List of the medicines recommended for registration by N 5-1/16 meeting decision of the Pharmacological Council of MoH of RA dated on May 13, 2016

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1 List of the medicines recommended for registration by N 5-1/16 meeting decision of the Pharmacological Council of MoH of A dated on May 13, 2016 President E. Amroyan 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. Betadine povidone-iodine suppositories vaginal 200mg; (14/2x7/) Alkaloid AD-Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje Macedonia Alkaloid AD-Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje Macedonia Betadine povidone-iodine external use 100mg/ml; 100ml plastic bottle-dropper Alkaloid AD-Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje Macedonia Alkaloid AD-Skopje, Blvd. Aleksandar Makedonski 12, 1000 Skopje Macedonia NovoNorm repaglinide tablets 0,5mg; (30/2x15/), in Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd-batch releaser, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D Ingelheim am hein, -bulk manufacturer, Catalent Schorndorf GmbH, Steinbeisstrasse 1 und 2, 73614, Schorndorf, packager Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd NovoNorm repaglinide tablets 2mg; (30/2x15/), Novo Nordisk A/S, Novo Alle, DK-2880 Novo Nordisk A/S, Novo Alle, DK

2 in Bagsvaerd-batch releaser, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D Ingelheim am hein, -bulk manufacturer, Catalent Schorndorf GmbH, Steinbeisstrasse 1 und 2, 73614, Schorndorf, packager Bagsvaerd 5. NovoNorm repaglinide tablets 1mg; (30/2x15/), in Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerdbatch releaser, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, D Ingelheim am hein, -bulk manufacturer, Catalent Schorndorf GmbH, Steinbeisstrasse 1 und 2, 73614, Schorndorf, -packager Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd Bicillin-3 benzathine, sodium, procaine powder for suspension for i/m IU IU IU; (50) glass vial 10ml Sintez OJSC, Pr. Konstitutsii, No. 7, Kurgan, ussia Sintez OJSC, Pr. Konstitutsii, No. 7, Kurgan, ussia Bicillin-3 benzathine, sodium, procaine powder for suspension for i/m IU IU IU; (50) glass vial 10ml Sintez OJSC, Pr. Konstitutsii, No. 7, Kurgan, ussia Sintez OJSC, Pr. Konstitutsii, No. 7, Kurgan, ussia

3 8. Omeprazole omeprazole capsules 20mg; Chapaev Chapaev str., Borisov , Cefotaxime cefotaxime (cefotaxime sodium) powder for 500mg; (10) glass vial Chapaev Chapaev str., Borisov , Cefotaxime cefotaxime (cefotaxime sodium) powder for 1000mg; (10) glass vials Chapaev Chapaev str., Borisov , Tebokan ginkgo biloba dry extract 40mg; (20/1x20/), in, (60/3x20/), in Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Str. 4, Karlsruhe Dr. Willmar Schwabe GmbH & Co. KG, Willmar- Schwabe-Str. 4, Karlsruhe Tebokan forte ginkgo biloba dry extract 120mg; (20/1x20/), in, (60/3x20/), in Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Str. 4, Karlsruhe Dr. Willmar Schwabe GmbH & Co. KG, Willmar- Schwabe-Str. 4, Karlsruhe Cycloserine cycloserine capsules 250mg; Belmedpreparaty UE, , Minsk, Fabritsius St., 30 Belmedpreparaty UE, , Minsk, Fabritsius St.,

4 14. Atoris atorvastatin (atorvastatin calcium) 20mg; KKA d.d., Novo mesto, KKA d.d., Novo Atoris atorvastatin (atorvastatin calcium) 10mg; KKA d.d., Novo mesto, KKA d.d., Novo Trachisan Lozenges lidocaine (lidocaine hydrochloride), chlorhexidine (chlorhexidine digluconate), tyrothricin lozenges 1mg+1mg+0.5m g; (20/2x10/) in Engelhard Arzneimittel GmbH & Co. KG, Herzbergstrasse 3, Niederdorfelden Engelhard Arzneimittel GmbH & Co. KG, Herzbergstrasse 3, Niederdorfelden anexa 1000 ranolazine tablets prolongedrelease 1000mg; (60/4x15/) in Menarini-Von Heyden GmbH, Leipziger Strasse 7-13, Dresden Menarini International O. L. S.A., 1, Avenue de la Gare, 1611 Luxembourg anexa 500 ranolazine tablets prolongedrelease 500mg; (60/3x20/) in Menarini-Von Heyden GmbH, Leipziger Strasse 7-13, Dresden Menarini International O. L. S.A., 1, Avenue de la Gare, 1611 Luxembourg Euphylline aminophylline tablets 150mg; (10/1x10/) in,, (10) in Chapaev Chapaev str., Borisov , Ketoprofen ompharm ketoprofen i/v and i/m 50mg/ml; (5/1x5/) ampoules 2m in l, (10/2x5/) ampoules 2ml in S.C. ompharm Company S..L., Ilfov, Otopeni, Str. Eroilor, Nr. 1A omania S.C. ompharm Company S..L., Ilfov, Otopeni, Str. omania

5 Eroilor, Nr. 1A 21. Metromicon Forte metronidazole, miconazole(mic onazole nitrate) suppositories vaginal (pessaries) 750mg+200mg; (7/1x7/) Farmaprim SL, Crinilor str., 5, Porumbeni, Criuleni dis., MD-4829 Moldova Farmaprim SL, Crinilor str., 5, Porumbeni, Criuleni dis., MD-4829 Moldova Pipolphen promethazine (promethazine hydrochloride) i/v and i/m 25mg/ml; (10) ampoules 2ml Egis Pharmaceuticals PLC, 1165 Budapest, Bokenyfoldi st Hungary Egis Pharmaceuticals PLC, 1106 Budapest, Kereszturi st Hungary Otofix 40mg/g+10mg /g ear drops,solution phenazone, lidocaine (lidocaine hydrochloride) drops ear (solution) 40mg/g+10mg/g ; 15ml glass bottle and dropper applicator Unipharm JSC, 3 Traiko Stanoev Str., Sofia 1797 Bulgaria Sopharma JSC, str. Iliensko shosse 16, 1220 Sofia Bulgaria Victoza liraglutide s/c 6mg/ml; (2) prefilled pen 3ml Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd eparil-gel N escin, diethylamine salicylate gel for external use 0.01g/g+0.05g/g ; 40g aluminium tube Madaus GmbH, Luetticher Strasse 5,Troisdorf, Madaus GmbH, Cologne Nifuroxazide nifuroxazide tablets 100mg; Chapaev Chapaev str., Borisov , Flemoclav Solutab amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium tablets dispersible 875mg+125mg; (14/2x7/) in Astellas Pharma Europe B.V., Hogemaat 2, 7942 JG Meppel the Netherlands Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden the Netherlands

6 clavulanate) 28. Bilobil forte ginkgo biloba dry extract capsules 80mg; (20/2x10/) in, (60/6x10/) in KKA d.d., Novo mesto, KKA d.d., Novo Structum chondroitin sulfate (chondroitin sulfate sodium) capsules 500mg; (60/3x20/) in, (60/5x12/) in Pierre Fabre Medicament Production, site Progipharm, ue du Lycee, Gien France Pierre Fabre Medicament Production, 45, place Abel Gance, Boulogne France Euphyllin aminophylline i/v 24mg/ml; (10) ampoules 5ml Yerevan Chemical- Pharmaceutical firm OJSC, Yerevan, Ajaryan street, 2 Line, No6 epublic of Armenia Yerevan Chemical- Pharmaceutical firm OJSC, Yerevan, Ajaryan street, 2 Line, No6 epublic of Armenia Vinorelbine Ebewe vinorelbine (vinorelbine tartrate) concentrate for i/v infusion 10mg/ml; (1) glass vial 5ml EBEWE Pharma Ges. m.b.h. Nfg. KG, Mondseestrasse 11, A Unterach am Attersee Austria EBEWE Pharma Ges. m.b.h. Nfg. KG, Mondseestrasse 11, A-4866 Unterach am Attersee Austria Vinorelbine Ebewe vinorelbine (vinorelbine tartrate) concentrate for i/v infusion 10mg/ml; (1) glass vials 1ml EBEWE Pharma Ges. m.b.h. Nfg. KG, Mondseestrasse 11, A Unterach am Attersee Austria EBEWE Pharma Ges. m.b.h. Nfg. KG, Mondseestrasse 11, A-4866 Unterach am Attersee Austria Asentra sertraline (sertraline hydrochloride) 50mg; (28/4x7/) in KKA d.d., Novo mesto, KKA d.d., Novo Edurant rilpivirine tablets film- 25mg; (30) in Janssen-Cilag S.p.A., Via C. Janssen, Borgo Italy Johnson & Johnson LLC, , ussia

7 coated plastic container San Michele, Latina Moscow, Krylatskaya str., 17, building PegIntron peginterferon alfa-2b powder lyophilized for 80mcg/0,5ml; (1) glass vial and solvent in ampoule 0.7ml Schering-Plough Labo N.V., Industriepark 30 B- 2220, Heist-op-den-Bergbatch releaser, secondary packager, Schering-Plough (Brinny) Company, Brinny, Inhanshannon, Co. Cork, Ireland- bulk manufacturer, primary packager, Hameln Pharmaceuticals GmbH, Langes Feld 13, Hameln, Lower Saxony, 31789, -solvent manufacturer Belgium Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne 6 Switzerland PegIntron peginterferon alfa-2b powder lyophilized for 50mcg/0.5ml; (1) glass vial and solvent in ampoule 0.7ml Schering-Plough Labo N.V., Industriepark 30 B- 2220, Heist-op-den-Bergbatch releaser, secondary packager, Schering-Plough (Brinny) Company, Brinny, Inhanshannon, Co. Cork, Ireland- bulk manufacturer, primary packager, Hameln Pharmaceuticals GmbH, Langes Feld 13, Hameln, Lower Saxony, 31789, -solvent manufacturer Belgium Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne 6 Switzerland PegIntron peginterferon alfa-2b powder lyophilized for 100mcg/0,5ml; (1) glass vial Schering-Plough Labo N.V., Industriepark 30 B- 2220, Heist-op-den-Berg- Belgium Schering-Plough Central East AG, Switzerland

8 and solvent in ampoule 0.7ml batch releaser, secondary packager, Schering-Plough (Brinny) Company, Brinny, Inhanshannon, Co. Cork, Ireland- bulk manufacturer, primary packager, Hameln Pharmaceuticals GmbH, Langes Feld 13, Hameln, Lower Saxony, 31789, -solvent manufacturer Weystrasse 20, 6000 Lucerne PegIntron peginterferon alfa-2b powder lyophilized for 120mcg/0,5ml; (1) glass vial and solvent in ampoule 0.7ml Schering-Plough Labo N.V., Industriepark 30 B- 2220, Heist-op-den-Bergbatch releaser, secondary packager, Schering-Plough (Brinny) Company, Brinny, Inhanshannon, Co. Cork, Ireland- bulk manufacturer, primary packager, Hameln Pharmaceuticals GmbH, Langes Feld 13, Hameln, Lower Saxony, 31789, -solvent manufacturer Belgium Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne 6 Switzerland Yaz light pink tabletdrospirenone, ethinylestradiol, white tabletinactive 3mg+0,02mg; (28/24 light pink tablet+4white tablet/) in Bayer Weimar GmbH & Co. KG, Dobereinerstrasse 20, Weimar Bayer Pharma AG, Mullerstrasse 178, 13353, Berlin Nalgesin naproxen (naproxen sodium) 275mg; (10/1x10/) in, (20/2x10/) in KKA d.d., Novo mesto, KKA d.d., Novo

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