PL Dziennik Urzędowy Unii Europejskiej C 295/1

Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od 1 lipiec 2010 do 31 sierpień 2010

(Opublikowano zgodnie z art. 13 lub art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady (1))

2010/C 295/01

— 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 5.7.2010 Daxas roflumilast Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636/001-003 Tabletka powlekana R03DX07 8.7.2010 27.7.2010 Leflunomide medac Leflunomid medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland EU/1/10/637/001-009 Tabletka powlekana L04AA13 30.7.2010 27.7.2010 Ozurdex deksametazon Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638/001 Implant do ciała szklistego w aplikatorze S01BA01 1.8.2010 26.8.2010 VPRIV Welagluceraza alfa Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646/001-002 Proszek do sporządzania roztworu do infuzji A16AB10 30.8.2010 31.8.2010 PecFent Fentanyl Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom EU/1/10/644/001-004 Aerozol do nosa, roztwór N02AB03 6.9.2010





— Wydanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr - 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 1.7.2010 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-021 6.7.2010 1.7.2010 Humira Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/03/256/001-010 5.7.2010 1.7.2010 Invega Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/07/395/001-095 6.7.2010 1.7.2010 Kiovig Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/05/329/001-006 5.7.2010 1.7.2010 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 5.7.2010 1.7.2010 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389/001-003 5.7.2010 1.7.2010 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-008 5.7.2010 1.7.2010 Rapamune Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001 EU/1/01/171/007-010 5.7.2010 1.7.2010 Sifrol Boehringer Ingelheim International GmbHBinger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050/001-006 EU/1/97/050/009-033 5.7.2010 1.7.2010 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 5.7.2010 1.7.2010 TachoSil Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/277/001-004 5.7.2010 1.7.2010 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 5.7.2010 1.7.2010 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/95/002/001-005 5.7.2010 1.7.2010 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 6.7.2010 1.7.2010 Viagra Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/98/077/002-004 EU/1/98/077/006-008 EU/1/98/077/010-019 5.7.2010 2.7.2010 ellaOne Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France EU/1/09/522/001 6.7.2010 2.7.2010 Eucreas Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 7.7.2010 2.7.2010 Galvus Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 7.7.2010 2.7.2010 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 7.7.2010 2.7.2010 Jalra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 7.7.2010 2.7.2010 Myocet Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France EU/1/00/141/001 7.7.2010 2.7.2010 NovoMix Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/142/004-005 EU/1/00/142/009-022 7.7.2010 2.7.2010 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-010 7.7.2010 2.7.2010 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-010 7.7.2010 2.7.2010 Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050/001-006 EU/1/97/050/009-033 8.7.2010 2.7.2010 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 7.7.2010 2.7.2010 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 7.7.2010 2.7.2010 Torisel Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/07/424/001 7.7.2010 2.7.2010 Velcade Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 6.7.2010 2.7.2010 Xiliarx Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 7.7.2010 2.7.2010 Xyrem UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312/001 6.7.2010 2.7.2010 Zeffix Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/114/001-003 8.7.2010 2.7.2010 Zyllt KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553/001-010 7.7.2010 5.7.2010 Celvapan Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/08/506/001 8.7.2010 5.7.2010 Ferriprox Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/99/108/001-003 8.7.2010 5.7.2010 Icandra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484/001-018 8.7.2010 5.7.2010 Rebetol Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/107/001-005 13.7.2010 5.7.2010 Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/08/463/001-003 8.7.2010 5.7.2010 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267/001-010 8.7.2010 5.7.2010 Thelin Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom EU/1/06/353/001-005 8.7.2010 5.7.2010 Zomarist Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483/001-018 8.7.2010 6.7.2010 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 8.7.2010 6.7.2010 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/001-005 8.7.2010 6.7.2010 Keppra UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/00/146/001-032 9.7.2010 6.7.2010 Rapamune Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001 EU/1/01/171/007-010 EU/1/01/171/013-014 12.7.2010 6.7.2010 Savene TopoTarget A/S Fruebjergvej 3, Copenhagen 2100, Danmark EU/1/06/350/001 12.7.2010 7.7.2010 ReFacto AF Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-004 12.7.2010 13.7.2010 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-007 15.7.2010 13.7.2010 Kepivance Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/05/314/001 15.7.2010 22.7.2010 Thelin Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom EU/1/06/353/001-005 26.7.2010 27.7.2010 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 29.7.2010 27.7.2010 Conbriza Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/09/511/001-004 29.7.2010 27.7.2010 GONAL-f Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 30.7.2010 27.7.2010 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 EU/1/98/070/012 29.7.2010 27.7.2010 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/02/213/013-016 EU/1/02/213/020 EU/1/02/213/022 29.7.2010 27.7.2010 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 EU/1/98/069/012 29.7.2010 27.7.2010 Ribavirin Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/509/001-004 30.7.2010 27.7.2010 Ribavirin Teva Pharma BV Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/527/001-016 31.7.2010 27.7.2010 Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/04/307/001-021 29.7.2010 28.7.2010 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-099 2.8.2010 28.7.2010 DaTSCAN GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom EU/1/00/135/001-002 2.8.2010 28.7.2010 DuoCover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/10/623/001-015 30.7.2010 28.7.2010 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 2.8.2010 28.7.2010 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 2.8.2010 28.7.2010 Fendrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/04/299/001-003 2.8.2010 28.7.2010 Ferriprox Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/99/108/001-006 30.7.2010 28.7.2010 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-004 30.7.2010 28.7.2010 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 30.7.2010 28.7.2010 Increlex Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/07/402/001 2.8.2010 28.7.2010 Invanz Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 2.8.2010 28.7.2010 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 2.8.2010 28.7.2010 Kaletra Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/01/172/001-007 2.8.2010 28.7.2010 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/298/001-003 2.8.2010 28.7.2010 Kogenate Bayer Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/143/001-011 30.7.2010 28.7.2010 Onsenal Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/03/259/001-006 30.7.2010 28.7.2010 Prevenar 13 Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique EU/1/09/590/001-006 3.8.2010 28.7.2010 Simponi Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546/001-004 2.8.2010 28.7.2010 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-011 2.8.2010 28.7.2010 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-003 2.8.2010 6.8.2010 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 12.8.2010 6.8.2010 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 10.8.2010 6.8.2010 Byetta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/06/362/001-004 10.8.2010 6.8.2010 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 10.8.2010 6.8.2010 Crixivan Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024/001-005 EU/1/96/024/008 EU/1/96/024/010 12.8.2010 6.8.2010 DuoPlavin Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France EU/1/10/619/001-015 11.8.2010 6.8.2010 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 11.8.2010 6.8.2010 Evicel OMRIX biopharmaceuticals S.A. / 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 11.8.2010 6.8.2010 Ferriprox Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/99/108/001-006 10.8.2010 6.8.2010 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535/001-016 10.8.2010 6.8.2010 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 12.8.2010 6.8.2010 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 11.8.2010 6.8.2010 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 12.8.2010 6.8.2010 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/97/049/001-039 10.8.2010 6.8.2010 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/085/001-034 10.8.2010 6.8.2010 Mepact IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France EU/1/08/502/001 13.8.2010 6.8.2010 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/08/448/001-002 10.8.2010 6.8.2010 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/05/324/001-002 10.8.2010 6.8.2010 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475/001-034 10.8.2010 6.8.2010 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-017 10.8.2010 6.8.2010 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 11.8.2010 6.8.2010 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 11.8.2010 6.8.2010 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 10.8.2010 6.8.2010 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603/001-015 11.8.2010 6.8.2010 Suboxone Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/06/359/001-004 10.8.2010 6.8.2010 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110/001-005 EU/1/99/110/008-010 10.8.2010 6.8.2010 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 11.8.2010 6.8.2010 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 10.8.2010 10.8.2010 Trisenox Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France EU/1/02/204/001 12.8.2010 12.8.2010 Celvapan Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/08/506/001 13.8.2010 12.8.2010 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/07/385/001-002 EU/1/07/385/004 13.8.2010 12.8.2010 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 13.8.2010 16.8.2010 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-009 18.8.2010 18.8.2010 alli Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-011 24.8.2010 18.8.2010 Binocrit Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich EU/1/07/410/001-026 20.8.2010 18.8.2010 Epoetin alfa Hexal Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411/001-026 20.8.2010 18.8.2010 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-021 20.8.2010 18.8.2010 IDflu Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507/001-006 20.8.2010 18.8.2010 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-168 20.8.2010 18.8.2010 Intanza Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/08/505/001-006 20.8.2010 18.8.2010 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604/001-010 20.8.2010 18.8.2010 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/05/331/001-055 20.8.2010 18.8.2010 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 20.8.2010 23.8.2010 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/97/046/001-039 24.8.2010 23.8.2010 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/086/001-034 24.8.2010 23.8.2010 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-021 25.8.2010 26.8.2010 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 31.8.2010 26.8.2010 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543/001-002 31.8.2010 26.8.2010 Cerezyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/97/053/001-005 30.8.2010 26.8.2010 Cimzia UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/09/544/001-002 30.8.2010 26.8.2010 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328/001-004 31.8.2010 26.8.2010 Docetaxel Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/611/001-002 31.8.2010 26.8.2010 Elonva N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/09/609/001-002 30.8.2010 26.8.2010 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 31.8.2010 26.8.2010 Hirobriz Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/594/001-010 31.8.2010 26.8.2010 Kaletra Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/01/172/001-008 31.8.2010 26.8.2010 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-044 31.8.2010 26.8.2010 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/001-024 31.8.2010 26.8.2010 Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/333/001-003 31.8.2010 26.8.2010 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 30.8.2010 26.8.2010 Onbrez Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593/001-010 31.8.2010 26.8.2010 Osseor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/287/001-006 31.8.2010 26.8.2010 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-008 30.8.2010 26.8.2010 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/453/002 31.8.2010 26.8.2010 Privigen CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland EU/1/08/446/001-006 31.8.2010 26.8.2010 Protelos Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/288/001-006 31.8.2010 26.8.2010 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/002 31.8.2010 26.8.2010 Stalevo Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-033 30.8.2010 26.8.2010 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/494/001-004 30.8.2010 26.8.2010 Tasigna Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-004 31.8.2010 26.8.2010 Telzir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/282/001-002 31.8.2010 26.8.2010 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498/001-008 31.8.2010 26.8.2010 Valdoxan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/08/499/001-008 31.8.2010 26.8.2010 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/055/001-004 30.8.2010 26.8.2010 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 31.8.2010 31.8.2010 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412/001-026 2.9.2010 31.8.2010 Actos Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/150/001-030 2.9.2010 31.8.2010 Adenuric Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/447/001-012 3.9.2010 31.8.2010 Angiox The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom EU/1/04/289/002 7.9.2010 31.8.2010 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/283/008-012 3.9.2010 31.8.2010 Arixtra Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-035 2.9.2010 31.8.2010 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 2.9.2010 31.8.2010 Corlentor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/317/001-014 2.9.2010 31.8.2010 Glustin Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/151/001-024 2.9.2010 31.8.2010 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 2.9.2010 31.8.2010 Humira Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/03/256/001-010 3.9.2010 31.8.2010 InductOs Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 3.9.2010 31.8.2010 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/00/152/001-020 3.9.2010 31.8.2010 Infanrix penta GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/00/153/001-010 3.9.2010 31.8.2010 Isentress Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 6.9.2010 31.8.2010 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437/001-004 2.9.2010 31.8.2010 Procoralan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/316/001-014 2.9.2010 31.8.2010 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 2.9.2010 31.8.2010 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/280/001-008 2.9.2010





— Wydanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Odrzucenie

Data wydania decyzji Nazwa produktu leczniczego Posiadacz pozwolenia na dopuszczenie do obrotu Numer pozycji w rejestrze wspólnotowym Data notyfikacji 27.7.2010 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland EU/1/01/179/001 29.7.2010





— 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 1.7.2010 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/07/079/001-004 4.7.2010 1.7.2010 Profender Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/05/054/001-031 6.7.2010 1.7.2010 Suprelorin VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/07/072/001-004 5.7.2010 2.7.2010 Cortavance VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/06/069/001 7.7.2010 2.7.2010 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/001 EU/2/97/004/003-040 7.7.2010 5.7.2010 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/001 EU/2/97/004/003-042 7.7.2010 27.7.2010 Equilis Prequenza Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/056/001-004 29.7.2010 27.7.2010 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/057/001-004 29.7.2010 27.7.2010 Equilis Te Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/055/001-002 29.7.2010 6.8.2010 Fevaxyn Pentofel Fort Dodge Laboratories Ireland Finisklin Industrial Estate - Sligo, Ireland EU/2/96/002/001-003 12.8.2010 18.8.2010 Zulvac 8 Bovis Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom EU/2/09/105/001-002 20.8.2010 18.8.2010 Zulvac 8 Ovis Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom EU/2/09/104/001-002 20.8.2010 26.8.2010 Advocate Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/03/039/001-030 30.8.2010 26.8.2010 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/06/070/001-008 27.8.2010





— Wydanie pozwolenia na dopuszczenie do obrotu (art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Odrzucenie

Data wydania decyzji Nazwa produktu leczniczego Posiadacz pozwolenia na dopuszczenie do obrotu Numer pozycji w rejestrze wspólnotowym Data notyfikacji 26.8.2010 Masivet AB Science S.A. 3 avenue George V, 75008 Paris, France EU/2/08/087/001-002 31.8.2010





— Wycofanie pozwolenia na dopuszczenie do obrotu (art. 38 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 5.7.2010 Nobilis Influenza H5N6 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/07/076/001-004 8.7.2010 7.7.2010 Nobilis Influenza H7N1 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/07/073/001-004 9.7.2010 22.7.2010 Medicinal Oxygen Air Liquide Santé Air Liquide Santé International 10 rue Cognacq-Jay, 75341 Paris Cedex 07, France EU/2/06/067/001-002 26.7.2010

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 30.4.2004, s. 1.