EN Official Journal of the European Union C 264/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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 264/01

— 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 20.7.2012 Bretaris Genuair aclidinium bromide Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/12/781/001-003 Inhalation powder R03BB05 25.7.2012 20.7.2012 Eklira Genuair aclidinium bromide Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/12/778/001-003 Inhalation powder R03BB05 25.7.2012 20.7.2012 Jentadueto linagliptin/metformin hydrochloride Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780/001-028 Film-coated tablet A10BD11 25.7.2012 23.7.2012 Fycompa Perampanel Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom EU/1/12/776/001-016 Film-coated tablet N03AX22 25.7.2012 23.7.2012 Kalydeco ivacaftor Vertex Pharmaceuticals (U.K.) Limited 88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom EU/1/12/782/001-002 Film-coated tablet Pending 25.7.2012





— 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 3.7.2012 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030/028-201 5.7.2012 3.7.2012 Kinzalkomb Bayer Pharma AG Berlin 13342, Deutschland EU/1/02/214/001-015 5.7.2012 3.7.2012 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/02/213/001-023 5.7.2012 3.7.2012 Prevenar 13 Wyeth-Lederle Vaccines S.A. Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique EU/1/09/590/001-006 5.7.2012 4.7.2012 Arixtra Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/02/206/001-035 6.7.2012 4.7.2012 Iasibon Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659/001-010 6.7.2012 4.7.2012 Potactasol Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland EU/1/10/660/001-002 6.7.2012 6.7.2012 Ganfort Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/06/340/001-002 10.7.2012 6.7.2012 Olazax Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597/001-005 10.7.2012 6.7.2012 Simulect Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 10.7.2012 6.7.2012 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/00/156/002-004 10.7.2012 12.7.2012 Edarbi Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/11/734/001-018 17.7.2012 12.7.2012 Ipreziv Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/11/735/001-018 17.7.2012 16.7.2012 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 18.7.2012 20.7.2012 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 24.7.2012 20.7.2012 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434/001-003 24.7.2012 20.7.2012 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/97/047/004-007 25.7.2012 20.7.2012 Celsentri ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/418/001-010 25.7.2012 20.7.2012 Cyanokit Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France EU/1/07/420/001-002 25.7.2012 20.7.2012 InductOs Medtronic Biopharma BV Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland EU/1/02/226/001 25.7.2012 20.7.2012 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468/001-002 24.7.2012 23.7.2012 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538/001-008 25.7.2012 23.7.2012 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001-002 27.7.2012 23.7.2012 Bridion N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/08/466/001-002 25.7.2012 23.7.2012 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543/001-002 25.7.2012 23.7.2012 Epivir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/96/015/001-005 27.7.2012 23.7.2012 Eucreas Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 25.7.2012 23.7.2012 Galvus Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 27.7.2012 23.7.2012 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 27.7.2012 23.7.2012 Ketek Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France EU/1/01/191/001-005 25.7.2012 23.7.2012 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/02/205/001-004 25.7.2012 23.7.2012 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/586/001-010 25.7.2012 26.7.2012 Celvapan Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/08/506/001 30.7.2012 26.7.2012 Esmya PregLem France SAS. 32, route de l'Eglise, 74140 Massongy, France EU/1/12/750/001 30.7.2012 26.7.2012 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15, B-1831 Diegem, België EU/1/08/473/001-003 30.7.2012 26.7.2012 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535/001-016 30.7.2012 26.7.2012 Onbrez Breezhaler Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593/001-010 30.7.2012 26.7.2012 Pradaxa Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442/001-016 30.7.2012 26.7.2012 Silapo STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland EU/1/07/432/001-022 30.7.2012 26.7.2012 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/710/001-007 30.7.2012 26.7.2012 Zalasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415/001-056 30.7.2012 31.7.2012 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/99/126/001-022 3.8.2012 31.7.2012 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 3.8.2012 31.7.2012 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 EU/1/99/119/017-023 3.8.2012 31.7.2012 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-007 2.8.2012 31.7.2012 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704/001-002 3.8.2012





— 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 4.7.2012 Sprimeo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/407/001-040 6.7.2012 6.7.2012 Sprimeo HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/683/001-080 10.7.2012 16.7.2012 Regranex Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/99/101/001 18.7.2012





— 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 16.7.2012 Nobivac L4 — Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/12/143/001-005 Suspension for injection QI07AB01 18.7.2012 23.7.2012 Cardalis Benazepril hydrochloride, Spironolactone CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/12/142/001-006 Tablet QC09BA07 25.7.2012





— 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 4.7.2012 Proteq West Nile MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/11/129/001-004 6.7.2012 6.7.2012 Vaxxitek HVT+ IBD Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/02/032/001-002 10.7.2012 12.7.2012 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/07/079/001-008 17.7.2012 12.7.2012 Novem Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/04/042/001-014 17.7.2012 20.7.2012 ProMeris Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/06/064/001-004 25.7.2012 20.7.2012 ProMeris Duo Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/065/001-010 25.7.2012

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.