EN Official Journal of the European Union C 59/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2014 to 31 January 2014

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

(2014/C 59/01)

— 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 08.01.2014 Diacomit Stiripentol Biocodex 7 avenue Gallieni, F-94250 Gentilly, France EU/1/06/367 Capsule, hard Powder for oral suspension N03AX17 10.01.2014 08.01.2014 Levetiracetam Hospira levetiracetam Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/13/889 Concentrate for solution for infusion N03AX14 10.01.2014 16.01.2014 Sovaldi sofosbuvir Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 Film-coated tablet Pending 17.01.2014 16.01.2014 Tivicay dolutegravir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/13/892 Film-coated tablet J05AX12 21.01.2014 16.01.2014 Xigduo dapagliflozin/metformin Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/13/900 Film-coated tablet A10BD15 21.01.2014 16.01.2014 Zoledronic acid Accord zoledronic acid Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/834 Concentrate for solution for infusion M05BA08 21.01.2014 30.01.2014 Tecfidera Dimethyl fumarate Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/13/837 Gastro-resistant capsule, hard N07XX09 03.02.2014





— 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 08.01.2014 BYDUREON Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/696 10.01.2014 08.01.2014 Ibandronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/798 10.01.2014 08.01.2014 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 10.01.2014 08.01.2014 Pramipexole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/728 10.01.2014 09.01.2014 Tractocile Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark EU/1/99/124 10.01.2014 10.01.2014 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119 14.01.2014 10.01.2014 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 14.01.2014 10.01.2014 Zeffix Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/114 14.01.2014 16.01.2014 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 21.01.2014 16.01.2014 Arzerra Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/625 21.01.2014 16.01.2014 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 21.01.2014 16.01.2014 Evra Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/02/223 21.01.2014 16.01.2014 Firdapse BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/09/601 21.01.2014 16.01.2014 INOmax Linde Healthcare AB SE-181 81 Lidingö, Sverige EU/1/01/194 21.01.2014 16.01.2014 IOA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/689 21.01.2014 16.01.2014 Nimvastid Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/525 21.01.2014 16.01.2014 Rapiscan Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom EU/1/10/643 21.01.2014 16.01.2014 Ribavirin Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/509 23.01.2014 16.01.2014 Ribavirin Teva Pharma BV Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/527 22.01.2014 16.01.2014 Zoely Theramex S.r.l. Via Messina 38, 20154 Milano, Italia EU/1/11/690 23.01.2014 16.01.2014 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 21.01.2014 17.01.2014 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland EU/1/11/740 21.01.2014 17.01.2014 Prialt Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/04/302 21.01.2014 22.01.2014 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560 24.01.2014 22.01.2014 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233 24.01.2014 22.01.2014 Kaletra AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/01/172 24.01.2014 22.01.2014 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654 24.01.2014 22.01.2014 Temozolomide Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/10/617 24.01.2014 22.01.2014 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 24.01.2014 22.01.2014 Zebinix BIAL — Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 24.01.2014 24.01.2014 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 28.01.2014 29.01.2014 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278 31.01.2014 29.01.2014 Levetiracetam Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/712 31.01.2014 29.01.2014 Rienso Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/12/774 31.01.2014 29.01.2014 RotaTeq Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/06/348 31.01.2014 29.01.2014 Wilzin Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/04/286 31.01.2014 29.01.2014 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 31.01.2014 31.01.2014 Crixivan Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024 04.02.2014 31.01.2014 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/07/384 04.02.2014 31.01.2014 Nexavar Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/06/342 04.02.2014 31.01.2014 Sildenafil Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/584 05.02.2014 31.01.2014 Travatan Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/01/199 04.02.2014 31.01.2014 Zoledronic acid Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/12/800 04.02.2014





— 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 16.01.2014 BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, E-36400 Porriño, España EU/2/11/122 21.01.2014 16.01.2014 Contacera Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/144 21.01.2014 24.01.2014 Proteq West Nile Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/11/129 28.01.2014 29.01.2014 Suvaxyn PCV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/099 31.01.2014

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, 30.4.04, p. 1.