EN Official Journal of the European Union C 76/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016

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

(2016/C 076/01)

— 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 11.1.2016 Eptifibatide Accord eptifibatide Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1065 Solution for infusion Solution for injection B01AC16 13.1.2016 14.1.2016 Benepali etanercept Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom EU/1/15/1074 Solution for injection L04AB01 18.1.2016 14.1.2016 Briviact brivaracetam UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 Film-coated tablet Oral solution Solution for injection or infusion N03AX23 18.1.2016 14.1.2016 Episalvan birch bark extract Birken AG Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland EU/1/15/1069 Gel Pending 18.1.2016 14.1.2016 Lopinavir/Ritonavir Mylan lopinavir/ritonavir Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/15/1067 Film-coated tablet J05AR10 18.1.2016 14.1.2016 Oncaspar pegaspargase Baxalta Innovations GmbH Industriestrasse 67, A-1221 Vienna, Österreich EU/1/15/1070 Powder and solvent for solution for injection/infusion L01XX24 18.1.2016 14.1.2016 Spectrila asparaginase medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/15/1072 Powder for concentrate for solution for infusion L01XX02 18.1.2016 18.1.2016 Pemetrexed Accord pemetrexed Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1071 Powder for concentrate for solution for infusion L01BA04 20.1.2016 18.1.2016 Pemetrexed Actavis pemetrexed Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/15/1063 Concentrate for solution for infusion L01BA04 21.1.2016

— 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 7.1.2016 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 11.1.2016 7.1.2016 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 11.1.2016 7.1.2016 Sildenafil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/584 11.1.2016 7.1.2016 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/901 11.1.2016 11.1.2016 Cometriq TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/13/890 13.1.2016 11.1.2016 Latuda Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/913 13.1.2016 11.1.2016 Sivextro Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/991 13.1.2016 11.1.2016 Yellox PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/11/692 13.1.2016 11.1.2016 Zinforo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/785 13.1.2016 12.1.2016 Atriance Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/403 14.1.2016 12.1.2016 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419 14.1.2016 12.1.2016 Gardasil Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 14.1.2016 12.1.2016 Gardasil 9 Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 14.1.2016 12.1.2016 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 14.1.2016 14.1.2016 Bronchitol Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom. EU/1/12/760 18.1.2016 14.1.2016 Caprelsa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/749 18.1.2016 14.1.2016 Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691 18.1.2016 14.1.2016 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 18.1.2016 14.1.2016 Glivec Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/198 18.1.2016 14.1.2016 Leganto UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 19.1.2016 14.1.2016 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 18.1.2016 14.1.2016 Pravafenix LABORATOIRES SMB SA 26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België EU/1/11/679 18.1.2016 14.1.2016 Rotarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/05/330 18.1.2016 14.1.2016 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424 18.1.2016 14.1.2016 Trobalt Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 18.1.2016 14.1.2016 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 18.1.2016 14.1.2016 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 18.1.2016 18.1.2016 Repso Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/674 20.1.2016 18.1.2016 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 20.1.2016 18.1.2016 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/11/671 20.1.2016 22.1.2016 Clopidogrel Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/561 26.1.2016 22.1.2016 Kadcyla Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/885 26.1.2016 22.1.2016 Levitra Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/248 26.1.2016 22.1.2016 Levodopa/Carbidopa/Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706 26.1.2016 22.1.2016 Neupro UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 26.1.2016 22.1.2016 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 26.1.2016 22.1.2016 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 26.1.2016 22.1.2016 Optaflu Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 26.1.2016 22.1.2016 Topotecan Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/09/536 27.1.2016 22.1.2016 Ulunar Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/917 26.1.2016 22.1.2016 Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077 26.1.2016 22.1.2016 Vivanza Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/249 26.1.2016 25.1.2016 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France EU/1/05/317 27.1.2016 25.1.2016 Cyramza Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/14/957 27.1.2016 25.1.2016 Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/708 27.1.2016 25.1.2016 Exviera AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/983 27.1.2016 25.1.2016 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 27.1.2016 25.1.2016 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119 27.1.2016 25.1.2016 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France EU/1/05/316 27.1.2016 25.1.2016 SANCUSO ProStrakan Limited Galabank Business Park, Galashiels TD1 1QH, United Kingdom EU/1/12/766 27.1.2016 25.1.2016 Sildenafil Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/09/595 27.1.2016 25.1.2016 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603 28.1.2016 25.1.2016 Stalevo Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/03/260 27.1.2016 25.1.2016 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311 27.1.2016 25.1.2016 Travatan Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/01/199 27.1.2016 25.1.2016 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 27.1.2016 25.1.2016 Viekirax AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/982 27.1.2016 28.1.2016 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 1.2.2016 28.1.2016 Clopidogrel Acino Acino AG Am Windfeld 35, 83714 D-Miesbach, Deutschland EU/1/09/532 1.2.2016 28.1.2016 Comtess Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/98/082 1.2.2016 28.1.2016 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 1.2.2016 28.1.2016 Defitelio Gentium S.p.A. Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia EU/1/13/878 1.2.2016 28.1.2016 Nonafact Sanquin Plasma Products B.V. Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland EU/1/01/186 1.2.2016 28.1.2016 Relistor PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/08/463 1.2.2016 28.1.2016 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 1.2.2016 28.1.2016 Sovaldi Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 1.2.2016 28.1.2016 Ultibro Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/862 1.2.2016 28.1.2016 Voriconazole Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/15/1004 1.2.2016 28.1.2016 Xoterna Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/863 1.2.2016

— 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 7.1.2016 Activyl Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/118 11.1.2016 7.1.2016 CaniLeish VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France EU/2/11/121 11.1.2016 7.1.2016 Cimalgex Vétoquinol SA Magny-Vernois, F-70200 Lure, France EU/2/10/119 11.1.2016 7.1.2016 Comfortis Eli Lilly and Company Ltd, Elanco Animal Health Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/10/115 11.1.2016 7.1.2016 Melosus CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland EU/2/10/116 11.1.2016 7.1.2016 Neocolipor Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/98/008 11.1.2016 7.1.2016 Veraflox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/10/107 11.1.2016 7.1.2016 Zulvac 1 + 8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/120 11.1.2016 14.1.2016 Procox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/11/123 18.1.2016 22.1.2016 ERYSENG PARVO Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170 Amer (Girona), España EU/2/14/167 26.1.2016 22.1.2016 Purevax RCPCh FeLV Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/047 26.1.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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