Manufacturer country License holder. KRKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto

Transcription

1 List of the medicines recommended for registration by N 12-1/15 meeting decision of the Pharmacological Council of MoH of A dated on December 04, 2015 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. Cordipin XL nifedipine modifiedrelease 40mg; (30/3x10/) in KKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto KKA d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Pantogam hopantenic acid (calcium hopantenate) 250mg; (50/5x10/) in PIQ-PHAMA LEK LLC, 46g, Beryozovaya str., Severnyj-Pervyj town, Belgorod district, Belgorod region, ussia "PIQ-PHAMA" LLC, , pereulok Oruzheyniy, 25, building 1, Moscow ussia inger sodium chloride, potassium chloride, calcium chloride (calcium chloride dihydrate) 8,6mg/ml+0,3mg/ ml+0,33mg/ml; 100ml, 200ml, 250ml, 500ml, 1000ml, 2000ml, 3000ml plastic pack Yerevan, affi epublic of 0064, Yerevan, affi epublic of Sodium chloride solution 0.9% sodium chloride 9mg/ml; 50ml, 100ml, 200ml, 250ml, 400ml, 500ml, 1000ml, 2000ml, 3000ml Yerevan, affi epublic of 0064, Yerevan, affi epublic of

2 5. Lespefril lespedeza bicolor solution oral 708mg/ml; 100ml glass or plastic bottle VIFITEH CJSC, SCAM, Obolensk v., corp. 84, corp. 87, build. 90, Serpukhov district, Moscow region, ussia VIFITEH CJSC, SCAM, Obolensk v., Serpukhov district, Moscow region, ussia Persen valeriana officinalis extract, melissa officinalis extract, mentha piperita extract coated 35mg+17,5mg+17,5mg; (40/4x10/), in Lek Pharmaceuticals d.d., Verovskova Str. 57, 1526 Ljubljana- bulk manufacturer, batch releaser, Lek Pharmaceuticals d.d.,trimlini 2D, Lendava, 9220, primary and secondary Lek Pharmaceuticals d.d., Verovskova Str. 57, 1526 Ljubljana, Neuromultivit vitamin B1, vitamin B6, vitamin B12 100mg+200mg+0, 2mg; (20/1x20/) in, (100/5x20/), in G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach -batch releaser, G.L. Pharma GmbH, Industriestrasse 1, 8502 Lannach, Austria -bulk manufacturer, Austria VALEANT LLC, Shabolovka st. 31, building 5, , Moscow ussia Tritace ramipril 5mg; (28/2x14.) in Sanofi-Aventis S.p.A., Strada Statale N17- km22, Scoppito Sanofi-Aventis Deutschland GmbH, D Frankfurt am Main Tritace ramipril 10mg; (28/2x14/) in Sanofi-Aventis S.p.A., Strada Statale N17- km22, Scoppito Sanofi-Aventis Deutschland GmbH, D Frankfurt am Main Tritace ramipril 2,5mg; (28/2x14.) in Sanofi-Aventis S.p.A., Strada Statale N17- km22, Scoppito Sanofi-Aventis Deutschland GmbH, D Frankfurt am Main

3 11 Warfarin warfarin (warfarin sodium) 2,5mg; (40/2x20/), in, (100/5x20/), in Belmedpreparaty UE, , Minsk, Fabritsius St., 30 Belmedpreparaty UE, , Minsk, Fabritsius St., Polyglucin- PharmaTech dextran 70 60mg/ml; 100ml, 200ml, 250ml, 400ml, 500ml Yerevan, affi epublic of 0064, Yerevan, affi epublic of Iono-Tech sodium acetate (sodium acetate trihydrate), sodium chloride, potassium chloride, calcium chloride (calcium chloride dihydrate), magnesium chloride (magnesium chloride hexahydrate) 5mg/ml+5,85mg/ ml+0,302mg/ml+ 0,36mg/ml+0,25m g/ml; 50ml, 100ml, 200ml, 250ml, 400ml, 500ml, 1000ml Yerevan, affi epublic of 0064, Yerevan, affi epublic of heopolyglu- cin-pharma- Tech dextran mg/ml; 100ml, 200ml, 250ml, 400ml, 500ml Yerevan, affi epublic of 0064, Yerevan, affi epublic of Spasmomen otilonium bromide 40mg; (30/2x15/) in, (30/3x10/), in Berlin-Chemie A.G.,Glienicker Weg 125, D Berlin-batch releaser, Berlin- Chemie A.G., Tempelhofer Weg 83, D Berlin,bulk manufacturer A. Menarini Industrie Farmaceutiche iunite S.r.l., Via Sette Santi, Firenze Encifer Iron sucrose complex i/v 20mg/ml; (5) ampoules 5ml Emcure Pharmaceuticals Ltd., Plot NO. J-174, J- 168, J-168/1, MIDC, Tarapur, Boisar, Thane Emcure Pharmaceuticals Ltd., T-184, M.I.D.C., Bhosari, Pune

4 401506, Maharashtra State , Maharashtra 17 Unigamma benfotiamine, pyridoxine (pyridoxine, cyanocobalamin 100mg+100mg+2 00mcg; (30/1x30/), in Unipharm Inc., 75 Progress Lane, Waterbury, Connecticut (CT), USA Unipharm Inc., 350, 5th avenue, suite 6701, New York, USA Advantan methylprednisolone (methylprednisolon e aceponate) emulsion for external use 1mg/g; 20g aluminium laminated tube Bayer Healthcare Manufacturing S.r.l., Via E. Schering 21, Segrate (Milano) Bayer Pharma AG, Mullerstrasse 178, 13353, Berlin Pregabalin Canon 75mg; (14/2x7/), in, Zarechnaya str Moskow region, Schelkovo ussia Zarechnaya str Moskow region, Schelkovo ussia Pregabalin Canon 150mg; (14/2x7/), in, Zarechnaya str Moskow region, Schelkovo ussia Zarechnaya str Moskow region, Schelkovo ussia Pregabalin Canon 300mg; (14/2x7/), in, Zarechnaya str Moskow region, Schelkovo ussia Zarechnaya str Moskow region, Schelkovo ussia Pregabalin- ichter 75mg; (14/1x14/) in, (56/4x14) in Gedeon ichter-us CJSC, Lesnaya st. 40, Shuvoye, Moscow region, Yegoriyevsky district, ussia Gedeon ichter PLC, Pregabalin- ichter 150mg;, Gedeon ichter-us CJSC, Lesnaya st. 40, Shuvoye, Moscow region, ussia Gedeon ichter PLC,

5 (56/4x14/), in Yegoriyevsky district, Pregabalin- ichter 300mg;, (56/4x14/), in Gedeon ichter-us CJSC, Lesnaya st. 40, Shuvoye, Moscow region, Yegoriyevsky district, ussia Gedeon ichter PLC, Nonpres eplerenone 50mg; (20/2x10/), in Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., Pabianice Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., Pabianice Nonpres eplerenone 25mg; (20/2x10/), in Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., Pabianice Pharmaceutical Works Polfa in Pabianice JSC, 5 Marszalka J. Pilsudskiego Str., Pabianice Gemcitabine (gemcitabine gemcitabine powder lyophilized for 200mg; (1) glass vial 10ml Belmedpreparaty UE, , Minsk, Fabritsius St., 30 Belmedpreparaty UE, , Minsk, Fabritsius St., Gemcitabine (gemcitabine gemcitabine powder lyophilized for 1000mg; (1) glass vial 50ml Belmedpreparaty UE, , Minsk, Fabritsius St., 30 Belmedpreparaty UE, , Minsk, Fabritsius St., Oftagel carbomer 974P gel eye 2,5mg/g; plastic vial-dropper 10g Santen Oy, Niittyhaankatu 20, Tampere-batch releaser, Ursapharm Arzneimittel GmbH, Industriestrasse 35, Saarbrucken, -bulk Finland Santen Oy, Niittyhaankatu 20, Tampere Finland

6 and secondary 30 Tlocin-0,4 tamsulosin (tamsulosin modifiedrelease, hard 0,4mg; (30/3x10/), in Zim Laboratories Ltd., B- 21/22, MIDC Area, Kalmeshwar , Dist. Nagpur (M.S.) Zim Laboratories Ltd., Ground Floor, Sadoday Gyan, Nelson Square, Chhindwara oad, Nagpur Mexicam meloxicam, lidocaine (lidocaine i/m 5mg/ml+3mg/ml; (6) ampoules 3ml Delta Pharma, Industrial Zone B4,10th of amadan city Egypt Delta Pharma, Industrial Zone B4,10th of amadan city Egypt Cavinton vinpocetine 5mg/ml; (10/2x5/) ampoules 2ml, in plastic tray Gedeon ichter PLC, 1103 Gedeon ichter PLC, Cavinton vinpocetine 5mg/ml; (10/2x5/) ampoules 5ml in plastic tray Gedeon ichter PLC, 1103 Gedeon ichter PLC, Cavinton Forte vinpocetine 10mg; (30/2x15/) in, (90/6x15/) in Gedeon ichter PLC, 1103 Gedeon ichter PLC, Cavinton vinpocetine 5mg; (50/2x25/), in Gedeon ichter PLC, 1103 Gedeon ichter PLC, Naphthyzin- Arsanit-S naphazoline drops nasal 0.5mg/ml; 10ml glass vial Yerevanyan str., Masisbatch releaser, secondary, PharmaTech CJSC, 111 affi str., 0064, Yerevan, epublic of -bulk epublic of Yerevanyan str., Masis epublic of

7 37 Naphthyzin- Arsanit-S naphazoline drops nasal 1mg/ml; 10ml glass vial Yerevanyan str., Masisbatch releaser, secondary, PharmaTech CJSC, 111 affi str., 0064, Yerevan, epublic of -bulk epublic of Yerevanyan str., Masis epublic of Naphthyzin- Arsanit naphazoline spray nasal 1mg/ml; 10ml glass or plastic vial and dispenser Yerevanyan str., Masisbatch releaser, secondary, PharmaTech CJSC, 111 affi str., 0064, Yerevan, epublic of -bulk epublic of Yerevanyan str., Masis epublic of