The most recent market data: Drugs approved for sale in Poland, December 2015

Drugs approved for sale in Poland, December 2015
Lz – hospital use
Rpz – restricted use
URPL, 2016
No Drug name Commonly used drug name Pharmaceutical form Dose Pack size Availability category Marketing authorisation holder Manufacturer Country of manufacturer
1 Adenosine Kabi Adenosinum Solution for injection in single-dose pre-filled syringe 3 mg/ml 1, 6, 10 single-dose pre-filled syringe(s) 1, 2, 4 ml Lz Fresenius Kabi Poland Sp. z o.o. Fresenius Kabi Austria GmbH Austria
2 Apap 325 mg Paracetamolum Coated tablets 325 mg 2, 6, 12, 24, 50 tablets OTC US Pharmacia Sp. z o.o. US Pharmacia Sp. z o.o. Poland
3-5 Aribit ODT Aripiprazolum Orodispersible tablets 10, 15, 30 mg 14, 28, 49 tablets in blister, in perforated blister Rx Medana Pharma S.A. Rontis Hellas Medical and Pharmaceutical Products S.A. Genepharm S.A. Pharmadox Healthcare Ltd. Greece
Greece
Malta
6 Aripiprazole Stada Aripiprazolum Tablets 15 mg 28 tablets Rx Stada Arzneimittel AG Stada Arzneimittel AG Centrafarm Services B.V. Stada Arzneimittel GmbH Germany
Netherlands
Austria
7-8 Arparial Metoprololi tartras + Ivabradinum Coated tablets 50 mg + 5 mg, 50 mg + 7,5 mg 56, 100, 112 tablets Rx Egis Pharmaceuticals PLC Les Laboratoires Servier Industrie France
9-12 Bloxazoc Metoprololi succinas Extended release tablets 23.75 mg 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets Rx Krka, d.d., Novo mesto Krka, d.d., Novo mesto Tad Pharma GmbH Slovenia
Germany
13 Bortezomib Actavis Bortezomibum Injection solution powder 3.5 mg 1 phial powder Rpz Actavis Group PTC ehf. S.C. Sindan-Pharma S.R.L. Romania
14-15 Bortezomib Teva Bortezomibum Injection solution powder 1, 3.5 mg 1 phial powder Rpz Teva Pharmaceuticals Polska Sp. z o.o Teva Gyogyszergyár Zrt. (Teva Pharmaceutical Works Private Limited Company) Pliva Hrvatska d o.o. Teva Operations Poland Sp. z o.o. Hungary
Croatia
Poland
16 Brinzolamide Pharmathen Brinzolamidum Eye drops, suspension 10 mg/ml 1, 5 bottle(s) 5 ml Rx Pharmathen S.A. Pharmaten S.A. Famar S.A., Plant A Balkanpharma-Razgrad AD Greece
Greece
Bulgaria
17-19 Cinacalcet Helm Cinacalcetum Coated tablets 30, 60, 90 mg 14, 28, 84 tablets Rx Helm AG GE Pharmaceuticals Ltd Bulgaria
20-21 Deprilept Escitalopramum Coated tablets 10, 20 mg 28, 56 tablets Rx Ranbaxy (Poland) Sp. z o.o. Ranbaxy Ireland Limited Terapia SA o companie Ranbaxy Basics GmbH Ireland
Romania
Germany
22 Dilizolen Linezolidum Coated tablets 600 mg 30 tablets Rx Glenmark Pharmaceuticals s.r.o. Glenmark Pharmaceuticals Europe Limited Glenmark Pharmaceuticals s.r.o. United Kingdom
Czech Republic
23 Doreta SR Tramadoli hydrochloridum + Paracetamolum Extended release tablets 75 mg + 650 mg 10, 20, 30, 50, 60, 90, 100 tablets Rx Krka, d.d., Novo mesto Krka, d.d., Novo mesto TAD Pharma GmbH Slovenia
Germany
24-25 Dulodet Duloxetini hydrochloridum Intestinal capsule, hard 30, 60 mg 28, 30, 56, 60, 84, 98, 100 tablets Rx Prototerapia Sp. z o.o. Pharmascience International Ltd Egis Pharmaceuticals PLC Cyprus
Hungary
26-27 Duloxetine Actavis Duloxetinum Intestinal capsule, hard 20, 40 mg 28, 30, 56, 60 capsules Rx Actavis Polska Sp. z o. o. Balkanpharma-Dupnitsa AD Bulgaria
28 Duloxetinum Dutasteridum Intestinal capsule, hard 0.5 mg 10, 30, 50, 60, 90 tablets Rx Cipla Europe NV S&D Pharma CZ, spol. s r.o. Cipla (EU) Limited Czech Republic
United Kingdom
29-30 Dutilox Duloxetinum Intestinal capsule, hard 30, 60 mg 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 98, 500, 504 capsules Rx Optimal Regulatory Solutions S.L Laboratorios Dr. Esteve S.A. Spain
31 Favynd Tiotropinum Inhalant powder in hard capsules 18 mcg 30 capsules, 30 capsules + inhaler Rx Boehringer Ingelheim International GmbH Boehringer Ingelheim Pharma GmbH & Co. KG Germany
32 Flonase Allergy Fluticasoni propionas Aerosol 50 mcg/dose 1 bottle 60 doses Rx GlaxoSmithKline Consumer Healthcare Sp. z o.o. Glaxo Wellcome S.A. Spain
33 Hydrocortisonum Amara Hydrocortisoni acetas Cream 5 mg/g 1 tube 10, 15, 20, 25, 30 g OTC Zaklad Farmaceutyczny "Amara" Sp. z o.o. Zaklad Farmaceutyczny "Amara" Sp. z o.o. Poland
34 Imatinib Fair-Med Imatinibum Coated tablets 100 mg 60 tablets Rpz Fair-Med Healthcare GmbH Remedica Ltd Pharmadox Healthcare Ltd. Fair-Med Healthcare GmbH Cyprus
Malta
Germany
35 Imatinib Fair-Med Imatinibum Coated tablets 400 mg 30, 90 tablets Rpz Fair-Med Healthcare GmbH Remedica Ltd Pharmadox Healthcare Ltd. Fair-Med Healthcare GmbH Cyprus
Malta
Germany
36 Imipenem/Cilastatin ACIC Imipenemum + Cilastatinum Powder for solution for infusion 500 mg + 500 mg 1, 10, 25 phial(s) powder Rx ACIC Europe Limited S.C. Antibiotice S.A. Romania
37 Kventiax SR Quetiapinum Extended release tablets 50 mg 10, 30, 50, 60, 90, 100 tablets Rx Krka, d.d., Novo mesto Krka, d.d., Novo mesto TAD Pharma GmbH Slovenia
Germany
38 Lifsar Pulmojet Salmeterolum + Fluticasoni propionas Powder for inhalation (50 mcg + 500 mcg)/dose 1 inhaler 60 doses Rx Zentiva, k.s Fisons Limited TA Aventis Pharma (Holmes Chapel) Zentiva Inhalationsprodukte GmbH Uzdaroji Akcine Bendrove "Oriola Vilnius" United Kingdom
Germany
Lithuania
39 Linezolid Infomed Linezolidum Infusion solution 2 mg/ml 1, 10, 30 bag(s) 300 ml Lz Infomed Fluids SRL Infomed Fluids SRL Romania
40 Loperamid Dr. Max Loperamidi hydrochloridum Tablets 2 mg 8, 10, 12, 18 tablets OTC Dr. Max Pharma Limited  Cipla (EU) Limited United Kingdom
41 Memolek Memantini hydrochloridum Coated tablets 5 mg, 10 mg, 15 mg, 20 mg 28 tablets Rx Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. z o.o. Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. z o.o Poland
42-43 Memolek Memantini hydrochloridum Coated tablets 10 mg, 20 mg 14, 28, 30, 56, 60, 90, 112, 120 tablets Rx Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. z o.o. Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. z o.o Poland
44 Mydrane Tropicamidum + Phenylephrini hydrochloridum + Lidocaini hydrochloridum Injection solution (0.2 mg + 3.1 mg + 10 mg)/ml 1, 20, 100 ampoule(s) 0.6 ml Rx Laboratoires Thea Delpharm Tours Laboratoires Thea France
France
45 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 2.5 mg 1, 4 single-dose pre-filled syringe 0.33 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
46 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 7.5 mg 1, 4 single-dose pre-filled syringe 0.3 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
47 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 10 mg 1, 4 single-dose pre-filled syringe 0.4 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
48 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 12.5 mg 1, 4 single-dose pre-filled syringe 0.31 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
49 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 15 mg 1, 4 single-dose pre-filled syringe 0.38 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
50 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 17.5 mg 1, 4 single-dose pre-filled syringe 0.44 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
51 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 20 mg 1, 4 single-dose pre-filled syringe 0.5 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
52 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 22.5 mg 1, 4 single-dose pre-filled syringe 0.56 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
53 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 25 mg 1, 4 single-dose pre-filled syringe 0.63 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
54 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 27.5 mg 1, 4 single-dose pre-filled syringe 0.69 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
55 Namaxir Methotrexatum Solution for injection in single-dose pre-filled syringe 30 mg 1, 4 single-dose pre-filled syringe 0.75 ml Rx Actavis Group PTC ehf. Actavis Italy S.p.A. S.C. Sindan-Pharma S.R.L. Italy
Romania
56-57 NiQuitin Menthol Nicotinum Medicated chewing gum 2 mg, 4 mg 4, 10, 30, 100 gums OTC Omega Pharma Poland Sp. z o.o. Fertin Pharma A/S Denmark
58-59 NiQuitin o smaku mentolowym Nicotinum Medicated chewing gum 2 mg, 4 mg 4, 10, 30, 100 gums OTC Omega Pharma Poland Sp. z o.o. Fertin Pharma A/S Denmark
60 Nystvagin Nystatinum Vaginal tablets 100 000 IU 10 tablets Rx Teva Pharmaceuticals Polska Sp. z o.o. ICN Polfa Rzeszow S.A. Poland
61-62 Omnisolvan Ambroxoli hydrochloridum Effervescent tablets 30, 60 mg 10, 20 tablets OTC Actavis Group PTC ehf. Hermes Arzneimittel GmbH Germany
63 Pemetreksed Adamed Pemetrexedum Powder for concentrate for solution for infusion 100 mg 1 phial 10 ml Rpz Adamed Sp. z o.o. Adamed Sp. z o.o. Synthon Hispania S.L. Synthon s.r.o. Poland
Spain
Czech Republic
64 Pemetreksed Adamed Pemetrexedum Powder for concentrate for solution for infusion 500 mg 1 phial 25 ml Rpz Adamed Sp. z o.o. Adamed Sp. z o.o. Synthon Hispania S.L. Synthon s.r.o. Poland
Spain
Czech Republic
65 Pemetreksed Adamed Pemetrexedum Powder for concentrate for solution for infusion 1000 mg 1 phial 50 ml Rpz Adamed Sp. z o.o. Adamed Sp. z o.o. Synthon Hispania S.L. Synthon s.r.o. Poland
Spain
Czech Republic
66-69 Pregabalin Teva Pregabalinum Hard capsules 25 mg, 75 mg, 150 mg, 300 mg 14, 56 capsules Rx Teva Pharmaceuticals Polska Sp. z o.o. Teva UK Ltd. Merckle GmbH Pliva Hrvatska d o.o. United Kingdom
Germany
Croatia
70-73 Prestilol Bisoprololi fumaras + Perindoprilum argininum Coated tablets 5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 5 mg, 10 mg + 10 mg 30, 90, 100 tablets Rx Les Laboratoires Servier Anpharm Przedsiębiorstwo Farmaceutyczne S.A., Les Laboratoires Servier Industrie Servier (Ireland), Industries Ltd. Egis Pharmaceuticals PLC Poland
France
Ireland
Hungary
74 Ralago Rasagilinum Tablets 1 mg 10, 14, 28, 30, 56, 60, 84, 90 tablets Rx Krka, d.d., Novo mesto Krka, d.d., Novo mesto Tad Pharma GmbH Slovenia
Germany
75-76 Reseligo Goserelinum Implant in single-dose pre-filled syringe 3.6 mg, 10.8 mg 1, 3 single-dose pre-filled syringe Rx Alvogen IPCo S.a.r.l. AMW GmbH Arzneimittelwerk Warngau Germany
77 Salbetan Betamethasoni dipropionas + Acidum salicylicum Topical solution (0.64 mg + 20 mg)/g 1 bottle 50, 100 ml Rx Sun-Farm Sp. z o.o. mibe GmbH Arzneimittel Germany
78 Srivasso Tiotropinum Inhalant powder in hard capsules 18 mcg 30 capsules, 30 capsules and inhaler Rx Boehringer Ingelheim International GmbH Boehringer Ingelheim Pharma GmbH & Co. KG Germany
79-80 Strodros Duloxetinum Rectal capsules, hard 20, 40 mg 14, 28, 56, 98 capsules Rx Zentiva, k.s. S.C. Zentiva S.A. Romania
81 Tadalafil Teva Tadalafilum Coated tablets 2.5 mg 14, 30, 56 tablets, 28 tablets in blister, 28 tablets in perforated blister Rx Teva Pharmaceuticals Polska Sp. z o.o. Merckle GmbH Pliva Hrvatska d o.o. Teva UK Ltd. Merckle GmbH Teva Pharma B.V. Teva Operations Poland Sp. z o.o. Teva Operations Poland Sp. z o.o. Teva Pharma S.L.U. Teva Gyogyszergyar Zrt. (Teva Pharmaceutical Works Private Limited Company) Germany
Croatia
United Kingdom
Germany
Netherlands
Poland
Poland
Spain
Hungary
82 Tadalafil Teva Tadalafilum Coated tablets 5 mg 14, 30, 84, 98 tablets, 28 tablets in blister, 28 tablets in perforated blister Rx Teva Pharmaceuticals Polska Sp. z o.o. Merckle GmbH Pliva Hrvatska d o.o. Teva UK Ltd. Merckle GmbH Teva Pharma B.V. Teva Operations Poland Sp. z o.o. Teva Operations Poland Sp. z o.o. Teva Pharma S.L.U. Teva Gyogyszergyar Zrt. (Teva Pharmaceutical Works Private Limited Company) Germany
Croatia
United Kingdom
Germany
Netherlands
Poland
Poland
Spain
Hungary
83 Tadalafil Teva Tadalafilum Coated tablets 10 mg 4 tablets in blister, in perforated blister, 24, 28 tablets Rx Teva Pharmaceuticals Polska Sp. z o.o. Merckle GmbH Pliva Hrvatska d o.o. Teva UK Ltd. Merckle GmbH Teva Pharma B.V. Teva Operations Poland Sp. z o.o. Teva Operations Poland Sp. z o.o. Teva Pharma S.L.U. Teva Gyogyszergyar Zrt. (Teva Pharmaceutical Works Private Limited Company) Germany
Croatia
United Kingdom
Germany
Netherlands
Poland
Poland
Spain
Hungary
84 Tadalafil Teva Tadalafilum Coated tablets 20 mg 2, 5, 8, 10, 15, 24, 28, 56 tablets, 4, 12 tablets in blister, in perforated blister Rx Teva Pharmaceuticals Polska Sp. z o.o. Merckle GmbH Pliva Hrvatska d o.o. Teva UK Ltd. Merckle GmbH Teva Pharma B.V. Teva Operations Poland Sp. z o.o. Teva Operations Poland Sp. z o.o. Teva Pharma S.L.U. Teva Gyogyszergyar Zrt. (Teva Pharmaceutical Works Private Limited Company) Germany
Croatia
United Kingdom
Germany
Netherlands
Poland
Poland
Spain
Hungary
85-87 Teicopix Teicoplaninum Powder and solvent for solution for injection or oral solution 100, 200, 400 mg 1, 5 phial(s) powder + 1, 5 ampoule(s) solvent 1.5 ml Lz Sandoz GmbH Lek Pharmaceuticals d.d. Salutas Pharma GmbH Slovenia
Germany
88-89 Trocordis Bosentanum Coated tablets 62.5 mg, 125 mg 10, 56 tablets Rpz Actavis Group PTC ehf. Balkanpharma-Dupnitsa AD Bulgaria
90 Vesicare Solifenacini succinas Oral suspension 1 mg/ml 1 bottle 150 ml Rx Astellas Pharma Sp. z o.o. Astellas Pharma Europe BV Netherlands