Page 1
N Trade name
International
nonproprietary name
(generic) or active
ingredients name
Drug formDose and
packagingManufacturer Country ATC1 code
Registration
number
Term of
registration
Legal Status
for SupplyLicense holder
1 Amlo-Denk 10amlodipine (amlodipine
mesilate monohydrate)tablets
10mg,
in blister (50/5x10/)
Denk Pharma GmbH
& Co. KG, Goellstr.
1, 84529 Tittmoning
Germany C08CA01 1613210.11.2016
10.11.2021PoM2
Denk Pharma
GmbH & Co. KG,
Prinzregentenstr.
79, 81675
Munchen,
Germany
2 Amlo-Denk 5amlodipine (amlodipine
mesilate monohydrate)tablets
5mg,
in blister (50/5x10/)
Denk Pharma GmbH
& Co. KG, Goellstr.
1, 84529 Tittmoning
Germany C08CA01 1613310.11.2016
10.11.2021PoM
Denk Pharma
GmbH & Co. KG,
Prinzregentenstr.
79, 81675
Munchen,
Germany
3 Amlonoramlodipine (amlodipine
besilate)tablets
10mg,
in blister (30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland C08CA01 1615023.11.2016
23.11.2021PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice,
Poland
4 Amlonoramlodipine (amlodipine
besilate)tablets
5mg,
in blister (30/3x10/)
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice
Poland C08CA01 1615123.11.2016
23.11.2021PoM
Pharmaceutical
Works Polfa in
Pabianice JSC, 5
Marszalka J.
Pilsudskiego Str., 95-
200 Pabianice,
Poland
LIST OF REGISTRED DRUGS IN ARMENIA
(01.11.2016-30.11.2016)
1
Page 2
5 Amoxicillin amoxicillingranules for oral
suspension
250mg/5ml,
40g granules in
100ml glass bottle
and measuring
spoon 5ml
Hemofarm A.D.
26300, Vrsac,
Beogradskii put bb-
batch releaser,
Hemofarm A.D.,
Vrsac, 26224,
Dubovac, str. Cara
Lazara bb, Serbia-
bulk manufacturere,
packager
Serbia J01CA04 1617123.11.2016
23.11.2021PoM
Hemofarm A.D.,
26300, Vrsac,
Beogradskii put bb,
Serbia
6 Antiflu
acetaminophen,
phenylephrine
(phenylephrine
hydrochloride),
chlorpheniramine
(chlorpheniramine
maleate)
tablets film-coated325mg+5mg+2mg,
in blister (12/1x12/)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA N02BE51 1615323.11.2016
23.11.2021OTC3
Bayer Consumer
Care AG, Peter
Merian-Strasse 84,
4052 Basel,
Switzerland
7 Antiflu
acetaminophen,
phenylephrine
(phenylephrine
hydrochloride),
chlorpheniramine
(chlorpheniramine
maleate)
powder for oral
solution with
lemon flavour
650mg+10mg+4mg
sachets (5)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA N02BE51 1615423.11.2016
23.11.2021OTC
for Bayer Consumer
Care AG, Peter
Merian-Strasse 84,
4052 Basel,
Switzerland
2
Page 3
8 Antiflu Kids
paracetamol, ascorbic
acid, chlorpheniramine
(chlorpheniramine
maleate)
powder for oral
solution with
raspberry flavour
160mg+50mg+ 1mg,
sachets (5)
Contract Pharmacal
Corporation, 135
Adams avenue,
Hauppauge, New
York 11788-batch
releaser, packager,
Contract Pharmacal
Corporation, 160
Commerce Drive
Hauppauge, New
York 11788, USA-
bulk manufacturer
USA N02BE51 1615523.11.2016
23.11.2021OTC
AO BAYER, 3rd
Rybinskaya St., 18,
build. 2, 107113
Moscow, Russia
9 Antimyk-Neu clotrimazole cream
10mg/g,
20g aluminium
tube
"NOKI" JV LTD Co.,
Nor-Kharberd,
Ararat region
Republic of
ArmeniaD01AC01 16142
10.11.2016
10.11.2021OTC
"NOKI" JV LTD
Co., Nor-Kharberd,
Ararat region,
Republic of
Armenia
10 Argosulfan sulfathiazole silvercream for external
use
20mg/g,
15g, 40g aluminium
tube,
400g plastic
container
Pharmaceutical
Company Jelfa S.A.,
ul. Wincentego Pola
21, 58-500 Jelenia
Gora
Poland D06BA02 1611410.11.2016
10.11.2021OTC
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
11 Bicillin-3
benzathine
benzylpenicillin,
benzylpenicillin sodium,
benzylpenicillin
procaine
powder for i/m
suspension for
injection
200000IU+
200000IU+
200000IU,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CE30 1611610.11.2016
10.11.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo
street, 139, Ukraine
12 Bicillin-5
benzathine
benzylpenicillin,
benzylpenicillin
procaine
powder for i/m
suspension for
injection
1200000IU+
300000IU,
glass vial (40)
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo street,
139
Ukraine J01CE30 1611710.11.2016
10.11.2021PoM
Kievmedpreparat
PJSC, 01032, Kiev,
Saksaganskogo
street, 139, Ukraine
3
Page 4
13 Cefepime-Asteria Inj. 1gcefepime (cefepime
hydrochloride)
powder for solution
for injection
1000mg,
glass vial (1, 10)
Hankook Korus
Pharm Co., Ltd, 78
Daepungsandan-ro,
Daeso-myeon,
Eumseong-gun,
Chungcheongbuk-do
Korea South J01DE01 1612610.11.2016
10.11.2021PoM
GL Corporation,
Woori Venture
Tower 201, 70,
Seonyu-ro,
Yeongdeungpo-ku,
Seoul, Korea South
14 Cefrobactum
cefoperazone
(cefoperazone sodium),
sulbactam (sulbactam
sodium)
powder for solution
for injection
1000mg+1000mg,
20ml glass vial (1)
Sanjivani Paranteral
Limited R-40, T.T.C.
Rabale, Thane-
Belapur Road, Navi
Mumbai 400 701
India J01DD62 1618823.11.2016
23.11.2021PoM
S.P. Incomed Pvt.
Ltd., H-680, Palam
Extn.-1, New Delhi
110 045, India
15 Chirocaine
levobupivacaine
(levobupivacaine
hydrochloride)
solution for
injection/infusion
5mg/ml,
10ml ampoules (10)
AbbVie S.r.l., S.R.
148 Pontina KM 52,
SNC - Campoverde
di Aprilia 04011
Aprilia (LT) -batch
releaser, secondary
packager, Curida AS,
Solbaervegen 5,
Elverum, NO-2409,
Norway- bulk
manufacturer,
primary packager
Italy N01BB10 1613710.11.2016
10.11.2021PoM
AbbVie
Biopharmaceuticals
GmbH,
Neuhofstrasse 23,
Postfach 6341 Baar,
Switzerland
16 Ciprinol ciprofloxacinsolution for
infusion
2mg/ml,
100ml glass vial
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1612010.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
17 Ciprinol
ciprofloxacin
(ciprofloxacin
hydrochloride
monohydrate)
tablets film-coated750mg,
in blister (10/1x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01MA02 1614623.11.2016
23.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
4
Page 5
18 Cipro-Denk 500
ciprofloxacin
(ciprofloxacin
hydrochloride)
tablets film-coated500mg,
in blister (10/1x10/)
Allphamed
PHARBIL
Arzneimittel GmbH,
Hildebrandstr. 12,
37081 Gottingen
Germany J01MA02 1613810.11.2016
10.11.2021PoM
Denk Pharma
GmbH & Co. KG,
Prinzregentenstr.
79, 81675
Muenchen,
Germany
19 Ciprofloxacin
ciprofloxacin
(ciprofloxacin
hydrochloride)
drops eye
3mg/ml,
10ml plastic vial-
dropper
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9
Republic of
ArmeniaS01AE03 16148
23.11.2016
23.11.2021PoM
Liqvor CJSC, 0089,
Yerevan, str.
Kochinyan, 7/9,
Republic of
Armenia
20 Clostilbegytclomifene (clomifene
citrate)tablets
50mg,
in glass vial (10)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary G03GB02 1610310.11.2016
10.11.2021PoM
Egis
Pharmaceuticals
PLC, 1106
Budapest,
Kereszturi ut 30-38,
Hungary
21Colchicine
Opocalciumcolchicine tablets
1mg,
in blister (20/1x20/)
S.C Zentiva S.A,
Theodor Pallady Blvd
nr. 50, sector 3,
Bucuresti, cod
032266
Romania M04AC01 1612910.11.2016
10.11.2021PoM
Laboratoires
MAYOLY
SPINDLER, 6
avenue de l`
Europe, 78400
Chatou, France
22 Co-Prenessaperindopril (perindopril
erbumine), indapamidetablets
4mg+1,25mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA04 1609110.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
23 Co-Prenessaperindopril (perindopril
erbumine), indapamidetablets
2mg+0,625mg,
in blister (30/3x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia C09BA04 1609210.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
5
Page 6
24 Curosurf poractant alfasuspension
endotracheal
80mg/ml,
1.5ml glass vial
Chiesi
Pharmaceuticals
GmbH, Gonzagagasse
16/16, Wien, 1010-
batch releaser, Chiesi
Farmaceutici S.p.A,
Via Palermo 26/A-
43122 Parma(PR),
Italy-bulk
manufacturer,
primary packager,
G.L. Pharma GmbH,
Arnethgasse 3, 1160
Wien, Austria-
secondary packager
Austria R07AA02 1618223.11.2016
23.11.2021PoM
Chiesi
Pharmaceuticals
GmbH,
Gonzagagasse
16/16, Wien, 1010,
Austria
25 Dafneginciclopirox (ciclopirox
olamine)cream vaginal
10mg/g,
78g aluminium
tube and (14)
applicator
Doppel Farmaceutici
S.R.L., Via Martiri
delle Foibe, 1, 29016
Cortemaggiore (PC)
Italy G01AX12 1613010.11.2016
10.11.2021PoM
Polichem S.r.l., Via
G. Marcora, 11,
20121 Milan (MI),
Italy
26 Dafneginciclopirox (ciclopirox
olamine)
suppositories
vaginal
100mg,
(6/1x6/) and
applicator (6)
Doppel Farmaceutici
S.R.L., Via Martiri
delle Foibe, 1, 29016
Cortemaggiore (PC)
Italy G01AX12 1613110.11.2016
10.11.2021PoM
Polichem S.r.l., Via
G. Marcora, 11,
20121 Milan (MI),
Italy
27 Daivobet
betamethasone
(betamethasone
dipropionate),
calcipotriol (calcipotriol
monohydrate)
ointment for
external use
0,5mg/g+ 0,05mg/g,
15g, 30galuminium
or plastic tube
LEO Laboratories
Limited, 285 Cashel
Road, Dublin 12
Ireland D05AX52 12750/122.11.2016
06.08.2018OTC
LEO
Pharmaceutical
Products Ltd A/S
(LEO Pharma
A/S),Industriparken
55, DK-2750
Ballerup, Denmark
6
Page 7
28 Diclac gel 5%diclofenac (diclofenac
sodium)gel for external use
50mg/g,
50g aluminium
tube
Salutas Pharma
GmbH,
Betriebsstaette
Osterweddingen,
Lange Goehren
3,Suelzetal, OT
Osterweddingen,Sac
hsen-Anhalt, 39171
Germany M02AA15 1618323.11.2016
23.11.2021OTC
Sandoz
Pharmaceuticals
d.d., Verovskova
Str. 57, 1000
Ljubljana, Slovenia
29 Dorzopt
dorzolamide
(dorzolamide
hydrochloride)
drops eye
20mg/ml,
5ml plastic vial-
dropper
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str. Eroilor,
Nr. 1A
Romania S01EC03 1611910.11.2016
10.11.2021PoM
S.C. Rompharm
Company S.R.L.,
Ilfov, 075100
Otopeni, Str.
Eroilor, Nr. 1A,
Romania
30 Efloran metronidazolesolution for
infusion
5mg/ml,
100ml glass bottle
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia J01XD01 1609010.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
31 Elonva corifollitropin alfasolution for
injection
150mcg/0,5ml,
0,5ml pre-filled
syringe and needle
(1)
Organon (Ireland)
Ltd., Drynam Road,
Swords, Co. Dublin -
batch releaser,
secondary packager,
Vetter Pharma-
Fertigung GmbH &
Co. KG,
Schutzenstrasse 87
and 99/101, D-88212
Ravensburg,
Germany-bulk
manufacturer,
primary packager
IrelandG03GA09;
new indication14120/1
23.11.2016
29.12.2019PoM
Schering-Plough
Central East AG,
Weystrasse 20, CH-
6000 Lucerne 6,
Switzerland
7
Page 8
32 Elonva corifollitropin alfasolution for
injection
100mg/0,5ml,
0,5ml pre-filled
syringeand needle
Organon (Ireland)
Ltd., Drynam Road,
Swords, Co. Dublin -
secondary packager,
batch releaser (bulk
manufacturer,
primary packager -
Vetter Pharma-
Fertigung GmbH &
Co. KG,
Schutzenstrasse 87
and 99/101, D-88212
Ravensburg,
Germany)
IrelandG03GA09;
new indication14121/1
23.11.2016
29.12.2019PoM
Central East AG,
Weystrasse 20, P.O.
Box CH-6000
Lucerne 6,
Switzerland
33Esomeprazol 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
34Esomeprazol 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
35 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
36 Formetinmetformin (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
8
Page 9
37 Formetinmetformin (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
38 Formetinmetformin (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
39 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
40 Ibuprofen Sandoz 600mg ibuprofen tablets film-coated600mg,
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
9
Page 10
41 Ibuprofen Sandoz 800mg ibuprofen tablets film-coated800mg,
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
42 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
43 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
10.11.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
44 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
10.11.2021PoM
VALEANT LLC,
Shabolovka st. 31,
building 5, 115162,
Moscow, Russia
10
Page 11
45 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
46 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
47 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
48 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
11
Page 12
49 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
50 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
51 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
52 Metvix methyl aminolevulinatecream 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
12
Page 13
53 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
54Mitoxantron 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
55Mitoxantron 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
56 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/UC4
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
57 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
13
Page 14
58 Naphthyzin-Arsanit naphazoline 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
59 Naphthyzin-Arsanit naphazoline 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
60 Nicoflex
capsaicin, ethyl
nicotinate,
ethylenglycol salicylate
ointment for
external use
0.15mg/g+20mg/g+9
0mg/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
61 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
62 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
14
Page 15
63 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
64 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
65 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
66 Ostiralraloxifene (raloxifene
hydrochloride)tablets film-coated
60mg,
in blister (28/2x14/)
Pharmathen
International S.A.,
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5, Rodopi
69300
Greece G03XC01 15410/116.11.2016
09.03.2021PoM
Pharmathen S.A.,
Dervenakion 6,
15351 Pallini,
Attiki, Greece
67 Paclitaxel paclitaxel
concentrate for
solution for
infusion
30mg/5ml,
5ml glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01CD01 1617223.11.2016
23.11.2021PoM
Belmedpreparaty
RUE, 220007,
Minsk, Fabritsius
St., 30, Belarus
68 Paclitaxel paclitaxel
concentrate for
solution for
infusion
100mg/16,7ml,
16.7ml glass vial (1)
Belmedpreparaty
RUE, 220007, Minsk,
Fabritsius St., 30
Belarus L01CD01 1617323.11.2016
23.11.2021PoM
Belmedpreparaty
RUE, 220007,
Minsk, Fabritsius
St., 30, Belarus
15
Page 16
69 Parietrabeprazole (rabeprazole
sodium)
tablets gastro-
resistant film-
coated
20mg,
blister (14/1x14/,
28/2x14/)
Cilag AG,
Schaffhausen CH-
8205, Hochstrasse
201
Switzerland A02BC04 12403/222.11.2016
19.04.2018PoM
Cilag AG,
Schaffhausen CH-
8205, Hochstrasse
201, Switzerland
70 Peritol
cyproheptadine
(cyproheptadine
hydrochloride)
tablets4mg,
in blister (20/2x10/)
Egis Pharmaceuticals
PLC, 9900, Kormend,
Matyas Kiraly u. 65
Hungary R06AX02 1610610.11.2016
10.11.2021PoM
Egis
Pharmaceuticals
PLC, 1106
Budapest,
Kereszturi ut 30-38,
Hungary
71 Piracetam piracetamsolution for
injection
200mg/ml,
5ml ampoules,
in blister (10,
10/2x5/)
Open joint stock
company
"Borisovskiy zavod
medicinskikh
preparatov" 64,
Chapaev str., Borisov
222518, Minsk region
Belarus N06BX03 1608810.11.2016
10.11.2021PoM
Open joint stock
company
"Borisovskiy zavod
medicinskikh
preparatov" 64,
Chapaev str.,
Borisov 222518,
Minsk region
72 Pofol Injection I.V. propofolemulsion for i/v
injection
10mg/ml,
50ml glass vial (1)
Dongkook
Pharmaceutical Co.,
Ltd., 33-19, Yongso 2-
gil, Gwanghyewon-
myeon, Jincheon-
gun,
Chungcheongbuk-do
Korea South N01AX10 1615223.11.2016
23.11.2021PoM
Dongkook
Pharmaceutical Co.,
Ltd., 7, Teheran-ro
108-gil, Gangnam-
gu, Seoul, Korea
South
73 Prestilol 10mg/10mg
bisoprolol (bisoprolol
fumarate), perindopril
(perindopril arginine)
tablets film-coated
10mg+10mg,
in plastic container
(30)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C09BX02 1616123.11.2016
23.11.2021PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
74 Prestilol 10mg/5mg
bisoprolol (bisoprolol
fumarate), perindopril
(perindopril arginine)
tablets film-coated
10mg+5mg,
in plastic container
(30)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C09BX02 1616223.11.2016
23.11.2021PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
16
Page 17
75 Prestilol 5mg/10mg
bisoprolol (bisoprolol
fumarate), perindopril
(perindopril arginine)
tablets film-coated
5mg+10mg,
in plastic container
(30)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C09BX02 1616323.11.2016
23.11.2021PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
76 Prestilol 5mg/5mg
bisoprolol (bisoprolol
fumarate), perindopril
(perindopril arginine)
tablets film-coated
5mg+5mg,
in plastic container
(30)
Les Laboratoires
Servier Industrie 905,
route de Saran, 45520
Gidy
France C09BX02 1616423.11.2016
23.11.2021PoM
Les Laboratoires
Servier, 50, rue
Carnot, 92284
Suresnes cedex,
France
77 Privigenhuman normal
immunoglobulin
solution for
infusion
100mg/ml,
25ml glass vial
CSL Behring AG,
Wankdorfstrasse 10,
CH-3000 Bern 22
Switzerland J06BA02 1610710.11.2016
10.11.2021PoM
CSL Behring AG,
Wankdorfstrasse
10, CH-3000 Bern
22, Switzerland
78 Privigenhuman normal
immunoglobulin
solution for
infusion
100mg/ml,
50ml glass vial
CSL Behring AG,
Wankdorfstrasse 10,
CH-3000 Bern 22
Switzerland J06BA02 1610810.11.2016
10.11.2021PoM
CSL Behring AG,
Wankdorfstrasse
10, CH-3000 Bern
22, Switzerland
79 Privigenhuman normal
immunoglobulin
solution for
infusion
100mg/ml,
200ml glass vial
CSL Behring AG,
Wankdorfstrasse 10,
CH-3000 Bern 22
Switzerland J06BA02 1610910.11.2016
10.11.2021PoM
CSL Behring AG,
Wankdorfstrasse
10, CH-3000 Bern
22, Switzerland
80 Privigenhuman normal
immunoglobulin
solution for
infusion
100mg/ml,
100ml glass vial
CSL Behring AG,
Wankdorfstrasse 10,
CH-3000 Bern 22
Switzerland J06BA02 1611010.11.2016
10.11.2021PoM
CSL Behring AG,
Wankdorfstrasse
10, CH-3000 Bern
22, Switzerland
81 Propafenon Alkaloid
propafenone
(propafenone
hydrochloride)
tablets film-coated150mg,
in blister (40/4x10/)
Alkaloid AD Skopje,
Blvd. Aleksandar
Makedonski 12, 1000
Skopje
Macedonia C01BC03 1612110.11.2016
10.11.2021PoM
Alkaloid AD
Skopje, Blvd.
Aleksandar
Makedonski 12,
1000 Skopje
17
Page 18
82 Psoridermclobetasol (clobetasol
propionate)
solution for topical
use
0,5mg/ml,
25ml plastic
container
Birzeit
Pharmaceutical
Company (BPC),
Ramallah,Industrial
Zone, P.O. box 79
Palestine D07AD01 1615623.11.2016
23.11.2021PoM
Pharmacare Int.
Co./German
Palestinian Joint
Venture, Jerusalem,
P.O. box 51621,
Palestine
83 Rosartrosuvastatin
(rosuvastatin calcium)tablets film-coated
40mg,
in blister (28/2x14/,
28/4x7/, 30/3x10/,
90/9x10/)
Actavis Ltd., BLB
015, BLB 016,
Bulebel Industrial
Estate, Zejtun, ZTN
3000
C10AA07 1608010.11.2016
10.11.2021PoM
"Actavis Group
PTC ehf",
Reykjavikurvegur
76-78, IS-220
Hafnarfjordur,
Iceland
84 Rosartrosuvastatin
(rosuvastatin calcium)tablets film-coated
10mg,
in blister (28/2x14/,
28/4x7/, 30/3x10/,
90/9x10/)
Actavis Ltd., BLB
015, BLB 016,
Bulebel Industrial
Estate, Zejtun, ZTN
3000
Malta C10AA07 1608110.11.2016
10.11.2021PoM
"Actavis Group
PTC ehf",
Reykjavikurvegur
76-78, IS-220
Hafnarfjordur,
Iceland
85 Rosartrosuvastatin
(rosuvastatin calcium)tablets film-coated
20mg,
in blister (28/2x14/,
28/4x7/, 30/3x10/,
90/9x10/)
Actavis Ltd., BLB
015, BLB 016,
Bulebel Industrial
Estate, Zejtun, ZTN
3000
Malta C10AA07 1608210.11.2016
10.11.2021PoM
"Actavis Group
PTC ehf",
Reykjavikurvegur
76-78, IS-220
Hafnarfjordur,
Iceland
86 Septolete D menthol benzalkonium chloride pastilles1mg,
in blister (30/2x15/)
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 R02AA16 1618423.11.2016
23.11.2021OTC
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
18
Page 19
87 Sertazolsertaconazole
(sertaconazole nitrate)
suppositories
vaginal300mg; (1)
"Rubicon" LLC, 62B,
M. Gorky street,
210002, Vitebsk
Belarus D01AC14 1618123.11.2016
23.11.2021PoM
"Rubicon" LLC,
62B, M. Gorky
street, 210002,
Vitebsk, Belarus
88 Sinaflan fluocinolone acetonideointment for
external use
0,25mg/g,
10g aluminium
tube
Akrikhin
Pharmaceuticals Co.,
142450, Moscow
region, Noginsk
district, Staraya
Kupavna, Kirova
street 29
Russia D07AC04 1613410.11.2016
10.11.2021PoM
Akrikhin
Pharmaceuticals
Co., 142450,
Moscow region,
Noginsk district,
Staraya Kupavna,
Kirova street 29,
Russia
89 Solian amisulpridetablets scored film-
coated
400mg,
in blister (30/3x10/)
Sanofi Winthrop
Industrie, 6,
Boulevard de l
Europe 21800
Quetigny
France N05AL05 1617623.11.2016
23.11.2021PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014
Paris, France
90 Solian amisulpride tablets scored100mg,
in blister (30/3x10)
Sanofi Winthrop
Industrie, 6,
Boulevard de l
Europe 21800
Quetigny
France N05AL05 1617723.11.2016
23.11.2021PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014
Paris, France
91 Solian amisulpride tablets scored200mg,
in blister (30/3x10/)
Sanofi Winthrop
Industrie, 6,
Boulevard de l
Europe 21800
Quetigny
France N05AL05 1617823.11.2016
23.11.2021PoM
Sanofi-Aventis
France, 1-13,
boulevard Romain
Rolland, 75014
Paris, France
92 Soolantra ivermectin cream
10mg/g,
2g, 15g, 30g, 45g
and 60g plastic tube
Laboratoires
Galderma Z.I.
Montdesir, 74540
Alby-sur-Cheran,
France
France D11AX22 1611510.11.2016
10.11.2021PoM
Galderma SA,
Zugerstrasse 8, CH-
6330 Cham,
Switzerland
93 Sulfasalazin sulfasalazine tablets film-coated500mg,
in blister (50/5x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto
Slovenia A07EC01 1614423.11.2016
23.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
19
Page 20
94 Sulfasalazin sulfasalazine tablets film-coated500mg,
in blister (50/5x10/)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto - batch
releaser, bulk
manufacturer, KRKA
d.d., Novo mesto,
Ulica Rada Pusenjaka
10, Ljutomer, 9240,
Slovenia-packager
Slovenia A07EC01 1614523.11.2016
23.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
95 Terbisilterbinafine (terbinafine
hydrochloride)tablets
250mg,
in blister (14/1x14/,
28/2x14/)
Gedeon Richter PLC,
Gyomroi ut 19-21,
1103 Budapest
Hungary D01BA02 1612310.11.2016
10.11.2021PoM
Gedeon Richter
PLC, Gyomroi ut
19-21, 1103
Budapest
96 Terbisilterbinafine (terbinafine
hydrochloride)
cream for external
use
10mg/g,
15g aluminium
tube
Gedeon Richter
OJSC, Gyomroi ut 19-
21, 1103 Budapest
Hungary D01AE15 1616823.11.2016
23.11.2021OTC
Gedeon Richter
PLC, Gyomroi ut
19-21, 1103
Budapest
97 Tetracycline-Belmed
tetracycline
(tetracycline
hydrochloride)
tablets film-coated
100mg,
in blister (10/1x10/,
20/2x10/)
Belmedpreparaty
RUE, 220007, Minsk,
Mayakovskogo St., 1
Belarus J01AA07 1611810.11.2016
10.11.2021PoM
Belmedpreparaty
RUE, 220007,
Minsk, Fabritsius
St., 30, Belarus
98 Thrombaspin acetylsalicylic acidtablets gastro-
resistant
100mg,
in blister (20/2x10/)
GM Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi
Georgia B01AC06 1617023.11.2016
23.11.2021OTC
GM
Pharmaceuticals
Ltd, PSP group 65,
Qvemo Phonichala
str., Tbilisi, Georgia
20
Page 21
99 Triumeq
dolutegravir
(dolutegravir sodium),
abacavir (abacavir
sulfate), lamivudine
tablets film-coated
50mg+600mg+
300mg,
in plastic container
(30)
Glaxo Wellcome
S.A., Avenida
Extremadura, 3,
09400 Aranda de
Duero, Burgos- batch
releaser, packager,
Glaxo Operations UK
Ltd, Priory Street,
Ware, Hertfordshire
SG12 0DJ, UK-bulk
manufacturer
Spain J05AR13մ 1614923.11.2016
23.11.2021PoM
ViiV Healthcare
UK Ltd., 980 Great
West Road,
Brentford,
Middlesex, TW8
9GS, UK
100 Utrogestan progesterone capsules soft200mg,
in blister (14/2x7/)
Cyndea Pharma SL,
Poligono Industrial
Emiliano Revilla
Sanz, Avenida de
Agreda, 31, Olvega
42110(Soria)
Spain G03DA04 1615923.11.2016
23.11.2021PoM
Besins Healthcare
SA, Avenue Louise
287, 1050 Brussels,
Belgium
101 Utrogestan progesterone capsules soft100mg,
in blister (28/2x14/)
Cyndea Pharma SL,
Poligono Industrial
Emiliano Revilla
Sanz, Avenida de
Agreda, 31, Olvega
42110(Soria)
Spain G03DA04 1616023.11.2016
23.11.2021PoM
Besins Healthcare
SA, Avenue Louise
287, 1050 Brussels,
Belgium
102 Vinpocetine Covex 5mg vinpocetine tablets
5mg,
in blister, (25/1x25/,
50/2x25/)
Kern Pharma S.L.,
C/Venus, 72 Pol. Ind.
Colon II, 08228
Terrasa, (Barcelona)
Spain N06BX18 1614723.11.2016
23.11.2021PoM
Covex S.A.,
C/Acero, 25, Pol.
Ind. Sur 28770
Colmenar Viejo,
(Madrid), Spain
21
Page 22
103 Virolex aciclovirpowder for solution
for infusion
250mg,
glass vial (5)
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto-batch releaser,
secondary packager,
GlaxoSmithKline
Manufacturing
S.p.A., Strada
Provinciale Asolana,
90, 43056 San Polo di
Torrile, Parma, Italy-
bulk manufacturer,
primary packager
Slovenia J05AB01 1612210.11.2016
10.11.2021PoM
KRKA d.d., Novo
mesto, Smarjeska
cesta 6, 8501 Novo
Mesto, Slovenia
104 Vitamin C ascorbic acid capsules500mg,
in blister (20/2x10/)
"NOKI" JV LTD Co.,
Nor-Kharberd,
Ararat region
Republic of
ArmeniaA11GA01 16141
10.11.2016
10.11.2021OTC
"NOKI" JV LTD
Co., Nor-Kharberd,
Ararat region,
Republic of
Armenia
105 Zalainsertaconazole
(sertaconazole nitrate)
suppositories
vaginal
300mg,
(1)
Trommsdorff GmbH
& Co. KG,
Arzneimittel,
Trommsdorffstrasse 2-
6, 52477, Alsdorf
Germany G01AF19 1615723.11.2016
23.11.2021PoM
Egis
Pharmaceuticals
PLC, 1106
Budapest,
Kereszturi st. 30-38,
Hungary
106 Zalainsertaconazole
(sertaconazole nitrate)
suppositories
vaginal
300mg,
(1)
Egis Pharmaceuticals
PLC, 1165 Budapest,
Bokenyfoldi st. 118-
120 - batch releaser,
Trommsdorff GmbH
& Co. KG,
Arzneimittel,
Trommsdorffstrasse 2-
6, 52477, Alsdorf,
Germany- bulk
manufacturer,
packager
Hungary G01AF19 1615823.11.2016
23.11.2021PoM
Egis
Pharmaceuticals
PLC, 1106
Budapest,
Kereszturi st. 30-38,
Hungary
22
Page 23
107 Zimfil-ODF 10 tadalafil films orodispersible10mg,
sachets (4, 10)
Zim Laboratories
Ltd., B-21/22, MIDC
Area, Kalmeshwar-
441 501, Dist. Nagpur
(M.S.)
India G04BE08 1612710.11.2016
10.11.2021PoM
Zim Laboratories
Ltd., Ground Floor,
Sadoday Gyan,
Nelson Square,
Chhindwara Road,
Nagpur-440 013,
India
108 Zimfil-ODF 20 tadalafil films orodispersible20mg,
sachets (4, 10)
Zim Laboratories
Ltd., B-21/22, MIDC
Area, Kalmeshwar-
441 501, Dist. Nagpur
(M.S.)
India G04BE08 1612810.11.2016
10.11.2021PoM
Zim Laboratories
Ltd., Ground Floor,
Sadoday Gyan,
Nelson Square,
Chhindwara Road,
Nagpur-440 013,
India
1 - Anatomical, Therapeutic Chemical Classification, 2 - PoM - Prescription only medicine, 3 - OTC - Over-the-Counter, 4 - PoM/UC - Prescription only medicine, Under Controlled
23