
hydrochloride)
tablets prolonged-
release
500mg,
in blister (28/2x14/)
Morningside
Pharmaceuticals Ltd,
5 Pavilion Way,
Loughborough,
Le115GW -batch
releaser, USV Ltd, H-
17/ H-18, IDC,
Mahatma Gandhi,
Udyog Nagar, Dabhel,
Daman, 396210, India-
bulk manufacturer,
packager
UK A10BA02 1420827.01.2015
27.01.2020PoM
Morningside
Healthcare Ltd, 115
Narborough Road,
Leicester LE30PA
(UK)
2704 Metabet SR
metformin
(metformin
hydrochloride)
tablets prolonged-
release
1000mg,
in blister (28/2x14/)
Morningside
Pharmaceuticals Ltd,
5 Pavilion Way,
Loughborough,
Le115GW -batch
releaser, USV Ltd, H-
17/ H-18, IDC,
Mahatma Gandhi,
Udyog Nagar, Dabhel,
Daman, 396210, India-
bulk manufacturer,
packager
UK A10BA02 1420927.01.2015
27.01.2020PoM
Morningside
Healthcare Ltd, 115
Narborough Road,
Leicester LE30PA
(UK)
2705 Metadon Alkaloid
methadone
(methadone
hydrochloride)
solution oral
10mg/ml,
100ml glass bottle and
graduated pipette,
1000ml glass bottle
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia N07BC02 1726713.12.2017
13.12.2022PoM/UC
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje, Macedonia
2706 Metagard CR-35
trimetazidine
(trimetazidine
hydrochloride)
tablets controlled-
release coated
35mg,
in blister (30/3x10/)
Ipca Laboratories
Limited, P.O. Sejavta,
Dist. Ratlam 457 002,
Madhya Pradesh
India C01EB15 1214701.02.2013
01.02.2018PoM
Ipca Laboratories Ltd,
48, Kandivli Ind.
Estate, Mumbai 400
067, India
584
2707 Meteospasmyl
alverine (alverine
citrate),
simethicone
capsules60mg+300mg,
in blister (30/3x10/)
Laboratoires Mayoly
Spindler, 6 avenue de
l`Europe B.P.
5178401 Chatou
Cedex -batch releaser,
packager, L.G.V.
Capsules, 20, rue
Louis-Charles Vernin,
77190 Dammarie-les-
Lys, France-bulk
manufacturer
France A03AX58 1499106.11.2015
06.11.2020OTC
Laboratoires Mayoly
Spindler, 6 avenue de
l`Europe B.P.
5178401 Chatou
Cedex, France
2708 Metfogamma
metformin
(metformin
hydrochloride)
tablets film-coated
850mg,
in blister (30/3x10/,
120/12x10/)
Artesan Pharma
GmbH & Co. KG,
Wendlandstrasse 1 D-
29439, Luchow
Germany A10BA02 1283917.09.2013
17.09.2018PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
2709 Metfogamma 1000
metformin
(metformin
hydrochloride)
tablets film-coated
1000mg,
in blister (30/2x15/,
120/8x15/)
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Bavaria
Germany A10BA02 1341314.04.2014
14.04.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
2710 Metfogamma 500
metformin
(metformin
hydrochloride)
tablets film-coated
500mg,
in blister
(30/3x10/, 120/12x10/)
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Bavaria
Germany A10BA02 1327204.03.2014
04.03.2019PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
2711 Metfogamma 850
metformin
(metformin
hydrochloride)
tablets film-coated850mg,
in blister (30/3x10/)
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning,
Bavaria
Germany A10BA02 1229722.03.2013
22.03.2018PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
585
2712 Metformin
metformin
(metformin
hydrochloride)
tablets500mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA10BA02 12134
01.02.2013
01.02.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2713 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated1000mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA10BA02 12675
04.07.2013
04.07.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
2714 Metformin
metformin
(metformin
hydrochloride)
tablets1000mg,
blisters (30/2x15/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA10BA02 13434/1
14.07.2016
14.04.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2715 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated500mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia A10BA02 1371924.07.2014
24.07.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
2716 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated850mg,
in blister (30/3x10/)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia A10BA02 1372024.07.2014
24.07.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
2717 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated1000mg,
glass bottle (30)
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje
Macedonia A10BA02 1372124.07.2014
24.07.2019PoM
Replek Farm Ltd.-
Skopje, 188 str. Kozle,
1000 Skopje,
Macedonia
586
2718 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated500mg,
in blister (60/6x10/)
Lek S.A.,16 Podlipie
Str., 95-010 Strykow Poland A10BA02 16445
06.03.2017
06.03.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
2719 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated1000mg,
in blister (60/4x15/)
Lek S.A.,16 Podlipie
Str., 95-010 Strykow Poland A10BA02 16446
06.03.2017
06.03.2022PoM
Sandoz
Pharmaceuticals d.d.,
Verovskova Str. 57,
1000 Ljubljana,
Slovenia
2720 Metformin
metformin
(metformin
hydrochloride)
tablets500mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA10BA02 17252
12.12.2017
12.12.2022PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2721 Metformin
metformin
(metformin
hydrochloride)
tablets film-coated
500mg,
in blister (10/1x10/,
30/3x10/)
Belmedpreparaty
RUE, 220006, Minsk,
1 Mayakovskogo st.
Belarus A10BA02 1688208.08.2017
08.08.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
2722 Metformin
metformin
(metformin
hydrochloride)
tablets coated 500mg,
in blisters (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64a, ul.
Chapaeva, Borisov,
Minsk region
Belarus A10BA02 1691208.08.2017
08.08.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64, ul.
Chapaeva, Borisov,
Minsk region, Belarus
587
2723 Metformin
metformin
(metformin
hydrochloride)
tablets coated 1000mg,
in blisters (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64a, ul.
Chapaeva, Borisov,
Minsk region
Belarus A10BA02 1691308.08.2017
08.08.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64, ul.
Chapaeva, Borisov,
Minsk region, Belarus
2724 Metformin
metformin
(metformin
hydrochloride)
tablets coated 850mg,
in blisters (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64a, ul.
Chapaeva, Borisov,
Minsk region
Belarus A10BA02 1691408.08.2017
08.08.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov", 64, ul.
Chapaeva, Borisov,
Minsk region, Belarus
2725Metformin Denk
1000
metformin
(metformin
hydrochloride)
tablets film-coated1000mg,
in blister (30/2x15/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany A10BA02 1623005.12.2016
05.12.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2726Metformin Denk
500
metformin
(metformin
hydrochloride)
tablets film-coated
500mg,
in blister (30/3x10/,
100/10x10/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany A10BA02 1433725.03.2015
25.03.2020PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
2727Metformin Denk
850
metformin
(metformin
hydrochloride)
tablets film-coated850mg,
in blister (30/2x15/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany A10BA02 1622905.12.2016
05.12.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
588
2728Methadone
Hydrochloride
methadone
(methadone
hydrochloride)
concentrate for oral
solution
25mg/ml,
150ml glass bottle
Rusan Pharma Ltd.,
Khasra No122MI,
Central Hope Town,
Selaqui, Dehradun
248 197, Uttarakhand
India N07BC02 1587523.08.2016
23.08.2021PoM/UC
Rusan Pharma Ltd.,
58-D, Govt. Ind.
Estate Charkop,
Kandivli (West)
Mumbai-400 067,
India
2729
Methadone
hydrochloride
tablets USP
methadone
(methadone
hydrochloride)
tablets5mg, (100) in plastic
container
Mallinckrodt Inc., 172
Railroad ave.,Hobart,
NY 13788
USA N07BC02 1399526.11.2014
26.11.2019PoM/UC
Mallinckrodt Inc.,
675 McDonnell
Boulevard,
Hazelwood, MO
63042, USA
2730
Methadone
hydrochloride
tablets USP
methadone
(methadone
hydrochloride)
tablets10mg; (100) in plastic
container
Mallinckrodt Inc., 172
Railroad ave.,Hobart,
NY 13788
USA N07BC02 1399626.11.2014
26.11.2019PoM/UC
Mallinckrodt Inc.,
675 McDonnell
Boulevard,
Hazelwood, MO
63042, USA
2731
Methadose
dispersible tablets
USP
methadone
(methadone
hydrochloride)
tablets for oral
suspension
40mg; (100) in plastic
container
Mallinckrodt Inc., 172
Railroad ave.,Hobart,
NY 13788
USA N07BC02 1399726.11.2014
26.11.2019PoM/UC
Mallinckrodt Inc.,
675 McDonnell
Boulevard,
Hazelwood, MO
63042, USA
2732 Methionine methionine tablets film-coated250mg,
in blister (50/5x10/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A05BA 1460503.07.2015
03.07.2020PoM
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28,
Russia
2733Methotrexat
"Ebewe"methotrexate
solution for
injection/infusion
10mg/ml,
1ml ampoules (10)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BA01 1605217.10.2016
17.10.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
589
2734Methotrexat
"Ebewe"methotrexate
solution for
injection/infusion
10mg/ml,
5ml ampoules (5)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01BA01 1605317.10.2016
17.10.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
2735 Methotrexate methotrexate tablets film-coated2,5mg,
in blister (20/2x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BA01 1418606.02.2015
06.02.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
2736 Methotrexate methotrexate tablets film-coated5mg,
in blister (20/2x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BA01 1418706.02.2015
06.02.2020PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
2737 Methotrexate
methotrexate
(methotrexate
sodium)
powder lyophilized
for solution for
injection
50mg,
glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01BA01 1579020.07.2016
20.07.2021PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
2738Methotrexate
Ebewemethotrexate tablets
5mg,
in plastic container (50)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee - batch
releaser, Haupt
Pharma Amareg
GmbH, Donaustaufer
Strasse 378, 93055
Regensburg, Germany-
bulk manufacturer,
packager
Austria L01BA01 1455409.06.2015
09.06.2020PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
590
2739Methotrexate
Ebewemethotrexate tablets
2,5mg,
in plastic container (50)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee - batch
releaser, Haupt
Pharma Amareg
GmbH, Donaustaufer
Strasse 378, 93055
Regensburg, Germany-
bulk manufacturer,
packager
Austria L01BA01 1455509.06.2015
09.06.2020PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
2740Methotrexate
Ebewemethotrexate tablets
10mg,
in plastic container (50)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee - batch
releaser, Haupt
Pharma Amareg
GmbH, Donaustaufer
Strasse 378, 93055
Regensburg, Germany-
bulk manufacturer,
packager
Austria L01BA01 1455609.06.2015
09.06.2020PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
2741Methotrexate
Orionmethotrexate tablets
2,5mg,
in plastic container (30,
100)
Orion Corporation,
Orionintie 1, 02200
Espoo-batch releaser
(Orion Corporation,
Tengstrominkatu 8,
20360 Turku, Finland-
bulk manufacturer,
packager)
Finland L01BA01 1448518.05.2015
18.05.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
591
2742Methotrexate
Orionmethotrexate tablets
10mg,
in plastic container (30,
100)
Orion Corporation,
Orionintie 1, 02200
Espoo-batch releaser
(Orion Corporation,
Tengstrominkatu 8,
20360 Turku, Finland-
bulk manufacturer,
packager)
Finland L01BA01 1448618.05.2015
18.05.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
2743 Methyluracil methyluracil suppositories rectal500mg
(10/2x5/)
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia L03AX 1256802.10.2013
02.10.2018PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2744 Methyluracil methyluracilointment for
external use
100mg/g,
15g aluminum tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus D03AX 1363427.06.2014
27.06.2019OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
2745 Methypred
methylprednisolon
(methylpredniso-
lone acetate)
suspension depot for
injection
40mg/ml,
1ml glass vial
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland H02AB04 1249117.05.2013
17.05.2018PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
2746 Methypred methylprednisolone tablets4mg,
in plastic container (30)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland H02AB04 1425420.02.2015
20.02.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
2747 Methypred methylprednisolone tablets16mg,
in plastic container (30)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland H02AB04 1426720.02.2015
20.02.2020PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
592
2748 Methypred
methylprednisolone
(methylprednisolon
e sodium succinate)
powder for solution
for injection
250mg,
glass vial (1)
Orion Corporation,
Orionintie 1, 02200
Espoo-batch releaser,
secondary packager,
Hikma Farmaceutica,
Estrada do Rio da Mo
n.8, 8A e 8B,
Fervenca, 2705-906
Terrugem SNT,
Portugal-bulk
manufacturer,
primary packager
Finland H02AB04 1628319.12.2016
19.12.2021PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
2749 Methypred
methylprednisolone
(methylprednisolon
e sodium succinate)
powder for solution
for injection
1000mg,
glass vial (1)
Orion Corporation,
Orionintie 1, 02200
Espoo-batch releaser,
secondary packager,
Hikma Farmaceutica,
Estrada do Rio da Mo
n.8, 8A e 8B,
Fervenca, 2705-906
Terrugem SNT,
Portugal-bulk
manufacturer,
primary packager
Finland H02AB04 1628419.12.2016
19.12.2021PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
2750 Metoclopramide
metoclopramide
(metoclopramide
hydrochloride)
solution for injection
5mg/ml,
2ml ampoules,
in blister (10, 10/1x10/)
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus A03FA01 1235309.04.2013
09.04.2018PoM
Open Joint Stock
Company
<Borisovskiy zavod
Medicinckikh
Preparatov>, 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
593
2751 Metoclopramide
metoclopramide
(metoclopramide
hydrochloride)
solution for injection5mg/ml,
2ml ampoules (10)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA03FA01 13314
04.03.2014
04.03.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2752 Metoclopramide
metoclopramide
(metoclopramide
hydrochloride)
tablets10mg,
in blister (50/5x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A03FA01 1455809.06.2015
09.06.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2753 Metoclopramide
metoclopramide
(metoclopramide
hydrochloride)
solution for injection
5mg/ml,
2ml ampoules (10), 2ml,
ampoules,
in blister (10/1x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus A03FA01 1694605.09.2017
05.09.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
2754 Metoject
methotrexate
(methotrexate
disodium)
solution for injection
10mg/ml,
0,75ml glass pre-filled
measuring syringe, blister
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
packager, batch
releaser (dosage form
manufacturer -
Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany)
Germany L01BA01 13162/122.11.2016
10.01.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
594
2755 Metoject
methotrexate
(methotrexate
disodium)
solution for injection
10mg/ml,
1ml glass pre-filled
measuring syringe, blister
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
packager, batch
releaser (dosage form
manufacturer -
Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany)
Germany L01BA01 13163/122.11.2016
10.01.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
2756 Metoject
methotrexate
(methotrexate
disodium)
solution for injection
10mg/ml,
1,5ml glass pre-filled
measuring syringe,
blister
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
packager, batch
releaser (dosage form
manufacturer -
Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany)
Germany L01BA01 13164/122.11.2016
10.01.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
2757 Metoject
methotrexate
(methotrexate
disodium)
solution for injection
10mg/ml,
2ml glass pre-filled
measuring syringe, blister
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
packager, batch
releaser (dosage form
manufacturer -
Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany)
Germany L01BA01 13165/122.11.2016
10.01.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
595
2758 Metoject
methotrexate
(methotrexate
disodium)
solution for injection
10mg/ml,
2,5ml glass pre-filled
measuring syringe, blister
Medac GmbH,
Theaterstrasse 6,
22880 Wedel -
packager, batch
releaser (dosage form
manufacturer -
Oncotec Pharma
Production GmbH,
Am Pharmapark,
06861 Dessau-
Rosslau, Germany)
Germany L01BA01 13166/122.11.2016
10.01.2019PoM
Medac GmbH,
Theaterstrasse 6,
22880 Wedel,
Germany
2759 Metoprolol
metoprolol
(metoprolol
tartrate)
tablets50mg,
in blister (30/3x10/)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia C07AB02 1373324.07.2014
24.07.2019PoM
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
2760 Metoprolol
metoprolol
(metoprolol
tartrate)
tablets100mg,
in blister (30/3x10/)
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx 121
Russia C07AB02 1373424.07.2014
24.07.2019PoM
Marbiopharm JSC,
424006, the Republic
of Mari El,Yoshkar-
Ola, st. Karl Marx
121, Russia
2761 Metoprolol
metoprolol
(metoprolol
tartrate)
tablets50mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaC07AB02 14885
24.09.2015
24.09.2020PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2762
Metoprolol
Tartrate Injection,
USP
metoprolol
(metoprolol
tartrate)
solution for
injection/infusion
1mg/ml,
5ml glass vials (10)
Agila Specialties
Private Limited,
Strides House, Opp.
IIM, Bilekahali,
Bannerghatta Road,
Banglore- 560 076
India C07AB02 1349315.05.2014
15.05.2019PoM
Sagent
Pharmaceuticals Inc,
1901 N. Roselle Road,
Suite 700 USA
596
2763 Metpure-XL 25
metoprolol
(metoprolol
succinate)
tablets prolonged
release film-coated
25mg; (30/3x10/) in
blister
Emcure
Pharmaceuticals Ltd.,
Lane No. 3, Phase II,
SIDCO Industrial
Complex, Bari-
Brahmana, Jammu
(J&K)-181 133
India C07AB02 1333117.03.2014
17.03.2019PoM
Emcure
Pharmaceuticals Ltd.,
T-184, M.I.D.C.,
Bhosari, Pune-
411026, Maharashtra,
India
2764 Metrogyl metronidazolesolution for i/v
injection
5mg/ml,
100ml plastic bottle
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.)
(Plot No 4, Phase IV,
G.I.D.C. Industrial
Area, Panoli: 394 116,
Gujarat State)
India J01XD01 1300128.10.2013
28.10.2018PoM
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.)
(B, Wing, 4-th Floor,
Hind Cycle
Road,Worli, Mumbai
400 030, India)
2765 Metrogyl metronidazolesolution for i/v
injection
5mg/ml,
100ml plastic bottle
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.)
(Plot No 304-308,
Phase IV, G.I.D.C.
Industrial Area,
Panoli: 394 116,
Gujarat State)
India J01XD01 1300228.10.2013
28.10.2018PoM
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.)
(Neelam Centre, B ,
Wing, 4-th Floor,
Hind Cycle
Road,Worli, Mumbai
400 030, India)
597
2766 Metrogyl metronidazole gel for external use
10mg/g,
30g aluminium or
laminated plastic tube
Unique
Pharmaceutical
Laboratories, Plot N
304-308, G.I.D.C.
Industrial Area,
Panoli: 394 116,
Gujarat State
India D06BX01 1463803.07.2015
03.07.2020PoM
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.)
Worli, Mumbai-400
030, India
2767 Metrogyl denta
metronidazole
(metronidazole
benzoate),
chlorhexidine
digluconate
(chlorhexidine
digluconate 20%
solution)
gel dental 10mg/g+0,5mg/g, 5g, 10g
and 20g plastic tube
Unique
Pharmaceutical
Laboratories (a
division of J. B.
Chemicals &
Pharmaceuticals Ltd.),
Plot No. 304-308,
G.I.D.C. Industrial
Area, Panoli: 394 116,
Gujarat State
India A01AB11 1693223.08.2017
23.08.2022OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
2768 Metromezol-Dent
metronidazole,
chlorhexidine
(chlorhexidine
digluconate)
gel10mg/g+0,5mg/g, 20g
aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus A01AB11 1385218.09.2014
18.09.2019OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
2769 Metromicon Forte
metronidazole,
miconazole(micona
zole nitrate)
suppositories vaginal
(pessaries)750mg+200mg, (7/1x7/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AF20 1562424.05.2016
24.05.2021PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
598
2770 Metromikon-Neometronidazole,
miconazole nitratesuppositories vaginal 500mg+100mg (14/2x7/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AF20 1353830.05.2014
30.05.2019PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
2771Metronidazol
Nycomedmetronidazole tablets film-coated
500mg,
in glass container (20)
Nycomed Danmark
ApS, Langebjerg 1,
DK-4000 Roskilde -
packager, batch
releaser (dosage form
manufacturer -
Nycomed Danmark
ApS, Adelgade 18 A,
DK-9500 Hobro,
Denmark)
Denmark P01AB01 1243707.05.2013
07.05.2018PoM
Nycomed Danmark
ApS, Langebjerg 1,
DK-4000 Roskilde,
Denmark
2772 Metronidazole metronidazole suppositories vaginal500mg
(10/2x5)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AF01 1259021.06.2013
21.06.2018PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
2773 Metronidazole metronidazole tablets250mg,
in blister (20/1x20/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia P01AB01 1409218.12.2014
18.12.2019PoM
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
2774 Metronidazole metronidazolesolution fori/v
infusion
5mg/ml,
100ml plastic pack
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaJ01XD01 14148
29.12.2014
29.12.2019PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
599
2775 Metronidazole metronidazole tablets
250mg,
in blister (10),
in blister/10/ (300)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk region
Belarus P01AB01 1697505.09.2017
05.09.2022PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64, ul.
Chapaeva, Borisov
222518, Minsk
region, Belarus
2776Metronidazole
0,5%metronidazole solution for infusion
5mg/ml,
100ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaJ01XD01 12633
21.06.2013
21.06.2018PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Armenia
2777Metronidazole 1%
gelmetronidazole gel
10mg/g,
20g tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD06BX01 13487
30.04.2014
30.04.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2778Metronidazole
Denta
metronidazole
(metronidazole
benzoate),
chlorhexidine
(chlorhexidine
gluconate 20%
solution)
gel for gums10mg/g+0,5mg/g, 20g
aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA01AB11 14079
16.12.2014
16.12.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2779Metronidazole
Nycomedmetronidazole tablets film-coated
500mg,
in glass container (20)
Takeda Pharma AS,
Jaama 55b Polva,
Polva county 63308-
batch releaser,
packager, Takeda
Pharma
A/S,Apotekerstien 9,
9500 Hobro, Denmark-
bulk manufacturer
Estonia P01AB01 1641210.02.2017
10.02.2022PoM
Takeda Pharma A/S,
Dybendal Alle 10,
2630 Taastrup,
Denmark
600
2780Metronidazole-
Asteriametronidazole tablets
500mg,
in blister (30/3x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth P01AB01 14424/228.10.2015
14.04.2020PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, South Korea
2781 Metvixmethyl
aminolevulinate
cream for external
use
160mg/g,
2g aluminium tube
Laboratoires
Galderma Z.I.
Montdesir, 74540
Alby-sur-Cheran
France L01XD03 1608910.11.2016
10.11.2021PoM
Galderma SA,
Zugerstrasse 8, CH-
6330 Cham,
Switzerland
2782 Mexicam meloxicam tablets film-coated15mg,
in strip (20/2x10/)
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city
Egypt M01AC06 1425220.02.2015
20.02.2020PoM
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city, Egypt
2783 Mexicam
meloxicam,
lidocaine (lidocaine
hydrochloride)
solution for i/m
injection
5mg/ml+3mg/ml, 3ml
ampoules (6)
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city
Egypt M01AC06 1511315.12.2015
15.12.2020PoM
Delta Pharma,
Industrial Zone
B4,10th of Ramadan
city, Egypt
2784 Mexidolethylmethylhydrox
ypyridine succinatetablets film-coated
125mg,
blisters (30/3x10/,
50/5x10/)
ZAO Zio-Zdorove,
142103, Moscow
region, Podolsk, str.
Zheleznodorozhnaya,
2
Russia N07XX 13818/116.02.2016
10.09.2019PoM
JSC NPK
PHARMASOFT,
115280, Moscow,
Avtozavodskaya str.,
17, b. 3, office 4,
Russia
2785 Mexidolethylmethylhydrox
ypiridine succinate
solution for i/v and
i/m injection
50mg/ml,
5ml ampoules (5)
OOO Ellara, 601122,
Vladimir reg.,
Petushinsky district,
Pokrov, str. Franza
Shtolverka, b. 20/2
Russia N07XX 13819/108.12.2015
10.09.2019PoM
OOO NPK
PHARMASOFT,
115280, Moscow,
Avtozavodskaya str.,
17, b. 3, office 4,
Russia
601
2786 Mexidolethylmethylhydrox
ypiridine succinate
solution for i/v and
i/m injection
50mg/ml,
2ml ampoules, in blister
(10/2x5/)
OOO Ellara, 601122,
Vladimir reg.,
Petushinsky district,
Pokrov, str. Franza
Shtolverka, b. 20/2
Russia N07XX 13820/108.12.2015
10.09.2019PoM
OOO NPK
PHARMASOFT,
115280, Moscow,
Avtozavodskaya str.,
17, b. 3, office 4,
Russia
2787 Mexidolethylmethylhydrox
ypyridine succinate
solution for i/v and
i/m injection
50mg/ml,
2ml ampoules , in blister
(10/2x5/)
FKP Armavirskaya
biofabrika, 352212,
Krasnodar reg.,
Novokubanskiy
district, Progress
settlement, str.
Mechnikova, b. 11
Russia N07XX 14834/118.01.2016
04.09.2020PoM
LLC NPK
PHARMASOFT,
115280,
Moscow,Avtozavodsk
aya str., 17, b. 3,
office 4, Russia
2788 Mexidolethylmethylhydrox
ypyridine succinate
solution for i/v and
i/m injection
50mg/ml,
5ml ampoules, in blister
(5/1x5/)
FKP Armavirskaya
biofabrika, 352212,
Krasnodar reg.,
Novokubanskiy
district, Progress
settlement, str.
Mechnikova, b. 11
Russia N07XX 14835/118.01.2016
04.09.2020PoM
LLC NPK
PHARMASOFT,
115280,
Moscow,Avtozavodsk
aya str., 17, b. 3,
office 4, Russia
2789 Mexilethylmethylhydrox
ypiridine succinatecapsules
125mg,
in blister (30/3x10/)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN07XX 13264
10.03.2014
10.03.2019PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2790 Mexilethylmethylhydrox
ypyridine succinate
solution for i/v and
i/m injection
50mg/ml; (10/2x5/)
ampoules 2ml, in blister
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN07XX 15281
04.02.2016
04.02.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
602
2791 Mexipam
ethylmethylhydrox
y-pyridine
succinate
solution for i/v and
i/m injection
50mg/ml,
2ml glass vials (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaN07XX 15977
15.09.2016
15.09.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2792 Mexiprimethylmethylhydrox
ypyridine succinate
solution for i/v and
i/m injection
50mg/ml,
5ml ampoules, in blister
(5/1x5/)
Scientific
Technological
Pharmaceutical Firm
POLISAN LLC, lit. A,
building 2, Salova st.
72, Saint Petersburg,
192102
Russia N07XX 1457209.06.2015
09.06.2020PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2793 Mexiprimethylmethylhydrox
ypyridine succinate
solution for i/v and
i/m injection
50mg/ml,
2ml ampoules, in blister
(10/2x5/)
Scientific
Technological
Pharmaceutical Firm
POLISAN LLC, lit. A,
building 2, Salova st.
72, Saint Petersburg,
192102
Russia N07XX 1457309.06.2015
09.06.2020PoM
Nizhpharm OJSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2794 Mexiprimethylmethylhydrox
ypyridine succinate
solution for i/m and
i/v injection
50mg/ml,
2ml ampoules, in blister
(10/2x5/)
FSUE Moscow
Endocrine Plant, 25,
Novokhokhlovskaya
st., Moscow, 109052
Russia N07XX 1627019.12.2016
19.12.2021PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2795 Mezym Fortepancreatin (lipase,
amylase, protease)tablets film-coated
(3500IU+4200IU+250IU),
in blister (20/1x20/,
40/2x20/, 80/4x20/,
100/5x20/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser (dosage form
manufacturer,
packager - Menarini-
Von Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden,
Germany)
Germany A09AA02 1260021.06.2013
21.06.2018OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
603
2796 Mezym Fortepancreatin (lipase,
amylase, protease)tablets film-coated
(3500IU+4200IU+250IU),
in blister (20/1x20/,
40/2x20/, 80/4x20/,
100/5x20/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, packager
(dosage form
manufacturer - Berlin-
Chemie AG,
Tempelhofer Weg 83,
12347 Berlin,
Germany)
Germany A09AA02 1260121.06.2013
21.06.2018OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
2797 Mezym forte 10000pancreatin (lipase,
amylase, protease)
tablets gastro-
resistant
not less than 10000U+not
less than 7500U+not less
than 375U,
in blister (10/1x10/,
20/2x10/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden,
Germany-bulk
manufacturer,
packager
Germany A09AA02 1613610.11.2016
10.11.2021OTC
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin,
Germany
2798 Mezym forte 10000pancreatin (lipase,
amylase, protease)
tablets gastro-
resistant
not less than 10000U+not
less than 7500U+not less
than-375U,
in blister (10/1x10/,
20/2x10/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany A09AA02 1666511.05.2017
11.05.2022OTC
Berlin-Chemie A.G.,
Glienicker Weg 125,
12489 Berlin,
Germany
2799 Miacalcic
calcitonin
(calcitonin salmon
synthetic)
solution for injection100IU/ml,
1ml ampoules (5)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland H05BA01 1634730.12.2016
30.12.2021PoM
Novartis Pharma AG,
35, Lichtstrasse, 4056
Basel, Switzerland
604
2800 MicoCortisone
miconazole
(miconazole
nitrate),
hydrocortisone
cream20mg/g+10mg/g, 10g
aluminium tube
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208
Bangladesh D01AC52 14349/121.10.2015
25.03.2020PoM
Orion Pharma Ltd.,
Orion House, 153-154
Tejgaon Industrial
Area, Dhaka-1208,
Bangladesh
2801 Micoflu fluconazole capsules150mg,
in blister (1)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia J02AC01 1430419.03.2015
19.03.2020PoM
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
2802 Miconazolmiconazole
(miconazole nitrate)suppositories vaginal
100mg
(7/1x7/)
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829
Moldova G01AF04 1675305.06.2017
05.06.2022PoM
Farmaprim SRL,
Crinilor str., 5,
Porumbeni, Criuleni
dis., MD-4829,
Moldova
2803 Miconazolemiconazole
(miconazole nitrate)
cream for external
use
20mg/g,
15g aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk region
Belarus D01AC02 1580420.07.2016
20.07.2021OTC
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64/27,
Chapaev str., Borisov
222120, Minsk
region, Belarus
2804
Miconazole 2%
cream for topical
use
miconazole
(miconazole nitrate)cream for topical use
20mg/g,
15g aluminium tube
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaD01AC02 12128
01.02.2013
01.02.2018OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2805 Microlax
sodium citrate,
sodium
laurylsulfoacetate,
sorbitol solution
solution rectal
90mg/ml+9mg/ml+
893mg/ml,
5ml microenema (4, 12)
Famar Orleans, 5
avenue de Concyr,
45071 Orleans, Cedex
2
France A06AG11 1649917.03.2017
17.03.2022OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
605
2806 Midazem midazolam solution for injection5mg/ml,
3ml ampoules (5)
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw
Poland N05CD08 1553319.04.2016
19.04.2021PoM/UC
Warsaw
Pharmaceutical
Works "Polfa" S.A.,
Karolkowa 22/24 str.,
01-207 Warsaw,
Poland
2807 Midianadrospirenone,
ethinylestradioltablets film-coated
3mg+0,03mg,
in blister (21/1x21/,
63/3x21/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AA12 1522330.12.2015
30.12.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
2808 Midromax
meldonium
(meldonium
dihydrate)
solution for i/v
injection
100mg/ml,
5ml ampoules,
in blister (10/2x5/)
British-Georgian
Factory EuroMedical
Ltd, Natakhtari, 3300,
Mtskheta
Georgia C01CX 1485304.09.2015
04.09.2020PoM
Unimed Group Corp.
Ltd, No29, 61
Mitskevich str., Vake-
saburtalo, Tbilisi,
Georgia
2809 MIG 400 ibuprofen tablets film-coated
400mg,
in blister
(10, 20/2x10/, 30/3x10/,
50/5x10/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin - batch
releaser, packager
(dosage form
manufacturer - Berlin-
Chemie AG,
Tempelhofer Weg 83,
12347 Berlin,
Germany)
Germany M01AE01 1302425.11.2013
25.11.2018OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
2810 MIG 400 ibuprofen tablets film-coated
400mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/,
50/5x10/)
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin -
packager, batch
releaser (bulk
manufacturer -
Menarini-Von
Heyden GmbH,
Leipziger Strasse 7-13,
01097 Dresden,
Germany)
Germany M01AE01 1319910.01.2014
10.01.2019OTC
Berlin-Chemie AG,
Glienicker Weg 125,
12489 Berlin,
Germany
606
2811 MIG for children ibuprofen suspension oral
20mg/ml,
100ml plastic bottle and
5ml measuring syringe
Berline-Chemie AG,
Glienicker Weg
125,12489 Berlin -
batch releaser (dosage
form manufacturer,
packager -
Farmasierra
Manufacturing S.L.,
Ctra. Irun, Km. 26,
200, San Sebastian de
los Reyes 28700,
Madrid, Spain)
Germany M01AE01 1276014.08.2013
14.08.2018OTC
Berline-Chemie AG,
Glienicker Weg
125,12489 Berlin,
Germany
2812 MIG for children ibuprofen suspension oral
20mg/ml,
100ml plastic bottle and
5ml measuring syringe
Farmasierra
Manufacturing S.L.,
Ctra. Irun, Km. 26,
200, San Sebastian de
los Reyes 28700,
Madrid
Spain M01AE01 1276114.08.2013
14.08.2018OTC
Berline-Chemie AG,
Glienicker Weg
125,12489 Berlin,
Germany
2813MIG for children
forteibuprofen suspension oral
40mg/ml,
100ml plastic bottle and
measuring syringe 5ml
Berline-Chemie AG,
Glienicker Weg
125,12489 Berlin -
batch releaser (dosage
form manufacturer,
packager -
Farmasierra
Manufacturing S.L.,
Ctra. Irun, Km. 26,
200, San Sebastian de
los Reyes 28700,
Madrid, Spain)
Germany M01AE01 1377305.09.2014
05.09.2019OTC
Berline-Chemie AG,
Glienicker Weg
125,12489 Berlin,
Germany
2814MIG for children
forteibuprofen suspension oral
40mg/ml,
100ml plastic bottle and
measuring syringe 5ml
Farmasierra
Manufacturing S.L.,
Ctra. Irun, Km. 26,
200, San Sebastian de
los Reyes 28700,
Madrid
Spain M01AE01 1377405.09.2014
05.09.2019OTC
Berline-Chemie AG,
Glienicker Weg
125,12489 Berlin,
Germany
607
2815 MigaDol 400 ibuprofen tablets film-coated
400mg,
in blister (10/1x10/,
100/10x10/)
Flamingo
Pharmaceuticals Ltd,
R-662,T.T.C. Ind.
Area, Rabale, Navi
Mumbai 400 701
India M01AE01 12451/220.06.2014
07.05.2018OTC
Flamingo
Pharmaceuticals Ltd,
P.O. Box No
27257,Mumbai 400
071, India
2816 Mildronat meldonium capsules
500mg,
in blister (20/2x10/,
60/6x10/)
Grindex JSC, Krustpils
street 53, LV-1057,
Riga
Latvia C01EB22 1221307.03.2013
07.03.2018PoM
Grindex JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2817 Mildronat meldonium solution for injection
100mg/ml,
5ml ampoules, in blister
(10/2x5/)
HBM Pharma s.r.o.,
Sklabinska 30, 03680,
Martin
Slovakia C01EB22 1302525.11.2013
25.11.2018PoM
Grindex JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2818 Mildronat
meldonium
(meldonium
dihydrate)
capsules250mg,
in blister (40/4x10/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia C01EB22 1629930.12.2016
30.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2819 Mildronat
meldonium
(meldonium
dihydrate)
solution for injection
100mg/ml,
5ml ampoules, in blister
(10/2x5/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga- batch
releaser, Santonika
UAB, 134B Veiveriu
street,Kaunas, LT-
46352, Lithuania-bulk
manufacturer,
packager
Latvia C01EB22 1630030.12.2016
30.12.2021PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2820 Mildronat
meldonium
(meldonium
dihydrate)
capsules
500mg,
in blister (20/2x10/,
60/6x10/)
Grindeks JSC,
Krustpils street 53, LV-
1057, Riga
Latvia C01EB22 1718530.11.2017
30.11.2022PoM
Grindeks JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
608
2821 Mildronat Neo
meldonium
(meldonium
phosphate)
tablets
500mg,
in blister (30/5x6/,
60/10x6/)
Grindex JSC, Krustpils
street 53, LV-1057,
Riga
Latvia C01EB22 1323724.02.2014
24.02.2019PoM
Grindex JSC,
Krustpils street 53,
LV-1057, Riga, Latvia
2822 Milgamma
thiamine (thiamine
hydrochloride),
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin,
lidocaine(lidocaine
hydrochloride)
solution for i/m
injection
100mg/2ml+ 100mg/2ml+
1mg/2ml+ 20mg/2ml,
2ml ampoules (5)
Solupharm
Pharmazeutische
Erzeugnisse GmbH,
Industriestrasse 3, D-
34212 Melsungen
Germany A11DB 1702426.09.2017
26.09.2022PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer str. 7, 71034
Boblingen, Germany
2823 Milgamma
benfotiamine,
pyridoxinbe
(pyridoxine
hydrochloride)
tablets coated
100mg+100mg,
in blisters (30/2x15/,
60/4x15/)
Mauermann -
Arzneimittel KG
Heinrich-Knote-
Strasse 2, Poecking,
Bayern, 82343 - batch
releaser, bulk
manufacturer,
Mauermann -
Arzneimittel KG,
Sankt-Sebastian-
Strasse 13, Aschering,
82343, Germany -
primary packager,
secondary packager
Germany A11DB 1690508.08.2017
08.08.2022PoM
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
2824 Milgamma protekt benfotiamine tablets film-coated
300mg,
in blister (30/3x10/,
60/6x10/, 90/9x10/,
100/10x10/)
Dragenopharm
Apotheker Puschl
GmbH, Gollstrasse 1,
84529 Tittmoning
Germany A11DA03 1471816.07.2015
16.07.2020OTC
Woerwag Pharma
GmbH & Co. KG,
Calwer Str. 7, 71034
Boblingen, Germany
609
2825 Milorex
amiloride
(amiloride
hydrochloride),
hydrochlorothia-
zide
tablets5mg+50mg,
in blister (30/3x10/)
Remedica Ltd,
Limassol Industrial
Estate, Aharnon
street, 3056 Limassol
Cyprus C03EA01 1468903.07.2015
03.07.2020PoM
Remedica Ltd.,
Limassol Industrial
Estate, Aharnon
street, P.O. Box
51706, 3508 Limassol,
Cyprus
2826 Minidiab glipizide tablets5mg,
in blister (30/2x15/)
Pfizer Italia S.r.l.
Localita Marino del
Tronto, 63100 Ascoli
Piceno
Italy A10BB07 1478914.08.2015
14.08.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York, 10017, USA
2827 Minirin
desmopressin
(desmopressin
acetate)
tablets0,1mg,
in plastic container (30)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel -
batch releaser
(Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland - bulk
manufacturer,
packager)
Germany H01BA02 1399226.11.2014
26.11.2019PoM
Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland
2828 Minirin
desmopressin
(desmopressin
acetate)
tablets0,2mg,
in plastic container (30)
Ferring GmbH,
Wittland 11, Postfach
21 45, D-24109 Kiel -
batch releaser
(Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland - bulk
manufacturer,
packager)
Germany H01BA02 1399326.11.2014
26.11.2019PoM
Ferring International
Center SA, Chemin
de la Vergognausaz
50, 1162 Saint-Prex,
Switzerland
610
2829 Mircera
methoxy
polyethylene glycol-
epoetin beta
solution for s/c and
i/v injection
0,05mg/0,3ml, 0,3ml pre-
filled syringe (1)
Roche Diagnostics
GmbH Sandhofer
Strasse 116 D-68305
Mannheim
Germany B03XA03 1369524.07.2014
24.07.2019PoM
F. Hoffmann-La
Roche Ltd.,
Grenzacherstrasse 124
CH-4070 Basel,
Switzerland
2830 Mirena levonorgestrelintrauterine delivery
system
52mg,
in blister (1)
Bayer Oy, Pansiontie
47, Turku, FI-20210Finland G02BA03 15649
19.05.2016
19.05.2021PoM
Bayer Oy, Pansiontie
47, Turku, FI-20210,
Finland
2831 Mirolute misoprostol tablets
200mcg,
in blister (4),
in plastic container (4)
Obninsk Chemical
Pharmaceutical
Company CJSC,
Kaluga reg.,
Kiyevskoe str.,b.103,
b.107, Obninsk
Russia G02AD06 1703426.09.2017
26.09.2022PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
2832 Miropriston mifepristone tablets200mg,
in blister (3/1x3/)
Obninsk Chemical
Pharmaceutical
Company CJSC,
249036, 4 Koroleva
str., Obninsk, Kaluga
region
Russia G03XB01 1642310.02.2017
10.02.2022PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2833 Mirtazapine Canon mirtazapine tablets film-coated
30mg,
in blister, (30/3x10/,
30/1x30/)
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo
Russia N06AX11 1527604.02.2016
04.02.2021PoM
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo,
Russia
2834 Mirtazapine Canon mirtazapine tablets film-coated45mg,
in blister (30/3x10/)
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo
Russia N06AX11 1527704.02.2016
04.02.2021PoM
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo,
Russia
611
2835 Mirvaso 3mg/g gel
brimonidine
(brimonidine
tartrate)
gel
3,3mg/g,
2g, 10g and 30g laminated
or polyfoil plastic tube
Laboratoires
Galderma Z.I.
Montdesir, 74540
Alby-sur-Cheran
France D11AX21 1502702.12.2015
02.12.2020PoM
Galderma SA,
Zugerstrasse 8, CH-
6330 Cham,
Switzerland
2836Mitoxantron
Ebewe 2mg/ml
mitoxantrone
(mitoxantrone
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
10ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01DB07 1617423.11.2016
23.11.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
2837Mitoxantron
Ebewe 2mg/ml
mitoxantrone
(mitoxantrone
hydrochloride)
concentrate for
solution for infusion
2mg/ml,
5ml glass vial (1)
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee
Austria L01DB07 1617523.11.2016
23.11.2021PoM
EBEWE Pharma Ges.
m.b.H. Nfg. KG,
Mondseestrasse 11, A-
4866 Unterach am
Attersee, Austria
2838 Mixtard 30insulin human
(recombinant DNA)
suspension for
injection
100IU/ml,
10ml glass vial (1)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AD01 1370124.07.2014
24.07.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2839 Mixtard 30insulin human
(recombinant DNA)
suspension for
injection
100IU/ml,
10ml glass vial (1)
Novo Nordisk
Production SAS, 45
avenue d`Orleans, F-
28000, Chartres
France A10AD01 1715907.11.2017
07.11.2022PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2840 Mixtard 30 Penfill insulin humansuspension for
injection
100IU/ml,
3ml glass cartridges (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AD01 13510/102.07.2014
30.05.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
2841 Moditen depo
fluphenazine
(fluphenazine
decanoate)
solution for i/m
injection
25mg/ml,
1ml ampoules, in blister
(5/1x5/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia N05AB02 1616723.11.2016
23.11.2021PoM/UC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
612
2842 Momederm
mometasone
(mometasone
furoate)
cream1mg/g,
15g, 30g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AC13 12221/105.09.2014
07.03.2018PoM
Valeant LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2843 Momederm
mometasone
(mometasone
furoate)
ointment for
external use
1mg/g,
15g aluminium tube
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D07AC13 1636530.12.2016
30.12.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
2844 Mononine 1000
human blood
coagulation factor
IX
powder and solvent
for solution for
injection or infusion
1000IU; I pack (glass vial
with powder and 10ml
glass vial with solvent), II
pack ( filter transfer
device 20/20, N1 syringe
10ml, N1 venipuncture
set, N2 alcohol swabs, N1
non-sterile plaster)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg-batch
releaser, CSL Behring
L.L.C., 1201 N Kinzie
Ave, Bradley, Illinois
(IL) 60915, USA-bulk
manufacturer,
packager
Germany B02BD04 1536826.02.2016
26.02.2021PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
2845 Mononine 500
human blood
coagulation factor
IX
powder and solvent
for solution for
injection or infusion
500IU; I pack (glass vial
with powder and 5ml
glass vial with solvent), II
pack ( filter transfer
device 20/20, N1 syringe
10ml, N1 venipuncture
set, N2 alcohol swabs, N1
non-sterile plaster)
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg-batch
releaser, CSL Behring
L.L.C., 1201 N Kinzie
Ave, Bradley, Illinois
(IL) 60915, USA-bulk
manufacturer,
packager
Germany B02BD04 1536926.02.2016
26.02.2021PoM
CSL Behring GmbH,
Emil-von-Behring-
Strasse 76, 35041
Marburg, Germany
613
2846
Monosorb XL
60mg Prolonged-
Release Tablets
isosorbide
mononitrate
tablets prolonged-
release
60mg,
in blister (28/2x14/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser (dosage form
manufacturer,
packager - Dexcel
Ltd., 1 Dexcel St., Or-
Akiva 30600, Israel)
UK C01DA14 1258607.06.2013
07.06.2018PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields
Industrial Estate,
Daventry,
Northamptonshire,
NN11 8PB, UK
2847Montelukast 10mg
film-coated tablets
montelukast
(montelukast
sodium)
tablets film-coated10mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK R03DC03 1485615.09.2015
15.09.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2848 Montevizin
tetryzoline
(tetryzoline
hydrochloride)
drops eye
0,5mg/ml,
10ml glass vial and
measuring dropper
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemomont d.o.o.,
81000,Podgorica, Ilije
Plamenca str. bb,
Montenegro-bulk
manufacturer,
packager
Serbia S01GA02 1627619.12.2016
19.12.2021OTC
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
614
2849 Montezim-10
montelukast
(montelukast
sodium)
tablets10mg,
in blister (30/3x10/)
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.)
India R03DC03 1519530.12.2015
30.12.2020PoM
Zim Laboratories
Ltd., Ground Floor,
Sadoday Gyan,
Nelson Square,
Chhindwara Road,
Nagpur-440 013,
India
2850 Montezim-5
montelukast
(montelukast
sodium)
tablets chewable5mg,
in blister (30/3x10/)
Zim Laboratories Ltd.,
B-21/22, MIDC Area,
Kalmeshwar-441 501,
Dist. Nagpur (M.S.)
India R03DC03 1527804.02.2016
04.02.2021PoM
Zim Laboratories
Ltd., Ground Floor,
Sadoday Gyan,
Nelson Square,
Chhindwara Road,
Nagpur-440 013,
India
2851 Montol
montelukast
(montelukast
sodium)
tablets chewable5mg,
in blister (28/4x7/)
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia - batch
releaser (bulk
manufacturer -
Pharmacare Pcl,
Beitunia Industrial
Zone, P.O. Box. 677,
Raballah, Palestine)
Cyprus R03DC03 12684/118.12.2014
17.07.2018PoM
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia, Cyprus
615
2852 Montol
montelukast
(montelukast
sodium)
tablets chewable10mg,
in blister (28/4x7/)
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia - batch
releaser (bulk
manufacturer -
Pharmacare Pcl,
Beitunia Industrial
Zone, P.O. Box. 677,
Raballah, Palestine)
Cyprus R03DC03 12685/118.12.2014
17.07.2018PoM
Delorbis
Pharmaceuticals Ltd.,
17 Athinon Street,
Ergates Industrial
Area, 2643 Ergates,
P.O. Box 28629, 2081
Lefkosia, Cyprus
2853 Monural
fosfomycin
(fosfomycin
trometamol)
granules for oral
solution
3g,
8g sachets (1, 2)
Zambon Switzerland
Ltd., Via Industria 13,
CH-6814, Cadempino
Switzerland J01XX01 14688/130.06.2016
29.06.2020PoM
Zambon S.P.A., Via
Lillo Del Duca, 10,
Bresso, 20091, Italy
2854 Moreal plus dexpanthenol spray nasal
10mg/ml,
20ml plastic container
(140 dose)
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel -
batch releaser (dosage
form manufacturer,
packager - Ursapharm
Arzneimittel GmbH,
Industriestrasse 66129
Saarbrucken,
Germany)
Germany R01AX10 1278514.08.2013
14.08.2018OTC
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel,
Germany
616
2855
Morfina
hydrohlorids-
Kalceks
morphine
hydrochloride
solution for i/v, i/m
and s/c injection
10mg/ml,
1ml ampoules in blister
(10/2x5/)
Kalceks JSC, 53
Krustpils Street, Riga,
LV-1057 - batch
releaser (HBM
Pharma s.r.o.,
Sklabinska 30, 03680
Martin, Slovakia-bulk
manufacturer,
packager)
Latvia N02AA01 1375605.08.2014
05.08.2019PoM/UC
Kalceks JSC, 53
Krustpils Street, Riga,
LV-1057, Latvia
2856Morphine
hydrochloride
morphine
(morphine
hydrochloride)
solution for injection
10mg/ml,
1ml ampoules,
in blister (100/20x5/)
"KPE" Zdorovje
narodu" LLC, 61002,
Kharkov, Melnikova
str. 41
Ukraine N02AA01 1627119.12.2016
19.12.2021PoM/UC
"KPE" Zdorovje
narodu" LLC, 61013,
Kharkov, Sevchenko
str. 22, Ukraine
2857 Motilium domperidone tablets film-coated
10mg,
in blister (10/1x10/,
30/1x30/)
Janssen-Cilag,
Domaine de
Maigremont, 27100
Val de Reuil
France A03FA03 1418306.02.2015
06.02.2020PoM
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
2858 Motoricum domperidone tablets10mg,
in blister (30/3x10/)
Medochemie Ltd., 2
Michael Eracleous
Street, Agios
Athanasios Industrial
Area, 4101, Agios
Athanassios, Limassol
Cyprus A03FA03 1231422.03.2013
22.03.2018PoM
Medochemie Ltd.,
P.O. Box 51409, 3505
Limassol, Cyprus
2859 Movalis meloxicam tablets7,5mg,
in blister (20/2x10/)
Boehringer Ingelheim
Ellas A.E., 5th km,
Paiania-Markopoulo,
194 00 Koropi
Greece M01AC06 1650617.03.2017
17.03.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
617
2860 Movalis meloxicam tablets15mg,
in blister (20/2x10/)
Boehringer Ingelheim
Ellas A.E., 5th km,
Paiania-Markopoulo,
194 00 Koropi
Greece M01AC06 1650717.03.2017
17.03.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
2861 Movalis meloxicamsolution for i/m
injection
15mg/1,5ml,
1,5ml ampoules (3)
Boehringer Ingelheim
Espana S.A., Prat de la
Riba, 50, 08174 Sant
Cugat del Valles,
Barcelona
Spain M01AC06 1716230.11.2017
30.11.2022PoM
Boehringer Ingelheim
International GmbH,
Binger Strasse 173,
55216 Ingelheim am
Rhein, Germany
2862 Moviprep
sachet A-macrogol
(macrogol 3350),
sodium sulfate,
sodium chloride,
potassium chloride;
sachet B-ascorbic
acid, sodium
ascorbate
powder for oral
solution
sachet A-100g+7.5g+
2.691g+1.015g, sachet B-
4.7g+5.9g,
(4/(2) sachetA(111.896 g)
+ (2) sachetB(10.6 g)/)
Norgine Limited,
New Road, Tir-Y-
Berth, Hengoed, Mid
Glamorgan, CF82 8SJ
UK A06AD 1480804.09.2015
04.09.2020PoM
Norgine B.V.,
Hogehilweg 7,
1101CA Amsterdam
ZO, the Netherlands
2863 Movix meloxicam tablets7,5mg,
in blister (20/2x10/)
Unipharm JSC, 3
Traiko Stanoev Str.,
Sofia 1797
Bulgaria M01AC06 1673105.06.2017
05.06.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2864 Movix meloxicam tablets15mg,
in blister (20/2x10/)
Unipharm JSC, 3
Traiko Stanoev Str.,
Sofia 1797
Bulgaria M01AC06 1673205.06.2017
05.06.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2865 Moxicin
moxifloxacin
(moxifloxacin
hydrochloride)
drops eye5mg/ml,
5ml plastic vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01AE07 14715
16.07.2015
16.07.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
618
2866 Moxicin
moxifloxacin
(moxifloxacin
hydrochloride)
solution for infusion
400mg/250ml, 250ml
plastic pack, in light-proof
bag
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaJ01MA14 14716
16.07.2015
16.07.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2867 Moxin
moxifloxacin
(moxifloxacin
hydrochloride)
tablets coated400mg,
in blister (5/1x5/)
GM Pharmaceuticals
Ltd, Phonichala 65,
0165 Tbilisi
Georgia J01MA14 1667211.05.2017
11.05.2022PoM
GM Pharmaceuticals
Ltd, Phonichala 65,
0165 Tbilisi, Georgia
2868 Moxi-Tech
moxifloxacin
(moxifloxacin
hydrochloride)
solution for infusion1,6mg/ml,
250ml plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaJ01MA14 14270
20.02.2015
20.02.2020PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
2869 Mucaltin althaeae officinalis tablets50mg,
in strip (10)
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260
RussiaR05CA;
herbal drug14071
19.12.2014
19.12.2019OTC
Tatchempharmprepar
aty JSC, 420091
Kazan, str.
Belomorskaya 260,
Russia
2870 Mucaltin althaea officinalis tablets
50mg,
in strip (10),
in plastic bottle (30)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
UkraineR05CA;
herbal drug16950
05.09.2017
05.09.2022OTC
Experimental Plant
"GNCLS" LLC, 61057,
Kharkov, Vorobyova
str., 8, Ukraine
2871 Mucosat-Belmed
chondroitin sulfate
(chondroitin sulfate
sodium)
solution for i/m
injection
100mg/ml,
2ml ampoules (5/1x5/,
10/2x5/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus M01AX25 1713507.11.2017
07.11.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
619
2872 Multimax vitamins, minerals tablets film-coated
1mg+5mcg+10mg+60mg+
1,5mg+ 1,7mg+2mg+
20mg+6mcg+
10mg+10mcg+
400mcg+35,5mg+20mg+9
mg+10mg+1mg+15mg+
12,5mcg+12,5mcg+2,5mg
+5mcg+ 2,5mÖ�g+5mcg+
5mcg+12,5mcg+
150mcg+20mg+
22mg+125mcg,
in blister (30/1x30/,
60/2x30/)
Unipharm Inc., 200
Hick str., Westbury,
New York 11590
USA A11AA04 1213701.02.2013
01.02.2018OTC
Unipharm Inc., 350,
5th avenue, suite
6701, New York,
10118, USA
2873 Multivitamin
vitamin A, vitamin
D3, vitaminE,
vitamin B1,vitamin
B2, vitamin B6,
nicotinamide,
vitamin B12, D-
panthenol
solution for injection
15,000IU+
1,000IU+20mg+
10mg+6.85mg+
3mg+35mg+
0.05mg+25mg, 100ml
glass vial (12)
Alfasan International
B.V., Kuipersweg 9-
3449 JA Woerden
the Netherlands
QA11B;
veterinary
drug
1449815.05.2015
15.05.2020PoM
Alfasan International
B.V., Kuipersweg 9-
3449 JA Woerden,
the Netherlands
2874
Multivitamin
solution for
injection
vitamin A, vitamin
D3, vitamin E,
vitamin B1, vitamin
B2, vitamin B6,
nicotinamide,
dexpanthenol,
vitamin B12
solution for injection
15000IU/ml+ 25mcg/ml+
20mg/ml+ 10mg/ml+
5mg/ml+3mg/ml+
35mg/ml+ 25mg/ml+
25mcg/ml, 100ml glass
bottle
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP
UK
QA11BA
veterinary
drug
1301325.11.2013
25.11.2018PoM
Norbrook
Laboratories Limited,
Station Works
Camlough Road,
Newry, Co. Down,
BT35 6JP, UK
620
2875 Mycamine
micafungin
(micafungin
sodium)
powder lyophilized
for solution for
infusion
100mg,
glass vial (1)
Astellas Ireland Co.,
Kerry County,
Killorglin- batch
releaser, secondary
packager, Astellas
Pharma Tech Co.,
Ltd., 30 Toidesakae-
machi, Takaoka city,
Toyama 939-1118,
Japan-bulk
manufacturer,
primary packager
Ireland J02AX05 1525029.12.2015
29.12.2020PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
2876 Mycamine
micafungin
(micafungin
sodium)
powder lyophilized
for solution for
infusion
50mg,
glass vial (1)
Astellas Ireland Co.,
Kerry County,
Killorglin- batch
releaser, secondary
packager, Astellas
Pharma Tech Co.,
Ltd., 30 Toidesakae-
machi, Takaoka city,
Toyama 939-1118,
Japan-bulk
manufacturer,
primary packager
Ireland J02AX05 1525129.12.2015
29.12.2020PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
2877 Mycoseptinundecylenic acid,
zinc undecylinateointment
1500mg+6000mg, 30g
aluminium tube
Zentiva, k.s., U
kabelovny 130, 102 37
Praha 10, Dolni
Mecholupy
Czech Republic D01AE54 1311824.12.2013
24.12.2018OTC
Zentiva, k.s., U
kabelovny 130, 102
37 Praha 10, Dolni
Mecholupy, Czech
Republic
2878 Mycosyst fluconazole capsules50mg,
in blister (7)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary J02AC01 1470016.07.2015
16.07.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
621
2879 Mycosyst fluconazole capsules100mg,
in blister (28/4x7/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary J02AC01 1470116.07.2015
16.07.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2880 Mycosyst fluconazole capsules150mg,
in blister (1, 2)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary J02AC01 1470216.07.2015
16.07.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2881 Mycosyst fluconazole solution for infusion2mg/ml,
100ml glass vial
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary J02AC01 1470316.07.2015
16.07.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2882 Mydocalm
tolperisone
(tolperisone
hydrochloride)
tablets film-coated50mg,
in blister (30/3x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M03BX04 1306025.11.2013
25.11.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2883 Mydocalm
tolperisone
(tolperisone
hydrochloride)
tablets film-coated150mg,
in blister (30/3x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M03BX04 1306125.11.2013
25.11.2018PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
2884Mydocalm solution
for injection
tolperisone
(tolperisone
hydrochloride),
lidocaine (lidocaine
hydrochloride)
solution for injection100mg/ml+ 2,5mg/ml,
1ml ampoules (5)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary M03BX04 1442714.04.2015
14.04.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
2885 Mydoptic
phenylephrine
(phenylephrine
hydrochloride)
drops eye25mg/ml; (1) and (10)
plastic vial-droppers 10ml
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01FB01 12686/1
28.11.2014
17.07.2018PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
622
2886 Myfortic
mycophenolic acid
(mycophenolate
sodium)
tablets gastro-
resistant
180mg,
in blister (120/12x10/)
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein
Switzerland L04AA06 1370424.07.2014
24.07.2019PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
2887 Myfortic
mycophenolic acid
(mycophenolate
sodium)
tablets gastro-
resistant
180mg,
in blister (120/12x10/)
Novartis Pharma
Produktions GmbH,
Oeflinger Strasse 44,
79664 Wehr
Germany L04AA06 1697705.09.2017
05.09.2022PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
2888 Myoxant
cisatracurium
(cisatracurium
besylate)
solution for i/v
injection
2mg/ml,
2.5ml glass vials (5)
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaM03AC11 14495
15.05.2015
15.05.2020PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
2889 Mythro 500
azithromycin
(azithromycin
dihydrate)
tablets film-coated500mg,
in blister (3/1x3/)
Akriti
Pharmaceuticals Pvt.
Ltd., Plot No. D-10, D-
11, M.I.D.C. Indl.
Estate, Nira Road,
Jejuri, Tal. Purandar
(Saswad), Dist. Pune-
412 303, Maharashtra
India J01FA10 1613510.11.2016
10.11.2021PoM
Akriti
Pharmaceuticals Pvt.
Ltd., 117, Block No. 2,
Emerald Plaza,
Hiranandani
Meadows, Barrister
Nath Pai Road, Thane
(West) 400 610, India
2890 5-NOK nitroxoline tablets coated50mg,
in plastic container (50)
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana-
batch releaser, Lek
Pharmaceuticals d.d.,
Kolodvorska cesta 27,
Menges, 1234,
Slovenia-bulk
manufacturer,
packager
Slovenia J01XX07 1435025.03.2015
25.03.2020PoM
Lek Pharmaceuticals
d.d., Verovskova Str.
57, 1526 Ljubljana,
Slovenia
623
2891 Najatox
Naja venom,
Methylsalicylate,
Camphora, Eucalipt
oil
ointment for
external use
12MU/100g+ 4g/100g+
3g/100g+2g/100g, 20g
aluminium tube
Mekophar Chemical-
Pharmaceutical JSC,
297/5 Ly Thoung Kiet
Street, Ward 15,
District 11, Ho Chi
Minh
VietnamM02AC
herbal drug12788
14.08.2013
14.08.2018OTC
Mekophar Chemical-
Pharmaceutical JSC,
297/5 Ly Thoung Kiet
Street, Ward 15,
District 11, Ho Chi
Minh, Vietnam
2892 Naklofen
diclofenac
(diclofenac
diethylamine)
gel10mg/g,
60g aluminium tube
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M02AA15 1352330.05.2014
30.05.2019OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2893 Naklofendiclofenac
(diclofenac sodium)
tablets prolonged
release film-coated
100mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01A B05 1357410.06.2014
10.06.2019PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2894 Naklofendiclofenac
(diclofenac sodium)
tablets gastro-
resistant
50mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01AB05 1652217.03.2017
17.03.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2895 Naklofendiclofenac
(diclofenac sodium)suppositories rectal
50mg,
in strip (10/2x5/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01AB05 1662525.04.2017
25.04.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2896 Naklofendiclofenac
(diclofenac sodium)solution for injection
75mg/3ml,
3ml ampoules (5)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01AB05 1667511.05.2017
11.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2897 Naklofen duodiclofenac
(diclofenac sodium)
capsules prolonged-
release
75mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01AB05 1536726.02.2016
26.02.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
624
2898 Nakom levodopa, carbidopa tablets250mg+25mg,
in blister (100/10x10/)
Lek d.d., Verovskova
Str. 57, 1526 LjubljanaSlovenia N04BA02 14166
24.12.2014
24.12.2019PoM
Lek d.d., Verovskova
Str. 57, 1526
Ljubljana, Slovenia
2899 Nalgesinnaproxen (naproxen
sodium)tablets film-coated
275mg,
in blister (10/1x10/,
20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01AE02 1564824.05.2016
24.05.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2900 Nalgesin fortenaproxen (naproxen
sodium)tablets film-coated
550mg,
in blister (10/1x10/,
20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia M01AE02 1580620.07.2016
20.07.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2901
NANIPRUS 30mg
powder and
solvent for solution
for infusion
nitroprusside
(nitroprusside
sodium)
powder and solvent
for solution for
infusion
30mg,
ampoule with powder (1),
5ml solvent in ampoule
and black light-proof
plastic bag
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria C02DD01 1541109.03.2016
09.03.2021PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
2902 Naphthizin
naphazoline
(naphazoline
nitrate)
drops nasal0,5mg/ml,
10ml plastic vial
PJSC "Farmak",
04080, Kiev, Frunze
str. 74
Ukraine R01AA08 1254706.06.2013
06.06.2018OTC
PJSC "Farmak",
04080, Kiev, Frunze
str. 63, Ukraine
2903 Naphthizin
naphazoline
(naphazoline
nitrate)
drops nasal0,1mg/ml,
10ml plastic vial
PJSC "Farmak",
04080, Kiev, Frunze
str. 74
Ukraine R01AA08 1254806.06.2013
06.06.2018OTC
PJSC "Farmak",
04080, Kiev, Frunze
str. 63, Ukraine
625
2904Naphthyzin-
Arsanitnaphazoline spray nasal
1mg/ml,
10ml glass or plastic vial
and dispenser
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA08 15124
15.12.2015
15.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2905Naphthyzin-
Arsanitnaphazoline drops nasal
1mg/ml,
5ml and 10ml plastic vial-
dropper
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA08 16124
10.11.2016
10.11.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2906Naphthyzin-
Arsanitnaphazoline drops nasal
0.5mg/ml,
5ml and 10ml plastic vial-
dropper
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA08 16125
10.11.2016
10.11.2021OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
626
2907Naphthyzin-
Arsanit-Snaphazoline drops nasal
0.5mg/ml,
10ml glass vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA08 15122
15.12.2015
15.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2908Naphthyzin-
Arsanit-Snaphazoline drops nasal
1mg/ml,
10ml glass vial
Arsanit Ltd, 110
Yerevanyan str.,
Masis- batch releaser,
secondary packager,
PharmaTech CJSC,
111 Raffi str., 0064,
Yerevan, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA08 15123
15.12.2015
15.12.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2909Naproxen 250mg
Tabletsnaproxen tablets
250mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK M01AE02 1522622.12.2015
22.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
627
2910Naproxen 500mg
Tabletsnaproxen tablets
500mg,
in blister (28/2x14/)
Accord Healthcare
Limited, Sage House, 319
Pinner Road, North
Harrow, Middlesex, HA1
4HF - batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK M01AE02 1522722.12.2015
22.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
2911 Naproxen-Akri naproxen tablets250mg,
in blister (30/3x10/)
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29
Russia M01AE02 1523023.12.2015
23.12.2020PoM
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29, Russia
2912 Naratriptan
naratriptan
(naratriptan
hydrochloride)
tablets film-coated2,5mg,
in blister (2/2x1/, 6/6x1/)
Chanelle Medical,
Loughrea, Co. Galway Ireland N02CC02 12542
06.06.2013
06.06.2018PoM
Ritm Farm LTD, 11/2
Totovents Street,
Apartment 34,
Yerevan, Armenia
2913 Nasivin
oxymetazoline
(oxymetazoline
hydrochloride)
drops nasal0,25mg/ml,
10ml glass bottle
Merck KGaA,
Frankfurter Strasse
250, 64 293
Darmstadt
Germany R01AA05 1549005.04.2016
05.04.2021OTC
Mecrk
Selbstmedikation
GmbH,
Roesslerstrasse 96,
64293, Darmstadt,
Germany
628
2914 Nasivin
oxymetazoline
(oxymetazoline
hydrochloride)
drops nasal0,1mg/ml,
5ml glass bottle
Merck KGaA,
Frankfurter Strasse
250, 64 293
Darmstadt
Germany R01AA05 1549105.04.2016
05.04.2021OTC
Mecrk
Selbstmedikation
GmbH,
Roesslerstrasse 96,
64293, Darmstadt,
Germany
2915 Nasivin
oxymetazoline
(oxymetazoline
hydrochloride)
drops nasal0,5mg/ml,
10ml glass bottle
Merck KGaA,
Frankfurter Strasse
250, 64 293
Darmstadt
Germany R01AA05 1549205.04.2016
05.04.2021OTC
Mecrk
Selbstmedikation
GmbH,
Roesslerstrasse 96,
64293, Darmstadt,
Germany
2916 Nasivin
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal0,5mg/ml,
10ml plastic bottle
Merck KGaA,
Frankfurter Strasse
250, 64 293
Darmstadt
Germany R01AA05 1549305.04.2016
05.04.2021OTC
Mecrk
Selbstmedikation
GmbH,
Roesslerstrasse 96,
64293, Darmstadt,
Germany
2917 Nasonex
mometasone
(mometasone
furoate)
spray nasal
(suspension)
50mcg/dose,
18g (140 dose) plastic
bottle with spray pump
Schering-Plough Labo
N.V., Industriepark
30 B-2220, Heist-op-
den-Berg
Belgium R01AD09 1445604.05.2015
04.05.2020PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
2918 Natalsid sodium alginate suppositories rectal250mg,
(10/2x5/)
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia B02BC 1663725.04.2017
25.04.2022OTC
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
2919 Nature Tears Liqvodextran (dextran
70), hypromellosedrops eye
1mg/ml+3mg/ml, 10ml
vial-dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01XA20 15447
02.04.2016
02.04.2021OTC
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of Armenia
629
2920 Navoproxin Plus
meclizine
hydrochloride,
pyridoxine
hydrochloride
tablets25mg+50mg,
in blister (20/2x10/)
Delta Pharma S.A.E.,
Industrial zone B4,
10th of Ramadan city
Egypt R06AE05 1506702.12.2015
02.12.2020PoM
Delta Pharma S.A.E.,
Industrial zone B4,
10th of Ramadan city,
Egypt
2921 Naxogin nimorazole tablets500mg,
glass vial (6)
Pfizer Italia S.r.l.
Localita Marino del
Tronto, 63100 Ascoli
Piceno
Italy P01AB06 1485918.09.2015
18.09.2020PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd Street, New
York, 10017, USA
2922 Naziloc
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal0.5mg/ml,
10ml plastic bottle
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA05 14773
03.08.2015
03.08.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2923 Naziloc
oxymetazoline
(oxymetazoline
hydrochloride)
drops nasal
0.5mg/ml,
5ml and 10ml plastic
bottle-dropper
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA05 14775
03.08.2015
03.08.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
630
2924 Naziloc
oxymetazoline
(oxymetazoline
hydrochloride)
drops nasal
0.25mg/ml,
5ml and 10ml plastic
bottle-dropper
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA05 14776
03.08.2015
03.08.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2925 Naziloc
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal0.25mg/ml,
10ml plastic bottle
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA05 14777
03.08.2015
03.08.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2926 Naziloc Baby
oxymetazoline
(oxymetazoline
hydrochloride)
drops nasal
0.1mg/ml,
5ml and 10ml plastic
bottle-dropper
Arsanit Ltd, 110
Yerevanyan str.,
Masis-batch releaser,
secondary packager,
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia-bulk
manufacturer,
primary packager
Republic of
ArmeniaR01AA05 14774
03.08.2015
03.08.2020OTC
Arsanit Ltd, 110
Yerevanyan str.,
Masis, Republic of
Armenia
2927 Nazol
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal
0,5mg/ml,
15ml, 30ml plastic vial
with pump dispencer
Istituto De Angeli
S.r.l., 50066 Reggello
(Florence),
Loc.,Prulli, 103/c
Italy R01AA05 1554825.04.2016
25.04.2021OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
631
2928 Nazol Advance
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal0,5mg/ml,
15ml, 30ml plastic bottle
Istituto De Angeli
S.r.l., 50066 Reggello
(Florence),
Loc.,Prulli, 103/c
Italy R01AA05 1554925.04.2016
25.04.2021OTC
Bayer Consumer Care
AG, Peter Merian
Strasse 84, 4052 Basel,
Switzerland
2929 Nazol Baby
phenylephrine
(phenylephrine
hydrochloride)
drops nasal
1,25mg/ml,
10ml, 15ml plastic bottle
(1)
Istituto De Angeli
S.r.l., 50066 Reggello
(Florence),
Loc.,Prulli, 103/c
Italy R01AA04 12156/118.06.2015
01.02.2018OTC
Bayer Consumer Care
AG, Peter Merian
Strasse 84, 4052 Basel,
Switzerland
2930 Nazol Kids
phenylephrine
(phenylephrine
hydrochloride)
spray nasal with
eucalypt
2,5mg/ml, 10ml plastic
bottle (1) and 15ml plastic
bottle (1)
Istituto De Angeli
S.r.l., 50066 Reggello
(Florence),
Loc.,Prulli, 103/c
Italy R01AA04 12157/125.08.2015
01.02.2018OTC
Bayer Consumer Care
AG, Peter Merian-
Strasse 84, 4052 Basel,
Switzerland
2931 Nebido
testosterone
(testosterone
undecanoate)
solution for injection250mg/ml,
4ml ampoule
Bayer Pharma AG, D-
13342 Berlin Germany G03BA03 12645
04.07.2013
04.07.2018PoM
Bayer Pharma AG,
Mullerstrasse 178,
13342 Berlin,
Germany
2932 Nebiletnebivolol (nebivolol
hydrochloride)tablets
5mg,
in blister (7/1x7/,
14/1x14/, 28/2x14/)
Berlin-Chemie A.G.,
Glienicker Weg 125 D-
12489 Berlin -
packager, batch
releaser (Berlin-
Chemie AG,
Tempelhofer Weg 83,
D-12347 Berlin,
Germany - bulk
manufacturer)
Germany C07AB12 1383618.09.2014
18.09.2019PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
632
2933 Nebilet Plus 5/12.5
nebivolol (nebivolol
hydrochloride),
hydrochloro-
thiazide
tablets film-coated5mg+12,5mg,
in blister (28/2x14/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany C07BB12 1625719.12.2016
19.12.2021PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
2934 Nebilet Plus 5/25
nebivolol (nebivolol
hydrochloride),
hydrochloro-
thiazide
tablets film-coated5mg+25mg,
in blister (28/2x14/)
Berlin-Chemie
A.G.,Glienicker Weg
125, D-12489 Berlin-
batch releaser,
packager, Berlin-
Chemie A.G.,
Tempelhofer Weg 83,
D-12347
Berlin,Germany-bulk
manufacturer
Germany C07BB12 1625819.12.2016
19.12.2021PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
2935 Nebivolol STADAnebivolol (nebivolol
hydrochloride)tablets
5mg,
in blisters (100/10x10/)
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel
Germany C07AB12 13215/125.12.2017
24.02.2019PoM
STADA Arzneimittel
AG, Stadastrasse 2-18,
D-61118 Bad Vilbel,
Germany
2936 Neiromidin
ipidacrine
(ipidacrine
hydrochloride)
tablets20mg,
in blister (50/5x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06DA05 1571922.06.2016
22.06.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
633
2937 Neiromidin
ipidacrine
(ipidacrine
hydrochloride)
solution for i/m and
s/c injection
5mg/ml,
1ml ampoules (10)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114-batch
releaser, Sopharma
JSC, str. Iliensko
shosse 16, 1220 Sofia,
Bulgaria-bulk
manufacturer,
packager
Latvia N06DA05 1575704.07.2016
04.07.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
2938 Neiromidin
ipidacrine
(ipidacrine
hydrochloride)
solution for i/m and
s/c injection
15mg/ml,
1ml ampoules (10)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114-batch
releaser, Sopharma
JSC, str. Iliensko
shosse 16, 1220 Sofia,
Bulgaria-bulk
manufacturer,
packager
Latvia N06DA05 1575804.07.2016
04.07.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
2939Nelsons Sootha
ChildrenBryonia dioica syrup
6C,
150ml plastic bottle and
measuring cup
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH
UK
R05X
homeopathic
drug
1351230.05.2014
30.05.2019PoM
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH,
UK
2940 Nemotan nimodipine tablets film-coated30mg,
in blister (30/3x10/)
Medochemie Ltd
(Factory AZ), 2
Michael Erakleous
street, Agios
Athanassios Industrial
Area, 4101 Agios
Athanassios, Limassol
Cyprus C08CA06 1706105.10.2017
05.10.2022PoM
Medochemie Ltd., 1-
10
Constantinoupoleos
street, 3011 Limassol,
Cyprus
2941 Nemozole albendazole tablets film-coated400mg,
in blister (1)
Ipca Laboratories Ltd,
P.O. Sejavta, Dist.
Ratlam 457 002,
Madhya Pradesh
India P02CA03 1358110.06.2014
10.06.2019PoM
Ipca Laboratories Ltd,
48, Kandivli Ind.
Estate, Mumbai 400
067, India
634
2942 Nemozole albendazole suspension oral20mg/ml,
20ml plastic container
Ipca Laboratories Ltd,
P.O. Sejavta, Dist.
Ratlam 457 002,
Madhya Pradesh
India P02CA03 1358210.06.2014
10.06.2019PoM
Ipca Laboratories Ltd,
48, Kandivli Ind.
Estate, Mumbai 400
067, India
2943 Neoderm
gramicidin,
neomycin
(neomycin sulfate),
nystatin,
triamcinolone
acetonide
cream
0,25mg/g+ 2,5mg/g+
100000IU/g+ 1mg/g,
10g and 20g aluminium
tube
Birzeit
Pharmaceutical
Company (BPC),
Ramallah,Industrial
Zone
Palestine D07X 1402926.11.2014
26.11.2019PoM
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
2944 Neosmectin
diosmectite
(smectite
dioctaedric)
powder for oral
suspension with
orange flavour
3000mg,
3,76g sachets (3, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A07BC05 12656/122.06.2015
04.07.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2945 Neosmectin
diosmectite
(smectite
dioctaedric)
powder for oral
suspension with
vanilla flavour
3000mg,
3,76g sachets (3, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/19
Russia A07BC05 12657/122.06.2015
04.07.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2946 Neosmectin
diosmectite
(smectite
dioctaedric)
powder for oral
suspension with
rasberry flavour
3000mg,
3,76g sachets (3, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/20
Russia A07BC05 12658/122.06.2015
04.07.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2947 Neosmectin
diosmectite
(smectite
dioctaedric)
powder for oral
suspension with
lemon flavour
3000mg,
3,76g sachets (3, 10)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/21
Russia A07BC05 12659/122.06.2015
04.07.2018OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
635
2948 Neoton
phosphocreatine
(phosphocreatine
sodium)
powder lyophilized
for solution for
infusion
1000mg,
50ml glass vial, solvent in
glass vial, infusion system
Alfa Wassermann
S.p.A., Via Enrico
Fermi, 1-65020,
Alanno
Italy C01EB06 1409518.12.2014
18.12.2019PoM
Alfa Wassermann
S.p.A., Via Enrico
Fermi, 1-65020,
Alanno, Italy
2949 Neoviroxodihydroacridiny
lacetate sodium
solution for i/m
injection
125mg/ml,
2ml ampoules (5)
FSBI Russian
Cardiology Research
and Production
Complex of the
Ministry of Health of
the Russian
Federation-
Experimental
production of
biomedical
preparations, 15-a,
3rd Cherepkovskaya
St., 121552, Moscow
Russia L03A 1437716.04.2015
16.04.2020PoM
Pharmsynthez OJSC,
188663, Leningrad
region, Vsevolzhsky
district, urban
settlement
Kuzmolovsky,
Kapitolovo station, N
134, letter 1, Russia
2950 Neranolketoprofen,
omeprazole
capsules modified-
release
100mg+20mg,
in plastic container (30)
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg - batch
releaser (packager -
Rottendorf Pharma
GmbH, Am
Fleigendahl 3, 59320
Ennigerloh,
Germany)
Germany M01AE53 1227922.03.2013
22.03.2018PoM
MEDA
Pharmaceuticals
Limited, Skyway
House, Parsonage
Road, Takeley, Bishop
636
2951 Neranolketoprofen,
omeprazole
capsules hard
modified-release
200mg+20mg,
in plastic container (30)
MEDA Pharma
GmbH & Co. KG,
Benzstrasse 1, 61352
Bad Homburg - batch
releaser (packager -
Rottendorf Pharma
GmbH, Am
Fleigendahl 3, 59320
Ennigerloh,
Germany)
Germany M01AE53 1228022.03.2013
22.03.2018PoM
MEDA
Pharmaceuticals
Limited, Skyway
House, Parsonage
Road, Takeley, Bishop
2952 Nervomix
valerianae radix,
melissae folium,
lupuli strobilus,
hyperici herba
capsules hard
210mg+52,5mg+
52,5mg+35mg, blisters
(30/3x10/, 60/3x20/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
PolandN05CM09;
herbal drug12133/2
09.06.2016
01.02.2018OTC
Adamed Consumer
Healthcare S.A.,
Pienkow 149, 05-152
Czosnow, Poland
2953 Nervomix
valerianae radix,
melissae folium,
lupuli strobilus,
hyperici herba
capsules hard
210mg+52,5mg+
52,5mg+35mg,
in blister (30/3x10/,
60/3x20/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
PolandN05CM;
herbal drug17085
16.10.2017
16.10.2022OTC
Adamed Consumer
Healthcare S.A.,
Pienkow 149, 05-152
Czosnow, Poland
2954 Neuromultivitvitamin B1, vitamin
B6, vitamin B12tablets film-coated
100mg+200mg+ 0,2mg,
in blister (20/1x20/,
100/5x20/)
G.L. Pharma GmbH,
Schlossplatz 1, 8502
Lannach -batch
releaser, G.L. Pharma
GmbH,
Industriestrasse 1,
8502 Lannach,
Austria -bulk
manufacturer,
packager
Austria A11DB 1508815.12.2015
15.12.2020OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
637
2955 Nevanac nepafenacdrops eye
(suspension)
1mg/ml,
5ml plastic bottle
S.A. Alcon-Couvreur
N.V., Rijksweg 14
2870 Puurs
Belgium S01BC10 1519830.12.2015
30.12.2020PoM
Alcon Laboratories
(UK) Ltd., Frimley
Business Park,
Frimley Camberley
Surrey, GU16 7SR,
UK
2956 Nevigramon nalidixic acid capsules500mg,
in plastic container (56)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary J01MB02 1314010.01.2014
10.01.2019PoM
Sanofi-Aventis
Private Co. Ltd.,1045
Budapest, To u. 1-5,
Hungary
2957 Nevralgin
acetylsalicylic acid,
paracetamol,
caffeine
tablets250mg+200mg+ 50mg,
in blister (20/2x10/)
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaN02BA51 15313
04.02.2016
04.02.2021OTC
NOKI JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
2958 Nevrolek
thiamine (thiamine
hydrochloride),
pyridoxine
(pyridoxine
hydrochloride),
cyanocobalamin,
lidocaine (lidocaine
hydrochloride)
solution for i/m
injection
50mg/ml+ 50mg/ml+
0,5mg/ml+ 10mg/ml, 2ml
ampoules (5),
2ml ampoules , in blister
(5/1x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine A11DB 1551919.04.2016
19.04.2021PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
2959 Nextibuprofen,
paracetamoltablets film-coated
400mg+200mg,
in blisters (2/1x2/, 4/2x2/,
6/1x6/, 10/1x10/,
12/1x12/, 12/2x6/,
20/2x10/, 24/2x12/)
Pharmstandard-
Tomskchimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia N02BE51 13807/130.06.2016
05.09.2019OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2960 Nextibuprofen,
paracetamoltablets film-coated
400mg+200mg,
in blister (2/1x2/, 4/2x2/,
6/1x6/, 10/1x10/,
12/1x12/, 12/2x6/,
20/2x10/, 24/2x12/)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia N02BE51 1662725.04.2017
25.04.2022OTC
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
638
2961 Neyrodolonflupirtine
(flupirtine maleate)capsules
100mg,
in blister (15/1x15/) and
(45/3x15/)
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo
Russia N02BG07 1711823.10.2017
23.10.2022PoM
CJSC Canonpharma
production, 105,
Zarechnaya str.
141100 Moskow
region, Schelkovo,
Russia
2962 Neyrotexethylmethylhydrox
ypyridine succinate
solution for i/m and
i/v injection
50mg/ml,
5ml ampoules,
in blister (5)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia N07XX 1648124.02.2017
24.02.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
2963 Neyrotexethylmethylhydrox
ypyridine succinate
solution for i/m and
i/v injection
50mg/ml,
2ml ampoules,
in blister (10/2x5/,
50/10x5)
"Sotex"PharmFirm"
CJSC, Bld. 10, 11, 12,
village Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345
Russia N07XX 1648224.02.2017
24.02.2022PoM
"Sotex"PharmFirm"
CJSC, Bld. 11, village
Belikovo, rural
settlement
Bereznjakovskoe,
Sergiev-Posad
municipal district,
Moscow Region,
141345, Russia
2964 Niclosamide niclosamide tablets chewable500mg,
in plastic container (4)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaP02DA01 15953
02.09.2016
02.09.2021PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
2965 Nicoflex
capsaicin, ethyl
nicotinate,
ethylenglycol
salicylate
ointment for
external use
0.15mg/g+20mg/g+90mg/
g,
50g aluminium tube
Reanal Private Co
Ltd., Telepes u. 54-
56., Budapest, 1147
Hungary M02A 1608710.11.2016
10.11.2021OTC
Medimpex Trading
Private Company
Limited, 1134
Budapest, Lehel utca
11, Hungary
639
2966Nicorandil 10mg
Tabletsnicorandil tablets
10mg,
in blister (60/6x10/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser, Dexcel Ltd.,
1 Dexcel Street, Or-
Akiva 30600, Israel-
bulk manufacturer,
packager
UK C01DX16 1539026.02.2016
26.02.2021PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields,
Daventry,
Northamptonshire,
NN11 8PB, UK
2967Nicorandil 20mg
Tabletsnicorandil tablets
20mg,
in blister (60/6x10/)
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields,
Daventry,
Northamptonshire,
NN11 8PB - batch
releaser, Dexcel Ltd.,
1 Dexcel Street, Or-
Akiva 30600, Israel-
bulk manufacturer,
packager
UK C01DX16 1538926.02.2016
26.02.2021PoM
Dexcel-Pharma Ltd.,
7 Sopwith Way,
Drayton Fields,
Daventry,
Northamptonshire,
NN11 8PB, UK
2968 Nicorette nicotinegum chewing with
menthol flavour
4mg,
in blister (15/1x15/,
30/2x15/, 105/7x15/)
McNeil AB
Norrbroplatsen 2,
Helsingborg, 25109
Sweden N07BA01 1664602.05.2017
02.05.2022OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
2969 Nicorette nicotinegum chewing with
menthol flavour
2mg,
in blister (15/1x15/,
30/2x15/, 105/7x15/)
McNeil AB
Norrbroplatsen 2,
Helsingborg, 25109
Sweden N07BA01 1664702.05.2017
02.05.2022OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
640
2970Nicotinic acid-
Darnitsanicotinic acid solution for injection
10mg/ml,
1ml ampoules,
in blister (10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13
Ukraine C10AC01 12570/130.08.2013
06.06.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13,
Ukraine
2971 Nidol nimesulidepowder for oral
suspension
100mg,
2g sachets (6, 10)
Polipharm Co., Ltd.,
109 Bangna-Trad
Road, Bang Phli
District, Samut
Prakan 10540
Thailand M01AX17 1266604.07.2013
04.07.2018PoM
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
2972 Nidol Gel nimesulide gel20mg/g,
30g aluminium tube
Polipharm Co., Ltd.,
109 Bangna-Trad
Road, Bang Phli
District, Samut
Prakan 10540
Thailand M02AA26 12714/110.12.2013
23.07.2018PoM
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
2973Nifedi-Denk10
Retardnifedipine
tablets extended-
release film-coated
10mg,
in blister (100/10x10/)
Denk Pharma GmbH
& Co. KG, Gollstr. 1,
84529 Tittmoning
Germany C08CA05 1222907.03.2013
07.03.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
2974Nifedi-Denk20
Retardnifedipine tablets film-coated
20mg,
in blister (100/10x10/)
Denk Pharma GmbH
& Co. KG, Gollstr. 1,
84529 Tittmoning
Germany C08CA05 1223007.03.2013
07.03.2018PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Munchen,
Germany
2975 Nifedipin nifedipine tablets coated10mg,
in blister (50/5x10/)
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region
Ukraine C08CA05 1722808.12.2017
08.12.2022PoM
PJSC "Technolog",
Manuylskogo str. 8,
20300
Uman,Cherkassy
region, Ukraine
641
2976 Nifuromed nifuroxazide suspension oral44mg/ml,
100ml glass bottle
Medical Horizon Ltd
(Masis, Masis Station,
Gordzaranayin 22)
Republic of
ArmeniaA07AX03 12993
28.10.2013
28.10.2018PoM
Medical Horizon Ltd
(Masis, Masis Station,
Gordzaranayin 22,
Republic of Armenia)
2977 Nifuroxazide nifuroxazide tablets100mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A07AX03 1562924.05.2016
24.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
2978 Nimelid nimesulidegranules for oral
suspension
100mg,
2g sachets (10, 30)
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania M01AX17 1492120.10.2015
20.10.2020PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A, Romania
2979 Nimesil nimesulidegranules for oral
suspension
100mg,
2g sachets
(9, 15, 30)
Laboratorios Menarini
S.A., str. Alfonso XII,
587 08918 Badalona
(Barcelona)
Spain M01AX17 1406219.12.2014
19.12.2019PoM
Laboratori Guidotti
S.p.A., Via Livornese,
897 56122 La
Vettola(Pisa), Italy
2980 Nimesil nimesulidegranules for oral
suspension
100mg,
2g sachets
(9, 15, 30)
Fine Foods and
Pharmaceuticals
N.T.M. S.P.A., Via
dell Artigianato, 8/10
24041
Brembate(Bergamo)
Italy M01AX17 1406319.12.2014
19.12.2019PoM
Laboratori Guidotti
S.p.A., Via Livornese,
897 56122 La
Vettola(Pisa), Italy
2981 Nimesubel nimesulide tablets100mg,
in blister (20/2x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus M01AX17 1402626.11.2014
26.11.2019PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
642
2982 Nimotop nimodipine tablets film-coated30mg,
in blister (100/10x10/)
Bayer Pharma AG, D-
51368 Germany C08CA06 13955
28.10.2014
28.10.2019PoM
Bayer Pharma AG, D-
13342,Berlin,
Germany
2983Nimotop solution
for infusionnimodipine solution for infusion
10mg/50ml,
50ml glass vial
Bayer Pharma AG, D-
51368 Germany C08CA06 13956
28.10.2014
28.10.2019PoM
Bayer Pharma AG, D-
13342,Berlin,
Germany
2984 Niperten
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07AB07 1552519.04.2016
19.04.2021PoM
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500,
Russia
2985 Niperten
bisoprolol
(bisoprolol
fumarate)
tablets film-coated2,5mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07AB07 1552619.04.2016
19.04.2021PoM
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500,
Russia
2986 Niperten
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07AB07 1552719.04.2016
19.04.2021PoM
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500,
Russia
2987 Niperten
bisoprolol
(bisoprolol
fumarate)
tablets film-coated5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C07AB07 1671423.05.2017
23.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2988 Niperten
bisoprolol
(bisoprolol
fumarate)
tablets film-coated10mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C07AB07 1671523.05.2017
23.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
643
2989 Niperten
bisoprolol
(bisoprolol
fumarate)
tablets film-coated2,5mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C07AB07 1671623.05.2017
23.05.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2990 Niperten Combi
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets10mg+10mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07FB07 1698405.09.2017
05.09.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2991 Niperten Combi
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets5mg+5mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07FB07 1698505.09.2017
05.09.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2992 Niperten Combi
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets5mg+10mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07FB07 1698605.09.2017
05.09.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2993 Niperten Combi
bisoprolol
(bisoprolol
fumarate),
amlodipine
(amlodipine
besilate)
tablets10mg+5mg,
in blister (30/3x10/)
KRKA-RUS LLC, 50
Moskovskaya Str.,
Istra, Moscow
Region,143500
Russia C07FB07 1698705.09.2017
05.09.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
2994 Nitro nitroglycerinconcentrate for
solution for infusion
5mg/ml,
2ml ampoules (5)
Orion Corporation,
Orionintie 1, 02200
Espoo
Finland C01DA02 1350630.05.2014
30.05.2019PoM
Orion Corporation,
Orionintie 1, 02200
Espoo, Finland
644
2995 Nitrocor nitroglycerin tablets sublingual0,5mg,
plastic container (40)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia C01DA02 13490/110.10.2017
15.05.2019PoM
OTCPharm PJSC,
123317, Moscow,
Testovskaya str., 10,
Russia
2996 Nitroglycerin nitroglycerin tablets sublingual0,5mg,
in plastic container (40)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia C01DA02 1323824.02.2014
24.02.2019PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
2997Nitroglycerin
PH&T
glyceryl (glyceryl
trinitrate)
concentrate for
solution for infusion
5mg/ml,
1ml ampoules (10)
Laboratorio Italiano
Biochimico
Farmaceutico
Lisapharma S.p.A.,
Via Licinio, 11-22036
Erba (CO)
Italy C01DA02 1365908.07.2014
08.07.2019PoM
PH&T S.p.A, Via
Marostica, 1-20146
Milan, Italy
2998 Nitroglycerin-AM nitroglycerin tablets sublingual0,5mg,
in plastic container (40)
Technolog PJSC,
Manuylskogo str. 8,
20300 Uman,
Cherkassy region
Ukraine C01DA02 1234109.04.2013
09.04.2018PoM
Technolog PJSC,
Manuylskogo str. 8,
20300 Uman,
Cherkassy region,
UKRAINE
2999 Nitromint nitroglycerinaerosol sublingual
dosed
0,4mg/dose,
10g aluminium tube (180
doses) and and 10g COC
tube (180 doses)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas kiraly st. 65
Hungary C01DA02 12784/108.04.2015
14.08.2018PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
3000 Nitrospray nitroglycerinspray sublingual
dosed
0,4mg/dose,
10ml plastic container
(200 doses)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia C01DA02 1368108.07.2014
08.07.2019PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
645
3001 Nitroxoline nitroxoline tablets coated50mg,
in blister (50/5x10/)
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, K. Marksa
str., 124
Russia J01XX07 1520030.12.2015
30.12.2020PoM
Irbitskiy
himfarmzavod JSC,
643 RU, Irbit, St.
Sverdlovsk, Kirova
str., 172, Russia
3002 Nitroxoline nitroxoline tablets film-coated50mg,
in blister (50/5x10/)
SIC "Borshchahivskiy
Chemical-
Pharmaceutical Plant"
PJSC, 17, Mira St,
Kyiv, 03134
Ukraine J01XX07 1648709.03.2017
09.03.2022PoM
SIC "Borshchahivskiy
Chemical-
Pharmaceutical
Plant" PJSC, 17, Mira
St, Kyiv, 03134,
Ukraine
3003 Nivalin
galantamine
(galantamine
hydrobromide)
tablets
10mg,
in blister (10/1x10/,
20/2x10/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N06DA04 1670323.05.2017
23.05.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
3004 Nivalin
galantamine
(galantamine
hydrobromide)
tablets
5mg,
in blister (10/1x10/,
20/1x20/, 60/3x20/)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N06DA04 1670423.05.2017
23.05.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
3005
Nivalin 10mg/ml
solution for
injection
galantamine
(galantamine
hydrobromide)
solution for injection10mg/ml,
1ml ampoules (10)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N06DA04 1698205.09.2017
05.09.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
3006
Nivalin 1mg/ml
solution for
injection
galantamine
(galantamine
hydrobromide)
solution for injection1mg/ml,
1ml ampoules (10)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N06DA04 1698005.09.2017
05.09.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
3007
Nivalin 2,5mg/ml
solution for
injection
galantamine
(galantamine
hydrobromide)
solution for injection2,5mg/ml,
1ml ampoules (10)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N06DA04 1697905.09.2017
05.09.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
646
3008
Nivalin 5mg/ml
solution for
injection
galantamine
(galantamine
hydrobromide)
solution for injection5mg/ml,
1ml ampoules (10)
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia
Bulgaria N06DA04 1698105.09.2017
05.09.2022PoM
Sopharma JSC, str.
Iliensko shosse 16,
1220 Sofia, Bulgaria
3009 Nixar bilastin tablets
20mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/,
50/5x10/)
A.Menarini
Manufacturing
Logistics and Services
S.r.l.,Via Campo Di
Pile, 67100 L` Aquila
Italy R06AX29 1706505.10.2017
05.10.2022PoM
Menarini
International
Operations
Luxembourg S.A.,1,
avenue de la Gare,
1611, Luxembourg
3010 Nizoral ketoconazole shampoo20mg/g,
60ml plastic bottle
Janssen
Pharmaceutica N.V.,
Turnhoutseweg 30, B-
2340 Beerse
Belgium D01AC08 14325/125.09.2017
25.03.2020OTC
Johnson & Johnson,
121614, Moscow,
Krylatskaya str., 17,
building 2, Russia
3011 Nizoral ketoconazolecream for external
use
20mg/g,
15g aluminium tube
Janssen
Pharmaceutica N.V.,
Turnhoutseweg 30, B-
2340 Beerse
Belgium D01AC08 1536326.02.2016
26.02.2021OTC
Johnson & Johnson
LLC, 121614,
Moscow, Krylatskaya
str., 17, building 2,
Russia
3012 Noctura
Kali brom, Coffea,
Passiflora, Avena
sativa, Alfalfa,
Valeriana
tablets6C+6C+6C+6C+6C+6C,
in blister (72/3x24/)
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH
UK
N05CM
homeopathic
drug
1351730.05.2014
30.05.2019PoM
A Nelson and Co
Limited, 5 Endeavour
Way, Wimbledon,
London SW19 8UH,
UK
3013 No-Dol Broncho
glycyrrhiza glabra,
menthol,
eucalyptus oil, anise
oil, peppermint oil,
pepper oil, pine oil
tablets orodispersible
27.5mg+10mg+
100mcg+100mcg+
50mcg+ 50mcg+25mcg,
in strip (100/25x4/)
Nabros Pharma Pvt.
Ltd., N.H. No. 8
Kajipura, Kheda,
387411, Gujarat
IndiaR05CA10;
herbal drug16226
05.12.2016
05.12.2021OTC
Nabros Pharma Pvt.
Ltd., N.H. No. 8
Kajipura, Kheda,
387411, Gujarat,
India
647
3014 No-Dol Flu
paracetamol,caffein
e, phenylephrine
(phenylephrine
hydrochloride),
chlorphenamine
(chlorphenamine
maleate)
tablets500mg+30mg+ 5mg+2mg,
in strip (200/50x4/)
Nabros Pharma Pvt.
Ltd., N.H. No. 8
Kajipura, Kheda,
387411, Gujarat
India N02BE51 1622705.12.2016
05.12.2021OTC
Nabros Pharma Pvt.
Ltd., N.H. No. 8
Kajipura, Kheda,
387411, Gujarat,
India
3015 NO-DOL-EMMSIL nimesulide tablets dispersible100mg,
in blister (4, 10)
Protech Biosystems
Pvt Ltd.,Plot No 145-
146, Pace City-1,
Sector-37 Gurgaon,
Haryana
India M01AX17 1236819.04.2013
19.04.2018PoM
Protech Biosystems
Pvt Ltd.,Plot No 145-
146, Pace City-1,
Sector-37 Gurgaon,
Haryana, India
3016 Noflux
rabeprazole
(rabeprazole
sodium)
tablets gastro-
resistant
10mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Laboratorios Liconsa
S.A., Avda.
Miralcampo, No7,
Poligono Industrial
Miralcampo 19200
Azuqueca de Henares
(Guadalajara), Spain -
bulk manufacturer,
packager)
Hungary A02BC04; 13712/114.08.2015
24.07.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
3017 Noflux
rabeprazole
(rabeprazole
sodium)
tablets gastro-
resistant
20mg,
in blister (14/2x7/,
28/4x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser
(Laboratorios Liconsa
S.A., Avda.
Miralcampo, No7,
Poligono Industrial
Miralcampo 19200
Azuqueca de Henares
(Guadalajara), Spain -
bulk manufacturer,
packager)
Hungary A02BC04 13713/114.08.2015
24.07.2019PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
648
3018 Nofung fluconazole capsules50mg,
in blister (7/1x7/, 14/2x7/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary J02AC01 1421920.02.2015
20.02.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
3019 Nofung fluconazole capsules150mg,
in blister (1, 4/1x4/)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120
Hungary J02AC01 1422020.02.2015
20.02.2020PoM
Egis Pharmaceuticals
PLC, 1106 Budapest,
Kereszturi st. 30-38,
Hungary
3020 Nolicin norfloxacin tablets film-coated400mg,
in blister (20/2x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA06 1706305.10.2017
05.10.2022PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
3021 Noliprel arginine
perindopril
arginine,
indapamide
tablets film-coated2,5mg+0,625mg,
in plastic container (30)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C09BA04 1680622.06.2017
22.06.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
3022 Noliprel Bi-Forte
perindopril
(perindopril
arginine),
indapamide
tablets film-coated10mg+2,5mg,
in plastic container (30)
Servier (Ireland)
Industries Ltd, Gorey
Road, Arklow-Co
Wicklow
Ireland C09BA04 1667311.05.2017
11.05.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
3023Noliprel Forte
arginine
perindopril
arginine,
indapamide
tablets film-coated5mg+1,25mg,
in plastic container (30)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C09BA04 1680722.06.2017
22.06.2022PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
649
3024 Nolpaza
pantoprazole
(pantoprazole
sodium)
powder for solution
for injection
40mg,
glass vial (1, 5,10)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
secondary packager,
Valdepharm, Parc
Industriel d incaville-
BP 606, 27100 Val de
Reuil Cedex, France-
bulk manufacturer,
primary packager
Slovenia A02BC02 1465703.07.2015
03.07.2020PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
3025 Nolpaza
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets gastro-
resistant
20mg,
in blister (14/1x14,
28/2x14/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia A02BC02 15914/110.11.2016
23.08.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
3026 Nolpaza
pantoprazole
(pantoprazole
sodium
sesquihydrate)
tablets gastro-
resistant
40mg,
in blister (14/1x14/,
28/2x14/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia A02BC02 1591523.08.2016
23.08.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
3027 Nonpres eplerenone tablets film-coated
50mg,
in blister (20/2x10/,
30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland C03DA04 15107/113.05.2016
15.12.2020PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
3028 Nonpres eplerenone tablets film-coated
25mg,
in blister (20/2x10/,
30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland C03DA04 15108/113.05.2016
15.12.2020PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
650
3029 Noofen
gamma-amino-beta-
phenylbutyric acid
hydrochloride
capsules250mg,
in blister (20/2x10/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX22 1617923.11.2016
23.11.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
3030 Noofen
gamma-amino-beta-
phenylbutyric acid
hydrochloride
capsules500mg,
in blister (24/4x6/)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX22 1618023.11.2016
23.11.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
3031 Noofen
gamma-amino-beta-
phenylbutyric acid
hydrochloride
powder for oral
solution
100mg,
1g sachets (15)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX22 1626919.12.2016
19.12.2021PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
3032 Noofen
gamma-amino-beta-
phenylbutyric acid
hydrochloride
powder for oral
solution
500mg,
2.5g sachet (5)
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114
Latvia N06BX22 1657503.04.2017
03.04.2022PoM
Olainfarm JSC, 5
Rupnicu Str., Olaine,
LV-2114, Latvia
3033 Nootropil piracetamsolution for i/v and
i/m injection
200mg/ml,
5ml ampoules (12)
Aesica
Pharmaceuticals S.r.l.,
Via Praglia, 15-10044
Pianezza (TO)
Italy N06BX03 1535926.02.2016
26.02.2021PoM
UCB Pharma S.A.,
Allee de la Recherche
60, B-1070 Bruxelles,
Belgium
3034 Nootropil piracetam tablets film-coated800mg,
in blister (30/2x15/)
UCB Pharma S.A.,
Chemin du Foriest, B-
1420 Braine-l'Alleud
Belgium N06BX03 1538426.02.2016
26.02.2021PoM
UCB Pharma S.A.,
Allee de la Recherche
60, B-1070 Bruxelles,
Belgium
3035 Norcolut norethisterone tablets5mg,
in blister (20/2x10/)
Gedeon Richter OJSC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03DC02 1506402.12.2015
02.12.2020PoM
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest,
Hungary
651
3036Norditropin
NordiLetsomatropin
solution for s/c
injection
6,7mg/ml,
1,5ml pre-filled pen
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd - batch
releaser (bulk
manufacturer,
packager - Novo
Nordisk A/S,
Denmark
Hagedornsvej 1, DK-
2820 Gentofte,
Denmark)
Denmark H01AC01 1398526.11.2014
26.11.2019PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3037 Normodipine
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C08CA01 1491920.10.2015
20.10.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
3038 Normodipine
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary C08CA01 1492020.10.2015
20.10.2020PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
3039 Nortivan valsartan tablets film-coated80mg,
in blister (30/3x10/)
Gedeon Richter
Polska Sp.z o.o.,
ul.Graniczna 35,
Grodzisk Mazowiecki,
05-825
Poland C09CA03 1604317.10.2016
17.10.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
3040 Nortivan valsartan tablets film-coated160mg,
in blister (30/3x10/)
Gedeon Richter
Polska Sp.z o.o.,
ul.Graniczna 35,
Grodzisk Mazowiecki,
05-825
Poland C09CA03 1604417.10.2016
17.10.2021PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
3041 Norvasc
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Heinrich-Mack-Str.
35, 89257, Illertissen
Germany C08CA01 1396128.10.2014
28.10.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd str., New
York 10017, USA
652
3042 Norvasc
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Heinrich-Mack-Str.
35, 89257, Illertissen
Germany C08CA01 1396228.10.2014
28.10.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd str., New
York 10017, USA
3043 Norvasc
amlodipine
(amlodipine
besilate)
tablets5mg,
in blister (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Heinrich-Mack-Str.
35, 89257, Illertissen -
packager, batch
releaser (Pfizer
Pharmaceuticals LLC,
Road #2, km 58.2
Barceloneta, 00617,
Puerto Rico, USA -
bulk manufacturer)
Germany C08CA01 1398826.11.2014
26.11.2019PoM
Pfizer H.C.P.
Corporation, 235,
East 42nd str., New
York 10017, USA
3044 Norvasc
amlodipine
(amlodipine
besilate)
tablets10mg,
in blister (30/3x10/)
Pfizer Manufacturing
Deutschland GmbH,
Heinrich-Mack-Str.
35, 89257, Illertissen -
packager, batch
releaser (Pfizer
Pharmaceuticals LLC,
Road #2, km 58.2
Barceloneta, 00617,
Puerto Rico, USA -
bulk manufacturer)
for Pfizer H.C.P.
Corporation, 235, East
42nd str., New York
10017, USA
Germany C08CA01 1398926.11.2014
26.11.2019PoM
3045 Norvir ritonavir tablets film-coated
100mg,
in plastic container (30,
60)
AbbVie Deutschland
GmbH & Co. KG,
Knollstrasse, 67061
Ludwigshafen
Germany J05AE03 1528004.02.2016
04.02.2021PoM
AbbVie
Biopharmaceuticals
GmbH, Neuhofstrasse
23,Postfach 6341
Baar, Switzerland
653
3046 Nosacare
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal
0,5mg/ml,
15ml plastic vial with
pump dispenser
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine R01AA05 1726113.12.2017
13.12.2022OTC
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
3047 Nosacare Baby
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal
0,25mg/ml,
15ml plastic vial with
pump dispenser
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine R01AA05 1725913.12.2017
13.12.2022OTC
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
3048Nosacare Extra
Moisturizing
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal
0,5mg/ml,
15ml plastic vial with
pump dispenser
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine R01AA05 1726213.12.2017
13.12.2022OTC
Pharmacare Int. Co.
/German Palestinian
Joint Venture,
Ramallah-Elmasion,
Emil habibi st.17,
Palestine
3049 Nosacare Mentho
oxymetazoline
(oxymetazoline
hydrochloride)
spray nasal
0,5mg/ml,
15ml plastic vial with
pump dispenser
Pharmacare PLC,
Ramallah, Betunia,
Industrial Zone
Palestine R01AA05 1726013.12.2017
13.12.2022OTC
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
3050 Nosh-ARPI
drotaverine
(drotaverine
hydrochloride)
tablets40mg,
in blister (24)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaA03AD02 13382
04.04.2014
04.04.2019OTC
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia
3051 No-spa
drotaverine
(drotaverine
hydrochloride)
solution for injection40mg/2ml,
2ml ampoules (25/5x5/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd. 3510
Miskolc,
Csanyikvolgy
Hungary A03AD02 1686711.07.2017
11.07.2022PoM
Sanofi-Aventis
Private Co. Ltd.,1045
Budapest, To u. 1-5,
Hungary
654
3052 No-spa
drotaverine
(drotaverine
hydrochloride)
tablets
40mg,
in blister (24/1x24/),
plastic container (100)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary A03AD02 1686811.07.2017
11.07.2022OTC
Sanofi-Aventis
Private Co. Ltd., 1045
Budapest, To u. 1-5,
Hungary
3053 No-spa forte
drotaverine
(drotaverine
hydrochloride)
tablets80mg,
in blister (24/1x24/)
Chinoin
Pharmaceutical and
Chemical Works
Private Co. Ltd., 2112
Veresegyhaz, Levai u.
5
Hungary A03AD02 1437125.03.2015
25.03.2020OTC
Sanofi-Aventis
Private Co. Ltd., 1045
Budapest, To u. 1-5,
Hungary
3054 Novocainprocaine (procaine
hydrochloride)solution for injection
5mg/ml,
5ml ampoules (10), 5ml
ampoules, dividella (10),
5ml ampoules , label
banderol (10)
Open Joint Stock
Company
"Borisovskiy zavod
Medicinskikh
Preparatov" (64/27,
Chapayev str., Borisov
222120, Minsk oblast)
Belarus N01BA02 1296728.10.2013
28.10.2018PoM
Open Joint Stock
Company
"Borisovskiy zavod
medicinskikh
preparatov" (64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus)
3055 Novocainprocaine (procaine
hydrochloride)solution for injection
5mg/ml,
5ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaN01BA02 16484
01.03.2017
01.03.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
3056 Novocainprocaine (procaine
hydrochloride)solution for injection
5mg/ml,
2ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaN01BA02 16485
01.03.2017
01.03.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
655
3057 Novocainprocaine (procaine
hydrochloride)solution for injection
20mg/ml,
2ml ampoules (10)
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2 Line,
No6
Republic of
ArmeniaN01BA02 16486/1
13.03.2017
01.03.2022PoM
Yerevan Chemical-
Pharmaceutical firm
OJSC, Yerevan,
Ajaryan street, 2
Line, No6, Republic
of Armenia
3058 Novocain-Darnitsaprocaine (procaine
hydrochloride)solution for injection
5mg/ml,
2ml ampoules
(10, (10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC (02093, Kiev,
Borispolskaya Str.,13)
Ukraine N01BA02 1296528.10.2013
28.10.2013PoM
Darnitsa
Pharmaceutical Firm
PrJSC (02093, Kiev,
Borispolskaya Str.,13,
Ukraine)
3059 Novocain-Darnitsaprocaine (procaine
hydrochloride)solution for injection
20mg/ml,
2ml ampoules
(10, 10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC (02093, Kiev,
Borispolskaya Str.,13)
Ukraine N01BA02 1296628.10.2013
28.10.2018PoM
Darnitsa
Pharmaceutical Firm
PrJSC (02093, Kiev,
Borispolskaya Str.,13,
Ukraine)
3060 Novocain-Darnitsaprocaine (procaine
hydrochloride)solution for injection
5mg/ml,
5ml ampoules (10), 5ml
ampoules, in blister
(10/2x5/)
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13
Ukraine N01BA02 1542316.03.2016
16.03.2021PoM
Darnitsa
Pharmaceutical Firm
PrJSC, 02093, Kiev,
Borispolskaya Str.,13,
Ukraine
3061Novocaine solution
0,5%
procaine (procaine
hydrochloride)solution for injection
5mg/ml,
100ml, 200ml and 250ml,
in plastic pack
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaN01BA02 15687
08.06.2016
08.06.2021PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
656
3062Novocain-
Zdorovye
procaine (procaine
hydrochloride)solution for injection
5mg/ml,
2ml ampoules (10), 2ml
ampoules, in blister
(5/1x5/, 10/2x5/,
10/1x10/),
5ml ampoules (10), 5ml
ampoules, in blister
(5/1x5/, 10/2x5/)
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22
Ukraine N01BA02 1662125.04.2017
25.04.2022PoM
Pharmaceutical
Company "Zdorovye"
LLC, 61013, Kharkov,
Shevchenko str., 22,
Ukraine
3063NovoMix 30
FlexPen
insulin aspart
(recombinant)
suspension for
injection
100U/ml,
3ml pre-filled pen (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AD05 1276614.08.2013
14.08.2018PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3064 NovoMix 30 Penfillinsulin aspart
(recombinant)
suspension for
injection
100U/ml,
3ml cartridges (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd
Denmark A10AD05 1276714.08.2013
14.08.2018PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3065 NovoNorm repaglinide tablets0,5mg,
in blister (30/2x15/)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd-batch
releaser, Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Binger Strasse 173, D-
55216 Ingelheim am
Rhein, Germany-bulk
manufacturer,
Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1 und
2, 73614, Schorndorf,
Germany-packager
Denmark A10BX02 1560224.05.2016
24.05.2021PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
657
3066 NovoNorm repaglinide tablets2mg,
in blister (30/2x15/)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd-batch
releaser, Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Binger Strasse 173, D-
55216 Ingelheim am
Rhein, Germany-bulk
manufacturer,
Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1 und
2, 73614, Schorndorf,
Germany-packager
Denmark A10BX02 1560324.05.2016
24.05.2021PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3067 NovoNorm repaglinide tablets1mg,
in blister (30/2x15/)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd-batch
releaser, Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Binger Strasse 173, D-
55216 Ingelheim am
Rhein, Germany-bulk
manufacturer,
Catalent Germany
Schorndorf GmbH,
Steinbeisstrasse 1 und
2, 73614, Schorndorf,
Germany-packager
Denmark A10BX02 1560424.05.2016
24.05.2021PoM
Նովո Նորդիսկ Ա/Ս,
Նովո Ալլե, ԴԿ-2880
Բագսվաերդ,
Դանիա
658
3068NovoRapid
FlexPeninsulin aspart
solution for s/c or i/v
injection
100U/ml,
3ml pre-filled pens (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd-batch
releaser, bulk
manufacturer,
primary packager,
Novo Nordisk A/S,
Brennum Park, DK-
3400 Hillerod,
Denmark- secondary
packager
Denmark A10AB05 1544102.04.2016
02.04.2021PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3069 NovoRapid Penfill insulin aspartsolution for s/c or i/v
injection
100U/ml,
3ml glass cartridges (5)
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd - batch
releaser, bulk
manufacturer,
primary packager,
Novo Nordisk A/S,
Hallas Alle, DK-4400
Kalundborg, Denmark-
secondary packager
Denmark A10AB05 1544002.04.2016
02.04.2021PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3070 NovoSeveneptacog alfa
(activated)
powder for solution
for injection
1mg (50 KIU),
2ml glass vial (1), 1,1ml
solvent in glass vial
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd - batch
releaser (bulk
manufacturer,
packager - Novo
Nordisk A/S,
Denmark
Hagedornsvej 1, DK-
2820 Gentofte,
Denmark)
Denmark B02BD08 1310509.12.2013
09.12.2018PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
659
3071 NovoSeveneptacog alfa
(activated)
powder for solution
for injection
2mg (100 KIU), 2ml glass
vial (1), 2,1ml solvent in
glass vial
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd - batch
releaser (bulk
manufacturer,
packager - Novo
Nordisk A/S,
Denmark
Hagedornsvej 1, DK-
2820 Gentofte,
Denmark)
Denmark B02BD08 1310609.12.2013
09.12.2018PoM
Novo Nordisk A/S,
Novo Alle, DK-2880
Bagsvaerd, Denmark
3072 Novynettedesogestrel,
ethinylestradioltablets film-coated
0,15mg+0,02mg,
in blister (21/1x21/,
63/3x21/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary G03AA09 1713707.11.2017
07.11.2022PoM
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest,
Hungary
3073 Nozemacid
oxytetracycline
(oxytetracycline
hydrochloride),
metronidazole
powder60%+30%,
2,5g and 5g sachet
Agrobioprom CJSC,
143985, Moscow,
Balashikhinski
district, Novo-Milet
r/d, Poltevskoe shosse,
4
Russia
QJ01AA56;
veterinary
drug
1676502.06.2017
02.06.2022OTC
Agrobioprom CJSC,
107139, Moscow,
pereulok
Orlikov,house 3,
Russia
3074 Nucleo CMP Forte
cytidine-5-
disodium
monophosphate+
(uridine-5-
trisodium
triphosphate,
uridine-5-disodium
diphosphate,
uridine-5-disodium
monophosphate)
capsules5mg+3mg,
in blister (30/2x15/)
Ferrer International,
SA., Joan Buscalla,1-9
08173 Sant Cugat del
Valles, Barcelona
Spain M09AX 1231822.03.2013
22.03.2018OTC
Ferrer International,
SA., Joan Gran Via
Carlos III, 94 08028,
Barcelona, Spain
660
3075 Nucleo CMP Forte
cytidine-5-
disodium
monophosphate +
(uridine-5-
trisodium
triphosphate,
uridine-5-disodium
diphosphate,
uridine-5-disodium
monophosphate)
powder lyophilized
for solution for
injection
10mg+6mg, ampoules (3),
2ml solvent in ampoules
(3)
Ferrer Internacional
S.A. Joan Buscalla, 1-9
08173 Sant Cugat del
Valles
Spain M09AX 1231922.03.2013
22.03.2018PoM
Ferrer Internacional
S.A., Spain Joan Gran
Via Carlos III, 97
08028
3076 Nulox speeditabs meloxicam tablets orodispersible
7,5mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
Alpex Pharma SA,
Via Cantonale, CH
6805 Mezzovico
Switzerland M01AC06 1250401.06.2013
01.06.2018PoM
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
3077 Nulox speedtabs meloxicam tablets orodispersible
15mg,
in blister (10/1x10/,
20/2x10/, 30/3x10/)
Alpex Pharma SA,
Via Cantonale, CH
6805 Mezzovico
Switzerland M01AC06 1250501.06.2013
01.06.2018PoM
Eurodrug
Laboratories S.A.,
Assesteenweg 117/7,
B-1740 Ternat,
Belgium
3078 Nurofen ibuprofen gel for external use50mg/g,
50g in aluminium tube
Farmasierra
Manufacturing S.L.,
Ctra. Irun, Km. 26,
200, San Sebastian de
los Reyes 28700,
Madrid
Spain M02AA13 12878/101.02.2014
19.09.2018OTC
Reckitt Benckiser
HealthCare Limited,
Dansom Lane, Hull,
East Yorkshire, XI08
7DS, UK
3079 Nurofen ibuprofen tablets coated
200mg,
in blister (6/x16/), (8/1x8/,
10/1x10/, 12/1x12/,
20/2x10/, 24/2x12/)
Reckitt Benckiser
Healthcare
International Ltd,
Thane Road,
Nottingham, NG90
2DB
UK M01AE01 1491309.10.2015
09.10.2020OTC
Reckitt Benckiser
Healthcare
International Ltd,
Thane Road,
Nottingham, NG90
2DB, UK
661
3080 Nurofen Express ibuprofen capsules soft200mg,
in blister (8/1x8/, 16/2x8/)
Banner Pharmacaps
Europe B.V., De
Posthoornstraat 7,
Tilburg, 5048AS
the Netherlands M01AE01 1580120.07.2016
20.07.2021OTC
Reckitt Benckiser
Healthcare
International Ltd,
Thane Road,
Nottingham, NG90
2DB, UK
3081Nurofen Express
NEO
ibuprofen (sodium
ibuprofen dihydrate)tablets coated
200mg,
blister (6/1x6/, 12/1x12/,
24/2x12/)
Reckitt Benckiser
Healthcare
International Limited,
Nottingham site, Thane
Road, Nottingham,
Nottinghamshire, NG90
2DB
UK M01AE01 1369024.07.2014
24.07.2019OTC
Reckitt Benckiser
Healthcare
International Limited,
Nottingham site, Thane
Road, Nottingham,
Nottinghamshire, NG90
2DB, UK
3082Nurofen for
childrenibuprofen
suspension oral with
strawberry flavour
20mg/ml,
100ml and 150ml plastic
bottle and measuring
syringe
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS
UK M01AE01 1547602.04.2016
02.04.2021OTC
Reckitt Benckiser
Healthcare
International Ltd,
Thane Road,
Nottingham, NG90
2DB, UK
3083Nurofen for
childrenibuprofen
suspension oral with
orage flavour
20mg/ml,
100ml and 150ml plastic
bottle and measuring
syringe
Reckitt Benckiser
HealthCare (UK)
Limited, Dansom
Lane, Hull, East
Yorkshire, HU8 7DS
UK M01AE01 1547702.04.2016
02.04.2021OTC
Reckitt Benckiser
Healthcare
International Ltd,
Thane Road,
Nottingham, NG90
2DB, UK
3084Nurofen for
childrenibuprofen suppositories rectal
60mg,
(10/2x5/)
Famar A.V.E., 49km
National Road Athens-
Lamia, 190 11,
Avlonas
Greece M01AE01 1598915.09.2016
15.09.2021OTC
Reckitt Benckiser
Healthcare
International Ltd,
Thane Road,
Nottingham, NG90
2DB, UK
662
3085 Nurofen forte ibuprofen tablets coated400mg,
in blister (12/1x12/)
Reckitt Benckiser
Healthcare
International Limited,
Nottingham site,
Thane Road,
Nottingham,
Nottinghamshire,
NG90 2DB
UK M01AE01 1361027.06.2014
27.06.2019OTC
Reckitt Benckiser
Healthcare
International
Limited, Nottingham
site, Thane Road,
Nottingham,
Nottinghamshire,
NG90 2DB, UK
3086 Nuroton Zero ibuprofen suspension oral
100mg/5ml,
100ml plastic bottle and
measuring cup
Pharmtechnology
LLC, Korzhenevskogo
str., 22, 220024,
Minsk
Belarus M01AE01 1701526.09.2017
26.09.2022OTC
Giga Farm LLC,
Gogunca str.3/5,
Gyumri, Republic of
Armenia
3087 Nuvaringetonogestrel,
ethinylestradiol
vaginal delivery
system (vaginal ring)11,7mg+2,7mg, sachet (1)
Organon (Ireland)
Limited, P.O. Box
2857, Drynam Road,
Swords, Co. Dublin -
secondary packager,
batch releaser (dosage
form manufacturer,
primary packager -
N.V. Organon,
Molenstraat 110, 5342
CC OSS, the
Netherlands)
Ireland G02BB01 12250/126.03.2014
07.03.2018PoM
Schering-Plough
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
3088 Nuvaringetonogestrel,
ethinylestradiol
vaginal delivery
system (vaginal ring)11,7mg+2,7mg, sachet (1)
N.V. Organon,
Kloosterstraat 6, 5349
AB Oss
the Netherlands G02BB01 1397426.11.2014
26.11.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, 6000
Lucerne 6,
Switzerland
3089 Nystatin nystatin tablets film-coated500000IU,
in blister (20/2x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus A07AA02 12762/122.01.2015
14.08.2018PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
663
3090 Nystatin nystatin tablets coated500000IU,
in blisters (20/2x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A07AA02 13584/116.11.2017
10.06.2019PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
3091 Nystatin nystatin ointment100000U/g,
15g aluminium tube
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus D01AA01 1424520.02.2015
20.02.2020PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
3092 Nystatin nystatin tablets film-coated500000IU,
in blister (20/2x10/)
Belmedpreparaty
RUE, 220006, Minsk,
Mayakovskogo st. 1
Belarus A07AA02 1726313.12.2017
13.12.2022PoM
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30,
Belarus
3093 Octagamimmunoglobulin
human normalsolution for infusion
50mg/ml,
20ml, 50ml, 100ml,
200ml glass vial
Octapharma
Pharmazeutica
Produktionsges.
m.b.H. Oberlaaer
Strasse 235, A-1100
Vienna
Austria J06BA 1254906.06.2013
06.06.2018PoM
Octapharma
Pharmazeutica
Produktionsges.
m.b.H. Oberlaaer
Strasse 235, A-1100
Vienna, Austria
3094 Octanate 1000IU
human blood
coagulation factor
VIII
powder lyophilized
for solution for
injection
1000IU/vial,
glass vial, 10ml glass vial
with solvent, disposable
syringe, double-ended
needle, filter needle,
injection needle and (2)
alcohol swabs
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD02 1406819.12.2014
19.12.2019PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
664
3095 Octanate 250IU
human blood
coagulation factor
VIII
powder lyophilized
for solution for
injection
250IU/vial,
glass vial, 5ml glass vial
with solvent, disposable
syringe, double-ended
needle, filter needle,
injection needle and (2)
alcohol swabs
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD02 1406619.12.2014
19.12.2019PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
3096 Octanate 500IU
human blood
coagulation factor
VIII
powder lyophilized
for solution for
injection
500IU/vial,
glass vial, 10ml glass vial
with solvent, disposable
syringe, double-ended
needle, filter needle,
injection needle and (2)
alcohol swabs
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD02 1406719.12.2014
19.12.2019PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
3097 Octanine F
human blood
coagulation factor
IX
powder and solvent
for solution for
injection
1000IU,
glass vial, 10ml solvent in
glass vial, disposable
syringe, transfer set
(double-ended needle,
filter needle), infusion set,
alcohol swabs (2)
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD04 1670723.05.2017
23.05.2022PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
3098 Octanine F
human blood
coagulation factor
IX
powder and solvent
for solution for
injection
500IU,
glass vial, 5ml solvent in
glass vial, disposable
syringe, transfer set
(double-ended needle,
filter needle), infusion set,
alcohol swabs (2)
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD04 1670823.05.2017
23.05.2022PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
665
3099 Octanine F
human blood
coagulation factor
IX
powder and solvent
for solution for
injection
250IU,
glass vial, 5ml solvent in
glass vial, disposable
syringe, transfer set
(double-ended needle,
filter needle), infusion set,
N2 alcohol swabs
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD04 1681022.06.2017
22.06.2022PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
3100 Octaplex
human blood
coagulation factor
II, human blood
coagulation factor
VII, human blood
coagulation factor
IX, human blood
coagulation factor
X, protein C,
protein S
powder and solvent
for solution for
infusion
14-38IU/ml+9-
24IU/ml+25IU/ml+18-
30IU/ml+13-31IU/ml+12-
32IU/ml,
glass vial with powder (1),
20ml glass vial with
solvent (1), transfer set
(1), disposable syringe
(1), infusion set (1),
alcohol swabs (2)
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna
Austria B02BD01 1616923.11.2016
23.11.2021PoM
Octapharma
Pharmazeutika
Produktionsges.
m.b.H., Oberlaaer
Strasse 235, A-1100
Vienna, Austria
3101 Octolipentioctic acid ( alfa-
lipoic acid)capsules
300mg,
in blister (30/3x10/)
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia A16AX01 1272823.07.2013
23.07.2018PoM
Pharmstandard-
Leksredstva OJSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
3102 Octolipenthioctic acid (alpha-
lipoic acid)tablets film-coated
600mg,
in blister (30/3x10/,
60/6x10/)
Pharmstandard-
Tomskhimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211
Russia A16AX01 1646206.03.2017
06.03.2022PoM
Pharmstandard-
Tomskhimpharm
OJSC, 634009, Tomsk,
avenue Lenina, 211,
Russia
3103 Octolipenthioctic acid (alfa-
lipoic acid)
concentrate for
solution for infusion
30mg/ml,
10ml ampoules (10/2x5/)
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28
Russia A16AX01 1676102.06.2017
02.06.2022PoM
Pharmstandard-
UfaVITA OJSC,
450077, Ufa, str.
Khudaiberdina 28,
Russia
666
3104 Odeston hymecromone tablets200mg,
in blister (50/5x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland A05AX02 1425620.02.2015
20.02.2020OTC
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice, Poland
3105 Oestrogelestradiol (estradiol
hemihydrate)gel transdermal
0,6mg/g,
80g aluminium tube
Besins Manufacturing
Belgium, Groot-
Bijgaardenstraat ,128-
1620, Drogenbos
Belgium G03CA03 1234309.04.2013
09.04.2018PoM
Besins Healthcare SA
, Avenue Louise 287,
1050 Brussels,
Belgium
3106 Oestrogelestradiol (estradiol
hemihydrate)gel transdermal
0,6mg/g,
80g plastic bottle
Besins Manufacturing
Belgium, Groot-
Bijgaardenstraat ,128-
1620, Drogenbos
Belgium G03CA03 1400126.11.2014
26.11.2019PoM
Besins Healthcare SA
, Avenue Louise 287,
1050 Brussels,
Belgium
3107
Oestrophan
0.25mg/ml
injection solution
cloprostenol
(cloprostenol
sodium)
solution for injection
0,25mg/ml,
2ml ampoules (10), 10ml
vial (1)
Bioveta a.s.,
Komenskeho 212,
68323 Ivanovice na
Hane
Czech Republic
QG02AD90;
veterinary
drug
1475203.08.2015
03.08.2020PoM
Bioveta a.s.,
Komenskeho 212,
68323 Ivanovice na
Hane, Czech
Republic
3108 Ofloxacin ofloxacin tablets coated200mg,
in blister (10)
Open Joint Stock
Company , 64/27,
Chapayev str., Borisov
222120, Minsk oblast
Belarus J01MA01 1281217.09.2013
17.09.2018PoM
Open Joint Stock
Company , 64/27,
Chapayev str.,
Borisov 222120,
Minsk oblast, Belarus
3109 Ofloxacin ofloxacin tablets coated200mg,
in blister (10)
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18
Russia J01MA01 1305325.11.2013
25.11.2018PoM
Pharmstandard-
Leksredstva JSC,
305022, Kursk,
Agregatnaya 2nd str.,
1a/18, Russia
667
3110 Ofloxacin 0.2% ofloxacin solution for infusion
2mg/ml,
50ml, 100ml and 200ml
plastic packs, in light-
proof bag
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111
Republic of
ArmeniaJ01MA01 14491
15.05.2015
15.05.2020PoM
PharmaTech CJSC,
0064, Yerevan, Raffi
str. 111, Republic of
Armenia
3111 Oftagel carbomer 974P gel eye2,5mg/g,
10g plastic vial-dropper
Santen Oy,
Niittyhaankatu 20,
33720 Tampere-batch
releaser, Ursapharm
Arzneimittel GmbH,
Industriestrasse 35,
66129 Saarbrucken,
Germany-bulk
manufacturer,
primary and
secondary packager
Finland S01XA20 1511115.12.2015
15.12.2020OTC
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
3112 Oftalmoferon
interferon alfa-2b,
diphenhydramine
(diphenhydramine
hydrochloride)
drops eye
not less than
10000IU/ml+ 1mg/ml,
5ml plastic vial-
dropper,10ml plastic vial-
dropper
"FIRN M" CJSC, 4,
Dzerzhinskogo str.,
Kokoshkino
Settlement, Naro-
Fominsky district,
Moskow region,
143390
Russia S01AD 1627919.12.2016
19.12.2021PoM
"FIRN M" CJSC, 15/1,
entrance "B", Borby
square, Moscow,
127055, Russia
3113 Oftan Catachrom
cytochrome C,
adenosine,
nicotinamide
drops eye
0,675mg/ml+
2mg/ml+20mg/ml, 10ml
plastic vial
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01XA 1266504.07.2013
04.07.2018PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
3114Oftan
Dexamethason
dexamethasone
(dexamethasone
sodium phosphate)
drops eye1mg/ml,
5ml plastic vial
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01BA01 1251923.07.2013
23.07.2018PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
668
3115Oftan
Dexamethason
dexamethasone
(dexamethasone
sodium phosphate)
drops eye1mg/ml,
5ml plastic bottle-dropper
Santen Oy,
Niittyhaankatu 20,
33720 Tampere-
batch releaser,
secondary packager,
Santen
Pharmaceutical
(China) Co., Ltd., No.
169 Tinglan Road,
Suzhou Industrial
Park, Suzhou, Jiangsu
Province, China- bulk
manufacturer,
primary packager
Finland S01BA01 1727913.12.2017
13.12.2022PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
3116 Oftan Timololtimolol (timolol
maleate)drops eye
5mg/ml,
5ml plastic vial
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01ED01 1237119.04.2013
19.04.2018PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
3117 Oftan Timololtimolol (timolol
maleate)drops eye
5mg/ml,
5ml plastic vial-dropper
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01ED01 1728013.12.2017
13.12.2022PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
3118 Oftaquix
levofloxacin
(levofloxacin
hemihydrate)
drops eye (solution)5mg/ml,
5ml plastic vial-dropper
Santen Oy,
Niittyhaankatu 20,
33720 Tampere
Finland S01AE05 1553219.04.2016
19.04.2021PoM
Santen Oy,
Niittyhaankatu 20,
33720 Tampere,
Finland
3119 Olankline olanzapine tablets film-coated5mg,
in blister (28/4x7/)
Dr. Reddy's
Laboratories Limited,
Andrha Pradesh
500900
India N05AH03 1213501.02.2013
01.02.2018PoM
Dr. Reddy's
Laboratories Limited,
Andrha Pradesh
500900, India
3120 Olankline olanzapine tablets film-coated10mg,
in blister (28/4x7/)
Dr. Reddy's
Laboratories Limited,
Andrha Pradesh
500900
India N05AH03 1213601.02.2013
01.02.2018PoM
Dr. Reddy's
Laboratories Limited,
Andrha Pradesh
500900, India
669
3121 Olanzapine olanzapine tablets coated5mg,
in blister (24)
Arpimed LLC, Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building
Republic of
ArmeniaN05AH03 12515
01.06.2013
01.06.2018PoM
Arpimed LLC,
Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Armenia
3122 Olanzapine olanzapine tablets film-coated10mg,
in blister (30/3x10/)
Arpimed LLC (Kotayk
Marz, Abovyan, 2nd
Micro-District, 19
Building)
Republic of
ArmeniaN05AH03 12900
07.10.2013
07.10.2018PoM
Arpimed LLC
(Kotayk Marz,
Abovyan, 2nd Micro-
District, 19 Building,
Republic of Armenia)
3123 Olazol
hippopheae oil,
chloramphenicol,
benzocaine, boric
acid
aerosol for external
use
0,09g+0,027g+
0,027g+0,0045g, 60g, 80g
aluminium container
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.
Russia D08AX 13030/115.01.2016
25.11.2018OTC
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.,
Russia
3124 Olestezin-AV
concentrate of sea
buckthorn oil,
sulfaetidol,
benzocaine
suppositories rectal330mg+50mg+ 100mg,
(10/2x5/)
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.
Russia C05AX 13243/115.01.2016
24.02.2019OTC
Altayvitamini CJSC,
659325, The Altay
territory, Biysk, 69
Zavodskaya Str.,
Russia
3125 Olfen Geldiclofenac
(diclofenac sodium)gel
10mg/g,
20g, 50g aluminium tube
Merckle GmbH,
Ludwig-Merckle-
Strasse 3, 89143
Blaubeuren - batch
releaser (Merckle
GmbH, Graf-Arco-
Strasse 3, 89079 Ulm,
Baden-Wurttemberg,
Germany - bulk
manufacturer)
Germany M02A A15 1344806.05.2014
06.05.2019OTC
TEVA
Pharmaceutical
Industries LTD, 5
Basel str., P.O. Box
3190, 49131 Petach
Tikva, Israel
670
3126 Olicard Retardisosorbide-5-
mononitrate
capsules hard
prolonged-release
40mg,
in blister (20/2x10/)
Temmler Pharma
GmbH & Co. KG,
Temmlerstrasse 2,
35039 Marburg -
packager, batch
releaser, (dosage form
manufacturer -
Valpharma
International S.P.A.,
Via G. Morgagni, 2-
47864 Pennabilli
(RN), Italy)
Germany C01DA14 12398/129.07.2014
19.04.2018PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
3127 Olicard Retardisosorbide-5-
mononitrate
capsules hard
prolonged-release
60mg,
in blister (20/2x10/)
Temmler Pharma
GmbH & Co. KG,
Temmlerstrasse 2,
35039 Marburg -
packager, batch
releaser, (dosage form
manufacturer -
Valpharma
International S.P.A.,
Via G. Morgagni, 2-
47864 Pennabilli
(RN), Italy)
Germany C01DA14 12399/129.07.2014
19.04.2018PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
3128 Olicard Retardisosorbide-5-
mononitrate
capsules hard
prolonged-release
40mg,
in blister (20/2x10/)
Temmler Pharma
GmbH & Co. KG,
Temmlerstrasse 2,
35039 Marburg -
packager, batch
relaser (dosage form
manufacturer -
Aptalis Pharma S.r.l.,
Via Martin Luther
King, 13, 20060
Pessano con Bornago
(MI), Italy)
Germany C01DA14 12615/129.07.2014
21.06.2018PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
671
3129 Olicard Retardisosorbide-5-
mononitrate
capsules hard
prolonged-release
60mg,
in blister (20/2x10/)
Temmler Pharma
GmbH & Co. KG,
Temmlerstrasse 2,
35039 Marburg -
packager, batch
relaser (dosage form
manufacturer -
Aptalis Pharma S.r.l.,
Via Martin Luther
King, 13, 20060
Pessano con Bornago
(MI), Italy)
Germany C01DA14 12616/129.07.2014
21.06.2018PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
3130 Oligovit
vitamin A,
cholecalciferol,
tocopherol acetate,
thiamine (thiamine
hydrochloride),
riboflavin, nicotinamide,
calcium pantotenate,
pyridoxine (pyridoxine
hydrochloride),
cyanocobalamin,
ascorbic acid, calcium
hydrogen phosphate
dihydrate, iron (iron
sulfate), magnesium
(magnesium oxide),
potassium (potassium
sulfate), zinc (zinc
sulfate heptahydrate),
copper (copper sulfate
pentahydrate),
manganese (manganese
sulfate monohydrate),
fluor (sodium fluoride),
molybdenum (sodium
molybdate dihydrate),
cobalt (cobalt sulfate)
tablets coated
5000IU+500IU+
12.5mg+5mg+
5mg+50mg+10mg+2.5mg
+0.0025mg+100mg+200m
g+ 10mg+3mg+
2.5mg+0.75mg+
0.5mg+0.5mg+
0.5mg+0.1mg+ 0.05mg,
in blister (30/3x10/),
Galenika a.d.,
Batajnicki drum bb,
11080 Belgrade
Serbia A11AA03 1476203.08.2015
03.08.2020OTC
Galenika a.d.,
Batajnicki drum bb,
11080 Belgrade,
Serbia
672
3131 Omacoromega-3
triglyceridescapsules soft
1000mg,
plastic container (28)
Abbott Laboratories
GmbH, Justus-von-
Liebig-Strasse 33,
31535 Neustadt -
batch releaser (
packager - GMPack
ApS, Plastvaenget 9,
9560 Hadsund,
Denmark) (bulk
manufacturer -
Patheon Softgels B.V.,
De Posthoornstraat 7,
5048 AS Tilburg, the
Netherlands)
Germany C10AX06 12364/229.12.2017
19.04.2018PoM
Abbott Laboratories
GmbH, Freundallee
9A, 30173 Hannover,
Germany
3132 Omaronpiracetam,
cinnarizinetablets
400mg+25mg, blisters
(30/3x10/, 60/6x10/,
90/9x10/)
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7
Russia N06BX 12131/103.02.2016
01.02.2018PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod, GSP-459,
Salganskaya st., 7,
Russia
3133 Omaronpiracetam,
cinnarizinetablets
400mg+25mg,
in blister (30/3x10,
60/6x10, 90/9x10)
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7
Russia N06BX 1716730.11.2017
30.11.2022PoM
Nizhpharm JSC,
603950, Nizhny
Novgorod,
Salganskaya st., 7,
Russia
3134 Omep-20 omeprazolecapsules gastro-
resistant
20mg,
in strip (100/10x10/),
in blister (30/3x10/)
Akriti
Pharmaceuticals Pvt.
Ltd., Plot No. D-10, D-
11, M.I.D.C. Indl.
Estate, Nira Road,
Jejuri, Tal. Purandhar
(Saswad), Dist. Pune-
412 303, Maharashtra
India A02BC01 1312010.01.2014
10.01.2019PoM
Akriti
Pharmaceuticals Pvt.
Ltd., 117, Block N0. 2,
Emerald Plaza,
Hiranandai Meadows,
Barrister Nath Pai
Road, Thane (West)
400 610, India
673
3135 Omeprazol omeprazolecapsules gastro-
resistant, hard
20mg,
in blister (30/3x10/)
Balkanpharma-
Razgrad AD, 68,
Aprilsko vastanie
Blvd, 7200 Razgrad
Bulgaria A02BC01 1682710.07.2017
10.07.2022PoM
Balkanpharma-
Dupnitsa AD,
(ACTAVIS GROUP),
str."Samokovsko
Shosse" N3, Dupnitsa
2600, Bulgaria
3136 Omeprazole omeprazole capsules20mg; (28) in plastic
container
Teva Pharma, S.L.U.
C/C, n0 4, Poligono
Industrial Malpica,
Zaragoza, 50016
Spain A02BC01 11625/104.11.2014
29.10.2019PoM
Somex Pharma, 600
High Road, Seven
Kings Ilford, Essex
IG3 8BS, UK
3137 Omeprazole omeprazolecapsules gastro-
resistant
20mg,
in blister (100/10x10/)
Medicamen Biotech
Ltd, SP-1192 A&B,
Phase IV,Industrial
Area,Bhiwadi,Dist.
Alwar (Rajasthan)
India A02BC01 1217001.02.2013
01.02.2018PoM
Troge Medical
GmbH, Milchstrasse
19, D-20148
Hamburg, Germany
3138 Omeprazole omeprazole capsules20mg,
in blister (30/3x10/)
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus A02BC01 1561124.05.2016
24.05.2021PoM
Open joint stock
company "Borisovskiy
zavod medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk
region, Belarus
3139 Omeprazole omeprazole capsules20mg,
in blister (20/2x10/)
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region
Republic of
ArmeniaA02BC01 16143
10.11.2016
10.11.2021PoM
"NOKI" JV LTD Co.,
Nor-Kharberd, Ararat
region, Republic of
Armenia
674
3140
Omeprazole
Delayed-Release
Capsule 20mg
omeprazolecapsules delayed-
release
20mg,
in blister (100/10x10/)
Intas Pharmaceuticals
Ltd., Plot No 457, 458
Village- Matoda, Tal-
Sanand, City- Matoda -
382 210, Dist.-
Ahmedabad
India A02BC01 1353430.05.2014
30.05.2019PoM
Intas Pharmaceuticals
Ltd.,Chinubhai
Centre, Off. Nehru
bridge, Ashram Road,
Ahmedabad, India
3141Omeprazole-
Asteria Cap. 20mgomeprazole capsules
20mg,
in blister (30/3x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
si, Chungcheongbuk-
do
Korea Sourth A02BC01 12391/206.11.2015
19.04.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
3142Omeprazole-
Asteria Cap. 20mgomeprazole capsules
20mg,
in blister (30/3x10/,
100/10x10/)
Hankook Korus
Pharm Co., Ltd, 30,
Gangjeo-ro, Jecheon-
Si, Chungcheongbuk-
do
Korea South A02BC01 1672905.06.2017
05.06.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, South Korea
3143 Omeprez omeprazole capsules20mg,
in blister (30/3x10/)
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A
Romania A02BC01 1234209.04.2013
09.04.2018PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 75100 Otopeni,
Str. Eroilor, Nr. 1A,
ROMANIA
3144 Omnadren 250
testosterone
(testosterone
propionate),
testosterone
(testosterone
phenylpropionate),
testosterone
(testosterone
isocaproate),
testosterone
(testosterone
decanoate)
solution for i/m
injection, oily
30mg/ml+
60mg/ml+60mg/ml+100m
g/ml,
1ml ampoules (5)
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland G03BA03 1603117.10.2016
17.10.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
675
3145 Omnic
tamsulosin
(tamsulosin
hydrochloride)
capsules modified-
release
0,4mg,
in blister (10/1x10/,
30/3x10/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands G04CA02 1486118.09.2015
18.09.2020PoM
Astellas Pharma
Europe B.V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
3146 Omnic Ocas
tamsulosin
(tamsulosin
hydrochloride)
tablets prolonged-
release coated
0,4mg,
in blister (10/1x10/,
30/3x10/)
Astellas Pharma
Europe B.V.,
Hogemaat 2, 7942 JG
Meppel
the Netherlands G04CA02 1486218.09.2015
18.09.2020PoM
Astellas Pharma
Europe B. V.,
Sylviusweg 62, 2333
BE Leiden, the
Netherlands
3147 Omnipaque iohexol solution for injection350mg iodine/ml, 100ml
plastic vial (10)
GE Healthcare
Ireland Limited, IDA
Business Park,
Carrigtohill Co. Cork
Ireland V08AB02 1722108.12.2017
08.12.2022PoM
GE Healthcare AS,
Nycoveien 1-2, P.O.
Box 4220 Nydalen,
NO-0401 Oslo,
Norway
3148 Omnipaque iohexol solution for injection350mg iodine/ml, 50ml
plastic vial (10)
GE Healthcare
Ireland Limited, IDA
Business Park,
Carrigtohill Co. Cork
Ireland V08AB02 1722208.12.2017
08.12.2022PoM
GE Healthcare AS,
Nycoveien 1-2, P.O.
Box 4220 Nydalen,
NO-0401 Oslo,
Norway
3149 Omniscan gadodiamidesolution for i/v
injection
287mg/ml (0.5mmol/ml),
20ml glass vial (1), 20ml
glass vials (10)
GE Healthcare
Ireland, IDA Business
Park, Carrigtohill Co.
Cork
Ireland V08CA03 1427126.02.2015
26.02.2020PoM
GE Healthcare AS,
Nycoveien 1-2, P.O.
Box 4220 Nydalen,
NO-0401 Oslo,
Norway
676
3150 Omnitusbutamirate
(butamirate citrate)syrup
0,8mg/ml,
200ml glass bottle and
measuring spoon
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm D.O.O.
Sabac, 15000, Sabac,
Hajduk Veljkova str.
No: bb-bulk
manufacturer,
packager
Serbia R05DB13 1419806.02.2015
06.02.2020OTC
Hemofarm A.D.,
26300 Vrsac,
Beogradskii put bb,
Serbia
3151 Omnopon-ZN
morphine
(morphine
hydrochloride),
noscapine,
papaverine
(papaverine
hydrochloride),
codeine, thebaine
solution for injection
11,5mg/ml+ 5.4mg/ml+
0.72mg/ml+ 1.44mg/ml+
0,1mg/ml,
1ml ampoules, in blister
(100/20x5/)
"KPE" Zdorovje
narodu" LLC, 61002,
Kharkov, Melnikova
str. 41
Ukraine N02AA51 1627219.12.2016
19.12.2021PoM/UC
"KPE" Zdorovje
narodu" LLC, 61013,
Kharkov, Sevchenko
str. 22, Ukraine
3152 Ompra-20 omeprazolecapsules gastro-
resistant
20mg,
in strip (100/10x10/)
Medicamen Biotech
Ltd.,SP-1192, A&B,
Phase-4, Industrial
Area, Bhiwadi, Distt.
Alwar, Rajasthan
301019
India A02BC01 1519430.12.2015
30.12.2020PoM
Veejay
Pharmaceutical Pvt.
Ltd., D. No 9-34/6,
Plot 8A, SV Nagar,
Kessara (M), Nagaram
(V), SV Road No 6,
OPP To Gayatri
Nivas, Near Vijaya
Hospitals Ecil X
Roads, Secunderabaad
Ap, 500083, India
3153On.setron-Denk
4mg ODTondansetron tablets orodispersible
4mg,
in blister (6/1x6/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany A04AA01 1474103.08.2015
03.08.2020PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
677
3154On.setron-Denk
8mg ODTondansetron tablets orodispersible
8mg,
in blister (6/1x6/)
Denk Pharma GmbH
& Co. KG, Goellstr. 1,
84529 Tittmoning
Germany A04AA01 1544902.04.2016
02.04.2021PoM
Denk Pharma GmbH
& Co. KG,
Prinzregentenstr. 79,
81675 Muenchen,
Germany
3155 Onbrez Breezhaler
indacaterol
(indacaterol
maleate)
powder for
inhalation, hard
capsules
150mcg,
in blister and inhaler
(10/1x10/, 30/3x10/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona-batch
releaser, packager,
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein,
Switzerland- bulk
manufacturer
Spain R03AC18 1623419.12.2016
19.12.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
3156 Onbrez Breezhaler
indacaterol
(indacaterol
maleate)
powder for
inhalation, hard
capsules
300mcg,
in blister and inhaler
(10/1x10/, 30/3x10/)
Novartis Farmaceutica
S.A., Ronda de Santa
Maria 158, 08210
Barbera del Valles,
Barcelona-batch
releaser, packager,
Novartis Pharma
Stein AG,
Schaffhauserstrasse,
4332 Stein,
Switzerland- bulk
manufacturer
Spain R03AC18 1623519.12.2016
19.12.2021PoM
Novartis Pharma AG,
Lichtstrasse 35, 4056
Basel, Switzerland
3157 Ondansetron
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for injection
2mg/ml,
2ml ampoules (5), 2ml
ampoules in blister
(5/1x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine A04AA01 1222507.03.2013
07.03.2018PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
678
3158 Ondansetron
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for injection
2mg/ml,
4ml ampoules (5), 4ml
ampoules in blister
(5/1x5/)
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov
Ukraine A04AA01 1222607.03.2013
07.03.2018PoM
Lekhim-Kharkiv JSC,
36, 17-go Partsyezda
str., 61115 Kharkov,
Ukraine
3159 Ondansetron
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for injection
2mg/ml,
4ml ampoules, (5) 4ml
ampoules,
in blister (5/1x5/)
Lekhim-Kharkiv
PrJSC, 36, Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv
Ukraine A04AA01 1716930.11.2017
30.11.2022PoM
Lekhim-Kharkiv
PrJSC, 36, Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv,
Ukraine
3160 Ondansetron
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for injection
2mg/ml,
2ml ampoules, (5) 2ml
ampoules,
in blister (5/1x5/)
Lekhim-Kharkiv
PrJSC, 36, Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv
Ukraine A04AA01 1717030.11.2017
30.11.2022PoM
Lekhim-Kharkiv
PrJSC, 36, Severyna
Pototskoho str.,
61115, Kharkiv
region, Kharkiv,
Ukraine
3161
Ondansetron
2mg/ml Solution
for Injection or
Infusion
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for
injection/infusion
2mg/ml,
4ml ampoules (5)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK A04AA01 1514117.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
679
3162
Ondansetron
2mg/ml Solution
for Injection or
Infusion
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for
injection/infusion
2mg/ml,
2ml ampoules (5)
Accord Healthcare
Limited, Sage House,319
Pinner Road, North
Harrow, Middlesex, HA1
4HF- batch releaser, Intas
Pharmaceuticals Limited,
Plot No 457 & 458 &
191/218 P, Sarkhej-Bavla
Highway, Matoda Village,
Sanand, District-
Ahmedabad, 382 210,
Gujarat, India- bulk
manufacturer, Accord
Healthcare Limited, Unit C
& D, Homefield Business
Park, Homefield Road,
Haverhill, CB9 8QP, UK-
primary and secondary
packager
UK A04AA01 1514217.12.2015
17.12.2020PoM
Accord Healthcare
Limited, Sage
House,319 Pinner
Road, North Harrow,
Middlesex, HA1 4HF,
UK
3163
Ondansetron-
Asteria Inj.
8mg/4ml
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for i/m and
/i/v injection
2mg/ml,
4ml ampoules (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea Sourth A04AA01 12998/120.08.2015
28.10.2018PoM
GL Corporation,
Woori Venture
Tower #201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
3164
Ondansetron-
Asteria Inj.
8mg/4ml
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for i/m and
i/v injection
2mg/ml,
4ml ampoules (10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South A04AA01 1684210.07.2017
10.07.2022PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
YoungDeungPo-Ku,
Seoul, Korea South
3165 Ondansetron-Teva
ondansetron
(ondansetron
hydrochloride
dihydrate)
solution for injection2mg/ml,
2ml ampoules (5)
Teva Pharmaceutical
Works Private
Limited Company, H-
2100 Godollo,
Tancsics Mihaly ut 82
Hungary A04AA01 1255306.06.2013
06.06.2018PoM
Teva Pharmaceutical
Industries Ltd., 5
Basel str., P.O. Box
3190, Petach Tikva,
49131, Israel
680