EN Official Journal of the European Union C 250/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 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 250/01

— 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 6.5.2011 Methylthioninium chloride Proveblue methylthioninium chloride Provepharm S.A.S. Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille EU/1/11/682/001 Solution for injection V03AB17 12.5.2011 18.5.2011 Eliquis apixaban Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691/001-005 Film-coated tablet B01A 20.5.2011 18.5.2011 Yellox bromfenac Croma-Pharma GmbH Industriezeile 6, A-2100 Leobendorf, Österreich EU/1/11/692/001 Eye drops, solution S01BC11 23.5.2011 15.6.2011 Cinryze c1 inhibitor, human ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België EU/1/11/688/001 Powder and solvent for solution for injection B02AB03 20.6.2011 16.6.2011 Clopidogrel Teva Pharma B.V. Clopidogrel Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/649/001-016 Film-coated tablet B01AC04 21.6.2011 16.6.2011 Leganto Rotigotine Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/11/695/001-055 Transdermal patch N04BC09 22.6.2011 16.6.2011 Rivastigmine Actavis Rivastigmine Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/11/693/001-016 Capsule, hard N06DA03 21.6.2011 17.6.2011 BYDUREON exenatide Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/11/696/001-002 powder and solvent for prolonged release suspension for injection A10BX04 23.6.2011 17.6.2011 NULOJIX belatacept Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694/001-002 powder for concentrate for solution for infusion L04AA28 23.6.2011 23.6.2011 Sprimeo HCT aliskiren hemifumarate / hydrochlorothiazide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/683/001-080 Film-coated tablet C09XA52 28.6.2011





— Issuing 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 17.6.2011 Movectro Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom 23.6.2011





— 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 2.5.2011 Combivir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/98/058/001-002 4.5.2011 2.5.2011 Kepivance Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/05/314/001 4.5.2011 2.5.2011 Kinzalkomb Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/02/214/001-015 4.5.2011 2.5.2011 Kinzalmono Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/98/091/001-014 4.5.2011 2.5.2011 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/98/090/001-020 4.5.2011 2.5.2011 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/02/213/001-023 4.5.2011 2.5.2011 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 4.5.2011 2.5.2011 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland EU/1/01/179/001 4.5.2011 2.5.2011 Pritor Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/98/089/001-022 4.5.2011 2.5.2011 PritorPlus Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/02/215/001-021 4.5.2011 2.5.2011 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/001-002 4.5.2011 2.5.2011 Revolade GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland EU/1/10/612/001-006 4.5.2011 2.5.2011 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 4.5.2011 5.5.2011 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/337/001-013 9.5.2011 6.5.2011 Foclivia Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/09/577/001-004 12.5.2011 6.5.2011 Kivexa ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/298/001-003 12.5.2011 6.5.2011 Rasilez HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 12.5.2011 6.5.2011 ReFacto AF Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/103/001-008 12.5.2011 6.5.2011 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 12.5.2011 6.5.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 12.5.2011 6.5.2011 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470/001-017 12.5.2011 6.5.2011 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 12.5.2011 6.5.2011 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 12.5.2011 12.5.2011 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 16.5.2011 12.5.2011 Extavia Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/454/001-002 EU/1/08/454/005-007 16.5.2011 12.5.2011 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France EU/1/01/191/001-005 16.5.2011 12.5.2011 MabCampath Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/01/193/001-002 16.5.2011 12.5.2011 Olanzapine Apotex Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/10/635/001-014 16.5.2011 16.5.2011 Elonva N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/09/609/001-002 18.5.2011 16.5.2011 Pramipexole Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/08/490/001-024 18.5.2011 16.5.2011 Yondelis Pharma Mar, S.A. Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana EU/1/07/417/001-002 18.5.2011 16.5.2011 Zavesca Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238/001 18.5.2011 18.5.2011 Arixtra Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-035 20.5.2011 18.5.2011 Celvapan Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/08/506/001 20.5.2011 18.5.2011 DepoCyte Pacira Limited 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom EU/1/01/187/001 20.5.2011 18.5.2011 Hepsera Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/03/251/001-002 20.5.2011 18.5.2011 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/97/049/001-039 23.5.2011 18.5.2011 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/085/001-034 23.5.2011 18.5.2011 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/001-014 23.5.2011 18.5.2011 PREZISTA Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/06/380/001-005 23.5.2011 18.5.2011 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 20.5.2011 18.5.2011 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 23.5.2011 18.5.2011 Sprimeo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-020 23.5.2011 18.5.2011 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 20.5.2011 18.5.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 23.5.2011 23.5.2011 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/97/046/001-039 26.5.2011 23.5.2011 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/086/001-034 30.5.2011 23.5.2011 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 26.5.2011 23.5.2011 Exalief BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal EU/1/09/520/001-020 26.5.2011 23.5.2011 Exelon Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066/001-026 26.5.2011 23.5.2011 Glivec Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 26.5.2011 23.5.2011 GONAL-f Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001/033-035 26.5.2011 23.5.2011 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/007 25.5.2011 23.5.2011 Prometax Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092/001-028 25.5.2011 23.5.2011 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 26.5.2011 23.5.2011 Rasilez Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 25.5.2011 23.5.2011 Riprazo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-040 26.5.2011 23.5.2011 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 26.5.2011 23.5.2011 Tasigna Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-006 25.5.2011 23.5.2011 Telzir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/282/001-002 26.5.2011 23.5.2011 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/001-014 25.5.2011 23.5.2011 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/001-014 25.5.2011 23.5.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 26.5.2011 23.5.2011 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-006 27.5.2011 23.5.2011 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 26.5.2011 27.5.2011 Avonex Biogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/97/033/002-006 1.6.2011 27.5.2011 Carbaglu Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France EU/1/02/246/001-003 1.6.2011 27.5.2011 CellCept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005/001-006 31.5.2011 27.5.2011 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/354/001-012 1.6.2011 27.5.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-021 31.5.2011 27.5.2011 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/247/001-002 1.6.2011 27.5.2011 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-016 1.6.2011 27.5.2011 Lucentis Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374/001 31.5.2011 27.5.2011 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/439/001-006 31.5.2011 27.5.2011 Myfenax Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/438/001-006 31.5.2011 27.5.2011 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227/001-002 EU/1/02/227/004 1.6.2011 27.5.2011 Olanzapine Neopharma Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom EU/1/07/426/001-011 31.5.2011 27.5.2011 Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/546/001-004 1.6.2011 27.5.2011 Temozolomide Hospira Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/615/001-024 31.5.2011 27.5.2011 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 31.5.2011 27.5.2011 Viracept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/97/054/001 EU/1/97/054/004-005 1.6.2011 7.6.2011 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011/001-004 9.6.2011 7.6.2011 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 9.6.2011 7.6.2011 Fabrazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/01/188/001-006 9.6.2011 7.6.2011 Irbesartan Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/376/001-033 9.6.2011 7.6.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 9.6.2011 7.6.2011 Norvir Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 EU/1/96/016/008 9.6.2011 7.6.2011 Tractocile Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, Copenhagen S 2300, Danmark EU/1/99/124/001-002 9.6.2011 7.6.2011 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/00/156/002-004 9.6.2011 14.6.2011 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 16.6.2011 14.6.2011 Doribax Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/08/467/001-002 16.6.2011 14.6.2011 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437/001-004 16.6.2011 14.6.2011 Olanzapine Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/427/001-057 16.6.2011 14.6.2011 Opgenra Howmedica International S. de R. L. Raheen Business Park, Limerick, Ireland EU/1/08/489/001-002 16.6.2011 14.6.2011 PecFent Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom EU/1/10/644/001-006 16.6.2011 14.6.2011 Ribavirin BioPartners BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland EU/1/10/626/001-004 16.6.2011 14.6.2011 Temodal Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/98/096/001-025 16.6.2011 14.6.2011 Twynsta Boehringer Ingelheim International GmbH Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland EU/1/10/648/001-028 16.6.2011 14.6.2011 Vidaza Celgene Europe Ltd Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom EU/1/08/488/001 16.6.2011 15.6.2011 InductOs Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 20.6.2011 15.6.2011 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/00/152/009-018 17.6.2011 15.6.2011 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 17.6.2011 15.6.2011 Ziagen ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/112/001-002 17.6.2011 16.6.2011 INCRELEX Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/07/402/001 21.6.2011 16.6.2011 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 22.6.2011 16.6.2011 Irbesartan HCT Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/377/001-028 21.6.2011 16.6.2011 Macugen Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/05/325/002 21.6.2011 16.6.2011 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475/001-034 21.6.2011 16.6.2011 Omnitrope Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich EU/1/06/332/001-012 21.6.2011 16.6.2011 Ozurdex Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638/001 21.6.2011 16.6.2011 Samsca Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom EU/1/09/539/001-004 21.6.2011 16.6.2011 Tysabri Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland EU/1/06/346/001 21.6.2011 16.6.2011 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 24.6.2011 16.6.2011 Zebinix BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal EU/1/09/514/001-020 21.6.2011 17.6.2011 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/97/046/001-039 23.6.2011 17.6.2011 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 23.6.2011 17.6.2011 INCRELEX Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/07/402/001 23.6.2011 17.6.2011 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-044 23.6.2011 17.6.2011 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 24.6.2011 17.6.2011 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/008-013 EU/1/07/400/017-024 23.6.2011 17.6.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 23.6.2011 17.6.2011 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/462/001-012 21.6.2011 17.6.2011 Relistor Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/08/463/001-011 21.6.2011 17.6.2011 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 21.6.2011 17.6.2011 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 24.6.2011 17.6.2011 Tasigna Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-008 23.6.2011 17.6.2011 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 23.6.2011 17.6.2011 Tysabri Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland EU/1/06/346/001 23.6.2011 17.6.2011 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163/001-002 21.6.2011 17.6.2011 Xolair Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/319/001-010 23.6.2011 23.6.2011 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-007 28.6.2011 23.6.2011 Docefrez Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/10/630/001-002 28.6.2011 23.6.2011 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 28.6.2011 23.6.2011 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 27.6.2011 23.6.2011 Ganfort Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/06/340/001-002 28.7.2011 23.6.2011 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 27.6.2011 23.6.2011 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 28.6.2011 23.6.2011 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067/001-002 27.6.2011 23.6.2011 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006/001-007 27.6.2011 23.6.2011 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389/001-003 28.6.2011 23.6.2011 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165/001-008 27.6.2011 23.6.2011 Protopic Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/02/201/001-006 27.6.2011 23.6.2011 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 28.6.2011 23.6.2011 Temozolomide HEXAL HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616/001-024 27.6.2011 23.6.2011 Temozolomide Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/10/617/001-024 27.6.2011 23.6.2011 Tevagrastim Teva GmbH Wasastraße 50, 01445 Radebeul, Deutschland EU/1/08/445/001-014 27.6.2011 23.6.2011 Torisel Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/07/424/001 27.6.2011 23.6.2011 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/96/020/001-009 27.6.2011 23.6.2011 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/055/001-004 28.6.2011 29.6.2011 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom EU/1/07/428/001 5.7.2011 29.6.2011 Aclasta Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 4.7.2011 29.6.2011 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/001-009 1.7.2011 29.6.2011 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/001-026 5.7.2011 29.6.2011 Advate Baxter AG Industriesstrasse 67, 1220 Vienna, Österreich EU/1/03/271/001-006 4.7.2011 29.6.2011 APTIVUS Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/05/315/001-002 4.7.2011 29.6.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 4.7.2011 29.6.2011 Bondenza Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/266/003-006 1.7.2011 29.6.2011 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 1.7.2011 29.6.2011 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265/003-006 1.7.2011 29.6.2011 Byetta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/06/362/001-004 5.7.2011 29.6.2011 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416/001-002 1.7.2011 29.6.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-022 1.7.2011 29.6.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-022 5.7.2011 29.6.2011 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-009 1.7.2011 29.6.2011 Ibandronic Acid Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/642/001-004 1.7.2011 29.6.2011 Instanyl Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/09/531/001-021 5.7.2011 29.6.2011 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 4.7.2011 29.6.2011 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/97/049/001-039 5.7.2011 29.6.2011 Keppra UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/00/146/001-032 4.7.2011 29.6.2011 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 5.7.2011 29.6.2011 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-016 1.7.2011 29.6.2011 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 1.7.2011 29.6.2011 Prevenar 13 Wyeth Lederle Vaccines S.A. Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium EU/1/09/590/001-006 5.7.2011 29.6.2011 Rasilez HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 1.7.2011 29.6.2011 Rebetol Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/107/001-005 1.7.2011 29.6.2011 Siklos ADDMEDICA 101, rue Saint Lazare, Paris 75009, France EU/1/07/397/001-004 4.7.2011 29.6.2011 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508/001-011 5.7.2011 29.6.2011 Telmisartan Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/610/031-060 5.7.2011 29.6.2011 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 1.7.2011 29.6.2011 Velcade Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 5.7.2011 29.6.2011 VPRIV Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646/003-006 5.7.2011 29.6.2011 Zometa Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176/001-006 1.7.2011





— Withdrawal of a marketing authorization (Article 13 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 14.6.2011 Humenza Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/10/629/001 16.6.2011





— 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 6.5.2011 CERTIFECT (S)-Methoprene, Fipronil, Amitraz MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/11/125/001-008 Spot-on solution QP53AX65 12.5.2011 6.5.2011 Zuprevo Tildipirosin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/124/001-008 Solution for injection QJ01FA96 12.5.2011 14.6.2011 MS-H vaccine Mycoplasma synoviae Strain MS-H live attenuated thermosensitive Pharmsure Ltd Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom EU/2/11/126/001 Eye drops, suspension QI01AE03 16.6.2011





— 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 16.5.2011 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/07/078/001-014 18.5.2011 18.5.2011 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-006 EU/2/04/044/013 23.5.2011 18.5.2011 Previcox Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/04/045/001-007 20.5.2011 18.5.2011 ProteqFlu Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/03/037/005 20.5.2011 18.5.2011 ProteqFlu-Te Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/03/038/005 20.5.2011 23.5.2011 Suvaxyn PCV Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom EU/2/09/099/001-006 25.5.2011 7.6.2011 Fevaxyn Pentofel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/96/002/001-003 9.6.2011 14.6.2011 Advocate Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/03/039/031-054 16.6.2011 14.6.2011 Naxcel Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/05/053/003 16.6.2011 15.6.2011 Convenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/06/059/001 17.6.2011 23.6.2011 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/026 EU/2/97/004/033-034 EU/2/97/004/039-040 EU/2/97/004/043-048 28.6.2011

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.