LIST of the medicines recommended for the registration by ... engl 8-2-19_1.pdf · Garamycin betamethasone (betamethasone valerate), gentamicin (gentamicin sulfate) ointment 1mg/g+1mg/g;

1

LISTof the medicines recommended for the registration by the Center according to the meeting decision N 8-2/19 on August 30, 2019

N Trade name

International non-proprietary (generic) names or names of active substances

dosage form dosage strength

& output form (packaging)

Manufacturer country License holder License holder country

Prescription status

Conclusion N & date

1.Olestezin-AV

concentrate of sea buckthorn oil,

sulfaetidol, benzocaine

suppositories rectal

330mg+50mg+100mg; (10/2x5/)

Altayvitaminy CJSC, 659325,

Altay region, Biysk, st.

Zavodskaya, 69

Russia



Zavodskaya, 69

Russia OTC 18731 30.08.2019

2.Tonofungyn fluconazole capsules hard 150mg; (2/2x1/)

in strip

Egyptian International

Pharmaceutical Industries Company

(EIPICO), 10th of Ramadan City, Industrial Area B1,P.O. box 149,Tenth

Egypt

Egyptian International

Pharmaceutical Industries Company

(EIPICO), 10th of Ramadan

City, Industrial Area B1,P.O. box 149,Tenth

Egypt R 18732 30.08.2019

3.Bifren phenybut capsules

250mg; (20/2x10/) in

blister

Pharma Start LLC, Boulevard

Vatslava Havela, 8, 03124, Kiev

Ukraine

Acino Ukraine LLC, Boulevard

Vatslava Havela, 8,

03124, Kiev

Ukraine R 18733 30.08.2019

President___________________E. Amroya

2

4.Zetoptic brinzolamide, timolol

(timolol maleate) drops eye

(suspension)

10mg/ml+5mg/ml; plastic vial

5ml

Liqvor CJSC, 0089, Yerevan, str. Kochinyan,

7/9

Republic of Armenia


7/9

Republic of Armenia R 18734

30.08.2019

5.Riidor cefepime (cefepime

hydrochloride)

powder for solution for injection or

infusion

1000mg; (1) and (50) glass vial

15ml

PharmaTech CJSC, 0064,

Yerevan, Raffi str. 111-batch releaser,

secondary packager, Topico Pharmaceuticals Pvt. Ltd., Plot 38,

Kukatpally, Hyderabad,

Telagana, India-bulk

manufacturer, primary packager

Republic of Armenia


Yerevan, Raffi str. 111


30.08.2019

6.Actria cefotaxime

(cefotaxime sodium)


infusion


10ml







Republic of Armenia




30.08.2019

7.Sintuss butamirate

(butamirate citrate) syrup 7.5mg/5ml; 200ml glass bottle and

Vetprom AD, Otez Paissij str. 26,

Radomir 2400 for

Bulgaria Vetprom AD,

Otez Paissij str. 26, Radomir

Bulgaria OTC 18737 30.08.2019

3

measuring cup Dahnson-BG Co Ltd., Otez Paissij str. 26, Radomir 2400, Bulgaria

2400 for Dahnson-BG Co

Ltd., Otez Paissij str. 26, Radomir 2400,

Bulgaria

8.Ornitine Canon

ornithine (ornithine aspartate)

granules for oral solution

3000mg; (30) sachets 5g

CJSC Canonpharma

production, 105, Zarechnaya str. 141100 Moskow

region, Schelkovo

Russia

CJSC Canonpharma


region, Schelkovo

Russia OTC 18738 30.08.2019

9.Brimoptic

timolol (timolol maleate), brimonidine (brimonidine tartrate)

drops eye 5mg/ml+2mg/ml;

vial-dropper 10ml


7/9

Republic of Armenia


7/9


30.08.2019

10.Pantoprazole

Canon

pantoprazole (pantoprazole sodium

sesquihydrate)

tablets gastro-resistant

40mg; (28/4x7/) in blister

CJSC Canonpharma


region, Schelkovo

Russia

CJSC Canonpharma


region, Schelkovo

Russia R 18740 30.08.2019

11.Pantoprazole

Canon

pantoprazole (pantoprazole sodium

sesquihydrate)


20mg; (28/4x7/) in blister

CJSC Canonpharma


region, Schelkovo

Russia

CJSC Canonpharma


region, Schelkovo

Russia OTC 18741 30.08.2019

12.Losartan losartan (losartan

potassium) tablets film-

coated

50mg; (10/1x10/),

(20/2x10/) and (30/3x10/) in

Belmedpreparaty RUE, 220006,

Minsk, Mayakovskogo st.

Belarus Belmedpreparaty RUE, 220007,

Minsk, Fabritsius St.,

Belarus R 18742 30.08.2019

4

blister 1/5 No6 30

13.Panzynorm forte 20 000

pancreatin (lipase, amylase, protease)

tablets gastro-resistant, coated

20000U+12000U+900U;

(10/1x10/) and (30/3x10/) 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 OTC 18743 30.08.2019

14.Maviret glecaprevir,

pibrentasvir tablets film-

coated

100mg+40mg; (84(4x21(7x3))

in blister

AbbVie Deutschland

GmbH & Co. KG, Knolstrasse,

67061 Ludwigshafen - batch releaser,

packager, quality control, Fournier

Laboratories Ireland Limited,

Anngrove, Carrigtwohill, Co.

Cork, Ireland- bulk manufacturer

Germany

AbbVie Biopharmaceutic

als GmbH, Neuhofstrasse 23, 6341 Baar

Switzerland R 18744 30.08.2019

15.Olazol

hippopheae oil, chloramphenicol, benzocaine, boric

acid

aerosol for external use

0,09g/g+0,027g/g+0,027g/g+0,0045g/g; 60g and 80g aluminium

container



Zavodskaya, 69

Russia



Zavodskaya, 69

Russia OTC 18745 30.08.2019

16.Zolacef 1g cefazolin (cefazolin

sodium)


infusion


10ml





Republic of Armenia




30.08.2019

5



17.Lasolvan ambroxol (ambroxol

hydrochloride) tablets

30mg; (20/2x10/) and (50/5x10/) in

blister

Boehringer Ingelheim Ellas A.E., 5th km,

Paiania-Markopoulo, 194

00 Koropi

Greece

Sanofi-Aventis Deutschland

GmbH, Industriepark

Hoechst, Bruningstrasse 50, D-65926 , Frankfurt am

Main

Germany OTC 18747 30.08.2019

18.Lamictal lamotrigine tablets

100mg; (30/3x10/) in

blister

GlaxoSmithKline Pharmaceuticals

S.A.,189 Grunwaldzka street, 60-322

Poznan

Poland

GlaxoSmithKline Trading CJSC,

119180, Moscow,

Yakimanskaya nab., 2

Russia R 18748 30.08.2019

19.Vitamin C 500 ascorbic acid, sodium

ascorbate tablets

chewable

199.5mg+300.5mg; (10/1x10/), (20/2x10/) and (100/10x10/) in blister, (10) in

blister, (30) and (50) in plastic

container

Pharmaceutical Company

Zdorovye LLC, 22 Shevchenko str., Kharkov, 61013

Ukraine

Pharmaceutical Company

Zdorovye LLC, 22 Shevchenko str., Kharkov,

61013

Ukraine OTC 18749 30.08.2019

20.Topepsil topiramate tablets film-

coated

100mg; (28/2x14) in

blister

Egis Pharmaceuticals

PLC, 1165 Budapest,

Bokenyfoldi st. 118-120-batch

releaser, packager, Generis

Farmaceutica, S.A., Rua Joao de

Hungary


PLC, 1106 Budapest,

Kereszturi ut 30-38

Hungary R 18750 30.08.2019

6

Deus, N 19, Venda Nova,

2700-487 Amadora,

Portugal-bulk manufacturer

21.Topepsil topiramate tablets film-

coated

25mg; (28/2x14/) in

blister


PLC, 1165 Budapest,

Bokenyfoldi st. 118-120-batch

releaser, packager, Generis

Farmaceutica, S.A., Rua Joao de

Deus, N 19, Venda Nova,

2700-487 Amadora,

Portugal-bulk manufacturer

Hungary


PLC, 1106 Budapest,

Kereszturi ut 30-38

Hungary R 18751 30.08.2019

22.

Celestoderm-V with

Garamycin

betamethasone (betamethasone

valerate), gentamicin (gentamicin sulfate)

ointment 1mg/g+1mg/g; 30g aluminium

tube

Schering-Plough Labo N.V.,

Industriepark 30 B-2220, Heist-op-

den-Berg

Belgium

Schering-Plough Central East

AG, Weystrasse 20, P.O. Box

CH-6000 Lucerne 6

Switzerland R 18752 30.08.2019

23.Biotaksim cefotaxime

(cefotaxime sodium)

powder for solution for i/m

and i/v injection

1000mg; (1) glass vial 10ml

Biosintez PJSC, Druzhby st. 4,

440033, Penza Russia

Biosintez PJSC, Druzhby st. 4,

440033, Penza Russia R 18753

30.08.2019

7

24.Corvitin quercetine, povidon

lyophilisate for solution for

injection

0,05g+0,45g; (5) glass vial

SIC "Borshchahivskiy

Chemical-Pharmaceutical Plant" PJSC, 17,

Mira St, Kyiv, 03134

Ukraine

SIC "Borshchahivski

y Chemical-Pharmaceutical Plant" PJSC, 17,

Mira St, Kyiv, 03134

Ukraine R 18756 30.08.2019

25.Korold-Asteria

paracetamol, pseudoephedrine (pseudoephedrine

hydrochloride), chlorphenamine (chlorphenamine

maleate)

tablets film-coated

500mg+30mg+2mg; (20/2x10/)

and (100/10x10/) in

blister

Hankook Korus Pharm Co., Ltd, 30, Gangjeo-ro,

Jecheon-si, Chungcheongbuk-

do

Korea South

GL Corporation, Woori Venture

Tower #201, 70, Seonyu-ro,

Yeongdeungpo-ku, Seoul

South Korea OTC 18757 30.08.2019

1

LIST of the medicines recommended for the registration under simplified procedure by the Center according to the meeting decision N 8-2/19

on August 30, 2019

N Trade name


dosage form dosage strength

& output form (packaging)


Pres-cription status

Conclusion N & date

Dexmedeto

midine

dexmedetomidine

(dexmedetomidine

hydrochloride)

concentrate

for solution

for infusion

100mcg/ml;

(5) ampoules

2ml

EVER Pharma

Jena GmbH,

Otto-Schott-

Strasse 15,

07745 Jena

Germany

EVER Valinject

GmbH,

Oberburgau 3,

4866 Unterach

am Attersee

Austria


1

LISTof the medicines recommended for the re-registration by the Center according to the meeting decision N 8-2/19 on August 30, 2019

N Trade name


dosage form dosage strength &

output form (packaging)


Prescrip-tion sta-

tus

Conclusion N & date

1.Phenobarbital phenobarbital tablets 100mg; (48/2x24/)

in blister

Arpimed LLC, Kotayk Marz, Abovyan, 2nd

Micro-District, 19 Building

Republic of Armenia




30.08.2019

2.

Calcium gluconate stabilized

calcium gluconate solution for injection

100mg/ml; (5) ampoules 10ml, (10) ampoules 10ml, (5/1x5/)

ampoules 10ml in blister, (10/2x5/)

ampoules 10ml in blister

PJSC "Farmak", 74 Frunze str., Kiev, 04080 for PJSC "Farmak", 63 Frunze str., Kiev, 04080,

Ukraine

Ukraine

PJSC "Farmak", 74 Frunze str., Kiev, 04080 for PJSC

"Farmak", 63 Frunze str., Kiev, 04080, Ukraine

Ukraine R 18759 30.08.2019

3.

Calcium gluconate stabilisate

calcium gluconate solution for injection

100mg/ml; (5) ampoules 5ml, (10) ampoules 5ml, (5/1x5/)

ampoules 5ml in blister, (10/2x5/) ampoules 5ml in

blister

PJSC "Farmak", 74 Frunze str.,

Kiev, 04080 Ukraine

PJSC "Farmak", 63 Frunze str., Kiev,

04080 Ukraine R 18760

30.08.2019


2

4. Norditropin

NordiLet somatropin solution for s/c injection

6,7mg/ml; pre-filled pen 1,5ml

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 Novo Nordisk A/S,

Novo Alle, DK-2880 Bagsvaerd

Denmark R 18761 30.08.2019

5. Paclitaxel

Ebewe paclitaxel concentrate for solution for infusion

6mg/ml; (1) glass vial 5ml

EBEWE Pharma Ges. m.b.H. Nfg.

KG, Mondseestrasse

11, A-4866 Unterach am

Attersee

Austria


KG, Mondseestrasse 11,

A-4866 Unterach am Attersee

Austria R 18762 30.08.2019

6. Paclitaxel


6mg/ml; (1) glass vial 25ml


KG, Mondseestrasse


Attersee

Austria




Austria R 18763 30.08.2019

7. Paclitaxel


6mg/ml; (1) glass vial 16,7ml


KG, Mondseestrasse


Attersee

Austria




Austria R 18764 30.08.2019

8. Norvasc amlodipine

(amlodipine tablets 5mg; (30/3x10/)

blisters R-Pharm

Germany GmbH, Heinrich-Mack-

Germany Pfizer H.C.P.

Corporation, 235, East 42nd street,

USA R 18765 30.08.2019

3

besilate) Str. 35, 89257, Illertissen

New York 10017

9.Norvasc

amlodipine (amlodipine

besilate) tablets 10mg; (30/3x10/)

in blister

R-Pharm Germany GmbH, Heinrich-Mack-Str. 35, 89257,

Illertissen

Germany

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

USA R 18766 30.08.2019

10.Solpadeine

Active paracetamol,

caffeine tablets soluble

500mg+65mg; (12/2x6/) in strip

Famar A.V.E. Anthoussa Plant, Anthousa Avenue

7, Anthousa Attikis, 15344

Greece

GlaxoSmithKline Consumer

Healhtcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8

9GS

UK OTC 18767 30.08.2019

1

LIST of variations requiring reformulation of registration certificate approved by the Center according to the meeting decision N 8-2/19

on August 30, 2019

N Trade name


dosage form

dosage strength & output form (packaging)


Prescrip-tion sta-

tus

Conclusion N & date

1.Tricor fenofibrate tablets film-

coated

145mg; (30/3x10/) in

blister

Recipharm Fontaine, Rue des Pres Potets, 21121 Fontaine les Dijon-

batch releaser, packager, Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill, Co.

Cork, Ireland- bulk manufacturer

France

Abbott Laboratories

GmbH, Freundallee 9A, 30173 Hannover

Germany R 17395/1 30.08.2019

2.Zovirax aciclovir cream for

external use

50mg/g; 2g aluminium

tube

Glaxo Operations UK Limited, Harmire

Road, Barnard Castle, Co Durham

DL12 8DT

UK

GlaxoSmithKline Consumer

Healhtcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8

9GS

UK OTC 14764/1 30.08.2019

3.Femilex lactic acid suppositories

vaginal 100mg;

(10/2x5/) Nizhpharm JSC, 603950, Nizhny

Novgorod,

Russia Nizhpharm JSC, 603950, Nizhny

Novgorod, Salganskaya st.,

Russia OTC 18158/1 30.08.2019


2

Salganskaya st., 7 7

4.Amiodarone

amiodarone (amiodarone

hydrochloride)

concentrate for solution for

infusion

50mg/ml; (10) ampoules 3ml, in blister, (10) ampoules 3ml label banderol, (10) ampoules 3ml dividella

Open joint stock company

"Borisovskiy zavod medicinskikh

preparatov", 64, No11/1, ul.

Chapaeva, Borisov, Minsk region

Belarus


"Borisovskiy zavod

medicinskikh preparatov", 64, ul. Chapaeva, Borisov, Minsk

region

Belarus R 17535/1 30.08.2019

5.Aksastrol anastrozole tablets film-

coated

1mg; (28/2x14/)

blisters

Remedica Ltd, Limassol Industrial Estate, Aharnon

street, 3056 Limassol

Cyprus Grindeks JSC,

Krustpils str. 53, LV-1057, Riga

Latvia R 14372/1 30.08.2019

6.Kestine ebastine tablets film-

coated

20mg; (10/1x10/) in

blister

Industrias Farmaceuticas

Almirall S.A., Ctra. Nacional II, Km. 593, 08740 Sant

Andreu de la Barca, Barcelona

Spain

Almirall, S.A., Ronda General

Mitre, 151, 08022

Barcelona

Spain R 16992/1 30.08.2019

7.Neuromultivit vitamin B1, vitamin

B6, vitamin B12 tablets film-

coated

100mg+200mg+0,2mg;

(20/1x20/) in blister,



(100/10x10/) in blister

G.L. Pharma GmbH,

Schlossplatz 1, 8502 Lannach -

batch releaser, G.L. Pharma GmbH,

Industriestrasse 1, 8502 Lannach, Austria -bulk

manufacturer, packager

Austria

VALEANT LLC, Shabolovka st. 31, building 5,

115162, Moscow

Russia OTC 18344/1 30.08.2019

8.Citramon P

acetylsalicylic acid, paracetamol, caffeine

(caffeine

tablets 240mg+180mg+30mg; (10), (10/1x10/) and

Pharmstandard-Leksredstva JSC,

305022, Kursk,

Russia Pharmstandard-

Leksredstva JSC, 305022,

Russia OTC 17387/1 30.08.2019

3

monohydrate) (20/2x10/) in blister

Agregatnaya 2nd str., 1a/18

Kursk, Agregatnaya

2nd str., 1a/18

9.

AMBROLYTIN 15mg/5ml

syrup

ambroxol (ambroxol hydrochloride) syrup

15mg/5ml; glass bottle 100ml and

plastic measuring cup, plastic bottle 100ml and plastic

measuring cup

Sopharma JSC, str. Iliensko shosse 16, 1220 Sofia - batch

releaser, Sopharma JSC, Vrabevo vlg.

5660, district of Lovetch, Bulgaria-bulk manufacturer,

packager

Bulgaria

Sopharma JSC, str. Iliensko

shosse 16, 1220 Sofia

Bulgaria ԱԴ 15460/2 30.08.2019

10.Aciclovir-Akri aciclovir tablets

200mg; (20/2x10/)

blisters

Akrikhin JSC, 142450, Moscow region, Noginsk district, Staraya Kupavna, Kirova

street 29

Russia

Akrikhin JSC, 142450,

Moscow region, Noginsk district,

Staraya Kupavna, Kirova

street 29

Russia R 14414/1 30.08.2019

11.Aciclovir-Akri aciclovir tablets

400mg; (20/2x10/)

blisters

Akrikhin JSC, 142450, Moscow region, Noginsk district, Staraya Kupavna, Kirova

street 29

Russia

Akrikhin JSC, 142450,

Moscow region, Noginsk district,

Staraya Kupavna, Kirova

street 29

Russia R 14415/1 30.08.2019

12.Betaserc

betahistine (betahistine

dihydrochloride) tablets

8mg; (30/1x30/) in

blister

Mylan Laboratories SAS, Route de

Belleville, Lieu-dit Maillard, 01400

Chatillon sur Chalaronne

France

Abbott Healthcare

Products B.V., C.J. van

Houtenlaan 36, NL-1381 CP

Weesp,

the Netherlands R 17656/1

30.08.2019

13.Betaserc betahistine

(betahistine tablets 16mg;

(30/2x15/) in


Belleville, Lieu-dit

France Abbott

Healthcare Products B.V.,


30.08.2019

4

dihydrochloride) blister Maillard, 01400 Chatillon sur Chalaronne

C.J. van Houtenlaan 36,

NL-1381 CP Weesp

14.Betaserc

betahistine (betahistine

dihydrochloride) tablets

24mg; (20/1x20/) and (60/3x20/) in

blister


Belleville, Lieu-dit Maillard, 01400

Chatillon sur Chalaronne

France

Abbott Healthcare

Products B.V., C.J. van

Houtenlaan 36, NL-1381 CP

Weesp


30.08.2019

15.Cordarone

amiodarone (amiodarone

hydrochloride) tablets

200mg; (30/2x15/) in

blister

Chinoin Pharmaceutical and

Chemical Works Private Co. Ltd.,

2112 Veresegyhaz, Levai u. 5,

Hungary

Sanofi-Aventis France, 1-13,

boulevard Romain Rolland,

75014 Paris

France R 15080/2 30.08.2019

16.

Fentavera 50mcg/h

transdermal patch

fentanyl patch transdermal

50mcg/h; (5) patches

Acino AG, Am Windfeld 35, 83714 Miesbach - batch

releaser, Luye Pharma AG, Am

Windfeld 27 und 35, 83714 Miesbach, Germany - bulk manufacturer,

packager

Germany Acino AG, Am Windfeld 35,

83714 Miesbach Germany R 13834/1

30.08.2019

17.

Fentavera 75mcg/h

transdermal patch

fentanyl patch transdermal

75mcg/h; (5) patches

Acino AG, Am Windfeld 35, 83714 Miesbach - batch

releaser, Luye Pharma AG, Am

Windfeld 27 und 35, 83714 Miesbach, Germany - bulk manufacturer,

packager

Germany Acino AG, Am Windfeld 35,

83714 Miesbach Germany R 13835/1

30.08.2019

1

LISTof the variations not requiring reformulation of registration certificate approved by the Center according to the meeting decision N 8-2/19 on

August 30, 2019

N Trade name


dosage form

dosage strength & output form (packaging)


Prescrip-tion sta-

tus

Conclusion N & date

1.Tobradex tobramycin,

dexamethasone drops eye

(suspension)

3mg/ml+1mg/ml; 5ml plastic

vial

S.A. Alcon-Couvreur N.V.,

Rijksweg 14 2870 Puurs

Belgium Novartis Pharma

AG, Lichtstrasse 35, 4056 Basel,

Switzerland R 18048/1 30.08.2019

2.Maxidex dexamethasone drops eye

(suspension)

1mg/ml; 5ml plastic

dropper-vial




AG, Lichtstrasse 35, 4056 Basel

Switzerland R 18183/1 30.08.2019

3.

Mydocalm solution for

injection

tolperisone (tolperisone

hydrochloride), lidocaine (lidocaine

hydrochloride)

solution for injection

100mg/ml+2,5mg/ml; (5)

ampoules 1ml

Gedeon Richter PLC, Gyomroi ut

19-21, 1103 Budapest

Hungary



Hungary R 14427/1 30.08.2019

4.CalciD-Denk

calcium (calcium carbonate),

colecalciferol

tablets effervescent

1000mg+22mcg(880IU); (20)

in plastic container

Losan Pharma GmbH, Otto- Hahn-Strasse 13,15, 79395

Neuenburg for Germany

Denk Pharma GmbH & Co. KG, Prinzregentenstr.

79, 81675 Muenchen

Germany R 16831/2 30.08.2019


2

5.Silkaderm tretinoin cream

0,5mg/g; aluminum tube

15g



Republic of Armenia



Republic of Armenia OTC 13552/1

30.08.2019

6.Floxaton

levofloxacin (levofloxacin hemihydrate)

tablets film-coated

500mg; (10/1x10/) in

blister

Medochemie Ltd., (Central Factory),

1-10 Constantinoupole

os street, 3011 Limassol

Cyprus

Medochemie Ltd., 1-10

Constantinoupoleos street, 3011

Limassol

Cyprus R 18249/1 30.08.2019

7.Cetrotide cetrorelix (cetrorelix

acetate)

powder lyophilized for solution for s/c

injection

0,25mg; N7 glass vials with

powder, N7 prefilled

syringes with solvent 1ml, N14 needles, N14 alcohol swabs; N1

glass vials with powder, N1

prefilled syringes with

solvent 1ml, N 2 needles, N 2 alcohol swabs

Baxter Oncology GmbH,

Kantstrasse 2, Halle/Westfalen,

33790

Germany

Merck Serono Europe Ltd., Marsh

Wall 56, London E14 9TP

UK R 15782/2 30.08.2019

8.Vametal

ondansetron (ondansetron hydrochloride

dihydrate)

solution for i/v and i/m injection

2mg/ml; glass vial 4ml

Help S.A., Pedini Ioanninon,

Ioannina, 45500 Greece

Medicus S.A., 10 Valaoritou str., GR

144 52, Metamorphosis,

Attika

Greece R 14112/2 30.08.2019

9.Vametal


dihydrate)

solution for i/v and i/m injection

2mg/ml; glass vial 2ml





Attika

Greece R 14114/2 30.08.2019

3

10. Vametal


dihydrate)

tablets film-coated

8mg; (15/3x5/) blisters





Attika

Greece R 14113/2 30.08.2019

11. Herbion

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


cesta 6, 8501 Novo Mesto-batch releaser, KRKA, tovarna zdravil,

d.d., Novo mesto,Povhova ulica 5,

8501 Novo Mesto, Slovenia-bulk manufacturer,

packager

Slovenia



Slovenia OTC 16497/1 30.08.2019

12. Glycerin glycerol suppositories

rectal

1,24g; (10/2x5/) in

blister

Nizhpharm JSC, 603950, Nizhny

Novgorod, Salganskaya st., 7

Russia



Russia OTC 17035/1 30.08.2019

13. Glycerin glycerol suppositories

rectal

2.11g; (10/2x5/) in

blister



Russia



Russia OTC 17036/1 30.08.2019

14. Naklofen diclofenac (diclofenac

sodium) solution for

injection 75mg/3ml; (5) ampoules 3ml



Slovenia



Slovenia R 16675/1 30.08.2019

15. Co-Diroton

lisinopril (lisinopril dihydrate),

hydrochlorothiazide tablets

20mg+12,5mg; (10/1x10/)

blister, (30/3x10/)

blisters


19-21, 1103 Budapest - batch releaser, Gedeon

Richter Poland Sp.z o.o.,

Hungary



Hungary R 14403/1 30.08.2019

4

ul.Graniczna 35,Grodzisk

Mazowiecki, 05-825, Poland - bulk


16. Co-Diroton

lisinopril (lisinopril dihydrate),

hydrochlorothiazide tablets

10mg+12,5mg; (10/1x10/)

blister, (30/3x10/)

blisters


19-21, 1103 Budapest - batch releaser, Gedeon

Richter Poland Sp.z o.o.,

ul.Graniczna 35,Grodzisk

Mazowiecki, 05-825, Poland - bulk


Hungary



Hungary R 14401/1 30.08.2019

17. Detralex diosmin, hesperidin tablets film-

coated

450mg+50mg; (30/2x15/),

(36/3x12/) and (60/4x15/) in

blister

Les Laboratoires Servier Industrie

905, route de Saran, 45520

Gidy

France

Les Laboratoires Servier, 50, rue Carnot, 92284

Suresnes cedex

France OTC 17194/1 30.08.2019

18. Detralex diosmin, hesperidin tablets film-

coated

900mg+100mg; (30/3x10/)

and (60/6x10/) in blister

Les Laboratoires Servier Industrie

905, route de Saran, 45520

Gidy

France

Les Laboratoires Servier, 50, rue Carnot, 92284

Suresnes cedex

France OTC 17509/2 30.08.2019

19. Arixtra

fondaparinux (fondaparinux

sodium)

solution for injection

5mg/ml; (10) pre-filled

syringes 0.5ml

Aspen Notre Dame de

Bondeville, 1 rue de l`Abbaye, 76960 Notre

Dame de Bondeville

France

Aspen Pharma Trading Limited, 3016 Lake Drive,

Citywest Business Campus, Dublin 24

Ireland R 14272/2 30.08.2019

5

20. Nurofen for

children ibuprofen suppositories rectal

60mg; (10/2x5/)

Famar A.V.E., 49km National Road Athens-Lamia, 190 11,

Avlonas

Greece

Reckitt Benckiser Healthcare

International Ltd, Thane Road,

Nottingham, NG90 2DB

UK OTC 15989/1 30.08.2019

21. Denk-Air

Junior 4mg montelukast

(montelukast sodium) tablets chewable 4mg;

(28/2x14/) in blister

Denk Pharma GmbH & Co. KG, Goellstr. 1, 84529

Tittmoning

Germany

Denk Pharma GmbH & Co. KG, Prinzregentenstr.

79, 81675 Muenchen

Germany R 16799/1 30.08.2019

22. Myfortic

mycophenolic acid (mycophenolate

sodium)


180mg; (120/12x10/) in

blister

Novartis Pharma Produktions

GmbH, Oeflinger Strasse 44, 79664

Wehr

Germany Novartis Pharma


Switzerland R 16977/1 30.08.2019

23. Trulicity dulaglutide solution for

injection

0,75mg/0.5ml; (4) pre-filled glass pen

0.5ml

Eli Lilly and Company,

Indianapolis, IN 46285

USA



USA R 17836/1 30.08.2019

24. Trulicity dulaglutide solution for

injection

1,5mg/0.5ml; (4) pre-filled glass pen

0.5ml



USA



USA R 17837/1 30.08.2019

25. Vurdon diclofenac (diclofenac

sodium)

tablets slow release film-

coated

100mg; (10/1x10/), in

blister



Help S.A., 10 Valaoritou str., GR

14452 Metamorphosis,

Attica

Greece R 14770/1 30.08.2019

26. Oxolin oxolin ointment nasal

2,5mg/g; 10g aluminium

tube



Russia



Russia OTC 17033/1 30.08.2019

6

27. Levofloxacin

0.5%

levofloxacin (levofloxacin hemihydrate)

solution for infusion

5mg/ml; 50ml plastic pack, 100ml plastic

pack



Republic of Armenia

PharmaTech CJSC, 0064, Yerevan,

Raffi str. 111

Republic of Armenia R 14713/1

30.08.2019

28. Pedeks permethrin solution for

external use 5mg/g; 60ml glass bottle

LMP Ltd., 1, Vietalvas street, Riga, LV-1009

Latvia LMP Ltd., 1,

Vietalvas street, Riga, LV-1009

Latvia OTC 15169/1 30.08.2019

29. Mexidol ethylmethylhydroxypy

ridine succinate tablets film-

coated

125mg; (30/3x10/) in

blister, (50/5x10/) in

blister

CJSC "ZiO-Zdorovie",

142103, Moscow region, Podolsk,

str. Zheleznodorozhn

aya, 2

Russia

LLC "RPC "PHARMASOFT",

115407, Moscow,Sudostroitelnaya str., bld. 41,

floor 1, premises 12

Russia R 18448/1 30.08.2019

30. GalvusMET

vildagliptin, metformin (metformin

hydrochloride)

tablets film-coated

50mg+1000mg; (30/3x10/)

and (60/6x10/) in blister

Novartis Pharma Produktions

GmbH, Oeflinger Strasse 44, 79664

Wehr

Germany Novartis Pharma


Switzerland R 18038/1 30.08.2019

31. Exforge H

amlodipine (amlodipine besilate),

valsartan, hydrochlorothiazide

tablets film-coated

5mg+160mg+12,5mg;

(14/1x14/) and (28/2x14/) in

blister

Novartis Farmaceutica

S.A., Ronda de Santa Maria, 158, 08210 Barbera del Valles, Barcelona

Spain

Novartis Pharma AG, 35,

Lichtstrasse, 4056 Basel

Switzerland R 17440/1 30.08.2019

32. Exforge H

amlodipine (amlodipine besilate),

valsartan, hydrochlorothiazide

tablets film-coated

10mg+160mg+12,5mg;

(14/1x14/) and (28/2x14/) in

blister

Novartis Farmaceutica

S.A., Ronda de Santa Maria, 158, 08210 Barbera del Valles, Barcelona

for

Spain

Novartis Pharma AG, 35,

Lichtstrasse, 4056 Basel

Switzerland R 17441/1 30.08.2019

33. Aclasta zoledronic acid

(zoledronic acid

solution for infusion

0,05mg/ml; 100ml plastic

Novartis Pharma Stein AG,

Schaffhauserstras

Switzerland Novartis Pharma

AG, 35, Lichtstrasse, 4056

Switzerland R 18084/1 30.08.2019

7

monohydrate) vial se, 4332 Stein- batch releaser,

secondary packager,

Fresenius Kabi Austria GmbH,

Hafnerstrasse 36, Graz, 8055, Austria- bulk


Basel

34. Bifiform

bifidobacterium longum, enterococcus

faecium

capsules gastro-resistant

not less than 1x10^7CFU+1

x10^7 CFU; (30) and (40) in aluminium

tube

Pfizer Consumer Manufacturing

Italy S.R.L., Via Nettunense, 90, Aprilia, 04011

Italy

Pfizer Innovations LLC, Presnenskaya

nab., building 10, Moscow, 123112

Russia OTC 17374/2 30.08.2019

35. Relium diazepam tablets film-

coated

5mg; (20/1x20/) in

blister

Tarchomin Pharmaceutical Works "Polfa"

S.A., 2,A. Fleminga str.,03-

176 Warsaw

Poland

Tarchomin Pharmaceutical

Works "Polfa" S.A., 2,A. Fleminga

str.,03-176 Warsaw

Poland R 15820/1 30.08.2019

36. Exoderil naftifine (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


Austria

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl,

Austria

Austria OTC 17187/1 30.08.2019

8

37. Viagra sildenafil (sildenafil

citrate) tablets film-

coated 25mg; (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 R 18317/1 30.08.2019



coated

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

blister



France


USA R 13918/2 30.08.2019



coated

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

blister



France


USA R 13919/2 30.08.2019

40. Azibiot

azithromycin (azithromycin

dihydrate)

tablets film-coated

500mg; (3/1x3/), in

blister



Slovenia



Slovenia R 14892/1 30.08.2019

41. Orgalutran ganirelix (ganirelix

acetate) solution for s/c

injection

0,25mg/0,5ml (0,5mg/ml); (5)

pre-filled syringes 0,5ml

N.V. Organon, Molenstraat 110, 5342 CC OSS-

secondary packager, batch releaser (legal address -N.V.

Organon, Kloosterstraat 6,

5349 AB Oss, the Netherlands),

Vetter Pharma-Fertigung GmbH

& Co. KG, Schutzenstrasse

87 and 99/101, D-88212

Ravensburg,

the Netherlands

Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne 6,

Switzerland R 14458/1 30.08.2019

9

Germany-bulk manufacturer,

primary packager

42. Furadonin nitrofurantoin tablets 50mg; (10), in

strip


"Borisovskiy zavod

medicinskikh preparatov" 64, Chapaev str.,

Borisov 222518, Minsk region

Belarus


"Borisovskiy zavod medicinskikh

preparatov" 64, Chapaev str.,

Borisov 222518, Minsk region

Belarus R 15524/1 30.08.2019

43. Tyzine

xylometazoline (xylometazoline hydrochloride)

spray nasal

1mg/ml; glass bottle 10ml (70

dose) with dosator

Famar Orleans, 5 avenue de

Concyr, 45071 Orleans, Cedex 2

France

Johnson & Johnson LLC, 121614,

Moscow, Krylatskaya str., 17,

building 2

Russia OTC 18358/1 30.08.2019

44. Tyzine

xylometazoline (xylometazoline hydrochloride)

spray nasal

0,5mg/ml; glass bottle 10ml (140 dose) with

dosator

Famar Orleans, 5 avenue de

Concyr, 45071 Orleans, Cedex 2

for

France

Johnson & Johnson LLC, 121614,

Moscow, Krylatskaya str., 17,

building 2

Russia OTC 18357/1 30.08.2019

45. Co-Amlessa

perindopril (perindopril tert-

butylamine), indapamide, amlodipine

(amlodipine besilate)

tablets 8mg+2,5mg+5mg; (30/3x10/)

in blister



Slovenia



Slovenia R 15857/1 30.08.2019

46. Flosteron

betamethasone (betamethasone dipropionate),

betamethasone (betamethasone

sodium phosphate)

suspension for injection

5mg/ml+2mg/ml; (5)

ampoules 1ml



Slovenia



Slovenia R 16523/1 30.08.2019

10

47. Puregon follitropin beta

(recombinant) solution for s/c

injection

600IU/0,72ml; cartridge 0,78ml, (6/2x3/) needles


secondary packager, batch releaser(legal address -N.V.


5349 AB Oss, the Netherlands)

(Vetter Pharma-Fertigung GmbH

& Co. KG, Mooswiesen 2,

88214 Ravensburg,


primary packager)

the Netherlands

Schering-Plough Central East AG, Weystrasse 20,

P.O. Box CH-6000 Lucerne 6

Switzerland R 14512/1 30.08.2019

48. Puregon follitropin beta

(recombinant) solution for s/c

injection

300IU/0,36ml; cartridge 0,42ml, (6/2x3/) needles


secondary packager, batch releaser(legal address -N.V.


5349 AB Oss, the Netherlands)

(Vetter Pharma-Fertigung GmbH

& Co. KG, Mooswiesen 2,

88214 Ravensburg,


the Netherlands

Schering-Plough Central East AG, Weystrasse 20,

P.O. Box CH-6000 Lucerne 6

Switzerland R 14511/1 30.08.2019

11

primary packager)

49. Tobrex tobramycin drops eye

(solution) 3mg/ml; 5ml plastic vial





Switzerland R 18041/1 30.08.2019

50. Laxalac lactulose solution oral

670mg/ml; glass bottle 100ml and measuring cup, plastic bottle 200ml

and measuring cup, plastic bottle 250ml

and measuring cup

Medical Horizon Ltd, Ararat

province, Masis city, Masis station, Gortsaranain 22

Republic of Armenia

Մեդիկալ Medical Horizon Ltd, Ararat

province, Masis city, Masis station,

Gortsaranain 22


30.08.2019

51. Zidin

chlorhexidine (chlorhexidine bigluconate)

suppositories vaginal

16mg; (10/2x5/)

Medical Horizon Ltd, Ararat

province, Masis city, Masis station, Gortsaranain 22

Republic of Armenia

Medical Horizon Ltd, Ararat province,

Masis city, Masis station,

Gortsaranain 22


30.08.2019

52. Alotendin

bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)

tablets

5mg+5mg; (28/4x7/) blisters,

(30/3x10/) blisters, (56/8x7/) blisters,

(90/9x10) blisters


PLC, 1165 Budapest,

Bokenyfoldi st. 118-120

Hungary


PLC, 1106 Budapest,

Kereszturi st. 30-38, Hungary

Hungary R 14046/1 30.08.2019

53. Alotendin


tablets


(30/3x10/) blisters, (56/8x7/)


PLC, 1165 Budapest,

Bokenyfoldi st.

Hungary


PLC, 1106 Budapest,

Kereszturi st. 30-38,

Hungary R 14047/1 30.08.2019

12

blisters, (90/9x10/)

blisters

118-120 Hungary

54. Alotendin


tablets



(90/9x10/) blisters


PLC, 1165 Budapest,


Hungary


PLC, 1106 Budapest,


Hungary R 14048/1 30.08.2019

55. Alotendin


tablets



(90/9x10/) blisters


PLC, 1165 Budapest,


Hungary


PLC, 1106 Budapest,


Hungary R 14049/1 30.08.2019

LIST of the medicines recommended for the registration by ... engl 8-2-19_1.pdf · Garamycin betamethasone (betamethasone valerate), gentamicin (gentamicin sulfate) ointment 1mg/g+1mg/g;

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