Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od 1 marzec 2011 r. do 30 kwiecień 2011 r.
(Opublikowano zgodnie z art. 13 lub art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady(1))
(2011/C 184/01)
(Dz.U.UE C z dnia 24 czerwca 2011 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 nazwa) | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Postać farmaceutyczna | Kod ATC (klasyfikacja anatomiczno-terapeutyczno-chemiczna) | Data notyfikacji |
| 4.3.2011 | Ifirmacombi | irbesartan / Hydrochlorotiazyd | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673/001-024 | Tabletka powlekana | C09DA04 | 8.3.2011 |
| 4.3.2011 | Pumarix | Pandemiczna szczepionka przeciw grypie (H5N1) (rozszczepiony wirion) inaktywowana, z adiuwantem | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/10/664/001 | Zawiesina i emulsja do sporządzania emulsji do wstrzykiwań | J07BB02 | 8.3.2011 |
| 4.3.2011 | Xeplion | paliperidon | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/672/001-006 | Zawiesina do wstrzykiwań o przedłużonym uwalnianiu | N05AX13 | 8.3.2011 |
| 10.3.2011 | Leflunomide Teva | Leflunomid | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/11/675/001-010 | Tabletka powlekana | L04AA13 | 14.3.2011 |
| 14.3.2011 | Repso | Leflunomid | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/11/674/001-010 | Tabletka powlekana | L04AA13 | 17.3.2011 |
| 14.3.2011 | Teysuno | Tegafur/gimeracyl/ oteracyl | Taiho Pharma Europe, Limited 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom | EU/1/11/669/001-004 | Kapsułki, twarde | L01BC53 | 17.3.2011 |
| 17.3.2011 | GILENYA | Fingolimod | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/11/677/001-004 | Kapsułki, twarde | L04AA27 | 22.3.2011 |
| 17.3.2011 | HALAVEN | erybulina | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/11/678/001-002 | Roztwór do wstrzykiwań | L01XX41 | 22.3.2011 |
| 17.3.2011 | JEVTANA | kabazytaksel | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | EU/1/11/676/001 | Koncentrat i rozpuszczalnik do sporządzania roztworu do infuzji | Pending | 22.3.2011 |
| 28.3.2011 | Trobalt | retygabina | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/11/681/001-013 | Tabletka powlekana | N03AX21 | 31.3.2011 |
| 13.4.2011 | Riprazo HCT | aliskirenu hemifumaran / hydrochlorotiazyd | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/11/680/001-080 | Tabletka powlekana | C09XA52 | 15.4.2011 |
| 14.4.2011 | Hizentra | Normalna immunoglobulina ludzka | CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | EU/1/11/687/001-012 | Roztwór do wstrzykiwań | J06BA01 | 18.4.2011 |
| 14.4.2011 | Pravafenix | fenofibrat / prawastatyna | LABORATOIRES SMB SA 26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe | EU/1/11/679/001-006 | Kapsułki, twarde | C10BA03 | 19.4.2011 |
| 14.4.2011 | Rasilamlo | aliskiren / amlodypina | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/11/686/001-056 | Tabletka powlekana | C09XA53 | 18.4.2011 |
– 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 pozycji w rejestrze wspólnotowym | Data notyfikacji |
| 4.3.2011 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358/001-021 | 8.3.2011 |
| 4.3.2011 | Vaniqa | Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/01/173/001-003 | 8.3.2011 |
| 8.3.2011 | Clopidogrel DURA | Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland | EU/1/09/560/001-009 | 10.3.2011 |
| 8.3.2011 | Clopidogrel Mylan | Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France | EU/1/09/559/001-016 | 10.3.2011 |
| 8.3.2011 | Rebetol | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/107/001-005 | 21.3.2011 |
| 8.3.2011 | Tarceva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311/001-003 | 10.3.2011 |
| 10.3.2011 | Abraxane | Abraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom | EU/1/07/428/001 | 22.3.2011 |
| 10.3.2011 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412/001-052 | 11.3.2011 |
| 10.3.2011 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412/001-052 | 14.3.2011 |
| 10.3.2011 | Clopidogrel Teva Pharma | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/561/001-010 | 14.3.2011 |
| 14.3.2011 | Actrapid | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/230/001-017 | 17.3.2011 |
| 14.3.2011 | BeneFIX | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 18.3.2011 |
| 14.3.2011 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | EU/1/07/410/001-052 | 17.3.2011 |
| 14.3.2011 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | EU/1/07/410/001-052 | 16.3.2011 |
| 14.3.2011 | Clopidogrel Acino | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/532/001-007 | 16.3.2011 |
| 14.3.2011 | Clopidogrel Hexal | Acino Pharma GmbH Am Windfeld 35, Miesbach 83714, Deutschland | EU/1/09/534/001-007 | 21.3.2011 |
| 14.3.2011 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411/001-052 | 17.3.2011 |
| 14.3.2011 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411/001-052 | 18.3.2011 |
| 14.3.2011 | Prometax | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/092/001-026 | 16.3.2011 |
| 14.3.2011 | Rivastigmine HEXAL | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/09/589/001-018 | 21.3.2011 |
| 14.3.2011 | Visudyne | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/00/140/001 | 21.3.2011 |
| 17.3.2011 | Actraphane | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/229/001-004 EU/1/02/229/011-019 EU/1/02/229/024-037 | 22.3.2011 |
| 17.3.2011 | Clopidogrel Sandoz | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/547/001-007 | 22.3.2011 |
| 17.3.2011 | Copalia HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/575/001-060 | 22.3.2011 |
| 17.3.2011 | Dafiro HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/574/001-060 | 22.3.2011 |
| 17.3.2011 | Exelon | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/066/001-026 | 22.3.2011 |
| 17.3.2011 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-032 | 22.3.2011 |
| 17.3.2011 | INOmax | INO Therapeutics AB SE-181 81 Lidingö, Sverige | EU/1/01/194/001-002 | 22.3.2011 |
| 17.3.2011 | Liprolog | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/01/195/001-027 | 22.3.2011 |
| 17.3.2011 | Mixtard | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/231/001-037 | 22.3.2011 |
| 17.3.2011 | NovoMix | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142/004-005 EU/1/00/142/009-025 | 22.3.2011 |
| 17.3.2011 | ProQuad | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/05/323/001-013 | 22.3.2011 |
| 17.3.2011 | Protaphane | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234/001-017 | 22.3.2011 |
| 18.3.2011 | Adrovance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364/001-009 | 23.3.2011 |
| 18.3.2011 | Fosavance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310/001-009 | 23.3.2011 |
| 18.3.2011 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | EU/1/03/256/001-010 | 23.3.2011 |
| 18.3.2011 | INOmax | INO Therapeutics AB SE-181 81 Lidingö, Sverige | EU/1/01/194/001-004 | 22.3.2011 |
| 18.3.2011 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437/001-004 | 23.3.2011 |
| 18.3.2011 | Kaletra | Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | EU/1/01/172/001-008 | 23.3.2011 |
| 18.3.2011 | Kivexa | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/04/298/001-003 | 23.3.2011 |
| 18.3.2011 | Luveris | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/155/001-007 | 23.3.2011 |
| 18.3.2011 | Menveo | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/614/001-002 | 23.3.2011 |
| 18.3.2011 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/001-006 EU/1/97/051/009-033 | 23.3.2011 |
| 18.3.2011 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/405/001-040 | 23.3.2011 |
| 18.3.2011 | Rasilez HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/491/001-080 | 23.3.2011 |
| 18.3.2011 | Riprazo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/409/001-040 | 23.3.2011 |
| 18.3.2011 | RoActemra | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492/001-006 | 23.3.2011 |
| 18.3.2011 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/013-033 | 23.3.2011 |
| 18.3.2011 | Simulect | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/084/001-002 | 23.3.2011 |
| 18.3.2011 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/01/200/001-002 | 23.3.2011 |
| 18.3.2011 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | EU/1/05/312/001 | 23.3.2011 |
| 18.3.2011 | Zerit | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009/001-009 | 23.3.2011 |
| 24.3.2011 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 29.3.2011 |
| 24.3.2011 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543/001-002 | 29.3.2011 |
| 24.3.2011 | Clopidogrel ratiopharm | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/554/001-008 | 28.3.2011 |
| 24.3.2011 | DuoTrav | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | EU/1/06/338/001-003 | 29.3.2011 |
| 24.3.2011 | Evoltra | Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/06/334/001-005 | 30.3.2011 |
| 24.3.2011 | Exforge HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569/001-060 | 30.3.2011 |
| 24.3.2011 | Forsteo | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/03/247/001-002 | 30.3.2011 |
| 24.3.2011 | Grepid | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, EAMSa | EU/1/09/535/001-016 | 29.3.2011 |
| 24.3.2011 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/01/183/001 EU/1/01/183/004-005 EU/1/01/183/007-008 EU/1/01/183/011 EU/1/01/183/013 EU/1/01/183/015 EU/1/01/183/018-032 | 28.3.2011 |
| 24.3.2011 | Humalog | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 | 28.3.2011 |
| 24.3.2011 | Imprida HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/570/001-060 | 30.3.2011 |
| 24.3.2011 | Insulatard | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233/001-017 | 28.3.2011 |
| 24.3.2011 | Levitra | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/03/248/001-020 | 30.3.2011 |
| 24.3.2011 | Myocet | Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France | EU/1/00/141/001 | 29.3.2011 |
| 24.3.2011 | Pandemrix | GlaxoSmithKline Biologicals SA. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/452/001 | 31.3.2011 |
| 24.3.2011 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/05/318/001-002 | 30.3.2011 |
| 24.3.2011 | Reyataz | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267/001-010 | 30.3.2011 |
| 24.3.2011 | Scintimun | CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette - France | EU/1/09/602/001-002 | 29.3.2011 |
| 24.3.2011 | Silodyx | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607/001-014 | 29.3.2011 |
| 24.3.2011 | Soliris | Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France | EU/1/07/393/001 | 28.3.2011 |
| 24.3.2011 | Sprimeo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/407/001-040 | 28.3.2011 |
| 24.3.2011 | Toviaz | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/386/001-018 | 30.3.2011 |
| 24.3.2011 | Urorec | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/608/001-014 | 29.3.2011 |
| 24.3.2011 | Vantavo | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572/001-009 | 28.3.2011 |
| 24.3.2011 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/01/200/001-002 | 29.3.2011 |
| 24.3.2011 | Zopya | Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland | EU/1/09/562/001-009 | 29.3.2011 |
| 24.3.2011 | Zostavax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/341/001-013 | 30.3.2011 |
| 28.3.2011 | Adenuric | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | EU/1/08/447/001-012 | 30.3.2011 |
| 28.3.2011 | Afinitor | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/538/001-008 | 30.3.2011 |
| 28.3.2011 | Evicel | OMRIX biopharmaceuticals SA. / N.V. 200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint- Genesius-Rode, Belgique / België | EU/1/08/473/001-003 | 5.4.2011 |
| 28.3.2011 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278/001-011 | 30.3.2011 |
| 28.3.2011 | Oprymea | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469/001-025 | 30.3.2011 |
| 28.3.2011 | Vizarsin | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551/001-012 | 30.3.2011 |
| 31.3.2011 | Ilaris | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564/001-002 | 4.4.2011 |
| 31.3.2011 | Temozolomide Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | EU/1/09/606/001-012 | 4.4.2011 |
| 8.4.2011 | Copalia | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/372/001-039 | 12.4.2011 |
| 8.4.2011 | Dafiro | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/371/001-039 | 12.4.2011 |
| 8.4.2011 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse -België | EU/1/07/395/001-095 | 12.4.2011 |
| 8.4.2011 | Neulasta | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227/001-004 | 12.4.2011 |
| 8.4.2011 | NovoRapid | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 EU/1/99/119/017-018 | 12.4.2011 |
| 8.4.2011 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France | EU/1/06/348/001-002 | 12.4.2011 |
| 8.4.2011 | Tyverb | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/440/001-003 | 12.4.2011 |
| 12.4.2011 | Aclasta | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308/001-002 | 14.4.2011 |
| 12.4.2011 | Emtriva | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/03/261/001-003 | 14.4.2011 |
| 12.4.2011 | Firdapse | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/09/601/001 | 14.4.2011 |
| 12.4.2011 | Kineret | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | EU/1/02/203/001-004 | 14.4.2011 |
| 12.4.2011 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/06/342/001 | 14.4.2011 |
| 12.4.2011 | Sildenafil ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603/001-015 | 14.4.2011 |
| 14.4.2011 | Bondenza | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/266/003-006 | 19.4.2011 |
| 14.4.2011 | Bondronat | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/012/004 EU/1/96/012/009-013 | 18.4.2011 |
| 14.4.2011 | Bonviva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/265/003-006 | 19.4.2011 |
| 14.4.2011 | Brinavess | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/645/001-002 | 18.4.2011 |
| 14.4.2011 | Ceplene | EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland | EU/1/08/477/001 | 18.4.2011 |
| 14.4.2011 | Integrilin | Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom | EU/1/99/109/001-002 | 20.4.2011 |
| 14.4.2011 | NutropinAq | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/00/164/003-005 | 19.4.2011 |
| 14.4.2011 | Preotact | Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/06/339/001-002 | 18.4.2011 |
| 14.4.2011 | Rotarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/05/330/001-011 | 18.4.2011 |
| 14.4.2011 | Travatan | Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | EU/1/01/199/001-002 | 18.4.2011 |
| 14.4.2011 | Zopya | Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland | EU/1/09/562/001-009 | 19.4.2011 |
| 18.4.2011 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/99/118/001-010 | 21.4.2011 |
| 18.4.2011 | DaTSCAN | GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom | EU/1/00/135/001-002 | 21.4.2011 |
| 18.4.2011 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | EU/1/04/281/001-005 | 21.4.2011 |
| 18.4.2011 | Firazyr | Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland | EU/1/08/461/001-002 | 21.4.2011 |
| 18.4.2011 | Humalog | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 | 21.4.2011 |
| 18.4.2011 | Kaletra | Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | EU/1/01/172/001-008 | 21.4.2011 |
| 18.4.2011 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/09/604/001-010 | 21.4.2011 |
| 18.4.2011 | Modigraf | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leider-dorp, Nederland | EU/1/09/523/001-002 | 21.4.2011 |
| 18.4.2011 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoS-mithKline Biologicals | GlaxoSmithKline Biologicals SA. rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578/001 | 21.4.2011 |
| 18.4.2011 | Pegasys | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221/001-010 | 21.4.2011 |
| 18.4.2011 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/405/001-040 | 21.4.2011 |
| 18.4.2011 | Somavert | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/02/240/001-004 | 21.4.2011 |
| 18.4.2011 | Telzir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/04/282/001-002 | 21.4.2011 |
| 18.4.2011 | Thalidomide Celgene | Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | EU/1/08/443/001 | 18.4.2011 |
| 18.4.2011 | Valtropin | BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | EU/1/06/335/001 | 21.4.2011 |
| 18.4.2011 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | EU/1/05/312/001 | 21.4.2011 |
| 20.4.2011 | Adcirca | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/476/005-006 | 27.4.2011 |
| 20.4.2011 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | EU/1/07/387/001-026 | 28.4.2011 |
| 20.4.2011 | Altargo | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/390/001-004 | 27.4.2011 |
| 20.4.2011 | Efient | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/08/503/001-016 | 28.4.2011 |
| 20.4.2011 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145/001 | 27.4.2011 |
| 20.4.2011 | Levitra | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/03/248/001-015 | 27.4.2011 |
| 20.4.2011 | Liprolog | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/01/195/001-027 | 27.4.2011 |
| 20.4.2011 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/453/002 | 28.4.2011 |
| 20.4.2011 | Remicade | Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-005 | 27.4.2011 |
| 20.4.2011 | Revasc | Canyon Pharmaceuticals Ltd 20-22 Bedford Row - WC1R 4JS London - United Kingdom | EU/1/97/043/001-003 | 27.4.2011 |
| 20.4.2011 | Simponi | Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland | EU/1/09/546/001-004 | 27.4.2011 |
| 20.4.2011 | Tolura | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632/001-021 | 28.4.2011 |
| 20.4.2011 | Tysabri | Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland | EU/1/06/346/001 | 27.4.2011 |
| 20.4.2011 | Vivanza | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/03/249/001-012 | 27.4.2011 |
| 20.4.2011 | Zerit | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009/001-009 | 27.4.2011 |
– Wycofanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady)
| Data wydania decyzji | Nazwa produktu leczniczego | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Data notyfikacji |
| 24.3.2011 | Onsenal | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 29.3.2011 |
| 31.3.2011 | Clopidogrel Sandoz | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/547/001-007 | 4.4.2011 |
| 20.4.2011 | Filgrastim ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/449/001-008 | 28.4.2011 |
– Wydanie pozwolenia na dopuszczenie do obrotu (art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady(1)): Zatwierdzenie
| Data wydania decyzji | Nazwa produktu leczniczego | INN (międzynarodowa niezastrzeżona nazwa) | Posiadacz pozwolenia na dopuszczenie do obrotu | Numer pozycji w rejestrze wspólnotowym | Postać farmaceutyczna | Kod ATC (klasyfikacja anatomiczno-terapeutyczno-chemiczna) | Data notyfikacji |
| 14.3.2011 | CaniLeish | Leishmania infantum białko ekskrecyjno -sekrecyjne (ESP) | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/11/121/001-009 | Liofilizat i rozpuszczalnik do sporządzenia zawiesiny do wstrzykiwań | QI07AO | 17.3.2011 |
| 14.3.2011 | ZULVAC 1+8 Ovis | Inaktywowany wirus choroby niebieskiego języka, serotyp 1, szczep BTV-8/ALG2006/01 E1 / Inaktywowany wirus choroby niebieskiego języka, serotyp 8, szczep BTV-8/BEL2006/02 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/11/120/001-003 | Zawiesina do wstrzykiwań | QI04AA02 | 17.3.2011 |
| 12.4.2011 | Veraflox | Pradofloksacyna | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | EU/2/10/107/001-014 | Tabletki Zawiesina doustna | QJ01MA | 14.4.2011 |
| 14.4.2011 | BLUEVAC BTV8 | Wirus choroby niebieskiego języka, inaktywowany, serotyp 8 | CZ Veterinaria, SA. La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA | EU/2/11/122/001-003 | Zawiesina do wstrzykiwań | QI02AA08 QI04AA02 | 18.4.2011 |
| 20.4.2011 | Procox | emodepsyd & toltrazuryl | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | EU/2/11/123/001-002 | Zawiesina doustna | QP52AX60 | 28.4.2011 |
– 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 pozycji w rejestrze wspólnotowym | Data notyfikacji |
| 10.3.2011 | Flexicam | Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark | EU/2/06/058/004 | 14.3.2011 |
| 14.3.2011 | Zulvac 8 Bovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/09/105/001-002 | 17.3.2011 |
| 18.3.2011 | Zubrin | Schering - Plough Limited Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom | EU/2/00/028/002-008 | 23.3.2011 |
| 28.3.2011 | BTVPUR AlSap 8 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | EU/2/09/094/001-005 | 31.3.2011 |
| 12.4.2011 | Zactran | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | EU/2/08/082/001-007 | 14.4.2011 |
| 14.4.2011 | Convenia | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/06/059/001 | 20.4.2011 |
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 7,
Westferry Circus, Canary Wharf
UK - LONDON E14 4H
______
(1) Dz.U. L 136 z 30.4.04, s. 1.
| Identyfikator: | Dz.U.UE.C.2011.184.1 |
| Rodzaj: | informacja |
| Tytuł: | Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od 1 marzec 2011 r. do 30 kwiecień 2011 r. |
| Data aktu: | 2011-06-24 |
| Data ogłoszenia: | 2011-06-24 |