EN Official Journal of the European Union C 190/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012

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

2012/C 190/01

— 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 7.5.2012 Riluzole Zentiva Riluzole Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/12/768/001 Film-coated tablet N07XX02 10.5.2012 10.5.2012 Pixuvri pixantrone CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom EU/1/12/764/001 powder for concentrate for solution for infusion L01DB11 14.5.2012 22.5.2012 Docetaxel Accord Docetaxel Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom EU/1/12/769/001-003 Concentrate for solution for infusion L01CD02 25.5.2012 22.5.2012 Docetaxel Kabi Docetaxel Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom EU/1/12/770/001-004 Concentrate for solution for infusion L01CD02 25.5.2012





— 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 7.5.2012 Intanza Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/08/505/001-003 9.5.2012 7.5.2012 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165/001-003 9.5.2012 10.5.2012 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 14.5.2012 10.5.2012 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France EU/1/98/086/001-034 14.5.2012 10.5.2012 Ibandronic Acid Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/642/001-004 14.5.2012 10.5.2012 Irbesartan / Hydrochlorothiazide Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/583/001-072 14.5.2012 10.5.2012 Siklos ADDMEDICA 101, rue Saint Lazare, Paris 75009, France EU/1/07/397/001-004 14.5.2012 10.5.2012 Telmisartan Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland EU/1/10/639/001-030 14.5.2012 10.5.2012 Telmisartan Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/610/001-060 14.5.2012 10.5.2012 Trobalt Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/681/001-013 14.5.2012 14.5.2012 Brilique AstraZeneca AB Södertälje S 151 85, Sverige EU/1/10/655/001-006 16.5.2012 14.5.2012 Invega Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/07/395/001-095 16.5.2012 14.5.2012 JEVTANA SANOFI 174, avenue de France, F-75013 Paris, France EU/1/11/676/001 16.5.2012 14.5.2012 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155/001-003 16.5.2012 14.5.2012 Possia AstraZeneca AB Södertälje S 151 85, Sverige EU/1/10/656/001-006 16.5.2012 14.5.2012 TOBI Podhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/10/652/001-003 16.5.2012 15.5.2012 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400/008-013 EU/1/07/400/017-024 17.5.2012 15.5.2012 Topotecan Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/633/001-002 17.5.2012 15.5.2012 Vizarsin KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551/001-027 17.5.2012 22.5.2012 Aerinaze Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/399/001-006 25.5.2012 22.5.2012 Fampyra Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699/001-004 25.5.2012 22.5.2012 Gardasil Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/357/001-008 EU/1/06/357/018-021 25.5.2012 22.5.2012 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom EU/1/11/678/001-002 25.5.2012 22.5.2012 Hizentra CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland EU/1/11/687/001-012 25.5.2012 22.5.2012 IDflu Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507/001-003 25.5.2012 22.5.2012 Pergoveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/07/396/001-003 25.5.2012 22.5.2012 Silgard Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358/001-008 EU/1/06/358/018-021 25.5.2012 22.5.2012 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-005 24.5.2012 22.5.2012 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-005 25.5.2012 22.5.2012 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 25.5.2012 25.5.2012 Benlysta Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/700/001-002 30.5.2012 25.5.2012 Betaferon Bayer Pharma AG D - 13342 Berlin, Deutschland EU/1/95/003/003-012 30.5.2012 25.5.2012 Busilvex Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France EU/1/03/254/002 31.5.2012 25.5.2012 Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/649/001-016 30.5.2012 25.5.2012 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511/001-005 31.5.2012 25.5.2012 DuoCover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/10/623/001-015 30.5.2012 25.5.2012 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416/001-002 31.5.2012 25.5.2012 Fosavance Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310/001-009 30.5.2012 25.5.2012 Irbesartan Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/576/001-039 30.5.2012 25.5.2012 Ixiaro Intercell AG Campus Vienna Biocenter 3 A-1030 Wien, Österreich EU/1/08/501/001-002 31.5.2012 25.5.2012 Keppra UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België EU/1/00/146/001-032 1.6.2012 25.5.2012 Kinzalkomb Bayer Pharma AG Berlin 13342, Deutschland EU/1/02/214/001-015 31.5.2012 25.5.2012 Kinzalmono Bayer Pharma AG Berlin 13342, Deutschland EU/1/98/091/001-014 31.5.2012 25.5.2012 Kuvan Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom EU/1/08/481/001-003 30.5.2012 25.5.2012 Lamivudine / Zidovudine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/663/001-002 1.6.2012 25.5.2012 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/98/090/001-022 31.5.2012 25.5.2012 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/02/213/001-023 31.5.2012 25.5.2012 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227/001-002 EU/1/02/227/004 1.6.2012 25.5.2012 Nevirapine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/598/001-004 30.5.2012 25.5.2012 Onduarp Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/729/001-006 30.5.2012 25.5.2012 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/07/394/001-009 31.5.2012 25.5.2012 Osseor Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/04/287/001-006 30.5.2012 25.5.2012 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-014 1.6.2012 25.5.2012 Pritor Bayer Pharma AG 13342 Berlin, Deutschland EU/1/98/089/001-022 30.5.2012 25.5.2012 PritorPlus Bayer Pharma AG 13342 Berlin, Deutschland EU/1/02/215/001-021 30.5.2012 25.5.2012 Protelos Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/04/288/001-006 25.5.2012 Rasilamlo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/686/001-056 30.5.2012 25.5.2012 Rasilez Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405/001-040 30.5.2012 25.5.2012 Rasilez HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491/001-080 31.5.2012 25.5.2012 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/730/001-060 31.5.2012 25.5.2012 Riprazo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/409/001-040 30.5.2012 25.5.2012 Riprazo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/680/001-080 1.6.2012 25.5.2012 Rivastigmine Actavis Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/11/693/001-016 1.6.2012 25.5.2012 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492/001-006 31.5.2012 25.5.2012 Sprimeo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-040 31.5.2012 25.5.2012 Sprimeo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/683/001-080 1.6.2012 25.5.2012 Temozolomide Hospira Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/615/001-002 EU/1/10/615/005-006 EU/1/10/615/009-010 EU/1/10/615/013-014 EU/1/10/615/017-018 EU/1/10/615/021-022 31.5.2012 25.5.2012 Tysabri Elan Pharma International Ltd. Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND EU/1/06/346/001 31.5.2012 25.5.2012 Vantavo Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572/001-004 EU/1/09/572/006-008 30.5.2012 25.5.2012 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 31.5.2012 25.5.2012 Vistide Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/97/037/001 31.5.2012 25.5.2012 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 30.5.2012 25.5.2012 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 31.5.2012 25.5.2012 Xolair Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/319/001-010 30.5.2012 31.5.2012 Lamivudine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/566/001-005 4.6.2012 31.5.2012 Peyona CHIESI FARMACEUTICI SpA Via Palermo 26/A, I-43100 Parma, ITALIA EU/1/09/528/001-002 4.6.2012 31.5.2012 Temozolomide Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/606/001-012 4.6.2012





— 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 10.5.2012 Valtropin BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland EU/1/06/335/001 14.5.2012 25.5.2012 Docefrez Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/10/630/001-002 31.5.2012 25.5.2012 Intrinsa Warner Chilcott UK Ltd Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom EU/1/06/352/001-003 31.5.2012





— Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 25.5.2012 Angiox The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom EU/1/04/289/001 31.5.2012 25.5.2012 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011/001-004 31.5.2012 25.5.2012 Luminity Lantheus MI UK Limited Festival House - 39 Oxford Street - Newbury - Berkshire RG14 1JG - United Kingdom EU/1/06/361/001-002 31.5.2012 25.5.2012 Mepact IDM PHARMA SAS 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France EU/1/08/502/001 1.6.2012 25.5.2012 Soliris Alexion Europe S.A.S. 25, boulevard de l’Amiral Bruix, 75016 Paris, France EU/1/07/393/001 31.5.2012 25.5.2012 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/07/424/001 30.5.2012 25.5.2012 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 31.5.2012 31.5.2012 Ceplene EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland EU/1/08/477/001 4.6.2012





— 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 10.5.2012 Circovac Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/07/075/001-004 14.5.2012 10.5.2012 Netvax Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/09/093/001-002 14.5.2012 22.5.2012 Convenia Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/059/001-002 30.5.2012 22.5.2012 Equip WNV Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/08/086/001-003 25.5.2012 22.5.2012 PRILACTONE CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/07/074/001-006 25.5.2012 25.5.2012 Onsior Novartis Animal Health UK Ltd Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom EU/2/08/089/001-021 1.6.2012 25.5.2012 Suprelorin VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros – France EU/2/07/072/001-004 1.6.2012

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.