EN Official Journal of the European Union C 128/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 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 128/01

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 6.1.2011 Potactasol topotecan Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland EU/1/10/660/001-002 powder for concentrate for solution for infusion L01XX17 10.1.2011 21.1.2011 Docetaxel Teva Pharma Docetaxel Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/10/662/001-002 Concentrate and solvent for solution for infusion L01CD02 26.1.2011 21.1.2011 Iasibon Ibandronic acid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659/001-010 Concentrate for solution for infusion Film-coated tablet M05BA06 25.1.2011 27.1.2011 Fluenz influenza vaccine (live attenuated, nasal) MedImmune, LLC Lagelandseweg 78, 6545 CG Nijmegen, Nederland EU/1/10/661/001-002 Nasal spray, suspension J07BB03 1.2.2011 18.2.2011 Entacapone Teva entacapone Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/665/001-004 Film-coated tablet N04BX02 22.2.2011 28.2.2011 Daliresp roflumilast Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/668/001-003 Film-coated tablet R03DX07 2.3.2011 28.2.2011 Esbriet Pirfenidone InterMune Europe Ltd Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom EU/1/11/667/001-003 Capsule, hard L04AX05 2.3.2011 28.2.2011 Lamivudine / Zidovudine Teva Lamivudine/Zidovudine Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/663/001-002 Film-coated tablet J05AR01 2.3.2011 28.2.2011 Libertek roflumilast Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/666/001-003 Film-coated tablet R03DX07 2.3.2011 28.2.2011 Xiapex collagenase clostridium histolyticum Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/1/11/671/001 Powder and solvent for solution for injection M09AB02 2.3.2011





— 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 6.1.2011 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 10.1.2011 6.1.2011 Irbesartan HCT Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France, F- 75013 Paris, France EU/1/06/377/001-028 11.1.2011 6.1.2011 Irbesartan Winthrop SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France, F- 75013 Paris, France EU/1/06/376/001-033 11.1.2011 6.1.2011 Lucentis Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374/001 11.1.2011 6.1.2011 Rapamune Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001 EU/1/01/171/007-010 EU/1/01/171/013-014 11.1.2011 6.1.2011 Resolor Movetis NV Veedijk 58, B-2300 Turnhout, België EU/1/09/581/001-008 11.1.2011 6.1.2011 Tepadina ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia EU/1/10/622/001-002 11.1.2011 6.1.2011 Yttriga Eckert & Ziegler Nuclitec GmbH Gieselweg 1, Braunschweig 38110, Deutschland EU/1/05/322/001 10.1.2011 11.1.2011 IntronA Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/99/127/011-039 EU/1/99/127/041-044 18.1.2011 11.1.2011 Pantoloc Control Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/519/001-004 13.1.2011 11.1.2011 Rapiscan Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/10/643/001 13.1.2010 13.1.2011 Clopidogrel Winthrop Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/08/465/001-020 17.1.2011 13.1.2011 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/037-039 17.1.2010 13.1.2011 INOmax INO Therapeutics AB SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 18.1.2011 13.1.2011 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, 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 17.1.2011 13.1.2011 Nimvastid KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/525/001-050 17.1.2011 13.1.2011 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 17.1.2011 17.1.2011 Cancidas Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196/001 EU/1/01/196/003 19.1.2011 17.1.2011 Kuvan Merck KGaA Frankfurter Straße 250, 64293 Darmstadt, Deutschland EU/1/08/481/001-003 19.1.2011 17.1.2011 Nevanac Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/07/433/001 19.1.2011 21.1.2011 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 25.1.2011 21.1.2011 Adenuric Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/447/001-004 25.1.2011 21.1.2011 Arzerra Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/625/001-002 26.1.2011 21.1.2011 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328/001-004 25.1.2011 21.1.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-021 25.1.2011 21.1.2011 Humira Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom EU/1/03/256/001-010 25.1.2011 21.1.2011 INOmax INO Therapeutics AB SE-181 81 Lidingö, Sverige EU/1/01/194/001-002 25.1.2011 21.1.2011 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/97/049/001-039 26.1.2011 21.1.2011 Kuvan Merck KGaA Frankfurter Straße 250, 64293 Darmstadt, Deutschland EU/1/08/481/001-003 25.1.2011 21.1.2011 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231/001-023 EU/1/02/231/036-037 25.1.2011 21.1.2011 Multaq Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/09/591/001-004 25.1.2011 21.1.2011 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/592/001-005 25.1.2011 21.1.2011 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/08/452/001 26.1.2011 21.1.2011 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-008 25.1.2011 21.1.2011 Rapamune Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/01/171/001 EU/1/01/171/007-010 EU/1/01/171/013-014 26.1.2011 21.1.2011 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 25.1.2011 21.1.2011 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/002 25.1.2011 21.1.2011 Revlimid Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/07/391/001-004 26.1.2011 21.1.2011 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 26.1.2011 21.1.2011 Sprimeo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-020 26.1.2011 21.1.2011 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland EU/1/09/605/001-012 26.1.2011 21.1.2011 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498/001-008 25.1.2011 21.1.2011 Valdoxan Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/08/499/001-008 26.1.2011 21.1.2011 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/280/001-008 25.1.2011 24.1.2011 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285/001-036 27.1.2011 24.1.2011 Ceplene EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland EU/1/08/477/001 27.1.2011 24.1.2011 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-039 27.1.2011 24.1.2011 Eucreas Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 27.1.2011 24.1.2011 Galvus Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 27.1.2011 24.1.2011 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 27.1.2011 24.1.2011 Jalra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 27.1.2011 24.1.2011 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134/001-037 27.1.2011 24.1.2011 NutropinAq Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/00/164/003-005 27.1.2011 24.1.2011 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 27.1.2011 24.1.2011 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 27.1.2011 24.1.2011 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133/001-032 27.1.2011 24.1.2011 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/009-011 EU/1/08/460/013-014 26.1.2011 24.1.2011 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique EU/1/05/330/001-011 27.1.2011 24.1.2011 SonoVue Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland EU/1/01/177/002 27.1.2011 24.1.2011 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508/001-010 27.1.2011 24.1.2011 Torisel Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom EU/1/07/424/001 27.1.2011 24.1.2011 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/009-011 EU/1/08/459/013-014 26.1.2011 24.1.2011 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/009-011 EU/1/08/458/013-014 26.1.2011 24.1.2011 Vistide Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/97/037/001 27.1.2011 24.1.2011 Xarelto Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/08/472/001-010 27.1.2011 24.1.2011 Xiliarx Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 27.1.2011 26.1.2011 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/05/324/001-002 27.1.2011 27.1.2011 Adrovance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364/001-009 1.2.2011 27.1.2011 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001-002 1.2.2011 27.1.2011 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/296/001-009 31.1.2011 27.1.2011 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 1.2.2011 27.1.2011 Icandra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484/001-018 1.2.2011 27.1.2011 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614/001 31.1.2011 27.1.2011 Nonafact Sanquin Plesmanlaan 125, Amsterdam 1066 CX, Nederland EU/1/01/186/001-002 1.2.2011 27.1.2011 Orgalutran N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland EU/1/00/130/001-002 31.1.2011 27.1.2011 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/462/001-012 1.2.2011 27.1.2011 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 1.2.2011 27.1.2011 Regranex Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/99/101/001 31.1.2011 27.1.2011 Remicade Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 1.2.2011 27.1.2011 Ribavirin Mylan Three Rivers Global Pharma Limited 20-22 Bedford Row, London WC1R4JS, United Kingdom EU/1/10/634/001-004 23.2.2011 27.1.2011 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 1.2.2011 27.1.2011 Sebivo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/388/001-003 1.2.2011 27.1.2011 Simponi Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546/001-004 31.1.2011 27.1.2011 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/297/001-008 1.2.2011 27.1.2011 Zomarist Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483/001-018 1.2.2011 1.2.2011 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/283/008-012 3.2.2011 1.2.2011 Emend Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-008 3.2.2011 1.2.2011 Exforge Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370/001-039 3.2.2011 1.2.2011 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-009 3.2.2011 1.2.2011 Imprida Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373/001-039 3.2.2011 1.2.2011 INCRELEX Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/07/402/001 3.2.2011 1.2.2011 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368/001-168 3.2.2011 1.2.2011 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030/028-195 3.2.2011 1.2.2011 Irbesartan Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/576/001-039 3.2.2011 1.2.2011 Nivestim Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/631/001-009 3.2.2011 1.2.2011 Orfadin Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sweden EU/1/04/303/001-003 3.2.2011 1.2.2011 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-020 3.2.2011 1.2.2011 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 3.2.2011 2.2.2011 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497/001-008 4.2.2011 2.2.2011 Prevenar Wyeth-Lederle Vaccines S.A. Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium EU/1/00/167/001-008 4.2.2011 2.2.2011 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 4.2.2011 2.2.2011 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige EU/1/01/189/001-006 4.2.2011 2.2.2011 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-009 4.2.2011 8.2.2011 Biopoin CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland EU/1/09/565/001-028 10.2.2011 8.2.2011 Temodal Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/98/096/001-025 14.2.2011 9.2.2011 Cimzia UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/09/544/001-002 11.2.2011 9.2.2011 Karvezide Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/98/085/001-034 11.2.2011 9.2.2011 Olazax Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597/001-005 11.2.2011 9.2.2011 Peyona CHIESI FARMACEUTICI SpA Via Palermo 26/A, I-43100 Parma, ITALIA EU/1/09/528/001-002 11.2.2011 9.2.2011 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 11.2.2011 9.2.2011 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 11.2.2011 11.2.2011 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/97/046/001-039 15.2.2011 11.2.2011 Azarga Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/08/482/001-002 15.2.2011 11.2.2011 Brinavess Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/645/001-002 15.2.2011 11.2.2011 Clopidogrel Krka KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556/001-011 15.2.2011 11.2.2011 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/086/001-034 15.2.2011 11.2.2011 Crixivan Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024/001-005 EU/1/96/024/008 EU/1/96/024/010 15.2.2011 11.2.2011 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573/001-028 15.2.2011 11.2.2011 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 15.2.2011 11.2.2011 Rilonacept Regeneron Regeneron UK Limited 40 Bank Street, E14 5DS London, United Kingdom EU/1/09/582/001 15.2.2011 11.2.2011 Zutectra Biotest Pharma GmbH Landsteinerstr.5, 63303 Dreieich, Deutschland EU/1/09/600/001 15.2.2011 11.2.2011 Zyllt KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553/001-010 15.2.2011 18.2.2011 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230/001-007 EU/1/02/230/016-017 22.2.2011 18.2.2011 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige EU/1/06/365/001-003 22.2.2011 18.2.2011 Keppra UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/00/146/001-032 22.2.2011 18.2.2011 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292/001-012 22.2.2011 18.2.2011 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/07/394/001-009 22.2.2011 18.2.2011 Renagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/123/005-013 22.2.2011 21.2.2011 Arzerra Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/625/001-003 25.2.2011 21.2.2011 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 28.2.2011 21.2.2011 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 25.2.2011 21.2.2011 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/237/001-009 23.2.2011 21.2.2011 Clopidogrel Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/540/001-016 24.2.2011 21.2.2011 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/354/001-011 23.2.2011 21.2.2011 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511/001-005 23.2.2011 21.2.2011 Dukoral Crucell Sweden AB SE-105 21 Stockholm, Sweden EU/1/03/263/001-003 1.3.2011 21.2.2011 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 23.2.2011 21.2.2011 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457/001-016 24.2.2011 21.2.2011 Enbrel Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom EU/1/99/126/001-021 25.2.2011 21.2.2011 Firazyr Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland EU/1/08/461/001-002 24.2.2011 21.2.2011 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 28.2.2011 21.2.2011 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 23.2.2011 21.2.2011 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233/005-007 25.2.2011 21.2.2011 Intanza Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/08/505/001-006 23.2.2011 21.2.2011 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437/001-004 24.2.2011 21.2.2011 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455/001-016 24.2.2011 21.2.2011 Kineret Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/02/203/001-004 25.2.2011 21.2.2011 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278/001-003 28.2.2011 21.2.2011 Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/333/001-003 28.2.2011 21.2.2011 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/05/331/001-055 25.2.2011 21.2.2011 Pritor Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/98/089/001-022 25.2.2011 21.2.2011 PritorPlus Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/02/215/001-021 28.2.2011 21.2.2011 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234/005-007 25.2.2011 21.2.2011 Protopic Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/02/201/001-006 28.2.2011 21.2.2011 Qutenza Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/09/524/001-002 25.2.2011 21.2.2011 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/462/001-012 25.2.2011 21.2.2011 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 25.2.2011 21.2.2011 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 25.2.2011 21.2.2011 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 25.2.2011 21.2.2011 Ribavirin Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/509/001-004 24.2.2011 21.2.2011 Ribavirin Teva Pharma BV Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/527/001-016 24.2.2011 21.2.2011 Riprazo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-020 28.2.2011 21.2.2011 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621/001-018 24.2.2011 21.2.2011 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620/001-016 24.2.2011 21.2.2011 Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/546/001-004 23.2.2011 21.2.2011 Sprimeo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-020 28.3.2011 21.2.2011 Stocrin Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111/001-005 EU/1/99/111/008-011 25.2.2011 21.2.2011 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-004 23.2.2011 21.2.2011 Tysabri Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland EU/1/06/346/001 23.2.2011 21.2.2011 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456/001-016 24.2.2011 21.2.2011 Ventavis Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland EU/1/03/255/001-008 23.2.2011 21.2.2011 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 2.3.2011 21.2.2011 Zylagren KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/558/001-010 28.2.2011 21.2.2011 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/022/016-017 23.2.2011 28.2.2011 Altargo Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/390/001-004 4.3.2011 28.2.2011 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-111 4.3.2011 28.2.2011 Arixtra Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-035 2.3.2011 28.2.2011 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 4.3.2011 28.2.2011 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 3.3.2011 28.2.2011 Clopidogrel Qualimed Qualimed 117, Allée des Parcs, 69800 Saint Priest, France EU/1/09/557/001-010 4.3.2011 28.2.2011 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland EU/1/09/555/001-009 4.3.2011 28.2.2011 Fabrazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/01/188/001-006 4.3.2011 28.2.2011 Firazyr Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland EU/1/08/461/001-002 4.3.2011 28.2.2011 IDflu Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507/001-006 3.3.2011 28.2.2011 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564/001-002 4.3.2011 28.2.2011 Invanz Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216/001-002 3.3.2011 28.2.2011 Kaletra Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom EU/1/01/172/001-008 4.3.2011 28.2.2011 Kinzalkomb Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/02/214/001-015 2.3.2011 28.2.2011 Kinzalmono Bayer Schering Pharma AG D-13342 Berlin, Deutschland EU/1/98/091/001-014 2.3.2011 28.2.2011 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/98/090/001-020 2.3.2011 28.2.2011 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/02/213/001-023 3.3.2011 28.2.2011 NovoMix Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/142/004-005 EU/1/00/142/009-025 3.3.2011 28.2.2011 Omnitrope Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich EU/1/06/332/001-009 2.3.2011 28.2.2011 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/011-015 3.3.2011 28.2.2011 Onglyza Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545/001-010 3.3.2011 28.2.2011 Osigraft Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland EU/1/01/179/001 4.3.2011 28.2.2011 Osseor Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/287/001-006 4.3.2011 28.2.2011 PegIntron Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België EU/1/00/131/001-050 3.3.2011 28.2.2011 PREZISTA Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België EU/1/06/380/001-005 4.3.2011 28.2.2011 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 2.3.2011 28.2.2011 Protelos Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France EU/1/04/288/001-006 4.3.2011 28.2.2011 Quadramet CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette - France EU/1/97/057/001 4.4.2011 28.2.2011 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 3.3.2011 28.2.2011 Siklos ADDMEDICA 101, rue Saint Lazare, Paris 75009, France EU/1/07/397/001-004 3.3.2011 28.2.2011 Tracleer Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-006 3.3.2011 28.2.2011 Vedrop Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92800 Puteaux - France EU/1/09/533/001-003 3.3.2011 28.2.2011 Ytracis CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette Cedex- France EU/1/03/250/001 4.3.2011





— 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 6.1.2011 Thelin Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/353/001-005 11.1.2011 1.2.2011 Clopidogrel 1A Pharma Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/542/001-007 3.2.2011





— 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 27.1.2011 Hiprabovis IBR Marker Live Live gE<sup>-</sup> tk<sup>-</sup> double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170- Amer (Girona), España EU/2/10/114/001-002 Lyophilisate for suspension QI02AD01 1.2.2011 11.2.2011 Comfortis Spinosad Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/10/115/001-010 Chewable tablet QP53BX03 15.2.2011 18.2.2011 Activyl Indoxacarb Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/10/118/001-014 Spot-on solution QP53AX27 22.2.2011 18.2.2011 Cimalgex Cimicoxib Vétoquinol SA Magny-Vernois - 70200 LURE - France EU/2/10/119/001-012 Tablet QM01AH93 24.2.2011 18.2.2011 Purevax Rabies Rabies recombinant canarypox virus (vCP65) MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/117/001-002 Suspension for injection QI06AX 22.2.2011 21.2.2011 Melosus Meloxicam CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland EU/2/10/116/001-004 Oral suspension QM01AC06 24.2.2011





— 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 6.1.2011 Econor Novartis Animal Health Austria GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-025 11.1.2011 13.1.2011 Duvaxyn WNV Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom EU/2/08/086/001-003 18.1.2011 13.1.2011 Palladia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/100/001-003 17.1.2011 17.1.2011 Zolvix Novartis Healthcare A/S Lyngbyvej 172, DK-2100 Copenhagen, Denmark EU/2/09/101/001-010 19.1.2011 21.1.2011 Dicural Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland EU/2/97/003/001-018 25.1.2011 21.1.2011 Zulvac 8 Ovis Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/09/104/001-002 26.1.2011 24.1.2011 Poulvac FluFend H5N3 RG Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/060/001-002 27.1.2011 24.1.2011 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/07/078/001-010 26.1.2011 27.1.2011 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/07/079/001-004 1.2.2011 27.1.2011 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/06/070/005-007 1.2.2011 11.2.2011 SevoFlo Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM EU/2/02/035/007 15.2.2011





— Suspension of a marketing authorization (Article 45 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 24.1.2011 Acticam Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, Belgïe EU/2/08/088/001-003 26.1.2011

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK - LONDON E14 4H

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

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