EN Official Journal of the European Union C 94/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 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 94/01

— 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 13.2.2012 Colobreathe Colistimethate sodium Forest Laboratories UK Ltd Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom EU/1/11/747/001 Inhalation powder, hard capsule R07AX 15.2.2012 17.2.2012 Caprelsa vandetanib AstraZeneca AB Building 411A, Floor 4, S-151 85 Sodertalje, Sverige EU/1/11/749/001-002 Film-coated tablet L01XE12 21.2.2012 17.2.2012 Vepacel Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated) Baxter Innovations GmbH Industriestrasse 67, A – 1221 Vienna, Österreich EU/1/12/752/001 Suspension for injection J07BB01 21.2.2012 17.2.2012 Zelboraf vemurafenib Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751/001 Film-coated tablet L01XE15 21.2.2012 23.2.2012 Esmya ulipristal PregLem France SAS. 32, route de l’Eglise, 74140 Massongy, France EU/1/12/750/001 Tablet Pending 28.2.2012





— 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 9.2.2012 Sumatriptan Galpharm Galpharm Healthcare Ltd. Dodworth Business ParkDodworth, Barnsley S75 3SP United Kingdom 13.2.2012





— 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 6.2.2012 Aclasta Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308/001-002 9.2.2012 6.2.2012 Aflunov Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658/001-002 9.2.2012 6.2.2012 Ambirix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, Rixensart, B-1330 Belgique EU/1/02/224/001-005 8.2.2012 6.2.2012 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 9.2.2012 6.2.2012 Corlentor Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes, Cedex, France EU/1/05/317/001-014 8.2.2012 6.2.2012 Dificlir FGK Representative Service GmbH Heimeranstrasse 35, 80339 München, Deutschland EU/1/11/733/001-004 9.2.2012 6.2.2012 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 8.2.2012 6.2.2012 Intanza Sanofi Pasteur MSD SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/08/505/001-006 8.12.2012 6.2.2012 Olanzapine Apotex Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/10/635/001-018 8.2.2012 6.2.2012 Optimark Covidien Deutschland GmbH Gewerbepark 1, 93333 Neustadt/Donau, Deutschland EU/1/07/398/001-014 8.2.2012 6.2.2012 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389/001-003 8.2.2012 6.2.2012 Prialt Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom EU/1/04/302/001-004 8.2.2012 6.2.2012 Rapamune Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/01/171/001 9.2.2012 6.2.2012 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 8.2.2012 6.2.2012 Rilonacept Regeneron Regeneron UK Limited 40 Bank Street, London E14 5DS, United Kingdom EU/1/09/582/001 9.2.2012 6.2.2012 Simponi Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546/001-004 8.2.2012 6.2.2012 Sonata Meda AB Pipers väg 2A, 170 09 Solna, Sverige EU/1/99/102/001-006 8.2.2012 6.2.2012 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/95/002/001-005 8.2.2012 6.2.2012 Tevagrastim Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/445/001-014 8.2.2012 6.2.2012 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/710/001-007 9.2.2012 6.2.2012 Yellox Croma-Pharma GmbH Industriezeile 6, A-2100 Leobendorf, Österreich EU/1/11/692/001 9.2.2012 9.2.2012 Aerius Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/160/001-013 EU/1/00/160/022-034 EU/1/00/160/036-069 13.2.2012 9.2.2012 Arzerra Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/625/001 EU/1/10/625/003 13.2.2012 9.2.2012 Azomyr Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/157/001-013 EU/1/00/157/022-067 13.2.2012 9.2.2012 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/592/001-005 13.2.2012 9.2.2012 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-014 13.2.2012 9.2.2012 Prepandemic Influenza Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/657/001-002 13.2.2012 9.2.2012 Prepandemic Influenza Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/657/001-002 13.2.2012 9.2.2012 Procoralan Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/05/316/001-014 13.2.2012 9.2.2012 Rivastigmine HEXAL HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/09/589/001-018 13.2.2012 13.2.2012 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392/001-003 15.2.2012 13.2.2012 Cystadane Orphan Europe S.a.r.l. Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France EU/1/06/379/001 15.2.2012 17.2.2012 Aerinaze Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/399/001-006 21.2.2012 17.2.2012 Elonva N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/09/609/001-002 22.2.2012 17.2.2012 Fablyn Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/1/08/500/001-004 22.2.2012 17.2.2012 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269/001-002 22.2.2012 17.2.2012 Gliolan medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg – Deutschland EU/1/07/413/001-003 22.2.2012 17.2.2012 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145/001 21.2.2012 17.2.2012 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 21.2.2012 17.2.2012 Myocet Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, France EU/1/00/141/001-002 22.2.2012 17.2.2012 Neoclarityn Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/161/001-013 EU/1/00/161/022-067 22.2.2012 17.2.2012 Olanzapine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/07/427/001-057 21.2.2012 17.2.2012 Olazax Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597/001-005 21.2.2012 17.2.2012 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige EU/1/01/189/001-006 22.2.2012 17.2.2012 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Deutschland EU/1/09/585/001-018 22.2.2012 17.2.2012 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/09/599/001-018 21.2.2012 17.2.2012 Tractocile Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark EU/1/99/124/001-002 21.2.2012 17.2.2012 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 22.2.2012 21.2.2012 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Republic of Ireland EU/1/04/306/001-003 23.2.2012 21.2.2012 Angiox The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom EU/1/04/289/001 23.2.2012 21.2.2012 Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/268/001-004 24.2.2012 21.2.2012 Cubicin Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328/001-004 24.2.2012 21.2.2012 Evra Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België EU/1/02/223/001-003 24.2.2012 21.2.2012 Fertavid Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/510/001-019 24.2.2012 21.2.2012 Glivec Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 23.2.2012 21.2.2012 Kaletra Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berks, SL6 4XE United Kingdom EU/1/01/172/001-008 23.2.2012 21.2.2012 Levitra Bayer Pharma AG 13342 Berlin, Deutschland EU/1/03/248/001-023 23.2.2012 21.2.2012 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292/001-012 23.2.2012 21.2.2012 PREZISTA Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België EU/1/06/380/001-005 23.2.2012 21.2.2012 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/05/323/001-013 24.2.2012 21.2.2012 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116/001-005 23.2.2012 21.2.2012 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/348/001-002 24.2.2012 21.2.2012 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 23.2.2012 21.2.2012 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België EU/1/08/494/001-004 24.2.2012 21.2.2012 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-026 23.2.2012 21.2.2012 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 24.2.2012 21.2.2012 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Researchdreef, 60, 1070 Brussel, België EU/1/08/470/001-019 23.2.2012 21.2.2012 Visudyne Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 23.2.2012 21.2.2012 Vivanza Bayer Pharma AG 13342 Berlin, Deutschland EU/1/03/249/001-015 24.2.2012 21.2.2012 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 24.2.2012 23.2.2012 Clopidogrel Qualimed Qualimed 117, Allée des Parcs, 69 800 Saint Priest, France EU/1/09/557/001-010 27.2.2012 23.2.2012 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383/001-018 27.2.2012 23.2.2012 Resolor Shire-Movetis NV Veedjik 58, B-2300 Turnhout, België EU/1/09/581/001-008 27.2.2012 27.2.2012 Bridion N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/08/466/001-002 29.2.2012 27.2.2012 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15, B-1831 Diegem, België EU/1/08/473/001-003 29.2.2012 27.2.2012 Instanyl Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/09/531/001-021 29.2.2012 27.2.2012 Irbesartan HCT Zentiva (Ex-Winthrop) Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/377/001-028 1.3.2012 27.2.2012 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 29.2.2012 27.2.2012 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 29.2.2012 27.2.2012 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 29.2.2012 27.2.2012 Twynsta Boehringer Ingelheim International GmbH Binger Strasse 173 – D - 55216 Ingelheim am Rhein, Deutschland EU/1/10/648/001-028 29.2.2012





— 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 9.2.2012 Clopidogrel Acino Pharma Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/549/001-007 13.2.2012 9.2.2012 Clopidogrel Hexal Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/534/001-007 13.2.2012 13.2.2012 Clopidogrel Acino Pharma GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/548/001-007 15.2.2012





— 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 23.2.2012 RevitaCAM Meloxicam Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM EU/2/12/138/001-003 Oromucosal spray QM01AC06 27.2.2012





— 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 17.2.2012 Purevax Rabies MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/10/117/001-003 21.2.2012 21.2.2012 Dicural Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/97/003/001-018 24.2.2012 27.2.2012 Reconcile Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/08/080/001-004 29.2.2012

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.