EN Official Journal of the European Union C 123/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 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 123/01

— 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 5.3.2014 Sirturo bedaquiline Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/901 Tablet J04A 7.3.2014 21.3.2014 Cometriq cabozantinib TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/13/890 Capsule, hard Pending 26.3.2014 21.3.2014 Eperzan albiglutide GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland EU/1/13/908 Powder and solvent for solution for injection A10BX13 26.3.2014 21.3.2014 Latuda lurasidone Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/913 Film-coated tablet N05AE05 27.3.2014 27.3.2014 Adempas riociguat Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/907 Film-coated tablet C02KX05 31.3.2014 27.3.2014 Bemfola follitropin alfa FINOX Biotech AG Gärten 71 FL-9496 Balzers Liechtenstein EU/1/13/909 Solution for injection in pre-filled pen G03GA05 31.3.2014 27.3.2014 Zoledronic acid Teva Generics Zoledronic Acid Teva Generics B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/912 Solution for infusion M05BA08 1.4.2014

— 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 21.3.2014 Winfuran Toray International U.K. Limited Verulam Gardens, 70 Gray’s Inn Road, London, WC1X 8NH, United Kingdom — 25.3.2014

— 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 3.3.2014 Opatanol Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/02/217 5.3.2014 3.3.2014 Peyona Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/09/528 5.3.2014 3.3.2014 Sildenafil Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/09/595 5.3.2014 5.3.2014 Azopt Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/00/129 10.3.2014 5.3.2014 Emadine Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/98/095 10.3.2014 5.3.2014 Forxiga Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/12/795 7.3.2014 5.3.2014 IntronA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/127 7.3.2014 5.3.2014 Tasmar Meda AB Pipers väg 2A, S-170 09 Solna, Sverige EU/1/97/044 7.3.2014 10.3.2014 Osigraft Olympus Biotech International Limited Block 2, International Science Centre, National Technology Park, Castletroy, Limerick, Ireland EU/1/01/179 12.3.2014 10.3.2014 Pedea Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/04/284 12.3.2014 10.3.2014 Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641 12.3.2014 12.3.2014 Qutenza Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/524 14.3.2014 12.3.2014 Tyverb Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/440 14.3.2014 12.3.2014 Vibativ Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/11/705 14.3.2014 14.3.2014 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/02/237 18.3.2014 14.3.2014 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/452 18.3.2014 14.3.2014 Zevalin Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland EU/1/03/264 18.3.2014 21.3.2014 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412 26.3.2014 21.3.2014 Binocrit Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/07/410 26.3.2014 21.3.2014 Ceplene Meda AB Box 906, SE-170 09 Solna, Sverige EU/1/08/477 26.3.2014 21.3.2014 Clopidogrel Acino Acino AG Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532 26.3.2014 21.3.2014 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/11/733 26.3.2014 21.3.2014 DuoTrav Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/06/338 25.3.2014 21.3.2014 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 26.3.2014 21.3.2014 Elonva Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/609 25.3.2014 21.3.2014 Entacapone Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/665 25.3.2014 21.3.2014 Epoetin alfa Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411 26.3.2014 21.3.2014 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 26.3.2014 21.3.2014 Nexium Control Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/13/860 25.3.2014 21.3.2014 Renvela Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/521 26.3.2014 21.3.2014 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/01/189 26.3.2014 21.3.2014 Soliris Alexion Europe SAS 25 boulevard de l'Amiral Bruix, F-75016 Paris, France EU/1/07/393 28.3.2014 21.3.2014 TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/277 25.3.2014 21.3.2014 Temozolomide SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/697 25.3.2014 21.3.2014 Vedrop Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/09/533 26.3.2014 21.3.2014 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 25.3.2014 21.3.2014 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 25.3.2014 21.3.2014 Ziagen ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/99/112 26.3.2014 27.3.2014 Altargo Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/390 31.3.2014 27.3.2014 Gardasil Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/06/357 31.3.2014 27.3.2014 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 31.3.2014 31.3.2014 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3, D-20354 Hamburg, Deutschland EU/1/09/605 2.4.2014

— 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 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 12.3.2014 Equisolon Prednisolone Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/14/161 Oral powder QH02AB06 14.3.2014 12.3.2014 Fungitraxx Itraconazole Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland EU/2/13/160 Oral solution QJ02AC02 17.3.2014

— 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 12.3.2014 BTVPUR AlSap 8 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/09/094 14.3.2014 12.3.2014 Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090 14.3.2014 12.3.2014 RevitaCAM Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/2/12/138 14.3.2014 14.3.2014 Bovilis BTV8 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/106 18.3.2014 14.3.2014 Panacur AquaSol Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/135 18.3.2014 31.3.2014 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/06/070 2.4.2014

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.

(2) OJ L 136, 30.4.04, p. 1.