EN Official Journal of the European Union C 124/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 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 124/01

— 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 9.3.2012 Mercaptopurine Nova Laboratories Mercaptopurine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727/001 Oral suspension L01BB02 13.3.2012 9.3.2012 Sepioglin pioglitazone Vaia S.A. 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα EU/1/12/754/001-021 Tablet A10BG03 13.3.2012 15.3.2012 Pioglitazone Actavis pioglitazone Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland EU/1/12/755/001-027 Tablet A10BG03 20.3.2012 15.3.2012 Pioglitazone Actavis Group pioglitazone Actavis Group PTC ehf. Reykjavíkurvegi 76 - 78, 220 Hafnarfjörður, Iceland EU/1/12/756/001-027 Tablet A10BG03 20.3.2012 21.3.2012 Paglitaz pioglitazone KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/721/001-021 Tablet A10BG03 26.3.2012 21.3.2012 Pioglitazone Accord pioglitazone Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom EU/1/11/722/001-030 Tablet A10BG03 27.3.2012 26.3.2012 Pioglitazone Teva pioglitazone Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/12/757/001-030 Tablet A10BG03 29.3.2012 26.3.2012 Pioglitazone Teva Pharma pioglitazone Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/12/758/001-030 Tablet A10BG03 29.3.2012





— 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 2.3.2012 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355/001-003 6.3.2012 2.3.2012 Daliresp Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/668/001-003 6.3.2012 2.3.2012 Esbriet InterMune UK Ltd Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom EU/1/11/667/001-004 6.3.2012 2.3.2012 Fampyra Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699/001-004 6.3.2012 2.3.2012 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 6.3.2012 2.3.2012 Leflunomide Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/675/001-010 6.3.2012 2.3.2012 Libertek Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/666/001-003 6.3.2012 2.3.2012 NutropinAq Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/00/164/003-005 6.3.2012 2.3.2012 Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641/001 6.3.2012 2.3.2012 Tandemact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/366/005-022 6.3.2012 2.3.2012 Valtropin BioPartners GmbH Kaiserpassage 11 – D-72764 Reutlingen, Deutschland EU/1/06/335/001 6.3.2012 6.3.2012 Clopidogrel Acino Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532/001-007 8.3.2012 6.3.2012 Repso Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/674/001-010 8.3.2012 6.3.2012 Rivastigmine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/513/001-020 8.3.2012 6.3.2012 Topotecan Actavis Actavis Group PTC ehf Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland EU/1/09/536/001-004 8.3.2012 8.3.2012 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/003-005 12.3.2012 8.3.2012 Firazyr Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland EU/1/08/461/001-002 12.3.2012 8.3.2012 Pritor Bayer Pharma AG 13342 Berlin, Deutschland EU/1/98/089/001-022 12.3.2012 8.3.2012 PritorPlus Bayer Pharma AG 13342 Berlin, Deutschland EU/1/02/215/001-021 12.3.2012 9.3.2012 Samsca Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom EU/1/09/539/001-004 13.3.2012 15.3.2012 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434/001-003 19.3.2012 15.3.2012 Carbaglu Orphan Europe Immeuble Le Wilson, 70 Avenue du General de Gaulle, 92800 Puteaux, France EU/1/02/246/001-003 19.3.2012 15.3.2012 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389/001-003 19.3.2012 15.3.2012 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 19.3.2012 15.3.2012 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386/001-018 19.3.2012 15.3.2012 Ventavis Bayer Pharma AG 13342 Berlin, Deutschland EU/1/03/255/001-008 19.3.2012 15.3.2012 Vizarsin KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551/001-012 19.3.2012 19.3.2012 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 21.3.2012 19.3.2012 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118/001-010 21.3.2012 19.3.2012 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 22.3.2012 19.3.2012 Benlysta Glaxo Group Limited Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/700/001-002 21.3.2012 19.3.2012 Byetta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/06/362/001-004 22.3.2012 19.3.2012 Fasturtec Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/00/170/001-002 21.3.2012 19.3.2012 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-005 22.3.2012 19.3.2012 IDflu Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507/001-006 22.3.2012 19.3.2012 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720/001-002 21.3.2012 19.3.2012 Intanza Sanofi Pasteur MSD SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/08/505/001-006 21.3.2012 19.3.2012 Intelence Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België EU/1/08/468/001-002 21.3.2012 19.3.2012 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 21.3.2012 19.3.2012 Kogenate Bayer Bayer Pharma AG 13342 Berlin, Deutschland EU/1/00/143/004-013 22.3.2012 19.3.2012 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604/001-010 21.3.2012 19.3.2012 Levitra Bayer Pharma AG 13342 Berlin, Deutschland EU/1/03/248/001-023 21.3.2012 19.3.2012 Norvir Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-008 21.3.2012 19.3.2012 PegIntron Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België EU/1/00/131/001-050 21.3.2012 19.3.2012 Prevenar 13 Wyeth-Lederle Vaccines S.A. Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique EU/1/09/590/001-006 22.3.2012 19.3.2012 Privigen CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland EU/1/08/446/001-006 21.3.2012 19.3.2012 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 21.3.2012 19.3.2012 Ranexa Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/462/001-012 22.3.2012 19.3.2012 Refludan Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/97/035/001-004 21.3.2012 19.3.2012 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 22.3.2012 19.3.2012 Resolor Shire-Movetis NV Veedjik 58, B-2300 Turnhout, België EU/1/09/581/001-008 21.3.2012 19.3.2012 Tasmar Meda AB Pipers väg 2A, 170 09 Solna, Sverige EU/1/97/044/001-009 21.3.2012 19.3.2012 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Researchdreef, 60, 1070 Brussel, België EU/1/08/470/001-013 EU/1/08/470/016-017 22.3.2012 19.3.2012 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 22.3.2012 21.3.2012 Atriance Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/403/001 26.3.2012 21.3.2012 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 26.3.2012 21.3.2012 Clopidogrel Krka d.d. KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562/001-009 26.3.2012 21.3.2012 Foclivia Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/09/577/001-004 26.3.2012 21.3.2012 Integrilin Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom EU/1/99/109/001-002 23.3.2012 21.3.2012 Rapiscan Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, UK EU/1/10/643/001 23.3.2012 21.3.2012 Revatio Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/05/318/001-003 26.3.2012 21.3.2012 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498/001-008 26.3.2012 21.3.2012 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 26.3.2012 21.3.2012 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704/001-002 23.3.2012 21.3.2012 Volibris Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/08/451/001-004 26.3.2012 21.3.2012 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703/001-003 23.3.2012 21.3.2012 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 23.3.2012 26.3.2012 Azilect Teva Pharma GmbH Graf-Arco-Str. 3, 89079 Ulm, Deutschland EU/1/04/304/001-007 28.3.2012 26.3.2012 Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Viale Shakespeare 47, 00144 Rome, Italia EU/1/11/716/001-005 28.3.2012 26.3.2012 Neupro Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland EU/1/05/331/001-055 28.3.2012 26.3.2012 Nimvastid KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/525/001-050 28.3.2012 26.3.2012 Pandemic influenza vaccine H5N1 BAXTER Baxter AG Industriestraße 67, A – 1221 Wien, Österreich EU/1/09/571/001-002 28.3.2012 26.3.2012 PegIntron Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België EU/1/00/131/001-050 28.3.2012 26.3.2012 Plenadren DuoCort Pharma AB Kullagatan 8-10, S-252 20 Helsingborg, Sverige EU/1/11/715/001-002 28.3.2012 26.3.2012 Valdoxan Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes, Cedex, France EU/1/08/499/001-008 28.3.2012 26.3.2012 ViraferonPeg Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België EU/1/00/132/001-050 28.3.2012 26.3.2012 VPRIV Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646/001-006 28.3.2012





— 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 15.3.2012 Livensa Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, 64331 Weiterstadt, Deutschland EU/1/06/351/001-003 19.3.2012





— 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 2.3.2012 Omnitrope Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/06/332/001-012 6.3.2012





— 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 8.3.2012 Zulvac 1+8 Bovis — Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/12/139/001-003 Suspension for injection QI02AA08 12.3.2012





— 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 2.3.2012 Easotic VIRBAC S.A 1ère Avenue 2065 m L.I.D. – 06516 Carros – France EU/2/08/085/001-006 6.3.2012 2.3.2012 Flexicam Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark EU/2/06/058/004 6.3.2012 9.3.2012 Purevax Rabies MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/117/001-003 13.3.2012 15.3.2012 BTVPUR AlSap 8 MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/09/094/001-004 19.3.2012 15.3.2012 Masivet AB Science S.A. 3 avenue George V, 75008 Paris, France EU/2/08/087/001-003 19.3.2012 15.3.2012 Recuvyra Nexcyon Pharmaceuticals Ltd. Bank Barn, How Mill, Brampton, Cumbria CA8 9JY, United Kingdom EU/2/11/127/001 20.3.2012 26.3.2012 Aivlosin ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom EU/2/04/044/001-013 28.3.2012





— 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 19.3.2012 Gonazon Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/03/040/001-002 22.3.2012 19.3.2012 Zubrin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/028/002-008 22.3.2012

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.

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