EN Official Journal of the European Union C 176/4

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2015 to 30 April 2015

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

(2015/C 176/02)

— Issuing of a marketing authorisation (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 13.4.2015 Ristempa pegfilgrastim Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/996 Solution for injection L03AA13 15.4.2015 24.4.2015 Arzerra Ofatumumab Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/625 Concentrate for solution for infusion L01XC10 28.4.2015

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 8.4.2015 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 10.4.2015 8.4.2015 Ammonaps Swedish Orphan International AB SE-112 76 Stockholm, Sverige EU/1/99/120 10.4.2015 8.4.2015 Daxas Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/10/636 10.4.2015 8.4.2015 Dukoral Valneva Sweden AB SE-105 21 Stockholm, Sverige EU/1/03/263 13.4.2015 8.4.2015 Invokana Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 10.4.2015 8.4.2015 ReFacto AF Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/103 10.4.2015 8.4.2015 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/09/599 10.4.2015 8.4.2015 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/05/330 10.4.2015 8.4.2015 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 10.4.2015 9.4.2015 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/802 13.4.2015 9.4.2015 Clopidogrel Acino Acino AG Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532 13.4.2015 9.4.2015 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560 13.4.2015 9.4.2015 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/09/559 13.4.2015 9.4.2015 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328 14.4.2015 9.4.2015 Eucreas Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/425 14.4.2015 9.4.2015 Forsteo Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/03/247 13.4.2015 9.4.2015 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 13.4.2015 9.4.2015 GONAL-f Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001 13.4.2015 9.4.2015 Levitra Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/248 13.4.2015 9.4.2015 M-M-RVAXPRO Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/337 13.4.2015 9.4.2015 Olanzapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/427 13.4.2015 13.4.2015 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/02/218 15.4.2015 13.4.2015 Azopt Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/00/129 15.4.2015 13.4.2015 Capecitabine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/762 15.4.2015 13.4.2015 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika EU/1/09/541 15.4.2015 13.4.2015 Ecansya Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 15.4.2015 13.4.2015 Icandra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484 16.4.2015 13.4.2015 SonoVue Bracco International B.V. Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland EU/1/01/177 15.4.2015 13.4.2015 Targretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/01/178 15.4.2015 13.4.2015 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/95/002 15.4.2015 13.4.2015 Tecfidera Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/13/837 15.4.2015 13.4.2015 Zomarist Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483 16.4.2015 13.4.2015 Zyllt Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553 15.4.2015 13.4.2015 Zyprexa Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/96/022 15.4.2015 13.4.2015 Zyprexa Velotab Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/99/125 15.4.2015 15.4.2015 Zevalin Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland EU/1/03/264 17.4.2015 20.4.2015 Combivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/98/058 22.4.2015 20.4.2015 Mekinist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/931 22.4.2015 24.4.2015 Abilify Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/04/276 28.4.2015 24.4.2015 ABILIFY MAINTENA Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/13/882 28.4.2015 24.4.2015 Atriance Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/403 28.4.2015 24.4.2015 Benlysta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/700 28.4.2015 24.4.2015 Bretaris Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/781 28.4.2015 24.4.2015 Daliresp Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/11/668 28.4.2015 24.4.2015 Daxas Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/10/636 28.4.2015 24.4.2015 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, D-80636 München, Deutschland EU/1/13/875 28.4.2015 24.4.2015 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/07/384 28.4.2015 24.4.2015 Eklira Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/778 28.4.2015 24.4.2015 Fosavance Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310 28.4.2015 24.4.2015 Galvus Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414 28.4.2015 24.4.2015 Hycamtin Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/96/027 28.4.2015 24.4.2015 Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/13/876 28.4.2015 24.4.2015 Jalra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485 28.4.2015 24.4.2015 JETREA ThromboGenics NV Gaston Geenslaan 1, B-3001 Leuven, België EU/1/13/819 28.4.2015 24.4.2015 Libertek Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/11/666 28.4.2015 24.4.2015 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155 28.4.2015 24.4.2015 Onglyza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/545 28.4.2015 24.4.2015 Rapiscan Rapidscan Pharma Solutions EU Ltd Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom EU/1/10/643 28.4.2015 24.4.2015 Tivicay ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/13/892 28.4.2015 24.4.2015 Toujeo Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 28.4.2015 24.4.2015 Trobalt Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 28.4.2015 24.4.2015 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/11/671 28.4.2015 24.4.2015 Xiliarx Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486 28.4.2015

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 13.4.2015 Rienso Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/774 15.4.2015

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 9.4.2015 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/97/004 13.4.2015 13.4.2015 BROADLINE Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/157 15.4.2015 13.4.2015 Draxxin Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/03/041 15.4.2015 13.4.2015 Porcilis Porcoli Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/96/001 15.4.2015 24.4.2015 Porcilis ColiClos Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/12/141 28.4.2015

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 30, Churchill Place, Canary Wharf UK — LONDON E14 5EU

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