EN Official Journal of the European Union C 258/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010

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

(2010/C 258/01)

— 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 11.3.2010 Revolade Eltrombopag GlaxoSmithKline Trading Services Limited 6900 CorkAirport Business Park, Kinsale Road, Cork, Ireland EU/1/10/612/001-006 Film-coated tablet B02BX05 15.3.2010 15.3.2010 DuoCover clopidogrel / acetylsalicylic acid Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/10/623/001-014 Film-coated tablet B01AC30 17.3.2010 15.3.2010 DuoPlavin clopidogrel / acetylsalicylic acid Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France EU/1/10/619/001-014 Film-coated tablet B01AC30 17.3.2010 15.3.2010 ImmunoGam Human Hepatitis B Immunoglobulin Cangene Europe Limited Parkshot House, 5 Kew Road, Richmond, SurreyTW9 2PR, United Kingdom EU/1/10/613/001-002 Solution for injection J06BB04 17.3.2010 15.3.2010 Menveo Meningococcal Group A, C, W135 and Y Conjugate Vaccine Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 - Siena, Italia EU/1/10/614/001 Powder and solution for injection Pending 17.3.2010 15.3.2010 Ristaben sitagliptin Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 Film-coated tablet A10BH01 17.3.2010 15.3.2010 Ristfor sitagliptin / metformin hydrochloride Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 Film-coated tablet A10BD07 17.3.2010 15.3.2010 Temozolomide HEXAL temozolomide HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616/001-024 Capsule, hard L01AX03 17.3.2010 15.3.2010 Temozolomide Hospira temozolomide Hospira UK Ltd. Queensway, Royal Leamington Spa, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/615/001-024 Capsule, hard L01AX03 17.3.2010 15.3.2010 Temozolomide Sandoz temozolomide Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/10/617/001-024 Capsule, hard L01AX03 17.3.2010 15.3.2010 Tepadina Thiotepa ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia EU/1/10/622/001-002 powder for concentrate for solution for infusion L01AC01 17.3.2010 23.3.2010 Arepanrix Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A) GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/10/624/001 Suspension and emulsion for emulsion for injection J07BB02 25.3.2010 6.4.2010 Ribavirin BioPartners Ribavirin BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland EU/1/10/626/001-004 Film-coated tablet J05AB04 9.4.2010 19.4.2010 Arzerra Ofatumumab Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/625/001-002 Concentrate for solution for infusion L01XC10 21.4.2010 29.4.2010 Raloxifene Teva Raloxifene hydrochloride Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/627/001-003 Film-coated tablet G03XC01 3.5.2010 10.5.2010 Docefrez Docetaxel Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/10/630/001-002 Powder and solvent for concentrate for solution for infusion L01CD02 12.5.2010 26.5.2010 Prolia denosumab Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 Solution for injection M05BX04 28.5.2010 4.6.2010 Tolura telmisartan KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632/001-021 Tablet C09CA07 8.6.2010 8.6.2010 Humenza Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A) Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/10/629/001 Suspension and emulsion for emulsion for injection J07BB02 10.6.2010 8.6.2010 Nivestim Filgrastim Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/631/001-009 Solution for injection or infusion L03AA02 10.6.2010 10.6.2010 Olanzapine Apotex Olanzapine Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/10/635/001-014 Film-coated tablet Orodispersible tablet N05AH03 14.6.2010 10.6.2010 Ribavirin Three Rivers Ribavirin Three Rivers Global Pharma Limited 20-22 Bedford Row, London WC1R4JS, United Kingdom EU/1/10/634/001-004 Capsule, hard J05AB04 14.6.2010 10.6.2010 Topotecan Hospira Topotecan Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/633/001-002 Concentrate for solution for infusion L01XX17 14.6.2010 14.6.2010 Votrient Pazopanib hydrochloride Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 Film-coated tablet L01XE11 16.6.2010

— 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 8.4.2010 Impulsor Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France 12.4.2010 8.4.2010 Milnacipran Pierre Fabre Medicament Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France 12.4.2010

— 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 11.3.2010 Cancidas Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196/001 EU/1/01/196/003 15.3.2010 11.3.2010 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-036 15.3.2010 11.3.2010 Diacomit Biocodex 7 avenue Gallieni, 94250 Gentilly, France EU/1/06/367/001-012 15.3.2010 11.3.2010 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573/001-028 15.3.2010 11.3.2010 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom EU/1/06/378/001-016 15.3.2010 11.3.2010 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/494/003-004 15.3.2010 11.3.2010 Zopya Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland EU/1/09/562/001-009 15.3.2010 15.3.2010 Abraxane Abraxis BioScience Limited Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom EU/1/07/428/001 17.3.2010 15.3.2010 Aerinaze SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/07/399/001-006 17.3.2010 15.3.2010 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 17.3.2010 15.3.2010 Aldara Meda AB Pipers väg 2A, Solna 170 73, Svërige EU/1/98/080/002 17.3.2010 15.3.2010 Altargo Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/390/001-004 17.3.2010 15.3.2010 Arcalyst Regeneron UK Limited 40 Bank Street, E14 5DS London, United Kingdom EU/1/09/582/001 17.3.2010 15.3.2010 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 19.3.2010 15.3.2010 Avonex Biogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/97/033/002-004 17.3.2010 15.3.2010 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-007 17.3.2010 15.3.2010 Biopoin CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/09/565/001-028 17.3.2010 15.3.2010 Byetta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/06/362/001-004 17.3.2010 15.3.2010 Carbaglu Orphan Europe Immeuble Le Wilson, 70 Avenue du General de Gaulle, 92800 Puteaux, France EU/1/02/246/001-003 17.3.2010 15.3.2010 Cayston GileadSciencesInternational Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543/001 17.3.2010 15.3.2010 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560/001-009 17.3.2010 15.3.2010 Clopidogrel Hexal Acino Pharma GmbH Am Windfeld 35, Miesbach 83714, Deutschland EU/1/09/534/001-007 17.3.2010 15.3.2010 Clopidogrel Teva Pharma Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/561/001-010 17.3.2010 15.3.2010 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-036 17.3.2010 15.3.2010 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328/001-002 17.3.2010 15.3.2010 Doribax Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/467/001-002 17.3.2010 15.3.2010 Duloxetine Boehringer Ingelheim Boehringer Ingelheim International GmbH Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland EU/1/08/471/001-012 17.3.2010 15.3.2010 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 17.3.2010 15.3.2010 Effentora Cephalon Europe 5 Rue Charles Martigny, Maisons-Alfort 94700, France EU/1/08/441/001-010 22.3.2010 15.3.2010 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige EU/1/06/365/001-003 17.3.2010 15.3.2010 Eucreas Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 17.3.2010 15.3.2010 Evoltra Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/334/001-005 17.3.2010 15.3.2010 Exjade Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356/001-009 17.3.2010 15.3.2010 Faslodex AstraZenecaUK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269/001 17.3.2010 15.3.2010 Firazyr Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland EU/1/08/461/001 17.3.2010 15.3.2010 GONAL-f Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001/001 EU/1/95/001/003-005 EU/1/95/001/009 EU/1/95/001/012 EU/1/95/001/021-022 EU/1/95/001/025-028 EU/1/95/001/031-035 17.3.2010 15.3.2010 Humira Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/03/256/001-010 17.3.2010 15.3.2010 Icandra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484/001-018 23.3.2010 15.3.2010 IntronA Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/127/011-044 17.3.2010 15.3.2010 Invirase Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 17.3.2010 15.3.2010 Iscover Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/070/012 17.3.2010 15.3.2010 Kepivance BiovitrumAB (publ) SE-112 76 Stockholm, Sverige EU/1/05/314/001 17.3.2010 15.3.2010 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/001-007 17.3.2010 15.3.2010 Mircera Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/001-024 17.3.2010 15.3.2010 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/337/001-013 17.3.2010 15.3.2010 Mozobil Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/537/001 19.3.2010 15.3.2010 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co. Clare, Ireland EU/1/05/331/001-055 18.3.2010 15.3.2010 Nimvastid KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/525/047-050 17.3.2010 15.3.2010 Norvir Abbott Laboratories Ltd Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-004 17.3.2010 15.3.2010 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165/001-007 17.3.2010 15.3.2010 Pergoveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/07/396/001-003 17.3.2010 15.3.2010 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/069/012 17.3.2010 15.3.2010 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/06/380/001-005 17.3.2010 15.3.2010 Rapamune Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/007-010 17.3.2010 15.3.2010 Remicade Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 17.3.2010 15.3.2010 Removab Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland EU/1/09/512/001-002 17.3.2010 15.3.2010 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 17.3.2010 15.3.2010 Reyataz Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267/001-010 17.3.2010 15.3.2010 Sebivo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 17.3.2010 15.3.2010 Sebivo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 17.3.2010 15.3.2010 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/494/001-002 17.3.2010 15.3.2010 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 17.3.2010 15.3.2010 Tamiflu Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 17.3.2010 15.3.2010 Thalidomide Celgene Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 17.3.2010 15.3.2010 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/96/020/001-009 17.3.2010 15.3.2010 Valtropin BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland EU/1/06/335/001 17.3.2010 15.3.2010 Vaniqa Laboratorios Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/01/173/001-003 17.3.2010 15.3.2010 Vantavo (ex Alendronate sodium and colecalciferol, MSD) Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 17.3.2010 15.3.2010 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 17.3.2010 15.3.2010 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 18.3.2010 15.3.2010 Zomarist Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483/001-018 17.3.2010 15.3.2010 Zylagren KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/558/001-010 17.3.2010 19.3.2010 Clopidogrel ratiopharm GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/541/001-008 23.3.2010 19.3.2010 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-036 23.3.2010 19.3.2010 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-036 23.3.2010 19.3.2010 Evoltra Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland EU/1/06/334/001-005 23.3.2010 19.3.2010 Kineret BiovitrumAB (publ) SE-112 76, Stockholm, Sverige EU/1/02/203/001-003 23.3.2010 19.3.2010 Renvela Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/09/521/001-007 23.3.2010 19.3.2010 Ventavis Bayer Schering Pharma AG Müllerstrasse 170-178, D-13342 Berlin, Deutschland EU/1/03/255/001-008 23.3.2010 22.3.2010 Fuzeon Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/252/001-003 24.3.2010 23.3.2010 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House, HighbridgeBusinessPark, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom EU/1/04/276/001-020 EU/1/04/276/024-036 25.3.2010 23.3.2010 Aerius Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/160/001-069 25.3.2010 23.3.2010 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Republic of Ireland EU/1/04/306/001 25.3.2010 23.3.2010 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-099 25.3.2010 23.3.2010 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland EU/1/02/218/001-003 EU/1/02/218/007-010 EU/1/02/218/012-016 EU/1/02/218/023 25.3.2010 23.3.2010 Azomyr Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/157/001-067 23.3.2010 23.3.2010 Cetrotide SERONO EUROPE LIMITED 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/99/100/001-003 25.3.2010 23.3.2010 Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/268/001-004 25.3.2010 23.3.2010 Clopidogrel Krka KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556/001-011 25.3.2010 23.3.2010 Clopidogrel ratiopharm Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/554/001-008 25.3.2010 23.3.2010 Clopidogrel Sandoz Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/547/001-007 25.3.2010 23.3.2010 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland EU/1/09/555/001-009 25.3.2010 23.3.2010 Clopidogrel Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/540/001-016 25.3.2010 23.3.2010 Copalia HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/575/001-060 25.3.2010 23.3.2010 Dafiro HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/574/001-060 25.3.2010 23.3.2010 Enviage Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/406/001-020 25.3.2010 23.3.2010 Exelon Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066/001-026 25.3.2010 23.3.2010 Exforge Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370/001-036 25.3.2010 23.3.2010 Humira Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/03/256/001-010 25.3.2010 23.3.2010 IDflu Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507/001-006 25.3.2010 23.3.2010 Imprida Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373/001-036 25.3.2010 23.3.2010 Ixiaro Intercell AG Campus Vienna Biocenter 3 A-1030 Wien, Österreich EU/1/08/501/001-002 25.3.2010 23.3.2010 Mabthera Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067/001-002 25.3.2010 23.3.2010 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/439/001-004 25.3.2010 23.3.2010 Myfenax Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/07/438/001-004 23.3.2010 23.3.2010 Neoclarityn Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/161/001-067 23.3.2010 23.3.2010 Norvir Abbott Laboratories Ltd Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-006 25.3.2010 23.3.2010 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/586/001-010 25.3.2010 23.3.2010 Prometax Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092/001-026 25.3.2010 23.3.2010 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 25.3.2010 23.3.2010 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-020 25.3.2010 23.3.2010 Simponi Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546/001-004 25.3.2010 23.3.2010 Sprimeo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-020 25.3.2010 23.3.2010 Stalevo Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-033 25.3.2010 23.3.2010 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 25.3.2010 23.3.2010 Synagis Abbott Laboratories Ltd Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/99/117/001-002 23.3.2010 23.3.2010 Tandemact Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwich, London WC2B 4AE, United Kingdom EU/1/06/366/005-022 25.3.2010 23.3.2010 Tasigna Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-004 25.3.2010 23.3.2010 Thalidomide Celgene Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom EU/1/08/443/001 25.3.2010 23.3.2010 Visudyne Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 25.3.2010 23.3.2010 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 25.3.2010 23.3.2010 Xeloda Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163/001-002 25.3.2010 26.3.2010 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA, Houten, Nederland EU/1/08/476/005-006 30.3.2010 26.3.2010 Avandamet SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/03/258/001-022 30.3.2010 26.3.2010 Avandia SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/002-018 30.3.2010 26.3.2010 Celsentri Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/418/001-010 29.3.2010 26.3.2010 Celsentri Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/418/001-010 29.3.2010 26.3.2010 Clopidogrel Qualimed Qualimed 117, Allée des Parcs, 69800 Saint Priest, France EU/1/09/557/001-010 30.3.2010 26.3.2010 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/354/001-009 30.3.2010 26.3.2010 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328/001-002 30.3.2010 26.3.2010 Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/02/219/001-003 EU/1/02/219/007-012 EU/1/02/219/014-022 EU/1/02/219/036 30.3.2010 26.3.2010 Exforge HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569/001-060 30.3.2010 26.3.2010 Galvus Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 30.3.2010 26.3.2010 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 29.3.2010 26.3.2010 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 29.3.2010 26.3.2010 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-004 30.3.2010 26.3.2010 Hirobriz Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/594/001-010 30.3.2010 26.3.2010 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564/001-002 30.3.2010 26.3.2010 Imprida HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/570/001-060 30.3.2010 26.3.2010 InductOs Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/02/226/001 30.3.2010 26.3.2010 Intanza Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon69007, France EU/1/08/505/001-006 30.3.2010 26.3.2010 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 30.3.2010 26.3.2010 Invega Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/07/395/001-095 29.3.2010 26.3.2010 Invirase Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 30.3.2010 26.3.2010 Isentress Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 30.3.2010 26.3.2010 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437/001 30.3.2010 26.3.2010 Jalra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 30.3.2010 26.3.2010 Kogenate Bayer Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/143/001-011 30.3.2010 26.3.2010 Onbrez Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593/001-010 30.3.2010 26.3.2010 Panretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/00/149/001 30.3.2010 26.3.2010 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 30.3.2010 26.3.2010 Remicade Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 30.3.2010 26.3.2010 Sustiva Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110/001-005 EU/1/99/110/008-010 30.3.2010 26.3.2010 Temomedac ALFRED E. TIEFENBACHER, (GmbH & Co. KG) Van-der-Smissen-Straße 1, Hamburg 22767, Deutschland EU/1/09/605/001-012 30.3.2010 26.3.2010 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 29.3.2010 26.3.2010 Vistide Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/97/037/001 30.3.2010 26.3.2010 Xagrid ShirePharmaceuticalContracts Ltd Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 29.3.2010 26.3.2010 Xiliarx Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 30.3.2010 30.3.2010 Aclasta Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 1.4.2010 30.3.2010 Actos Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/150/001-024 1.4.2010 30.3.2010 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 1.4.2010 30.3.2010 Celvapan Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/08/506/001 1.4.2010 30.3.2010 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, 69800 Saint Priest, France EU/1/09/559/001-016 1.4.2010 30.3.2010 Evicel OMRIX biopharmaceuticals S.A. / N.V. 200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België EU/1/08/473/001-003 1.4.2010 30.3.2010 Extavia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/454/001-002 EU/1/08/454/005-007 1.4.2010 30.3.2010 Glubrava Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/07/421/001-009 1.4.2010 30.3.2010 Glustin Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/151/001-024 1.4.2010 30.3.2010 INCRELEX Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/07/402/001 1.4.2010 30.3.2010 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 1.4.2010 30.3.2010 Kaletra Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/01/172/004-007 31.3.2010 30.3.2010 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/010-011 6.4.2010 30.3.2010 Lucentis Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374/001 1.4.2010 30.3.2010 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 31.3.2010 30.3.2010 RoActemra Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 1.4.2010 30.3.2010 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 1.4.2010 30.3.2010 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 1.4.2010 30.3.2010 Xolair Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/319/001-010 31.3.2010 6.4.2010 Retacrit HOSPIRA Enterprises B.V. Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland EU/1/07/431/001-025 14.4.2010 6.4.2010 Silapo STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland EU/1/07/432/001-022 9.4.2010 9.4.2010 Avaglim SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/06/349/001-010 13.4.2010 9.4.2010 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France EU/1/01/191/001-005 13.4.2010 9.4.2010 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 13.4.2010 15.4.2010 Firdapse EUSA Pharma SAS 3 Allée des Séquoias, Limonest 69760, FRANCE EU/1/09/601/001 20.4.2010 19.4.2010 Ifirmasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480/001-018 23.4.2010 22.4.2010 Sildenafil Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/584/001-018 26.4.2010 22.4.2010 Tracleer ActelionRegistration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-006 26.4.2010 27.4.2010 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 29.4.2010 27.4.2010 Aldara Meda AB Pipers väg 2A, Solna 170 73, Svërige EU/1/98/080/001-002 29.4.2010 27.4.2010 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253/001-003 29.4.2010 27.4.2010 Altargo Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/390/001-004 29.4.2010 27.4.2010 Bridion N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/08/466/001-002 29.4.2010 27.4.2010 Doribax Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/467/001-002 29.4.2010 27.4.2010 Exelon Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/066/001-026 29.4.2010 27.4.2010 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 - Siena, Italia EU/1/07/385/001-002 EU/1/07/385/004 29.4.2010 27.4.2010 Fuzeon Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/252/001-003 29.4.2010 27.4.2010 Kinzalkomb Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/02/214/001-015 29.4.2010 27.4.2010 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland EU/1/02/213/001-023 3.5.2010 27.4.2010 Remicade Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 29.4.2010 27.4.2010 RoActemra Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 29.4.2010 27.4.2010 Tamiflu Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 29.4.2010 27.4.2010 Tarceva Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 29.4.2010 27.4.2010 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/95/002/001-005 29.4.2010 27.4.2010 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-002 29.4.2010 27.4.2010 Velcade Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 29.4.2010 27.4.2010 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470/014-015 29.4.2010 29.4.2010 Aclasta Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 3.5.2010 29.4.2010 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 3.5.2010 29.4.2010 Ceplene EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland EU/1/08/477/001 3.5.2010 29.4.2010 Clopidogrel Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/08/465/001-020 3.5.2010 29.4.2010 Epivir Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/96/015/001-005 4.5.2010 29.4.2010 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 - Siena, Italia EU/1/07/385/001-002 EU/1/07/385/004 3.5.2010 29.4.2010 Humira Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/03/256/001-010 4.5.2010 29.4.2010 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233/001-017 3.5.2010 29.4.2010 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/08/468/001 3.5.2010 29.4.2010 Iscover Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b EU/1/98/070/005a-005b EU/1/98/070/006a-006b EU/1/98/070/007a-007b EU/1/98/070/008-010 EU/1/98/070/011a-011b EU/1/98/070/012 4.5.2010 29.4.2010 Kepivance BiovitrumAB (publ) SE-112 76 Stockholm, Sverige EU/1/05/314/001 3.5.2010 29.4.2010 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-043 4.5.2010 29.4.2010 Mircera Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/001-024 4.5.2010 29.4.2010 NeoRecormon Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/97/031/019-046 4.5.2010 29.4.2010 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b EU/1/98/069/012 3.5.2010 29.4.2010 PritorPlus Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/02/215/001-021 3.5.2010 29.4.2010 Prometax Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092/001-026 4.5.2010 29.4.2010 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234/001-017 3.5.2010 29.4.2010 Tygacil Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/06/336/001 3.5.2010 29.4.2010 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, MiddlesexUB6 0NN, United Kingdom EU/1/07/440/001-002 3.5.2010 29.4.2010 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 3.5.2010 5.5.2010 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Republic of Ireland EU/1/04/306/001-003 7.5.2010 5.5.2010 BeneFIX Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/97/047/001-007 7.5.2010 5.5.2010 Bondenza Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/266/003-006 7.5.2010 5.5.2010 Bonviva Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265/003-006 7.5.2010 5.5.2010 Celsentri Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/418/001-010 7.5.2010 5.5.2010 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/001-005 7.5.2010 5.5.2010 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-021 7.5.2010 5.5.2010 Kiovig Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/05/329/001-006 7.5.2010 5.5.2010 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 7.5.2010 5.5.2010 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 7.5.2010 5.5.2010 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 7.5.2010 5.5.2010 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-021 7.5.2010 5.5.2010 Sprycel Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-011 7.5.2010 5.5.2010 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-003 7.5.2010 5.5.2010 ViraferonPeg Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/132/001-050 7.5.2010 5.5.2010 Visudyne Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 7.5.2010 10.5.2010 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 12.5.2010 10.5.2010 Combivir Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/98/058/001-002 12.5.2010 10.5.2010 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/00/152/001-020 12.5.2010 10.5.2010 Optimark Covidien Deutschland GmbH Gewerbepark 1, Neustadt/Donau 93333, Deutschland EU/1/07/398/001-014 12.5.2010 10.5.2010 Orgalutran N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland EU/1/00/130/001-002 12.5.2010 10.5.2010 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/462/001-012 12.5.2010 10.5.2010 Tysabri Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland EU/1/06/346/001 12.5.2010 10.5.2010 Xeristar Boehringer Ingelheim International GmbH Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland EU/1/04/297/001-008 12.5.2010 10.5.2010 Ziagen Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom EU/1/99/112/001-002 12.5.2010 12.5.2010 Aclasta Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 18.5.2010 12.5.2010 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-021 18.5.2010 12.5.2010 Kuvan Merck KGaA Frankfurter Straße 250, 64293 Darmstadt, Deutschland EU/1/08/481/001-003 18.5.2010 12.5.2010 Olazax GlenmarkPharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597/001-005 18.5.2010 26.5.2010 Avandia SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom EU/1/00/137/002-018 28.5.2010 26.5.2010 Cyanokit Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France EU/1/07/420/001 28.5.2010 26.5.2010 Kivexa Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/04/298/001-003 28.5.2010 26.5.2010 Myocet Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France EU/1/00/141/001 28.5.2010 26.5.2010 Olanzapine Glenmark Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom EU/1/09/587/001-017 1.6.2010 26.5.2010 Olanzapine Glenmark Europe Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom EU/1/09/588/001-012 1.6.2010 26.5.2010 Olazax Disperzi GlenmarkPharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/592/001-005 28.5.2010 26.5.2010 Prevenar Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 - 1348 Louvain-La-Neuve, Belgique EU/1/00/167/001-008 28.5.2010 26.5.2010 Telzir Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom EU/1/04/282/001-002 28.5.2010 26.5.2010 Trizivir Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/156/002-004 28.5.2010 26.5.2010 Xagrid ShirePharmaceuticalContracts Ltd Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295/001 28.5.2010 2.6.2010 Abraxane Abraxis BioScience Limited Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom EU/1/07/428/001 4.6.2010 2.6.2010 Avastin Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 7.6.2010 2.6.2010 Bridion N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/08/466/001-002 4.6.2010 2.6.2010 Celsentri Pfizer Limited Ramsgate Road, Sandwich, KentCT13 9NJ, United Kingdom EU/1/07/418/001-010 4.6.2010 2.6.2010 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 4.6.2010 2.6.2010 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, BerkshireRG1 3EB, United Kingdom EU/1/07/392/001-002 7.6.2010 2.6.2010 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 7.6.2010 2.6.2010 Fertavid SP Europe Rue de Stalle, 73 B-1180 Bruxelles, Belgique EU/1/09/510/001-019 4.6.2010 2.6.2010 Humira Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom EU/1/03/256/001-010 7.6.2010 2.6.2010 Intrinsa Warner Chilcott Pharmaceuticals UK Ltd Whitehall Lane, Egham, SurreyTW20 9NW, United Kingdom EU/1/06/352/001-003 4.6.2010 2.6.2010 Prezista Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/06/380/001-005 4.6.2010 2.6.2010 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 4.6.2010 2.6.2010 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-017 4.6.2010 2.6.2010 Renagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/123/005-013 7.6.2010 2.6.2010 Stalevo Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/1/03/260/001-033 4.6.2010 2.6.2010 Velcade Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 4.6.2010 2.6.2010 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/08/470/001-017 7.6.2010 2.6.2010 Zavesca ActelionRegistration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238/001 4.6.2010 4.6.2010 DepoCyte Pacira Limited West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, United Kingdom EU/1/01/187/001 8.6.2010 4.6.2010 Metalyse Boehringer Ingelheim International GmbH Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland EU/1/00/169/004-006 8.6.2010 4.6.2010 Mircera Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/001-024 8.6.2010 4.6.2010 Nymusa CHIESI FARMACEUTICI SpA Via Palermo 26/A, I-43100 Parma, ITALIA EU/1/09/528/001-002 8.6.2010 4.6.2010 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 8.6.2010 4.6.2010 RoActemra Roche Registration Limited 6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 8.6.2010 4.6.2010 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386/001-018 8.6.2010 4.6.2010 Zerit Bristol-MyersSquibbPharma EEIG Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009/001-009 8.6.2010 8.6.2010 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-044 10.6.2010 10.6.2010 Comtan Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/081/001-004 14.6.2010 10.6.2010 Comtess Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/1/98/082/001-003 EU/1/98/082/005 14.6.2010 10.6.2010 ellaOne Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France EU/1/09/522/001 14.6.2010 10.6.2010 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 15.6.2010 10.6.2010 Opgenra Howmedica International S. de R. L. Raheen Business Park, Limerick, Ireland EU/1/08/489/001-002 15.6.2010 10.6.2010 Pergoveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/07/396/001-003 14.6.2010 10.6.2010 Vasovist TMC Pharma Services Ltd Eversley, Hampshire, RG27 0NT, United Kingdom EU/1/05/313/001-009 14.6.2010 14.6.2010 Lyrica Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/04/279/001-044 16.6.2010 14.6.2010 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 17.6.2010 17.6.2010 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355/001-003 21.6.2010 17.6.2010 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/001-007 21.6.2010 17.6.2010 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 21.6.2010 17.6.2010 Onsenal Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/03/259/001-006 21.6.2010 17.6.2010 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-003 21.6.2010

— 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 29.4.2010 Agenerase Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/00/148/001-004 5.5.2010 26.5.2010 Duloxetine Boehringer Ingelheim Boehringer Ingelheim International GmbH Binger Strasse 173 - D-55216 Ingelheim am Rhein, Deutschland EU/1/08/471/003-005 EU/1/08/471/011-012 28.5.2010

— 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 15.3.2010 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-002 17.3.2010 15.3.2010 Draxxin Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/03/041/004 17.3.2010 15.3.2010 Incurin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/018/001 17.3.2010 15.3.2010 Masivet AB Science S.A. 3 avenue George V, 75008 Paris, France EU/2/08/087/001-002 17.3.2010 15.3.2010 Meloxivet Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België EU/2/07/077/001-005 17.3.2010 15.3.2010 SevoFlo Abbott Laboratories Limited Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM EU/2/02/035/007 17.3.2010 16.3.2010 Rabigen SAG2 VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France EU/2/00/021/001-002 19.3.2010 22.3.2010 Purevax FeLV Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/00/019/005-007 24.3.2010 23.3.2010 Ibraxion Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/99/017/001-006 23.3.2010 23.3.2010 Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/001-009 25.3.2010 26.3.2010 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/06/070/001-007 30.3.2010 30.3.2010 Acticam Omnipharm Ltd Suite 3, 24 High Street, Ruddington, Nottingham, NG11 6EA, United Kingdom EU/2/08/088/001-004 1.4.2010 9.4.2010 Slentrol Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/07/071/001-003 13.4.2010 27.4.2010 Vaxxitek HVT+ IBD Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/02/032/001-002 29.4.2010 29.4.2010 Trocoxil Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ United Kingdom EU/2/08/084/001-005 4.5.2010 26.5.2010 Ibaflin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/022/001a-001b EU/2/00/022/002a-002b EU/2/00/022/003a-003b EU/2/00/022/004a-004b EU/2/00/022/005-017 28.5.2010 26.5.2010 Naxcel Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/05/053/001-003 28.5.2010 2.6.2010 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/026 EU/2/97/004/033-034 4.6.2010 10.6.2010 Flexicam Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark EU/2/06/058/001-004 14.6.2010

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

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 14.6.2010 Pruban Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/024/001 16.6.2010

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.