EN Official Journal of the European Union C 184/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 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 184/01

— 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 4.3.2011 Ifirmacombi Irbesartan/hydrochlorothiazide KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673/001-024 Film-coated tablet C09DA04 8.3.2011 4.3.2011 Pumarix Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/10/664/001 Suspension and emulsion for emulsion for injection J07BB02 8.3.2011 4.3.2011 Xeplion paliperidone Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672/001-006 Prolonged release suspension for injection N05AX13 8.3.2011 10.3.2011 Leflunomide Teva leflunomide Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/675/001-010 Film-coated tablet L04AA13 14.3.2011 14.3.2011 Repso leflunomide Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/674/001-010 Film-coated tablet L04AA13 17.3.2011 14.3.2011 Teysuno Tegafur/gimeracil/oteracil Taiho Pharma Europe, Limited 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom EU/1/11/669/001-004 Capsule, hard L01BC53 17.3.2011 17.3.2011 GILENYA Fingolimod Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677/001-004 Capsule, hard L04AA27 22.3.2011 17.3.2011 HALAVEN eribulin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/11/678/001-002 Solution for injection L01XX41 22.3.2011 17.3.2011 JEVTANA cabazitaxel Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/11/676/001 Concentrate and solvent for solution for infusion Pending 22.3.2011 28.3.2011 Trobalt retigabine Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/681/001-013 Film-coated tablet N03AX21 31.3.2011 13.4.2011 Riprazo HCT aliskiren hemifumarate / hydrochlorothiazide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/680/001-080 Film-coated tablet C09XA52 15.4.2011 14.4.2011 Hizentra human normal immunoglobulin CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland EU/1/11/687/001-012 Solution for injection J06BA01 18.4.2011 14.4.2011 Pravafenix fenofibrate / pravastatin LABORATOIRES SMB SA 26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe EU/1/11/679/001-006 Capsule, hard C10BA03 19.4.2011 14.4.2011 Rasilamlo aliskiren / amlodipine Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/686/001-056 Film-coated tablet C09XA53 18.4.2011





— 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 4.3.2011 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-021 8.3.2011 4.3.2011 Vaniqa Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/01/173/001-003 8.3.2011 8.3.2011 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560/001-009 10.3.2011 8.3.2011 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France EU/1/09/559/001-016 10.3.2011 8.3.2011 Rebetol Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/107/001-005 21.3.2011 8.3.2011 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 10.3.2011 10.3.2011 Abraxane Abraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom EU/1/07/428/001 22.3.2011 10.3.2011 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412/001-052 11.3.2011 10.3.2011 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412/001-052 14.3.2011 10.3.2011 Clopidogrel Teva Pharma Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/561/001-010 14.3.2011 14.3.2011 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230/001-017 17.3.2011 14.3.2011 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-007 18.3.2011 14.3.2011 Binocrit Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich EU/1/07/410/001-052 17.3.2011 14.3.2011 Binocrit Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich EU/1/07/410/001-052 16.3.2011 14.3.2011 Clopidogrel Acino Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532/001-007 16.3.2011 14.3.2011 Clopidogrel Hexal Acino Pharma GmbH Am Windfeld 35, Miesbach 83714, Deutschland EU/1/09/534/001-007 21.3.2011 14.3.2011 Epoetin alfa Hexal Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411/001-052 17.3.2011 14.3.2011 Epoetin alfa Hexal Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411/001-052 18.3.2011 14.3.2011 Prometax Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092/001-026 16.3.2011 14.3.2011 Rivastigmine HEXAL HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/09/589/001-018 21.3.2011 14.3.2011 Visudyne Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 21.3.2011 17.3.2011 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229/001-004 EU/1/02/229/011-019 EU/1/02/229/024-037 22.3.2011 17.3.2011 Clopidogrel Sandoz Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/547/001-007 22.3.2011 17.3.2011 Copalia HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/575/001-060 22.3.2011 17.3.2011 Dafiro HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/574/001-060 22.3.2011 17.3.2011 Exelon Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066/001-026 22.3.2011 17.3.2011 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 22.3.2011 17.3.2011 INOmax INO Therapeutics AB SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 22.3.2011 17.3.2011 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/01/195/001-027 22.3.2011 17.3.2011 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231/001-037 22.3.2011 17.3.2011 NovoMix Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/142/004-005 EU/1/00/142/009-025 22.3.2011 17.3.2011 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 22.3.2011 17.3.2011 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234/001-017 22.3.2011 18.3.2011 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/001-009 23.3.2011 18.3.2011 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-009 23.3.2011 18.3.2011 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 23.3.2011 18.3.2011 INOmax INO Therapeutics AB SE-181 81 Lidingö, Sverige EU/1/01/194/001-004 22.3.2011 18.3.2011 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437/001-004 23.3.2011 18.3.2011 Kaletra Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom EU/1/01/172/001-008 23.3.2011 18.3.2011 Kivexa ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/298/001-003 23.3.2011 18.3.2011 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/001-007 23.3.2011 18.3.2011 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614/001-002 23.3.2011 18.3.2011 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 23.3.2011 18.3.2011 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 23.3.2011 18.3.2011 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 23.3.2011 18.3.2011 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-040 23.3.2011 18.3.2011 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 23.3.2011 18.3.2011 Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050/013-033 23.3.2011 18.3.2011 Simulect Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 23.3.2011 18.3.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 23.3.2011 18.3.2011 Xyrem UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312/001 23.3.2011 18.3.2011 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009/001-009 23.3.2011 24.3.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 29.3.2011 24.3.2011 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543/001-002 29.3.2011 24.3.2011 Clopidogrel ratiopharm Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/554/001-008 28.3.2011 24.3.2011 DuoTrav Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/06/338/001-003 29.3.2011 24.3.2011 Evoltra Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/334/001-005 30.3.2011 24.3.2011 Exforge HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569/001-060 30.3.2011 24.3.2011 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/03/247/001-002 30.3.2011 24.3.2011 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535/001-016 29.3.2011 24.3.2011 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 28.3.2011 24.3.2011 Humalog Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 28.3.2011 24.3.2011 Imprida HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/570/001-060 30.3.2011 24.3.2011 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233/001-017 28.3.2011 24.3.2011 Levitra Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/03/248/001-020 30.3.2011 24.3.2011 Myocet Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France EU/1/00/141/001 29.3.2011 24.3.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 31.3.2011 24.3.2011 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/001-002 30.3.2011 24.3.2011 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267/001-010 30.3.2011 24.3.2011 Scintimun CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette - France EU/1/09/602/001-002 29.3.2011 24.3.2011 Silodyx Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/607/001-014 29.3.2011 24.3.2011 Soliris Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France EU/1/07/393/001 28.3.2011 24.3.2011 Sprimeo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-040 28.3.2011 24.3.2011 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386/001-018 30.3.2011 24.3.2011 Urorec Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/608/001-014 29.3.2011 24.3.2011 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 28.3.2011 24.3.2011 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 29.3.2011 24.3.2011 Zopya Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland EU/1/09/562/001-009 29.3.2011 24.3.2011 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 30.3.2011 28.3.2011 Adenuric Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/447/001-012 30.3.2011 28.3.2011 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 30.3.2011 28.3.2011 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 5.4.2011 28.3.2011 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-011 30.3.2011 28.3.2011 Oprymea KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469/001-025 30.3.2011 28.3.2011 Vizarsin KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551/001-012 30.3.2011 31.3.2011 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564/001-002 4.4.2011 31.3.2011 Temozolomide Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/606/001-012 4.4.2011 8.4.2011 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-039 12.4.2011 8.4.2011 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-039 12.4.2011 8.4.2011 Invega Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/07/395/001-095 12.4.2011 8.4.2011 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227/001-004 12.4.2011 8.4.2011 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/1/99/119/017-018 12.4.2011 8.4.2011 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 12.4.2011 8.4.2011 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-003 12.4.2011 12.4.2011 Aclasta Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 14.4.2011 12.4.2011 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/03/261/001-003 14.4.2011 12.4.2011 Firdapse BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/09/601/001 14.4.2011 12.4.2011 Kineret Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/02/203/001-004 14.4.2011 12.4.2011 Nexavar Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/06/342/001 14.4.2011 12.4.2011 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603/001-015 14.4.2011 14.4.2011 Bondenza Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/266/003-006 19.4.2011 14.4.2011 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 18.4.2011 14.4.2011 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265/003-006 19.4.2011 14.4.2011 Brinavess Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/645/001-002 18.4.2011 14.4.2011 Ceplene EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland EU/1/08/477/001 18.4.2011 14.4.2011 Integrilin Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/99/109/001-002 20.4.2011 14.4.2011 NutropinAq Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/00/164/003-005 19.4.2011 14.4.2011 Preotact Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/06/339/001-002 18.4.2011 14.4.2011 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 18.4.2011 14.4.2011 Travatan Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/01/199/001-002 18.4.2011 14.4.2011 Zopya Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland EU/1/09/562/001-009 19.4.2011 18.4.2011 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 21.4.2011 18.4.2011 DaTSCAN GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom EU/1/00/135/001-002 21.4.2011 18.4.2011 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 21.4.2011 18.4.2011 Firazyr Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland EU/1/08/461/001-002 21.4.2011 18.4.2011 Humalog Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 21.4.2011 18.4.2011 Kaletra Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom EU/1/01/172/001-008 21.4.2011 18.4.2011 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604/001-010 21.4.2011 18.4.2011 Modigraf Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/523/001-002 21.4.2011 18.4.2011 Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578/001 21.4.2011 18.4.2011 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-010 21.4.2011 18.4.2011 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 21.4.2011 18.4.2011 Somavert Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/240/001-004 21.4.2011 18.4.2011 Telzir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/282/001-002 21.4.2011 18.4.2011 Thalidomide Celgene Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 18.4.2011 18.4.2011 Valtropin BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland EU/1/06/335/001 21.4.2011 18.4.2011 Xyrem UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312/001 21.4.2011 20.4.2011 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/476/005-006 27.4.2011 20.4.2011 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/001-026 28.4.2011 20.4.2011 Altargo Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/390/001-004 27.4.2011 20.4.2011 Efient Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/08/503/001-016 28.4.2011 20.4.2011 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 27.4.2011 20.4.2011 Levitra Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/03/248/001-015 27.4.2011 20.4.2011 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/01/195/001-027 27.4.2011 20.4.2011 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/453/002 28.4.2011 20.4.2011 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 27.4.2011 20.4.2011 Revasc Canyon Pharmaceuticals Ltd 20-22 Bedford Row - WC1R 4JS London - United Kingdom EU/1/97/043/001-003 27.4.2011 20.4.2011 Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/546/001-004 27.4.2011 20.4.2011 Tolura KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632/001-021 28.4.2011 20.4.2011 Tysabri Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland EU/1/06/346/001 27.4.2011 20.4.2011 Vivanza Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/03/249/001-012 27.4.2011 20.4.2011 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009/001-009 27.4.2011





— 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 24.3.2011 Onsenal Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/03/259/001-006 29.3.2011 31.3.2011 Clopidogrel Sandoz Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/547/001-007 4.4.2011 20.4.2011 Filgrastim ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/449/001-008 28.4.2011





— 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 14.3.2011 CaniLeish Leishmania infantum Excreted Secreted Proteins (ESP) VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/11/121/001-009 Lyophilisate and solvent for suspension for injection QI07AO 17.3.2011 14.3.2011 ZULVAC 1+8 Ovis Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 / Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/11/120/001-003 Suspension for injection QI04AA02 17.3.2011 12.4.2011 Veraflox Pradofloxacin Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/10/107/001-014 Oral suspension Tablet QJ01MA 14.4.2011 14.4.2011 BLUEVAC BTV8 Bluetongue virus inactivated, serotype 8 CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA EU/2/11/122/001-003 Suspension for injection QI02AA08 QI04AA02 18.4.2011 20.4.2011 Procox emodepside & toltrazuril Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/11/123/001-002 Oral suspension QP52AX60 28.4.2011





— 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 10.3.2011 Flexicam Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark EU/2/06/058/004 14.3.2011 14.3.2011 Zulvac 8 Bovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/105/001-002 17.3.2011 18.3.2011 Zubrin Schering - Plough Limited Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom EU/2/00/028/002-008 23.3.2011 28.3.2011 BTVPUR AlSap 8 MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/09/094/001-005 31.3.2011 12.4.2011 Zactran MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/08/082/001-007 14.4.2011 14.4.2011 Convenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/06/059/001 20.4.2011

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, 30.4.04, p. 1.

(2) OJ L 136, 30.4.04, p. 1.