EN Official Journal of the European Union C 61/1

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

(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 61/01

— 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 29.11.2010 Aflunov Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658/001-002 suspension for injection in prefilled syringe J07BB02 3.12.2010 29.11.2010 Leflunomide ratiopharm leflunomide ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654/001-004 Film-coated tablet L04AA13 6.12.2010 29.11.2010 Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/657/001-002 suspension for injection in prefilled syringe J07BB02 3.12.2010 3.12.2010 Brilique ticagrelor AstraZeneca AB Södertälje S 151 85, Sverige EU/1/10/655/001-006 Film-coated tablet B01AC24 7.12.2010 3.12.2010 Possia ticagrelor AstraZeneca AB Södertälje S 151 85, Sverige EU/1/10/656/001-006 Film-coated tablet B01AC24 7.12.2010





— 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 3.11.2010 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229/001-037 8.11.2010 3.11.2010 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA, Houten, Nederland EU/1/08/476/005-006 9.11.2010 3.11.2010 Bridion N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/08/466/001-002 9.11.2010 3.11.2010 Combivir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/98/058/001-002 9.11.2010 3.11.2010 Doribax Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/467/001-002 9.11.2010 3.11.2010 Effentora Cephalon Europe 5 Rue Charles Martigny, Maisons-Alfort 94700, France EU/1/08/441/001-010 9.11.2010 3.11.2010 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 5.11.2010 3.11.2010 Enyglid KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/580/001-021 9.11.2010 3.11.2010 Filgrastim Hexal HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/08/496/001-016 9.11.2010 3.11.2010 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 5.11.2010 3.11.2010 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 8.11.2010 3.11.2010 Norvir Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-007 8.11.2010 3.11.2010 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475/001-034 9.11.2010 3.11.2010 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 9.11.2010 3.11.2010 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 5.11.2010 3.11.2010 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-020 9.11.2010 3.11.2010 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 9.11.2010 3.11.2010 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 9.11.2010 3.11.2010 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 8.11.2010 3.11.2010 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 9.11.2010 3.11.2010 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 9.11.2010 3.11.2010 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 8.11.2010 3.11.2010 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 9.11.2010 3.11.2010 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 8.11.2010 3.11.2010 Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/08/495/001-016 9.11.2010 5.11.2010 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 9.11.2010 5.11.2010 Diacomit Biocodex 7 avenue Gallieni, 94250 Gentilly, France EU/1/06/367/001-012 9.11.2010 5.11.2010 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 9.11.2010 5.11.2010 Irbesartan Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France, F- 75013 Paris, France EU/1/06/376/001-033 9.11.2010 5.11.2010 Torisel Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/07/424/001 9.11.2010 5.11.2010 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/97/029/001-010 9.11.2010 12.11.2010 Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP EU/1/03/270/001-003 16.11.2010 12.11.2010 Xolair Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/319/001-010 16.11.2010 19.11.2010 Qutenza Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/524/001-002 23.11.2010 26.11.2010 Ambirix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/02/224/001-005 1.12.2010 26.11.2010 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 1.12.2010 26.11.2010 Cancidas Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196/001 EU/1/01/196/003 1.12.2010 26.11.2010 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392/001-002 2.12.2010 26.11.2010 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 1.12.2010 26.11.2010 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-021 1.12.2010 26.11.2010 Iressa AstraZeneca AB Sodertalje S 151 85, Sverige EU/1/09/526/001-002 1.12.2010 26.11.2010 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 1.12.2010 26.11.2010 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 1.12.2010 26.11.2010 Livensa Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland EU/1/06/351/001-003 1.12.2010 26.11.2010 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 1.12.2010 26.11.2010 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497/001-008 1.12.2010 26.11.2010 Prevenar 13 Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15, B-1348 Louvain-la-Neuve, Belgium EU/1/09/590/001-006 1.12.2010 26.11.2010 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 1.12.2010 26.11.2010 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 1.12.2010 26.11.2010 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 1.12.2010 26.11.2010 Temozolomide Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/606/001-012 1.12.2010 26.11.2010 Thalidomide Celgene Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 1.12.2010 26.11.2010 Truvada Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/04/305/001-002 1.12.2010 26.11.2010 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 1.12.2010 26.11.2010 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 1.12.2010 26.11.2010 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 1.12.2010 26.11.2010 Zeffix Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/99/114/001-003 1.12.2010 29.11.2010 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/001-009 6.12.2010 29.11.2010 alli Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-015 3.12.2010 29.11.2010 Atriance Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/403/001 3.12.2010 29.11.2010 Cimzia UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/09/544/001-002 2.12.2010 29.11.2010 Corlentor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/317/001-014 2.12.2010 29.11.2010 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328/001-004 6.12.2010 29.11.2010 DepoCyte Pacira Limited 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom EU/1/01/187/001 18.1.2011 29.11.2010 Exalief BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal EU/1/09/520/001-020 2.12.2010 29.11.2010 Fertavid SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/09/510/001-019 6.12.2010 29.11.2010 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-009 1.12.2010 29.11.2010 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 2.12.2010 29.11.2010 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 2.12.2010 29.11.2010 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/05/331/001-055 2.12.2010 29.11.2010 NeuroBloc Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/00/166/001-003 2.12.2010 29.11.2010 PREZISTA Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/06/380/001-005 2.12.2010 29.11.2010 Procoralan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/05/316/001-014 2.12.2010 29.11.2010 Puregon Organon N.V. Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nederland EU/1/96/008/001-041 6.12.2010 29.11.2010 Remicade Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 6.12.2010 29.11.2010 Sebivo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 6.12.2010 29.11.2010 Sildenafil Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/584/001-018 2.12.2010 29.11.2010 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom EU/1/06/347/001-008 3.12.2010 29.11.2010 Travatan Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/01/199/001-002 2.12.2010 29.11.2010 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/00/156/002-004 2.12.2010 29.11.2010 Tysabri Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland EU/1/06/346/001 2.12.2010 29.11.2010 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 2.12.2010 29.11.2010 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom EU/1/02/212/001-026 6.12.2010 29.11.2010 Zebinix BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal EU/1/09/514/001-020 2.12.2010 3.12.2010 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-099 7.12.2010 3.12.2010 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389/001-003 7.12.2010 3.12.2010 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 7.12.2010 3.12.2010 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009/001-009 7.12.2010 6.12.2010 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564/001-002 8.12.2010 6.12.2010 Kiovig Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/05/329/001-006 9.12.2010 6.12.2010 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 8.12.2010 13.12.2010 Diacomit Biocodex 7 avenue Gallieni, 94250 Gentilly, France EU/1/06/367/001-012 15.12.2010 13.12.2010 Flebogamma DIF Instituto Grifols, S.A. Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa EU/1/07/404/001-008 15.12.2010 13.12.2010 Invega Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/07/395/001-095 15.12.2010 13.12.2010 Kaletra Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom EU/1/01/172/001-008 15.12.2010 13.12.2010 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 15.12.2010 13.12.2010 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 15.12.2010 13.12.2010 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 15.12.2010 13.12.2010 Velcade Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 15.12.2010 17.12.2010 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 22.12.2010 20.12.2010 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Republic of Ireland EU/1/04/306/001-003 4.1.2011 20.12.2010 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-099 23.12.2010 20.12.2010 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 23.12.2010 20.12.2010 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 23.12.2010 20.12.2010 Celsentri ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/418/001-010 23.12.2010 20.12.2010 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom EU/1/06/360/001-013 23.12.2010 20.12.2010 Conbriza Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/09/511/001-004 23.12.2010 20.12.2010 DuoCover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/10/623/001-015 23.12.2010 20.12.2010 DuoPlavin Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France EU/1/10/619/001-015 23.12.2010 20.12.2010 Emselex Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/04/294/001-028 23.12.2010 20.12.2010 Exjade Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356/001-009 23.12.2010 20.12.2010 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 23.12.2010 20.12.2010 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-005 23.12.2010 20.12.2010 Javlor Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France EU/1/09/550/001-012 23.12.2010 20.12.2010 Kogenate Bayer Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/143/004-013 23.12.2010 20.12.2010 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067/001-002 23.12.2010 20.12.2010 Macugen Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom EU/1/05/325/002 23.12.2010 20.12.2010 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 23.12.2010 20.12.2010 Mycamine Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/08/448/001-002 23.12.2010 20.12.2010 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/05/324/001-002 22.12.2010 20.12.2010 Optison GE Healthcare AS Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norway EU/1/98/065/001-002 22.12.2010 20.12.2010 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/001-014 23.12.2010 20.12.2010 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-008 23.12.2010 20.12.2010 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 23.12.2010 20.12.2010 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/494/001-004 23.12.2010 20.12.2010 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom EU/1/06/347/001-008 23.12.2010 20.12.2010 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 23.12.2010 20.12.2010 Tasigna Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-006 23.12.2010 20.12.2010 Tasigna Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-006 23.12.2010 20.12.2010 Thalidomide Celgene Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 23.12.2010 20.12.2010 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/001-014 23.12.2010 20.12.2010 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/001-014 23.12.2010 20.12.2010 Ventavis Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland EU/1/03/255/001-008 23.12.2010 20.12.2010 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom EU/1/02/212/001-026 23.12.2010 20.12.2010 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 27.12.2010 20.12.2010 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 22.12.2010 20.12.2010 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/009-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-040 23.12.2010 20.12.2010 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/99/125/017-020 23.12.2010





— 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 13.12.2010 Arepanrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/10/624/001 15.12.2010





— Suspension of a marketing authorization (Article 20 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 3.12.2010 Avaglim SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/06/349/001-010 7.12.2010 3.12.2010 Avandamet SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/03/258/001-022 7.12.2010 3.12.2010 Avandia SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/002-018 7.12.2010





— 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 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 5.11.2010 BTVPUR AlSap 2-4 Bluetongue virus serotypes 2-4 MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/108/001-005 Suspension for injection QI02AA08 QI04AA02 9.11.2010 19.11.2010 Meloxoral Meloxicam Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/10/111/001-004 Oral suspension QM01AC06 23.11.2010 17.12.2010 BTVPUR AlSap 1 Bluetongue Virus Serotype 1 antigen MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/112/001-005 Suspension for injection QI02AA08 QI04AA02 22.12.2010 17.12.2010 BTVPUR AlSap 1-8 Bluetongue Virus Serotype 1 antigen - Bluetongue Virus Serotype 8 antigen MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/113/001-005 Suspension for injection QI02AA08 QI04AA02 22.12.2010





— 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 3.11.2010 Melovem Dopharma Research B.V. Zalmweg 24, 4941 VX Raamsdonksveer, Nederland EU/2/09/098/001 8.11.2010 26.11.2010 ProMeris Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland EU/2/06/064/001-004 3.12.2010 26.11.2010 ProMeris Duo Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland EU/2/06/065/001-010 3.12.2010 29.11.2010 Circovac Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/07/075/001-004 3.12.2010 3.12.2010 Masivet AB Science S.A. 3 avenue George V, 75008 Paris, France EU/2/08/087/001-002 7.12.2010 13.12.2010 Poulvac FluFend H5N3 RG Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom EU/2/06/060/001-002 15.12.2010 20.12.2010 Improvac Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/095/001-006 23.12.2010 20.12.2010 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/001 EU/2/97/004/003-048 23.12.2010

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.

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