LIST of the medicines recommended for the registration by ...

[Pages:15]LIST of the medicines recommended for the registration by the Center according to the meeting decision N 9-2/19 on September 13, 2019

President___________________E. Amroya

N Trade name

International nonproprietary (generic) names or names of

active substances

dosage form

dosage strength & output form (packaging)

Manufacturer

country

License holder

License holder country

Prescription sta-

tus

Conclusion N & date

1.

Decaris

levamisole (levamisole hydrochloride)

2.

Decaris

levamisole (levamisole hydrochloride)

tablets tablets

50mg; (2/1x2/) in blister

Gedeon Richter PLC, Gyomroi ut 19-

21, 1103 Budapestbatch releaser, S.C. Gedeon

Richter Romania S.A., 99-105 Guza

Voda str.,Targu-

Mures, Romania-bulk manufacturer,

packager, quality control

150mg; (1) in blister

Gedeon Richter PLC, Gyomroi ut 19-

21, 1103 Budapestbatch releaser,

Hungary Hungary

Gedeon Richter PLC, Gyomroi ut

19-21, 1103 Budapest

Gedeon Richter PLC, Gyomroi ut

19-21, 1103 Budapest

Hungary Hungary

R

18810 27.09.2019

R

18811 27.09.2019

1

Bromocriptin-

3.

Richter

bromcriptine (bromocriptine

mesilate)

4.

Izigel M

ibuprofen, levomenthol

5.

Regulax Picosulphate

sodium picosulfate (sodium picosulfate

monohydrate)

tablets gel for external

use

drops oral

S.C. Gedeon Richter

Romania S.A., 99-105 Guza

Voda str.,Targu-

Mures, Romania-bulk manufacturer,

packager, quality control

2,5mg; (30) glass bottle

Gedeon Richter PLC, Gyomroi ut 19-

21, 1103 Budapest

50mg/g;+30mg/g; aluminium tube 40g

Balkanpharma -Razgrad AD,

68 Aprilsko Vastanie Blvd, 7200 Razgrad

7,5mg/ml; glass bottle 20ml

Krewel Meuselbach GmbH, Krewel str. 2, 53783 Eitorf-batch

releaser, Krewel Meuselbach GmbH, XavierVorbruggen str. 6, 98708 Gehren, Germany-bulk manufacturer, packager, quality control

Hungary Bulgaria

Germany

Gedeon Richter PLC, Gyomroi ut

19-21, 1103 Budapest

GM Pharmaceuticals Ltd, Phonichala

65

Krewel Meuselbach GmbH, Krewel str. 2, 53783 Eitorf

Hungary Georgia

Germany

R R

OTC

18812 27.09.2019

18813 27.09.2019

18814 27.09.2019

2

6.

MetromiconNeo

metronidazole, miconazole

(miconazole nitrate)

suppositories vaginal

500mg+100mg; (14/2x7/)

Farmaprim LTD, Crinilor

str., 5, Porumbeni, Criuleni dis.,

MD-4829

Moldova

Farmaprim LTD, Crinilor str., 5, Porumbeni,

Criuleni dis., MD4829

Moldova

7.

Clomezole

metronidazole, neomycin (neomycin sulfate), clotrimazole

suppositories vaginal

500mg+200mg+150 mg; (10/2x5/)

Farmaprim LTD, Crinilor

str., 5, Porumbeni, Criuleni dis.,

MD-4829

Moldova

Farmaprim LTD, Crinilor str., 5, Porumbeni,

Criuleni dis., MD4829

Moldova

KRKA d.d.,

Novo mesto,

Smarjeska

cesta 6, 8501

vitamin A,vitamin

Novo Mesto-

8.

Pikovit Forte

D3,vitamin C, nicotinamide,vitamin

E, calcium pantotenate, vitamin B6, vitaminB2,vitamin B1,folic acid,vitamin

tablets coated

5000IU+400IU+60m g+20mg+15mg+10 mg+2mg+1,7mg+1, 5mg+0,4mg+6mcg; (30/2x15/) in blister

quality control, batch releaser,

KRKA d.d., Novo mesto, Ulica Rada Pusenjaka 10,

Slovenia

KRKA d.d., Novo mesto, Smarjeska

cesta 6, 8501 Novo Mesto

Slovenia

B12

Ljutomer,

9240,

Slovenia-bulk

manufacturer,

packager

vitamin A, vitamin D3,

KRKA d.d.,

vitamin C,

600IU+80IU+10mg+ Novo mesto,

nicotinamide, calcium

3mg+1,20mg+0,3m Smarjeska

KRKA d.d., Novo

9.

Pikovit D

pantotenate, vitamin B2, vitamin B6,

tablets coated

g+0,3mg+0,25mg+0 cesta 6, 8501 ,04mg+0,2mcg+12, Novo Mesto-

Slovenia

mesto, Smarjeska cesta 6, 8501

Slovenia

vitamin B1, folic acid,

5mg+10mg;

quality control,

Novo Mesto

vitamin B12, calcium,

(30/2x15/) in blister batch releaser,

phosphorus

KRKA d.d.,

Novo mesto,

R R OTC OTC

18815 27.09.2019

18816 27.09.2019

18817 27.09.2019

18818 27.09.2019

3

Ulica Rada Pusenjaka 10,

Ljutomer, 9240,

Slovenia-bulk manufacturer,

packager

10.

Lorista

losartan (losartan potassium)

tablets film-coated

25mg; (28/2x14/) in blister, (28/4x7/) in

blister

KRKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto

Slovenia

KRKA d.d., Novo mesto, Smarjeska

cesta 6, 8501 Novo Mesto

Slovenia

R

11.

Lorista

losartan (losartan potassium)

tablets film-coated

50mg; (28/2x14/) blisters, (28/4x7/)

blisters

KRKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto

Slovenia

KRKA d.d., Novo mesto, Smarjeska

cesta 6, 8501 Novo Mesto

Slovenia

R

12.

Lorista H

losartan (losartan potassium),

hydrochlorothiazide

tablets film-coated

50mg+12,5mg; (28/2x14/) blisters, (28/4x7/) blisters

KRKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto

Slovenia

KRKA d.d., Novo mesto, Smarjeska

cesta 6, 8501 Novo Mesto

Slovenia

R

influenza vaccine

ABBOTT

inactivated (surface

Biologicals

antigen)-

B.V. Veerweg

A/Michigan45/2015

15mcg

12, 8121 AA

13.

Influvac

(H1N1) pdm 09-like strain (A/

Singapore/GP1908/2 015, IVR-180), A/ Singapore INFIMH16-0019/2016,

suspension for injection

haemagglutinin/dos e+15mcg

haemagglutinin/dos e+15mcg

haemagglutinin/dos e; (1) pre-filled

Olst-packager, batch releaser,

Abbott Biologicals B.V., C.J. van Houtenlaan

the Netherlands

ABBOTT Biologicals B.V.

C.J. van Houtenlaan 36, 1381 CP Weesp

the Netherlands

R

(H3N2)-like strain (A/

syringe 0,5ml

36, WEESP,

Singapore INFIMH-

1381CP, the

16-0019/2016 NIB-

Netherlands-

104),

bulk

B/Colorado/06/2017-

manufacturer,

18819 27.09.2019

18820 27.09.2019

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18823 27.09.2019

4

like strain (B/ Victoria/2/87/ lineage) (B/Maryland/15/2016,

NYMC BX-69 A)

14.

Piracetam

piracetam

capsules

quality control

400mg; (10/1x10/) and (60/6x10/) in

blister

Open joint stock company

"Borisovskiy zavod

medicinskikh preparatov" 64, Chapaev str., Borisov 222120, Minsk

region

Belarus

18824 27.09.2019

5

LIST of the medicines recommended for the re-registration by the Center according to the meeting decision N 9-2/19 on September 13, 2019

President___________________E. Amroya

International non-

proprietary

dosage strength &

N Trade name (generic) names or dosage form

output form

names of active

(packaging)

substances

Manufacturer

country

License holder

License holder country

Prescrip- Conclusion N

tion status

& date

1.

Formidron

formaldehyde

solution for external use

37mg/ml; glass bottle 30ml

Esco-Pharm LLC, NorNorq, Mikoyan 13, Yerevan

Republic of Armenia

Esco-Pharm LLC, Nor-Norq,

Mikoyan 13, Yerevan

Republic of Armenia

Ketonal 50mg

2.

capsules

ketoprofen

capsules

50mg; (25) glass container

Lek Pharmaceuticals d.d., Verovskova Str.

57, 1526 Ljubljana

Slovenia

Lek Pharmaceuticals d.d., Verovskova

Str. 57, 1526 Ljubljana

Slovenia

3.

Cyclodol

trihexyphenidyl (trihexyphenidyl hydrochloride)

tablets

2mg; (40/1x40/) in blister, (48/2x24/)

in blister

Arpimed LLC, Kotayk Marz, Abovyan, 2nd

Micro-District, 19 Building

Republic of Armenia

Arpimed LLC, Kotayk Marz, Abovyan, 2nd Micro-District, 19 Building

Republic of Armenia

4.

Viagra

sildenafil (sildenafil citrate)

tablets orodispersible

50mg; (2/1x2/) in blister, (4/1x4/) in blister, (8/2x4/) in

blister

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poce-sur-Cisse

France

Pfizer H.C.P. Corporation, 235, East 42nd Street, New York 10017

USA

OTC R R R

18825 27.09.2019

18826 27.09.2019

18827 27.09.2019

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1

5.

Dimexid

dimethylsulfoxide

concentrate for solution for external use

100ml; glass bottle 100ml

Esco-Pharm LLC, NorNorq, Mikoyan 13, Yerevan

Republic of Armenia

Esco-Pharm LLC, Nor-Norq,

Mikoyan 13, Yerevan

Republic of Armenia

N.V. Organon,

Kloosterstraat 6, 5349

AB Oss- batch releaser,

secondary packager,

Vetter Pharma-

Schering-Plough

6.

Orgalutran

ganirelix (ganirelix solution for s/c

acetate)

injection

0,25mg/0,5ml; (5) pre-filled syringes

0,5ml

Fertigung GmbH & Co. KG, Schutzenstrasse

87 and 99/101, D-

the Netherlands

Central East AG, Weystrasse

20, CH-6000

Switzerland

88212 Ravensburg,

Lucerne 6

Germany- bulk

manufacturer, primary

packager, quality

control

7.

Viagra

sildenafil (sildenafil citrate)

tablets filmcoated

50mg; (1) in blister, (4/1x4/) in

blister

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poce-sur-Cisse

France

Pfizer H.C.P. Corporation, 235, East 42nd Street, New York 10017

USA

8.

Viagra

sildenafil (sildenafil citrate)

tablets filmcoated

100mg; (1) in blister, (4/1x4/) in

blister

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poce-sur-Cisse

France

Pfizer H.C.P. Corporation, 235, East 42nd Street, New York 10017

USA

9.

Promedols

trimeperidine (trimeperidine hydrochloride)

solution for i/m, i/v and s/c

injection

20mg/ml; N10(2x5) and N100(20x5) glass

vial

Kalceks JSC, 53 Krustpils Street, Riga,

LV-1057 - batch releaser (HBM Pharma s.r.o., Sklabinska 30, 03680 Martin, Slovakia-

bulk manufacturer, packager)

Latvia

Kalceks JSC, 53 Krustpils Street, Riga, LV-1057

Latvia

OTC R R R R

18829 27.09.2019

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18833 27.09.2019

2

LIST of variations requiring reformulation of registration certificate approved by the Center according to the meeting decision N 9-2/19

on September 13, 2019

President___________________E. Amroya

N Trade name

International nonproprietary (generic) names or names of

active substances

dosage form

dosage strength & output form (packaging)

Manufacturer

country

License holder

License holder country

Prescription sta-

tus

Conclusion N & date

1.

Yarina

Bayer Pharma

AG, Mullerstrasse

178, 13353,

Berlin-batch

releaser,

drospirenone, ethinylestradiol

tablets film-coated

3mg+30mcg; (21/1x21/) blister

packager, Bayer Weimer GmbH

und Co.KG,

Germany

Bayer AG, KaiserWilhelm-Allee 1, 51373 Leverkusen

Germany

R

14428/2 27.09.2019

Doebereinerstrass

e 20, 99427,

Weimer,

Germany-bulk

manufacturer

1

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