EN Official Journal of the European Union C 71/2

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 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 071/02)

— 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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 12.1.2015 Rasagiline ratiopharm rasagiline Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/977 Tablet N04BD02 14.1.2015 15.1.2015 Cosentyx secukinumab Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/980 Powder and solution for injection Solution for injection in a pre-filled syringe Solution for injection in pre-filled pen L04AC10 19.1.2015 15.1.2015 Exviera dasabuvir AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/14/983 Film-coated tablet Pending 19.1.2015 15.1.2015 Ofev Nintedanib Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 Capsule, soft L01XE31 19.1.2015 15.1.2015 Otezla apremilast Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/14/981 Film-coated tablet L04AA32 16.1.2015 15.1.2015 Senshio ospemifene Shionogi Limited 33 Kingsway, London WC2B 6UF, United Kingdom EU/1/14/978 Film-coated tablet G03XC05 19.1.2015 15.1.2015 Sevelamer carbonate Zentiva Sevelamer carbonate Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/952 Film-coated tablet Powder for oral suspension V03AE02 19.1.2015 15.1.2015 Vectibix panitumumab Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 Concentrate for solution for infusion L01XC08 19.1.2015 15.1.2015 Viekirax ombitasvir/paritaprevir/ritonavir AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/14/982 Film-coated tablet Pending 19.1.2015 19.1.2015 Cerdelga eliglustat Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/974 Capsule, hard A16AX10 21.1.2015 19.1.2015 Zontivity vorapaxar Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/14/976 Film-coated tablet Pending 21.1.2015

— 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 7.1.2015 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 9.1.2015 12.1.2015 Defitelio Gentium S.p.A. Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia EU/1/13/878 14.1.2015 12.1.2015 Emselex Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen, L-2540 Luxembourg EU/1/04/294 14.1.2015 12.1.2015 ProQuad Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/05/323 14.1.2015 12.1.2015 Savene Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/06/350 14.1.2015 12.1.2015 Temozolomide Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/615 14.1.2015 12.1.2015 Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 14.1.2015 12.1.2015 Zostavax Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/341 14.1.2015 15.1.2015 Advate Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/03/271 19.1.2015 15.1.2015 Byetta AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/06/362 19.1.2015 15.1.2015 Caprelsa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/749 19.1.2015 15.1.2015 Cholib Abbott Healthcare Products Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom EU/1/13/866 19.1.2015 15.1.2015 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/317 19.1.2015 15.1.2015 Focetria Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/07/385 19.1.2015 15.1.2015 Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 19.1.2015 15.1.2015 Incresync Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/842 19.1.2015 15.1.2015 Latuda Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/913 19.1.2015 15.1.2015 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711 19.1.2015 15.1.2015 Memantine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/13/836 19.1.2015 15.1.2015 Nivestim Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/631 19.1.2015 15.1.2015 Opsumit Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/13/893 17.1.2015 15.1.2015 Picato Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/12/796 19.1.2015 15.1.2015 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/316 19.1.2015 15.1.2015 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 19.1.2015 15.1.2015 Revolade GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/10/612 19.1.2015 15.1.2015 SANCUSO ProStrakan Limited Galabank Business Park, Galashiels TD1 1QH, United Kingdom EU/1/12/766 19.1.2015 15.1.2015 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 19.1.2015 15.1.2015 TOBI Podhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/652 19.1.2015 15.1.2015 Vipdomet Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/843 19.1.2015 15.1.2015 Vipidia Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/844 19.1.2015 15.1.2015 Votrient Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/628 19.1.2015 15.1.2015 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 19.1.2015 19.1.2015 Aclasta Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/308 21.1.2015 19.1.2015 BYDUREON AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/696 21.1.2015 19.1.2015 Cometriq TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/13/890 21.1.2015 19.1.2015 Gliolan medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/07/413 21.1.2015 19.1.2015 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 21.1.2015 19.1.2015 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/901 21.1.2015 22.1.2015 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 26.1.2015 22.1.2015 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 26.1.2015 22.1.2015 Lyrica Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/04/279 26.1.2015 22.1.2015 Spedra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/13/841 26.1.2015 27.1.2015 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/08/473 29.1.2015 27.1.2015 Levetiracetam Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/701 30.1.2015 27.1.2015 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 30.1.2015 27.1.2015 Myocet Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/00/141 30.1.2015 27.1.2015 Pramipexole Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/490 30.1.2015 27.1.2015 VPRIV Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646 29.1.2015 27.1.2015 Yellox PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Czech Republic EU/1/11/692 29.1.2015 30.1.2015 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 3.2.2015 30.1.2015 Pioglitazone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/757 3.2.2015 30.1.2015 Pioglitazone Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/758 3.2.2015 30.1.2015 Tresiba Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/807 3.2.2015 30.1.2015 Trisenox Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/02/204 5.2.2015 30.1.2015 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 3.2.2015 30.1.2015 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/11/671 3.2.2015

— Issuing 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 INN (International Non-Proprietary Name) Holder of the marketing authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 15.1.2015 NEXGARD SPECTRA Afoxolaner/milbemycin oxime Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/14/177 Chewable tablet QP54AB51 19.1.2015

— 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 12.1.2015 Coxevac CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/10/110 14.1.2015 15.1.2015 BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, E-36400 Porriño, España EU/2/11/122 19.1.2015 30.1.2015 Emdocam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, België EU/2/11/128 3.2.2015

— Withdrawal of a marketing authorisation (Article 38 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 15.1.2015 Slentrol Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/07/071 19.1.2015 15.1.2015 TruScient Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/136 19.1.2015

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.