List of the medicines recommended for registration by N 6-1/16 meeting decision of the Pharmacological Council of MoH of RA dated on June 10, 2016

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1 List of the medicines recommended for registration by N 6-1/16 meeting decision of the Pharmacological Council of MoH of A dated on June 10, 2016 President E. Amroyan 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 status Conclusion N & date 1. Paclitaxel 6mg/ml paclitaxel 6mg/ml; glass vial 16,7ml Actavis Italy S.p.A., Viale Pasteur, 10, Nerviano, Milan Italy Pharmaceuticals LLC, Vanahovit 8, Proshyan v., Ashtarak Ave., Kotayk Marz 2413 epublic of Paclitaxel 6mg/ml paclitaxel 6mg/ml; glass vial 5ml Actavis Italy S.p.A., Viale Pasteur, 10, Nerviano, Milan Italy Pharmaceuticals LLC, Vanahovit 8, Proshyan v., Ashtarak Ave., Kotayk Marz 2413 epublic of Paclitaxel 6mg/ml paclitaxel 6mg/ml; glass vial 25ml Actavis Italy S.p.A., Viale Pasteur, 10, Nerviano, Milan Italy Pharmaceuticals LLC, Vanahovit 8, Proshyan v., Ashtarak Ave., Kotayk Marz 2413 epublic of Paclitaxel 6mg/ml paclitaxel 6mg/ml; glass vial 50ml Actavis Italy S.p.A., Viale Pasteur, 10, Nerviano, Milan Italy Pharmaceuticals LLC, Vanahovit 8, Proshyan v., Ashtarak Ave., Kotayk Marz 2413 epublic of

2 5. Impaza affinity purified antibodies to endothelial NO synthase to be sucked not more than ng/g; (20/1x20/), Holding LLC, 54, Buguruslanskaya st., Chelyabinsk ussia Holding LLC, 9 bld., 3rd Samotyochny per., Moscow ussia Anaferon kids affinity purified antibodies to human interferon gamma to be sucked not more than ng/g; (20/1x20/), Holding LLC, 54, Buguruslanskaya st., Chelyabinsk ussia Holding LLC, 9 bld., 3rd Samotyochny per., Moscow ussia Gardasil human type 6 L1 protein, human type 11 L1 protein, human type 16 L1 protein, human type 18 L1 protein suspension for i/m injection 20mcg/dose+40m cg/dose+40mcg/d ose+20mcg/dose; 0,5ml/dose glass vial Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlembatch releaser, secondary, Merck Sharp & Dohme Corp., 770 Sumneytown Pike,West Point, 19486, USAbulk manufacturer, primary the Netherlands Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne Gardasil human type 6 L1 protein, human type 11 L1 protein, human type 16 L1 protein, human type 18 L1 protein suspension for i/m injection 20mcg/dose+40m cg/dose+40mcg/d ose+20mcg/dose; 0,5ml/dose prefilled syringe, (1) or (2) needles Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlembatch releaser, secondary, Merck Sharp & Dohme Corp., 770 Sumneytown Pike,West Point, 19486, USAbulk manufacturer, primary the Netherlands Schering-Plough Central East AG, Weystrasse 20, 6000 Lucerne ectodelt 100 prednisone suppositories rectal 100mg; (2) Trommsdorff GmbH & Co. KG, Arzneimittel, Trommsdorffstrasse 2-6, 52477, Alsdorf Trommsdorff GmbH & Co. KG, Arzneimittel, Trommsdorffstrasse 2-6, 52477, Alsdorf

3 10. Sulfasalazi ne-en sulfasalazine gastroresistant 500mg; (50/5x10/), in KKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Slovenia KKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Slovenia Anaferon affinity purified antibodies to human interferon gamma to be sucked not more than ng/g; (20/1x20/) Holding LLC, 54, Buguruslanskaya st., Chelyabinsk ussia Holding LLC, 9 bld., 3rd Samotyochny per., Moscow ussia Sulfocamp hocaine sulfocamphoric acid, procaine base injection 49,6mg/ml+50,4m g/ml; (10) ampoules 2ml Yerevan Chemical- Pharmaceutical firm OJSC, Yerevan, Ajaryan street, 2 Line, No6 epublic of Yerevan Chemical- Pharmaceutical firm OJSC, Yerevan, Ajaryan street, 2 Line, No6 epublic of Groprinosi n-ichter inosine pranobex syrup 50mg/ml; 150ml glass bottle and plastic syringe 0.5ml-5ml Gedeon ichter Polska Sp. z o.o., ul. Ks. J. Poniatowskiego 5, Grodzisk Mazowiecki, batch releaser, Gedeon ichter omania S.A., Guza Voda str., , Targu-Mures, omania-bulk manufacturer, Gedeon ichter PLC, Gyomroi ut 19-21, 1103 Budapest Hungary Septolete plus menthol cetylpyridinium (cetylpyridinium chloride), benzocaine pastilles 1mg+5mg; (18/2x9/), KKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto - batch releaser, KKA d.d., Novo mesto, Ulica ada Pusenjaka 10, Ljutomer, 9240, Slovenia-bulk manufacturer, Slovenia KKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Slovenia

4 15. Gexosept- n chlorhexidine 16mg; (10/2x5/) suppositories vaginal ubicon LLC, 62B, M. Gorky street, , Vitebsk Belarus ubicon LLC, 62B, M. Gorky street, , Vitebsk Belarus Folacin folic acid 5mg; (30/3x10/) in JADAN- GALENSKI LABOATOIJ d.d., Svilno 20, ijeka Croatia JADAN- GALENSKI LABOATOIJ d.d., Svilno 20, ijeka Croatia Fenkarol quifenadine (quifenadine hydrochloride) 10mg; (20/2x10/), upnicu Str., Olaine, upnicu Str., Olaine, Fenkarol quifenadine (quifenadine hydrochloride) 25mg; (20/2x10/), upnicu Str., Olaine, upnicu Str., Olaine, Fenkarol quifenadine (quifenadine hydrochloride) 50mg; (15/1x15/),, (30/2x15/), in upnicu Str., Olaine, upnicu Str., Olaine, Haemodes um- PharmaTe ch polyvinylpyrrolidon e, sodium chloride, potassium chloride, calcium chloride (calcium chloride dihydrate), magnesium chloride (magnesium chloride hexahydrate), sodium hydrocarbonate 60mg/ml+5,5mg/ ml+0,42mg/ml+0, 375mg/ml+0,005 mg/ml+0,23mg/ml ; 100ml, 200ml, 250ml, 400ml, 500ml plastic pack PharmaTech CJSC, 0064, Yerevan, affi str. 111 epublic of PharmaTech CJSC, 0064, Yerevan, affi str. 111 epublic of Neiromidin ipidacrine (ipidacrine 20mg; (50/5x10/), upnicu Str., Olaine, upnicu Str., Olaine,

5 hydrochloride) 22. Atortonus atorvastatin (atorvastatin calcium trihydrate) filmcoated 20mg; (30/3x10/) Arpimed LLC, Kotayk Marz, Abovyan, 2nd Micro-District, 19 Building epublic of Arpimed LLC, Kotayk Marz, Abovyan, 2nd Micro-District, 19 Building epublic of Vermox mebendazole 100mg; (6/1x6/) in Gedeon ichter PLC, Gyomroi ut 19-21, 1103 Budapest- batch releaser, Gedeon ichter omania S.A., Guza Voda str., , Targu- Mures, omania-bulk manufacturer, Hungary Gedeon ichter PLC, Gyomroi ut 19-21, 1103 Budapest Hungary Brimica Genuair aclidinium (aclidinium bromide), formoterol fumarate dihydrate powder for inhalation 340mcg/dose+12 mcg/dose; (1) inhaler with 60 unit doses, (3) inhalers with 180(3x60) unit doses Industrias Farmaceuticas Almirall S.A., Ctra. Nacional II, Km. 593, Sant Andreu de la Barca, Barcelona Spain Berlin-Chemie AG, Glienicker Weg 125, Berlin months Folic acid folic acid filmcoated 0.4mg; (30/3x10/) Valenta Pharmaceuticals JSC, , Moscow egion, Shchelkovo, Fabrichnaya St., 2 ussia Valenta Pharmaceuticals JSC, , Moscow egion, Shchelkovo, Fabrichnaya St., 2 ussia Polvertic betahistine (betahistine dihydrochloride) 24mg; (20/2x10/), (30/3x10/) in, (40/4x10/), (50/5x10/) in, (60/6x10/), (100/10x10/) in Medana Pharma JSC, Sieradz, W. Lokietka 10 - batch releaser, Catalent Schorndorf GmbH, Steinbeisstrasse 1und 2, 73614, Schorndorf, -bulk Medana Pharma JSC, Sieradz, W. Lokietka

6 manufacturer, Medana Pharma JSC, str. Polskiej Organizacji Wojskowej 57, Sieradz, 27. Polvertic betahistine (betahistine dihydrochloride) 16mg; (20/2x10/), (30/3x10/) in, (50/5x10/), (60/6x10/) in, (100/10x10/) in Medana Pharma JSC, Sieradz, W. Lokietka 10 - batch releaser, Catalent Schorndorf GmbH, Steinbeisstrasse 1und 2, 73614, Schorndorf, -bulk manufacturer, Medana Pharma JSC, str. Polskiej Organizacji Wojskowej 57, Sieradz, Medana Pharma JSC, Sieradz, W. Lokietka Polvertic betahistine (betahistine dihydrochloride) 8mg; (30/3x10/) in, (50/5x10/), (100/10x10/) in, (120/12x10/) in Medana Pharma JSC, Sieradz, W. Lokietka 10 - batch releaser, Catalent Schorndorf GmbH, Steinbeisstrasse 1und 2, 73614, Schorndorf, -bulk manufacturer, Medana Pharma JSC, str. Polskiej Organizacji Wojskowej 57, Sieradz, Medana Pharma JSC, Sieradz, W. Lokietka

7 29. Bifiform bifidobacterium longum, enterococcus faecium capsules gastroresistant 1x10^7CFU + 1x10^7 CFU; (30) in aluminium container Ferrosan A/S, Sydmarken 5, Soeborg,DK Denmark Ferrosan A/S, Sydmarken 5, Soeborg,DK Denmark mg/ml; (1) glass vial 16ml oche Diagnostics La oche Ltd. -secondary oche Ltd., mg/ml; (1) glass vial 16ml oche Diagnostics La oche Ltd. -secondary oche Ltd., mg/ml; (1) glass vial 16ml oche Diagnostics La oche Ltd. oche Ltd.,

8 -secondary mg/ml; (1) glass vial 4ml oche Diagnostics La oche Ltd. -secondary oche Ltd., mg/ml; (1) glass vial 4ml oche Diagnostics La oche Ltd. -secondary oche Ltd., mg/ml; (1) glass vial 4ml oche Diagnostics La oche Ltd. -secondary oche Ltd.,

9 36. Tamiflu oseltamivir (oseltamivir phosphate) powder for oral suspension 6mg/ml; (1) glass bottle, plastic bottle adaptor, plastic measuring cup 55ml and oral dispenser oche Ltd., batch releaser, ottendorf Pharma GmbH, Ostenfelder Strasse 51-61, Ennigerloh, bulk manufacturer, F. Hoffmann-La oche Ltd, Betriebsstandort oche Ltd.,

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