Wykaz Produktów Leczniczych, które uzyskały pozwolenie na dopuszczenie do obrotu w sierpniu 2017r. 1 Allopurinol Medreg Allopurinolum tabletki 100 mg 100 tabl. 2 Allopurinol Medreg Allopurinolum tabletki 300 mg 100 tabl. 3 Amlozek Swift Amlodipinum tabletki ulegające 4 Amlozek Swift Amlodipinum tabletki ulegające 5 mg 7 tabl. 10 tabl. 8 10 mg 7 tabl. 10 tabl. 8 5 ApoSoli Solifenacini succinas tabletki powlekane 5 mg 6 ApoSoli Solifenacini succinas tabletki powlekane 10 mg 7 Auroverin MR Mebeverini kapsułki o 200 mg 30 kaps. hydrochloridum 60 kaps. 8 Bikalutamid Farmax Bicalutamidum tabletki powlekane 50 mg 40 tabl. 8 100 tabl. 5909991339425 5909991339432 5909991339449 5909991339456 5909991339463 5909991339470 5909991339487 5909991339494 5909991339500 5909991339517 5909991334789 5909991334796 5909991334802 5909991334819 5909991334826 5909991334833 5909991334840 5909991334857 5909991334864 5909991334871 5909991334888 5909991334895 5909991334901 5909991334918 5909991334925 5909991334932 5909991334949 5909991334956 5909991334963 5909991334970 5909991340834 5909991340841 5909991340858 5909991340865 5909991340902 5909991340919 Medreg s.r.o. 24189 Medis International a.s. Medreg s.r.o. 24190 Medis International a.s. Adamed Sp. z Adamed Sp. z 24203 Pabianickie Zakłady Farmaceutyczne Polfa S.A. Adamed Sp. z 24204 Pabianickie Zakłady Farmaceutyczne Polfa S.A. Adamed Sp. z Apotex Europe B.V. 24179 Apotex Nederland B.V. Apotex Europe B.V. 24180 Apotex Nederland B.V. Aurovitas, Unipessoal, Lda. 24186 A Swift Services (Malta) Ltd. MT 8 Bikalutamid Farmax Bicalutamidum tabletki powlekane 50 mg 5909991344085 SVUS Pharma a.s. 24235 Genepharm S.A. GR 5909991344092 SVUS Pharma a.s. 5909991344108 5909991344115 5909991344122 5909991344139 5909991344146 5909991344153 5909991344160 Strona 1 z 8
9 Bikalutamid Farmax Bicalutamidum tabletki powlekane 150 mg 5909991344191 SVUS Pharma a.s. 5909991344207 5909991344214 40 tabl. 5909991344221 5909991344238 5909991344245 8 5909991344252 5909991344269 100 tabl. 5909991344276 10 Bilaxten Bilastinum roztwór doustny 2.5 mg/ml 1 butelka 120 ml 5909991342623 Menarini International Operations Luxembourg S.A. 24236 Genepharm S.A. SVUS Pharma a.s. 24211 Berlin-Chemie AG FA Farma S.A. GR 11 Bilaxten Bilastinum tabletki ulegające 10 mg 10 tabl. 12 Capecitabine LEK-AM Capecitabinum tabletki powlekane 500 mg 1 z z z 5909991342586 Menarini International 5909991342593 Operations Luxembourg S.A. 5909991342609 5909991342616 5909991340230 5909991340247 5909991340254 Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z 24210 FA Farma S.A. A. Menarini Manufacturing Logistics and Services S.r.l. 24205 Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z IT 13 Clatra Bilastinum roztwór doustny 2,5 mg/ml 1 butelka 120 ml 5909991341688 Menarini International Operations Luxembourg S.A. 24196 Berlin-Chemie AG FA Farma S.A. 14 Clatra Bilastinum tabletki ulegające 10 mg 10 tabl. 15 Darunavir Teva Darunavirum tabletki powlekane 150 mg 240 tabl. w blistrze 240 tabl. w blistrze perforowanym 16 Darunavir Teva Darunavirum tabletki powlekane 300 mg w blistrze w blistrze perforowanym 17 Darunavir Teva Darunavirum tabletki powlekane 400 mg w blistrze w blistrze perforowanym 18 Darunavir Teva Darunavirum tabletki powlekane 600 mg w blistrze w blistrze perforowanym z z z z z z z z 5909991341640 Menarini International 5909991341657 Operations Luxembourg S.A. 5909991341664 5909991341671 5909991338121 5909991338114 5909991338145 5909991338152 5909991338176 5909991338169 5909991338220 5909991338237 Sp. z Sp. z Sp. z Sp. z 24195 FA Farma S.A. A. Menarini Manufacturing Logistics and Services S.r.l. 24191 Merckle GmbH IVA Hrvatska d (Pliva Teva Pharma B.V. 24192 Merckle GmbH IVA Hrvatska d (Pliva Teva Pharma B.V. 24193 Merckle GmbH IVA Hrvatska d (Pliva Teva Pharma B.V. 24194 Merckle GmbH IVA Hrvatska d (Pliva Teva Pharma B.V. IT Strona 2 z 8
19 Ditanpine Amlodipinum + Valsartanum 20 Ditanpine Amlodipinum + Valsartanum 21 Ditanpine Amlodipinum + Valsartanum 22 Emtricitabine/Tenofovir disoproxil Accord Biuletyn 2017-08 tabletki powlekane 5 mg + 80 mg 7 tabl. 9 280 tabl. tabletki powlekane 5 mg + 160 mg 7 tabl. 9 280 tabl. tabletki powlekane 10 mg + 160 mg 7 tabl. 9 280 tabl. Emtricitabinum + tabletki powlekane 200 mg + 245 Tenofovirum disoproxilum mg w blistrze w blistrze perforowanym w butelce w blistrze w blistrze perforowanym w blistrze w blistrze perforowanym w butelce 23 Entecavir Alvogen Entecavirum tabletki powlekane 0,5 mg z z z z z z z z z z 5909991342722 5909991342739 5909991342746 5909991342753 5909991342760 5909991342777 5909991342784 5909991342791 5909991342807 5909991342814 5909991342821 5909991342838 5909991342845 5909991342852 5909991342869 5909991342876 5909991342883 5909991342890 5909991342906 5909991342913 5909991342920 5909991342937 5909991342944 5909991342951 5909991342968 5909991342975 5909991342982 5909991343507 5909991343514 5909991343521 5909991343538 5909991343545 5909991343552 5909991343569 5909991343576 5909991342319 5909991342326 Polfarmex S.A. 24212 Balkanpharma Dupnitsa AD BG Polfarmex S.A. 24213 Balkanpharma Dupnitsa AD BG Polfarmex S.A. 24214 Balkanpharma Dupnitsa AD BG Alvogen Malta Operations (ROW) Ltd. 24240 Pharmadox Healthcare Ltd. 24231 Medis International a.s. vyrobni zavod Bolatice MT 24 Entecavir Alvogen Entecavirum tabletki powlekane 1 mg z z 5909991342333 5909991342340 Alvogen Malta Operations (ROW) Ltd. 24232 Medis International a.s. vyrobni zavod Bolatice 25 Epigapent Gabapentinum tabletki powlekane 600 mg 100 tabl. w blistrze 100 tabl. w butelce 5909991340704 5909991340711 Glenmark Pharmaceuticals s.r.o. 24184 Glenmark Pharmaceuticals s.r.o. Glenmark Pharmaceuticals Europe Limited 26 Epigapent Gabapentinum tabletki powlekane 800 mg 100 tabl. w blistrze 100 tabl. w butelce 5909991340728 5909991340735 Glenmark Pharmaceuticals s.r.o. 24185 Glenmark Pharmaceuticals s.r.o. Glenmark Pharmaceuticals Europe Limited Strona 3 z 8
27 Everolimus Teva Everolimusum tabletki 2,5 mg 10 tabl. w blistrze w blistrze perforowanym 5909991338299 5909991338305 5909991338336 5909991338343 5909991338312 5909991338329 Sp. z 24216 Merckle GmbH IVA Hrvatska d (Pliva Teva UK Limited Teva Gyogyszergyar Zrt. 28 Everolimus Teva Everolimusum tabletki 5 mg 10 tabl. w blistrze w blistrze perforowanym 5909991338350 5909991338367 5909991338398 5909991338404 5909991338374 5909991338381 Sp. z 24217 Merckle GmbH IVA Hrvatska d (Pliva Teva UK Limited Teva Gyogyszergyar Zrt. 29 Everolimus Teva Everolimusum tabletki 7,5 mg 10 tabl. w blistrze w blistrze perforowanym 5909991338411 5909991338428 Sp. z 5909991338459 5909991338466 5909991338435 5909991338442 24218 Merckle GmbH IVA Hrvatska d (Pliva Teva UK Limited Teva Gyogyszergyar Zrt. 30 Everolimus Teva Everolimusum tabletki 10 mg 10 tabl. w blistrze w blistrze perforowanym 5909991338473 5909991338480 5909991338510 5909991338527 5909991338497 5909991338503 Sp. z 24219 Merckle GmbH IVA Hrvatska d (Pliva Teva UK Limited Teva Gyogyszergyar Zrt. 31 Iprixon Neb Ipratropii bromidum + roztwór do nebulizacji (0,5 mg + 2,5 30 amp. 2,5 ml 5906414003031 Adamed Sp. z 24237 Genetic S.p.A IT Salbutamolum mg)/2,5 ml 32 Lactulosum Takeda Forte Lactulosum syrop 667 mg/ml 1 butelka 150 ml 5903263900825 Takeda Pharma Sp. z 24225 Takeda Pharma Sp. z 33 Meprelon Methylprednisolonum proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań/ do infuzji 34 Meprelon Methylprednisolonum proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań/ do infuzji 16 mg 3 amp. proszku + 3 amp. 1 ml rozp. 5909991343491 Sun-Farm Sp. z 24233 mibe GmbH Arzneimittel 32 mg 3 amp. proszku + 3 amp. 1 ml rozp. 5909991343583 Sun-Farm Sp. z 24234 mibe GmbH Arzneimittel 35 Metamizole Kabi Metamizolum natricum monohydricum roztwór do wstrzykiwań 500 mg/ml 5 amp. 2 ml 5 amp. 5 ml 10 amp. 2 ml 10 amp. 5 ml 5909991343088 5909991343071 5909991343101 5909991343095 36 NeoGrip Inosinum pranobexum syrop 50 mg/ml 1 butelka 200 ml 5909991339524 PharmaSwiss Česká republika s.r.o. Fresenius Kabi Polska Sp. z 24221 HBM Pharma s.r.o. SK 24197 ICN Polfa Rzeszów S.A. Strona 4 z 8
37 Nevirapine Accord Nevirapinum tabletki 200 mg z z 1 z 38 Nodofree Dorzolamidum krople do oczu, 20 mg/ml 1 butelka 5 ml roztwór 3 butelki 5 ml 5909991340926 5909991340933 5909991340940 5909991344306 5909991344313 Warszawskie Zakłady Farmaceutyczne POLFA S.A. 24183 Pharmadox Healthcare Ltd. 24239 Warszawskie Zakłady Farmaceutyczne POLFA S.A. MT 39 Nodofree Combi Dorzolamidum + Timololum krople do oczu, roztwór (20 mg + 5 mg)/ml 1 butelka 5 ml 3 butelki 5 ml 5909991340674 5909991340681 Warszawskie Zakłady Farmaceutyczne POLFA S.A. 24215 Warszawskie Zakłady Farmaceutyczne POLFA S.A. 40 Omnipap Noc Paracetamolum + Diphenhydramini hydrochloridum tabletki powlekane 500 mg + 25 mg 16 tabl. 2 1 pojemnik 500 g 41 Oviderm Propylenglycolum krem 250 mg/g 1 tuba 100 g 42 Prasteronum Aflofarm Prasteronum tabletki 10 mg 5909991343125 5909991343132 5909991343149 5909991343156 5909991343163 Actavis Group PTC ehf. 24224 Balkanpharma-Dupnitsa AD BG 5909991340056 5909991340063 Galenica AB 24182 Bioglan AB SE 5909991343477 Aflofarm Farmacja Polska Sp. z 24238 Aflofarm Farmacja Polska Sp. 5909991343484 z 43 Rozor Rosuvastatinum + tabletki powlekane 10 mg + 10 mg 10 tabl. 5909991342630 BGP Products Poland Sp. z 24220 Medreich Plc Ezetimibum 5909991342647 5909991342654 5909991342661 44 SmofKabiven extra Nitrogen Produkt złożony emulsja do infuzji - 1 worek 506 ml 1 worek 1012 ml 1 worek 1518 ml 1 worek 2025 ml 1 worek 2531 ml 3 worki 2531 ml 4 worki 1012 ml 4 worki 1518 ml 4 worki 2025 ml 6 worków 506 ml 45 SmofKabiven extra Nitrogen EF Produkt złożony emulsja do infuzji - 1 worek 506 ml 1 worek 1012 ml 1 worek 1518 ml 1 worek 2025 ml 1 worek 2531 ml 3 worki 2531 ml 4 worki 1012 ml 4 worki 1518 ml 4 worki 2025 ml 6 worków 506 ml 5909991342357 5909991342388 5909991342371 5909991342364 5909991342395 5909991342401 5909991342425 5909991342418 5909991342432 5909991342449 5909991342470 5909991342456 5909991342487 5909991342494 5909991342463 5909991342500 5909991342524 5909991342517 5909991342531 5909991342548 Fresenius Kabi AB 24222 Fresenius Kabi AB SE Fresenius Kabi AB 24223 Fresenius Kabi AB SE 6 worków 506 ml 5909991342548 46 Solifenacin Stada Solifenacini succinas tabletki powlekane 5 mg 5909991340872 STADA Arzneimittel AG 24177 STADA Arzneimittel AG Centrafarm Services B.V. Clonmel Healthcare Ltd. STADA Arzneimittel AG Stada Nordic ApS IE AT DK 47 Solifenacin Stada Solifenacini succinas tabletki powlekane 10 mg 5909991340896 STADA Arzneimittel AG 24178 STADA Arzneimittel AG Centrafarm Services B.V. Clonmel Healthcare Ltd. STADA Arzneimittel AG Stada Nordic ApS IE AT DK Strona 5 z 8
48 Sotret Isotretinoinum kapsułki miękkie 10 mg 20 kaps. 30 kaps. 50 kaps. 60 kaps. 90 kaps. 100 kaps. 49 Sotret Isotretinoinum kapsułki miękkie 20 mg 20 kaps. 30 kaps. 50 kaps. 60 kaps. 90 kaps. 100 kaps. 5909991344405 5909991335625 5909991335632 5909991344412 5909991335649 5909991335656 5909991344429 5909991335687 5909991335694 5909991344436 5909991335700 5909991335717 5909991342296 5909991342302 Ranbaxy (Poland) Sp. z Ranbaxy (Poland) Sp. z 24226 SC Terapia S.A. RO Alkaloida Chemical Co. Zrt. Sun Pharmaceutical Industries Europe B.V. 24227 Alkaloida Chemical Co. Zrt. Sun Pharmaceutical Industries Europe B.V. SC Terapia S.A. 50 Sprintafen Ketoprofenum tabletki powlekane 25 mg 10 tabl. Omega Pharma Limited 24202 Abiogen Pharma S.p.A. IT 51 Tadalafil Belupo Tadalafilum tabletki powlekane 5 mg 5909991341886 Belupo lijekovi i kozmetika d.d. 24228 52 Tadalafil Belupo Tadalafilum tabletki powlekane 10 mg 5909991341893 Belupo lijekovi i kozmetika d.d. 24229 RO 53 Tadalafil Belupo Tadalafilum tabletki powlekane 20 mg 2 tabl. 54 Tadilecto Tadalafilum tabletki powlekane 2,5 mg 2 tabl. 8 55 Tadilecto Tadalafilum tabletki powlekane 5 mg 2 tabl. 8 56 Tadilecto Tadalafilum tabletki powlekane 10 mg 2 tabl. 8 57 Tadilecto Tadalafilum tabletki powlekane 20 mg 2 tabl. 8 5909991341909 5909991341916 Belupo lijekovi i kozmetika d.d. 24230 5909991341923 5909991340957 Krka, d.d., Novo mesto 24173 Krka, d.d., Novo mesto SI 5909991340964 5909991340971 5909991340988 5909991340995 5909991341008 5909991341015 5909991341022 5909991341039 Krka, d.d., Novo mesto 24174 Krka, d.d., Novo mesto SI 5909991341046 5909991341053 5909991341060 5909991341077 5909991341084 5909991341091 5909991341107 5909991341152 Krka, d.d., Novo mesto 24175 Krka, d.d., Novo mesto SI 5909991341169 5909991341176 5909991341183 5909991341190 5909991341206 5909991341213 5909991341220 5909991341237 Krka, d.d., Novo mesto 24176 Krka, d.d., Novo mesto SI 5909991341244 5909991341251 5909991341268 5909991341275 5909991341282 5909991341299 5909991341305 Strona 6 z 8
58 Tigecycline Sandoz Tigecyclinum proszek do 50 mg 1 fiol. proszku sporządzania 10 fiol. proszku roztworu do infuzji 5907626708080 5907626708097 Sandoz GmbH 24181 LEK Pharmaceuticals d.d. Galenicum Health, S.L. SAG Manufacturing S.L.U. Pharmadox Healthcare, Ltd. SI MT 59 Tigecycline Teva Tigecyclinum proszek do sporządzania roztworu do infuzji 50 mg 1 fiol. proszku 10 fiol. proszku 5909991340001 5909991340018 Sp. z 24198 Merckle GmbH SAG Manufacturing S.L.U. Pharmadox Healthcare, Ltd. Galenicum Health S.L MT 60 Tonicard Propafenoni hydrochloridum 61 Tonicard Propafenoni hydrochloridum tabletki powlekane 150 mg 100 tabl. tabletki powlekane 300 mg 100 tabl. 62 Vardenafil Accord Vardenafilum tabletki powlekane 5 mg 2 tabl. 63 Vardenafil Accord Vardenafilum tabletki powlekane 10 mg 2 tabl. 64 Vardenafil Accord Vardenafilum tabletki powlekane 20 mg 2 tabl. 65 Vardenafil Zentiva Vardenafilum tabletki ulegające 66 Venlafaxine Vitama Venlafaxinum kapsułki o 67 Venlafaxine Vitama Venlafaxinum kapsułki o 10 mg 10 tabl. 37,5 mg 7 kaps. 14 kaps. 28 kaps. 56 kaps. 84 kaps. 100 kaps. 75 mg 7 kaps. 14 kaps. 28 kaps. 56 kaps. 84 kaps. 100 kaps. 5909991341534 5909991341541 5909991341558 5909991341565 5909991341572 5909991341589 5909991341596 5909991341602 5909991341619 5909991341626 5909991341695 5909991341701 5909991341718 5909991341725 5909991341732 5909991341749 5909991341756 5909991341763 5909991341770 5909991341787 5909991341794 5909991341800 5909991341817 5909991341824 5909991341831 5909991340780 5909991340797 5909991340803 5909991342036 5909991342043 5909991342050 5909991342067 5909991342074 5909991342081 5909991342098 5909991342104 5909991342111 5909991342128 5909991342135 5909991342142 24187 Wessling Hungary Kft. 24188 Wessling Hungary Kft. 24199 Wessling Hungary Kft. Laboratori Fundació Dau 24200 Wessling Hungary Kft. Laboratori Fundació Dau 24201 Wessling Hungary Kft. Laboratori Fundació Dau Zentiva, k.s. 24172 Saneca Pharmaceuticals a.s. SK Vitama S.A. 24206 Aspire Pharma Limited Vitama S.A. 24207 Aspire Pharma Limited Strona 7 z 8
68 Venlafaxine Vitama Venlafaxinum kapsułki o 150 mg 7 kaps. 14 kaps. 28 kaps. 56 kaps. 84 kaps. 100 kaps. 69 Venlafaxine Vitama Venlafaxinum kapsułki o 225 mg 7 kaps. 14 kaps. 28 kaps. 56 kaps. 84 kaps. 100 kaps. 5909991342159 5909991342166 5909991342173 5909991342180 5909991342197 5909991342203 5909991342210 5909991342227 5909991342234 5909991342241 5909991342258 5909991342265 Vitama S.A. 24208 Aspire Pharma Limited Vitama S.A. 24209 Aspire Pharma Limited Strona 8 z 8