Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 maja 2015 r. do dnia 31 maja 2015 r.
Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 maja 2015 r. do dnia 31 maja 2015 r.
(2015/C 211/01)
(Dz.U.UE C z dnia 26 czerwca 2015 r.)
| Data wydania decyzji | Nazwa produktu leczniczego | INN (międzynarodowa niezastrzeżona nazwa) | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Postać farmaceutyczna | Kod АТС (klasyfikacja anatomiczno-terapeutyczno-chemiczna) | Data notyfikacji |
| 6.5.2015 | Zykadia | cerytynib | Novartis Europharm Limited Frimley Business Park, Camberley GUI 6 7SR, United Kingdom | EU/1/15/999 | Kapsułki, twarde | L01XE | 8.5.2015 |
| 27.5.2015 | Akynzeo | Netupitant+Palo-nosetron | Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 1 5, Ireland | EU/1/15/1001 | Kapsułki, twarde | A04AA55 | 29.5.2015 |
| 27.5.2015 | Jinarc | tolwaptan | Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | Tabletki | Pending | 29.5.2015 |
| 27.5.2015 | Synjardy | empagliflozyna/ metformina | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | Tabletka powlekana | A10BD20 | 29.5.2015 |
| 27.5.2015 | Voriconazole Hospi-ra | Worykonazol | Hospira UK Limited Queensway Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1004 | Proszek do sporządzania roztworu do infuzji | J02AC03 | 29.5.2015 |
| 28.5.2015 | Lenvima | lenwatynib | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts ALIO 9SN, United Kingdom | EU/1/15/1002 | Kapsułki, twarde | L01XE29 | 1.6.2015 |
| Data wydania decyzji | Nazwa produktu leczniczego | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Data notyfikacji |
| 5.5.2015 | Copalia | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 7.5.2015 |
| 5.5.2015 | Copalia HCT | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 7.5.2015 |
| 5.5.2015 | Dafiro | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 7.5.2015 |
| 5.5.2015 | Dafiro HCT | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 7.5.2015 |
| 5.5.2015 | Erivedge | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 8.5.2015 |
| 5.5.2015 | Exforge | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 7.5.2015 |
| 5.5.2015 | Exforge HCT | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 7.5.2015 |
| 5.5.2015 | Imprida | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 7.5.2015 |
| 5.5.2015 | INCRELEX | Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 7.5.2015 |
| 5.5.2015 | Irbesartan/Hydro-chlorothiazide Teva | Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 8.5.2015 |
| 5.5.2015 | Orfadin | Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige | EU/1/04/303 | 8.5.2015 |
| 5.5.2015 | Sycrest | Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland | EU/1/10/640 | 7.5.2015 |
| 5.5.2015 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 8.5.2015 |
| 5.5.2015 | Telzir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/282 | 7.5.2015 |
| 5.5.2015 | Tyverb | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 7.5.2015 |
| 5.5.2015 | Voncento | CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 7.5.2015 |
| 5.5.2015 | Votrient | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 7.5.2015 |
| 5.5.2015 | Zoledronic acid Teva Pharma | Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 7.5.2015 |
| 5.5.2015 | Zypadhera | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/479 | 7.5.2015 |
| 6.5.2015 | Arzerra | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 8.5.2015 |
| 6.5.2015 | Celsentri | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 8.5.2015 |
| 6.5.2015 | Celvapan | Baxter AG Industriestraße 67, A-1221 Wien, Österreich | EU/1/08/506 | 8.5.2015 |
| 6.5.2015 | Clopidogrel Krka | Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 8.5.2015 |
| 6.5.2015 | Imatinib Teva | Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 8.5.2015 |
| 6.5.2015 | Optaflu | Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 8.5.2015 |
| 6.5.2015 | Revolade | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 8.5.2015 |
| 6.5.2015 | Tafinlar | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 8.5.2015 |
| 13.5.2015 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 19.5.2015 |
| 13.5.2015 | Efficib | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.5.2015 |
| 13.5.2015 | Granupas | Lucane Pharma 172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | 19.5.2015 |
| 13.5.2015 | Janumet | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.5.2015 |
| 13.5.2015 | Leflunomide ra-tiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 19.5.2015 |
| 13.5.2015 | Luminity | Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | EU/1/06/361 | 19.5.2015 |
| 13.5.2015 | Memantine Merz | Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/12/799 | 19.5.2015 |
| 13.5.2015 | Ovitrelle | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165 | 19.5.2015 |
| 13.5.2015 | Trizivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 19.5.2015 |
| 13.5.2015 | Velmetia | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.5.2015 |
| 13.5.2015 | Vyndaqel | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/11/717 | 19.5.2015 |
| 27.5.2015 | Aflunov | Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/658 | 29.5.2015 |
| 27.5.2015 | Ariclaim | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/283 | 29.5.2015 |
| 27.5.2015 | Brinavess | Cardiome UK Limited Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 29.5.2015 |
| 27.5.2015 | Clopidogrel TAD | TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | EU/1/09/555 | 29.5.2015 |
| 27.5.2015 | Cometriq | TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 29.5.2015 |
| 27.5.2015 | Cymbalta | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/296 | 29.5.2015 |
| 27.5.2015 | Erivedge | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 29.5.2015 |
| 27.5.2015 | Esmya | Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magya-rország | EU/1/12/750 | 29.5.2015 |
| 27.5.2015 | Foclivia | Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 29.5.2015 |
| 27.5.2015 | Gardasil | Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 29.5.2015 |
| 27.5.2015 | Imnovid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 29.5.2015 |
| 27.5.2015 | INCRELEX | Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 29.5.2015 |
| 27.5.2015 | Jentadueto | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.5.2015 |
| 27.5.2015 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 29.5.2015 |
| 27.5.2015 | Levetiracetam Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/712 | 29.5.2015 |
| 27.5.2015 | Myclausen | Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | EU/1/10/647 | 29.5.2015 |
| 27.5.2015 | Nexium Control | Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 29.5.2015 |
| 27.5.2015 | Nivestim | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/631 | 29.5.2015 |
| 27.5.2015 | Prepandrix | GlaxoSmithKline Biologicals SA rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/08/453 | 29.5.2015 |
| 27.5.2015 | Raloxifene Teva | Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/627 | 29.6.2015 |
| 27.5.2015 | Relistor | TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/08/463 | 29.5.2015 |
| 27.5.2015 | Resolor | Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/09/581 | 29.5.2015 |
| 27.5.2015 | Selincro | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/12/815 | 29.5.2015 |
| 27.5.2015 | Silgard | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 29.5.2015 |
| 27.5.2015 | Sonata | Meda AB Pipers väg 2 A, S-170 09 Solna, Sverige | EU/1/99/102 | 29.5.2015 |
| 27.5.2015 | Sovaldi | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 29.5.2015 |
| 27.5.2015 | Targretin | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 29.5.2015 |
| 27.5.2015 | Temodal | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/98/096 | 29.5.2015 |
| 27.5.2015 | Temozolomide Accord | Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 29.5.2015 |
| 27.5.2015 | Thalidomide Celge-ne | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 29.5.2015 |
| 27.5.2015 | Tolucombi | Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 29.5.2015 |
| 27.5.2015 | Volibris | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 29.5.2015 |
| 27.5.2015 | Xeristar | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/297 | 29.5.2015 |
| 27.5.2015 | Xtandi | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 29.5.2015 |
| 27.5.2015 | Yentreve | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/280 | 29.5.2015 |
| 27.5.2015 | Yondelis | Pharma Mar SA Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 29.5.2015 |
| 28.5.2015 | Aclasta | Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 1.6.2015 |
| 28.5.2015 | alli | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 1.6.2015 |
| 28.5.2015 | Dificlir | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/11/733 | 1.6.2015 |
| 28.5.2015 | Invega | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | EU/1/07/395 | 1.6.2015 |
| 28.5.2015 | Januvia | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 1.6.2015 |
| 28.5.2015 | Lonquex | UAB "Sicor Biotech" M olėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 1.6.2015 |
| 28.5.2015 | Ristaben | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 1.6.2015 |
| 28.5.2015 | Topotecan Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/633 | 1.6.2015 |
| 28.5.2015 | Tygacil | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 1.6.2015 |
| Data wydania decyzji | Nazwa produktu leczniczego | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Data notyfikacji |
| 5.5.2015 | Clopidogrel DURA | Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland | EU/1/09/560 | 7.5.2015 |
| 6.5.2015 | Provenge | Dendreon UK Limited 41 Chalton Street, London NW1 1JD, United Kingdom | EU/1/13/867 | 8.5.2015 |
| Data wydania decyzji | Nazwa produktu leczniczego | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Data notyfikacji |
| 5.5.2015 | MS-H Vaccine | Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 7.5.2015 |
| 5.5.2015 | Purevax RCP | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/052 | 7.5.2015 |
| 13.5.2015 | Nobilis IB 4-91 | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 19.5.2015 |
| 13.5.2015 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland | EU/2/07/078 | 19.5.2015 |
| 27.5.2015 | Meloxivet | Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/07/077 | 29.5.2015 |
| 27.5.2015 | Purevax FeLV | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/00/019 | 29.5.2015 |
| 27.5.2015 | Purevax RCPCh | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/050 | 29.5.2015 |
| 27.5.2015 | Suprelorin | VIRBAC SA 1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, France | EU/2/07/072 | 29.5.2015 |
Osoby zainteresowane dostępem do publicznego sprawozdania oceniającego dla danego produktu leczniczego oraz do związanych z nim decyzji prosimy o kontakt z:
The European Medicines Agency
30, Churchill Place, Canary Wharf
UK - LONDON E14 5EU
| Identyfikator: | Dz.U.UE.C.2015.211.1 |
| Rodzaj: | informacja |
| Tytuł: | Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 maja 2015 r. do dnia 31 maja 2015 r. |
| Data aktu: | 2015-06-26 |
| Data ogłoszenia: | 2015-06-26 |