EN Official Journal of the European Union C 295/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

2010/C 295/01

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 5.7.2010 Daxas roflumilast Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636/001-003 Film-coated tablet R03DX07 8.7.2010 27.7.2010 Leflunomide medac leflunomide medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland EU/1/10/637/001-009 Film-coated tablet L04AA13 30.7.2010 27.7.2010 Ozurdex dexamethasone Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638/001 Intravitreal implant in applicator S01BA01 1.8.2010 26.8.2010 VPRIV Velaglucerase alfa Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646/001-002 Powder for solution for infusion A16AB10 30.8.2010 31.8.2010 PecFent Fentanyl Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom EU/1/10/644/001-004 Nasal spray, solution N02AB03 6.9.2010





— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 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 GmbH Binger 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





— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 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





— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 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





— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 26.8.2010 Masivet AB Science S.A. 3 avenue George V, 75008 Paris, France EU/2/08/087/001-002 31.8.2010





— Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 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

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK - LONDON E14 4H

(1) OJ L 136, 30.4.2004, p. 1.