Zestawienie decyzji wspólnotowych w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 sierpnia 2009 r. do dnia 31 sierpnia 2009 r.
(Opublikowano zgodnie z art. 13 lub art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady(1))
(2009/C 231/05)
(Dz.U.UE C z dnia 25 września 2009 r.)
– Wydanie pozwolenia na dopuszczenie do obrotu (Art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady) Zatwierdzenie
| Data wydania decyzji | Nazwa produktu leczniczego | INN (międzynarodowa niezastrzeżona prawnie nazwa) | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer wpisu w rejestrze wspólnotowym | Postać farmaceutyczna | Kod ATC (Anatomiczno-Terapeutyczna Klasyfikacja Chemiczna) | Data notyfikacji |
| 3.8.2009 | Afinitor | Ewerolimus | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/09/538/001-006 | Tabletka | L01XE10 | 5.8.2009 |
| 3.8.2009 | Samsca | tolwaptan | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM | EU/1/09/539/001-004 | Tabletka | C03XA01 | 5.8.2009 |
– Zmiana pozwolenia na dopuszczenie do obrotu (Art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie
| Data wydania decyzji | Nazwa produktu leczniczego | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer wpisu w rejestrze wspólnotowym | Data notyfikacji |
| 3.8.2009 | SUTENT | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/06/347/001-008 | 5.8.2009 |
| 3.8.2009 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | EU/1/06/343/001-007 | 5.8.2009 |
| 3.8.2009 | INTELENCE | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | EU/1/08/468/001 | 5.8.2009 |
| 3.8.2009 | Revatio | Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/05/318/001 | 5.8.2009 |
| 3.8.2009 | PegIntron | Schering Plough Europe Rue de Stalle, 73 1180 Bruxelles BELGIQUE Stallestraat, 73 1180 Brussel BELGIË | EU/1/00/131/001-050 | 5.8.2009 |
| 3.8.2009 | Champix | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/06/360/001-012 | 5.8.2009 |
| 3.8.2009 | FOSAVANCE | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/05/310/001-009 | 5.8.2009 |
| 6.8.2009 | Lucentis | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/06/374/001 | 10.8.2009 |
| 6.8.2009 | TESAVEL | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/07/435/001-018 | 10.8.2009 |
| 6.8.2009 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/08/458/001-014 | 10.8.2009 |
| 6.8.2009 | Tasigna | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/07/422/001-004 | 10.8.2009 |
| 6.8.2009 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/08/460/001-014 | 10.8.2009 |
| 6.8.2009 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/08/459/001-014 | 10.8.2009 |
| 7.8.2009 | CELSENTRI | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/07/418/001-010 | 11.8.2009 |
| 7.8.2009 | Prepandrix | GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE | EU/1/08/453/002 | 11.8.2009 |
| 7.8.2009 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/04/279/001-043 | 11.8.2009 |
| 7.8.2009 | Revlimid | Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM | EU/1/07/391/001-004 | 11.8.2009 |
| 13.8.2009 | Oprymea | KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | EU/1/08/469/001-025 | 17.8.2009 |
| 13.8.2008 | Clopidogrel BMS | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | EU/1/08/464/001-019 | 17.8.2009 |
| 13.8.2008 | Clopidogrel Winthrop | Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France 75013 Paris FRANCE | EU/1/08/465/001-019 | 17.8.2009 |
| 18.8.2009 | Nobilis Influenza H5N6 | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | EU/2/07/076/001-004 | 20.8.2009 |
| 20.8.2009 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/04/279/001-043 | 24.8.2009 |
| 20.8.2009 | SUTENT | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/06/347/001-008 | 24.8.2009 |
| 20.8.2009 | TESAVEL | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/07/435/001-018 | 24.8.2009 |
| 20.8.2009 | Pramipexole Teva | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | EU/1/08/490/001-016 | 24.8.2009 |
| 20.8.2009 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | EU/1/08/442/001-008 | 24.8.2009 |
| 20.8.2009 | Apidra | Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND | EU/1/04/285/001-036 | 24.8.2009 |
| 21.8.2009 | PEGASYS | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | EU/1/02/221/001-010 | 25.8.2009 |
| 21.8.2009 | Galvus | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/07/414/001-010 EU/1/07/414/018 | 25.8.2009 |
| 21.8.2009 | TORISEL | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | EU/1/07/424/001 | 25.8.2009 |
| 21.8.2009 | Jalra | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/08/485/001-011 | 25.8.2009 |
| 21.8.2009 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | EU/1/07/439/001-004 | 25.8.2009 |
| 21.8.2009 | TARGRETIN | Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | EU/1/01/178/001 | 25.8.2009 |
| 21.8.2009 | AVANDIA | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | EU/1/00/137/002-018 | 25.8.2009 |
| 21.8.2009 | Myfenax | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | EU/1/07/438/001-004 | 25.8.2009 |
| 21.8.2009 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | EU/1/01/172/001-006 | 25.8.2009 |
| 21.8.2009 | Myozyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | EU/1/06/333/001-003 | 25.8.2009 |
| 21.8.2009 | Luminity | Lantheus MI UK Limited One South Place London EC2M 2WG UNITED KINGDOM | EU/1/06/361/001-002 | 25.8.2009 |
| 21.8.2009 | Januvia | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/07/383/001-018 | 25.8.2009 |
| 21.8.2009 | Rotarix | GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE | EU/1/05/330/001-011 | 25.8.2009 |
| 21.8.2009 | Privigen | CSL Behring GmbH Emil von Behring Strasse 76 35041 Marburg DEUTSCHLAND | EU/1/08/446/001-006 | 25.8.2009 |
| 21.8.2009 | Competact | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE UNITED KINGDOM | EU/1/06/354/001-009 | 25.8.2009 |
| 21.8.2009 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM | EU/1/04/276/001-020 EU/1/04/276/024-036 | 25.8.2009 |
| 21.8.2009 | Mabthera | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | EU/1/98/067/001-002 | 25.8.2009 |
| 25.8.2009 | Epoetin alfa Hexal | Hexal AG Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND | EU/1/07/411/001-020 | 27.8.2009 |
| 25.8.2009 | Avandamet | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | EU/1/03/258/001-022 | 27.8.2009 |
| 25.8.2009 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare 1611 Luxembourg LUXEMBOURG | EU/1/08/462/001-012 | 27.8.2009 |
| 25.8.2009 | Tasigna | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/07/422/001-004 | 27.8.2009 |
| 25.8.2009 | Binocrit | Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH | EU/1/07/410/001-020 | 27.8.2009 |
| 25.8.2009 | Xiliarx | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/08/486/001-011 | 27.8.2009 |
| 27.8.2009 | Thalidomide Celgene | Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA UNITED KINGDOM | EU/1/08/443/001 | 1.9.2009 |
| 27.8.2009 | CELVAPAN | Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH | EU/1/08/506/001 | 1.9.2009 |
| 27.8.2009 | Champix | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/06/360/001-012 | 1.9.2009 |
| 27.8.2009 | Zeffix | Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM | EU/1/99/114/001-003 | 1.9.2009 |
| 27.8.2009 | Iscover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b EU/1/98/070/005a-005b EU/1/98/070/006a-006b EU/1/98/070/007a-007b EU/1/98/070/008-010 EU/1/98/070/011a-011b | 1.9.2009 |
| 27.8.2009 | Xeristar | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | EU/1/04/297/001-008 | 31.8.2009 |
| 27.8.2009 | Vfend | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | EU/1/02/212/001-026 | 1.9.2009 |
| 28.8.2009 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/08/460/001-014 | 1.9.2009 |
| 28.8.2009 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/08/459/001-014 | 1.9.2009 |
| 28.8.2009 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/08/458/001-014 | 1.9.2009 |
| 28.8.2009 | Irbesartan Krka | KRKA, d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | EU/1/08/480/001-018 | 1.9.2009 |
| 28.8.2009 | Volibris | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | EU/1/08/451/001-004 | 1.9.2009 |
| 28.8.2009 | Panretin | Eisai Limited, European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | EU/1/00/149/001 | 1.9.2009 |
| 28.8.2009 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | EU/1/03/256/001-010 | 1.9.2009 |
| 28.8.2009 | Forsteo | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND | EU/1/03/247/001-002 | 1.9.2009 |
| 28.8.2009 | Invanz | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/02/216/001-002 | 1.9.2009 |
| 28.8.2009 | Zerit | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | EU/1/96/009/001-009 | 1.9.2009 |
| 28.8.2009 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE | EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b | 1.9.2009 |
| 28.8.2009 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND | EU/1/07/412/001-020 | 1.9.2009 |
| 28.8.2009 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | EU/1/02/213/001-023 | 1.9.2009 |
| 28.8.2009 | Eucreas | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/07/425/001-018 | 1.9.2009 |
| 28.8.2009 | Aldara | Meda AB Pipers väg 2 SE-170 73 Solna SVËRIGE | EU/1/98/080/001 | 1.9.2009 |
| 28.8.2009 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | EU/1/07/382/001-018 | 1.9.2009 |
| 31.8.2009 | Betaferon | Bayer Schering Pharma AG Müllerstrasse 170-178 13342 Berlin DEUTSCHLAND | EU/1/95/003/009-010 | 2.9.2009 |
| 31.8.2009 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate Co.Clare IRELAND | EU/1/05/331/001-055 | 2.9.2009 |
| 31.8.2009 | Icandra | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB UNITED KINGDOM | EU/1/08/484/001-018 | 2.9.2009 |
| 31.8.2009 | Mimpara | Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND | EU/1/04/292/001-012 | 2.9.2009 |
| 31.8.2009 | Tandemact | Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwich London WC2B 4AE UNITED KINGDOM | EU/1/06/366/005-022 | 2.9.2009 |
| 31.8.2009 | Gardasil | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk 69007 Lyon FRANCE | EU/1/06/357/001-021 | 2.9.2009 |
| 31.8.2009 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited Unit 13, Stillorgan Industrial Park Blackrock, Co.Dublin IRELAND | EU/1/07/430/001-002 | 2.9.2009 |
– Zmiana pozwolenia na dopuszczenie do obrotu (Art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie
| Data wydania decyzji | Nazwa produktu leczniczego | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer wpisu w rejestrze wspólnotowym | Data notyfikacji |
| 27.8.2009 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM | EU/2/04/044/001-010 | 31.8.2009 |
| 31.8.2009 | Locatim | Biokema Anstalt Pflugstrasse 12 9490 Vaduz, Fürstentum LIECHTENSTEIN | EU/2/99/011/001 | 2.9.2009 |
Osoby pragnące zapoznać się z ogólnie dostępną oceną przedmiotowych produktów leczniczych oraz odnoszącymi się do nich decyzjami, proszone są o kontakt z:
The European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
UNITED KINGDOM
______
(1) Dz.U. L 136 z 30.4.2004, s. 1.
| Identyfikator: | Dz.U.UE.C.2009.231.20 |
| Rodzaj: | zawiadomienie |
| Tytuł: | Zestawienie decyzji wspólnotowych w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od dnia 1 sierpnia 2009 r. do dnia 31 sierpnia 2009 r. |
| Data aktu: | 2009-09-25 |
| Data ogłoszenia: | 2009-09-25 |