EN Official Journal of the European Union C 316/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011

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

2011/C 316/01

— 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 13.7.2011 Benlysta belimumab Glaxo Group Limited Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/700/001-002 powder for concentrate for solution for infusion L04AA26 15.7.2011 13.7.2011 Temozolomide Sun temozolomide Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/697/001-012 Capsule, hard L01AX03 18.7.2011 13.7.2011 Xgeva denosumab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703/001-002 Solution for injection M05BX04 15.7.2011 13.7.2011 Yervoy ipilimumab Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698/001-002 Concentrate for solution for infusion L01XC11 15.7.2011 18.7.2011 Victrelis boceprevir Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704/001 Capsule, hard J05AE 20.7.2011 20.7.2011 Fampyra fampridine Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699/001-002 Prolonged-release tablet N07XX07 25.7.2011 20.7.2011 TOBI Podhaler Tobramycin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/10/652/001-003 Inhalation powder, hard capsule J01GB01 25.7.2011 26.7.2011 Ibandronic acid Sandoz Ibandronic acid Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/11/685/001-005 Film-coated tablet M05BA06 28.7.2011 27.7.2011 Zoely nomegestrol/estradiol Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom EU/1/11/690/001-002 Film-coated tablet G03AA14 1.8.2011 18.8.2011 Entacapone Orion entacapone Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/708/001-004 Film-coated tablet N04BX02 22.8.2011 24.8.2011 Levodopa/Carbidopa/Entacapone Orion Levodopa, carbidopa, entacapone Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706/001-033 Film-coated tablet N04BA03 29.8.2011 24.8.2011 Trajenta linagliptin Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/11/707/001-011 Film-coated tablet A10BH05 30.8.2011 26.8.2011 Levetiracetam ratiopharm levetiracetam ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/702/001-031 Film-coated tablet Oral solution N03AX14 31.8.2011 26.8.2011 Levetiracetam Teva levetiracetam Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/701/001-028 Film-coated tablet N03AX14 31.8.2011





— 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 5.7.2011 Irbesartan Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/376/001-033 7.7.2011 5.7.2011 Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/08/463/001-011 7.7.2011 7.7.2011 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/005 EU/1/06/364/009 11.7.2011 7.7.2011 Ammonaps Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige EU/1/99/120/001-004 12.7.2011 7.7.2011 Hirobriz Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/594/001-010 11.7.2011 7.7.2011 Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/523/001-002 11.7.2011 7.7.2011 Removab Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland EU/1/09/512/001-002 11.7.2011 11.7.2011 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/1/99/119/017-023 13.7.2011 11.7.2011 Onbrez Breezhaler Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593/001-010 13.7.2011 11.7.2011 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/07/394/001-009 13.7.2011 13.7.2011 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603/001-015 18.7.2011 13.7.2011 Stocrin Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111/001-005 EU/1/99/111/008-011 18.7.2011 13.7.2011 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 18.7.2011 13.7.2011 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 18.7.2011 13.7.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 18.7.2011 18.7.2011 Crixivan Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024/001-005 EU/1/96/024/010 20.7.2011 18.7.2011 Intrinsa Warner Chilcott UK Ltd Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom EU/1/06/352/001-003 20.7.2011 18.7.2011 Livensa Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland EU/1/06/351/001-003 20.7.2011 18.7.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 20.7.2011 18.7.2011 ReFacto AF Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-008 20.7.2011 18.7.2011 Savene SpePharm Holding BV Kingsfordweg 151, GR Amsterdam 1043, Nederland EU/1/06/350/001 20.7.2011 20.7.2011 Atriance Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/403/001 25.7.2011 20.7.2011 Betaferon Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland EU/1/95/003/003-012 25.7.2011 20.7.2011 Esbriet InterMune UK Ltd 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom EU/1/11/667/001-003 26.7.2011 20.7.2011 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 25.7.2011 20.7.2011 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444/001-012 25.7.2011 20.7.2011 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1+3, Oberhaching 82041, Deutschland EU/1/09/585/001-018 25.7.2011 20.7.2011 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/09/599/001-018 25.7.2011 20.7.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-008 EU/1/06/358/018-021 25.7.2011 20.7.2011 Zalasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415/001-056 25.7.2011 26.7.2011 Avaglim SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/06/349/001-010 28.7.2011 26.7.2011 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 28.7.2011 26.7.2011 Busilvex Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France EU/1/03/254/002 28.7.2011 26.7.2011 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-009 28.7.2011 26.7.2011 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/247/001-002 28.7.2011 26.7.2011 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, Rixensart, B-1330 Belgique EU/1/00/152/001-008 EU/1/00/152/019-020 28.7.2011 26.7.2011 Kuvan Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom EU/1/08/481/001-003 28.7.2011 26.7.2011 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614/001-003 28.7.2011 26.7.2011 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 28.7.2011 26.7.2011 Retacrit Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/07/431/001-025 28.7.2011 26.7.2011 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/494/001-004 28.7.2011 26.7.2011 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/297/001-008 28.7.2011 27.7.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 2.8.2011 27.7.2011 Beromun Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/99/097/001 1.8.2011 27.7.2011 Bondenza Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/266/003-006 29.7.2011 27.7.2011 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265/003-006 29.7.2011 27.7.2011 Copalia Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-039 1.8.2011 27.7.2011 Dafiro Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-039 1.8.2011 27.7.2011 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416/001-002 29.7.2011 27.7.2011 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 3.8.2011 27.7.2011 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573/001-028 29.7.2011 27.7.2011 Exforge Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370/001-039 29.7.2011 27.7.2011 Exjade Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356/001-009 1.8.2011 27.7.2011 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269/001-002 1.8.2011 27.7.2011 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/005 EU/1/05/310/009 29.7.2011 27.7.2011 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-008 EU/1/06/357/018-021 29.7.2011 27.7.2011 Imprida Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373/001-039 29.7.2011 27.7.2011 Integrilin Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/99/109/001-002 1.8.2011 27.7.2011 Kiovig Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/05/329/001-006 29.7.2011 27.7.2011 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604/001-010 2.8.2011 27.7.2011 Nevanac Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/07/433/001 29.7.2011 27.7.2011 PhotoBarr Axcan Pharma International BV Engelenkampstraat 72, 6131 JJ Sittard, Nederland EU/1/04/272/001-002 2.8.2011 27.7.2011 PREZISTA Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/06/380/001-005 2.8.2011 27.7.2011 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 1.8.2011 27.7.2011 Relistor TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom EU/1/08/463/001-011 1.8.2011 27.7.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-021 2.8.2011 27.7.2011 Sycrest N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640/001-006 2.8.2011 27.7.2011 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498/001-008 29.7.2011 27.7.2011 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 3.8.2011 27.7.2011 Valdoxan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/08/499/001-008 1.8.2011 27.7.2011 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/005 EU/1/09/572/009 1.8.2011 27.7.2011 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/280/001-008 29.7.2011 1.8.2011 alli Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-016 3.8.2011 1.8.2011 Doribax Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/467/001-002 3.8.2011 1.8.2011 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-021 3.8.2011 1.8.2011 Iressa AstraZeneca AB Sodertalje S 151 85, Sverige EU/1/09/526/001-002 3.8.2011 1.8.2011 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 2.8.2011 1.8.2011 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-014 3.8.2011 1.8.2011 Rivastigmine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/513/001-020 3.8.2011 1.8.2011 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 3.8.2011 5.8.2011 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355/001-003 10.8.2011 5.8.2011 Biograstim CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/08/450/001-010 10.8.2011 5.8.2011 Biopoin CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/09/565/001-028 10.8.2011 5.8.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-022 10.8.2011 5.8.2011 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 10.8.2011 5.8.2011 Hepsera Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/03/251/001-002 10.8.2011 5.8.2011 Hycamtin SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/96/027/001 EU/1/96/027/003-007 10.8.2011 5.8.2011 InductOs Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 10.8.2011 5.8.2011 Silapo STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland EU/1/07/432/001-022 10.8.2011 5.8.2011 Synflorix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/09/508/001-010 10.8.2011 5.8.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 10.8.2011 10.8.2011 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 12.8.2011 10.8.2011 Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/268/001-004 12.8.2011 10.8.2011 Filgrastim Hexal HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/08/496/001-016 12.8.2011 10.8.2011 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 12.8.2011 10.8.2011 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 12.8.2011 10.8.2011 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/586/001-010 12.8.2011 10.8.2011 Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/488/001 12.8.2011 10.8.2011 Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/08/495/001-016 12.8.2011 18.8.2011 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/283/008-012 22.8.2011 18.8.2011 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/085/001-034 22.8.2011 18.8.2011 Osseor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/287/001-006 22.8.2011 18.8.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 22.8.2011 18.8.2011 Protelos Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/288/001-006 22.8.2011 18.8.2011 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 22.8.2011 18.8.2011 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 22.8.2011 19.8.2011 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 23.8.2011 24.8.2011 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 30.8.2011 24.8.2011 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 30.8.2011 24.8.2011 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126/001-022 9.9.2011 24.8.2011 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 30.8.2011 24.8.2011 IntronA Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/127/011-039 EU/1/99/127/041-044 30.8.2011 24.8.2011 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 30.8.2011 24.8.2011 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 30.8.2011 24.8.2011 Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP EU/1/03/270/001-005 30.8.2011 24.8.2011 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 30.8.2011 24.8.2011 Mepact IDM PHARMA SAS 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France EU/1/08/502/001 30.8.2011 24.8.2011 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/98/090/017-022 29.8.2011 24.8.2011 Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/523/001-002 29.8.2011 24.8.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 26.8.2011 24.8.2011 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/08/448/001-002 26.8.2011 24.8.2011 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/05/331/001-055 26.8.2011 24.8.2011 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497/001-008 30.8.2011 24.8.2011 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 29.8.2011 24.8.2011 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland EU/1/01/179/001 30.8.2011 24.8.2011 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 26.8.2011 24.8.2011 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/001-014 26.8.2011 24.8.2011 Rebetol Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/107/001-005 29.8.2011 24.8.2011 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267/001-010 30.8.2011 24.8.2011 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 30.8.2011 24.8.2011 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 30.8.2011 24.8.2011 Stalevo Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-038 30.8.2011 24.8.2011 Starlix Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/174/001-021 30.8.2011 24.8.2011 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 26.8.2011 24.8.2011 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 30.8.2011 24.8.2011 Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/122/001-002 30.8.2011 24.8.2011 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/001-014 30.8.2011 24.8.2011 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/001-014 30.8.2011 24.8.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 30.8.2011 24.8.2011 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 30.8.2011 24.8.2011 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 30.8.2011 24.8.2011 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-026 30.8.2011 24.8.2011 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 30.8.2011 24.8.2011 Yttriga Eckert & Ziegler Nuclitec GmbH Gieselweg 1, Braunschweig 38110, Deutschland EU/1/05/322/001-002 29.8.2011 24.8.2011 Zevalin Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/03/264/001 30.8.2011 24.8.2011 Zometa Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176/001-009 30.8.2011 26.8.2011 Alisade Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/08/474/001-003 31.8.2011 26.8.2011 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434/001-003 31.8.2011 26.8.2011 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 31.8.2011 26.8.2011 Corlentor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/317/001-014 31.8.2011 26.8.2011 Fertavid SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/09/510/001-019 31.8.2011 26.8.2011 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 31.8.2011 26.8.2011 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-168 31.8.2011 26.8.2011 Procoralan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/316/001-014 31.8.2011 26.8.2011 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 31.8.2011 26.8.2011 Sebivo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 31.8.2011 26.8.2011 Tepadina ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia EU/1/10/622/001-002 31.8.2011 26.8.2011 Topotecan Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/552/001-004 31.8.2011





— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): Accepted

Date of the Décision 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 5.8.2011 Proteq West Nile West Nile recombinant canarypox virus (vCP2017 virus) MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/11/129/001-004 Suspension for injection QI05AX 10.8.2011 5.8.2011 Zulvac 1 Bovis Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/130/001-003 Suspension for injection QI02AA08 10.8.2011 5.8.2011 Zulvac 1 Ovis Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/131/001-006 Suspension for injection QI04AA02 10.8.2011 18.8.2011 Emdocam Meloxicam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe EU/2/11/128/001-003 Solution for injection QM01AC06 22.8.2011





— 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 7.7.2011 Leucofeligen FeLV/RCP VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France EU/2/09/097/001-002 11.7.2011 7.7.2011 Palladia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/100/001-003 12.7.2011 7.7.2011 ProMeris Duo Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/065/001-010 11.7.2011 11.7.2011 Trocoxil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/08/084/001-005 13.7.2011 13.7.2011 Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/001-018 18.7.2011 20.7.2011 Posatex Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/081/001-003 25.7.2011 27.7.2011 Poulvac FluFend H5N3 RG Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/060/001-002 1.8.2011 27.7.2011 ProMeris Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/064/001-004 1.8.2011 27.7.2011 Slentrol Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/07/071/001-003 2.8.2011 5.8.2011 Cerenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/06/062/001-005 10.8.2011 5.8.2011 Virbagen Omega VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/01/030/001-004 10.8.2011 19.8.2011 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061/001-004 23.8.2011 19.8.2011 Zolvix Novartis Healthcare A/S Lyngbyvej 172, DK-2100 Copenhagen, Danmark EU/2/09/101/001-010 23.8.2011 24.8.2011 Suvaxyn Aujeszky 783 +O/W Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland EU/2/98/009/001-006 30.8.2011





— 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 10.8.2011 Yarvitan Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België EU/2/06/063/001-003 12.8.2011

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.

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