Official Journal C 76 of the European Union Volume 59 English edition Information and Notices 26 February 2016 Contents IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES European Commission 2016/C 076/01 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 076/02 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) . 10 EN 26.2.2016 EN Official Journal of the European Union C 76/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION 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) (1) OJ L 136, 30.4.2004, p. 1. C 76/2 — Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted EN INN (International Number of the entry in ATC code (Anatomi- Date of the Name of the medicinal Date of noti- Non-Proprietary Holder of the marketing authorisation the Community Regis- Pharmaceutical form cal Therapeutic Che- decision product fication Name) ter mical Code) 11.1.2016 Eptifibatide Accord eptifibatide Accord Healthcare Limited EU/1/15/1065 Solution for infusion B01AC16 13.1.2016 Sage House, 319 Pinner Road, North Harrow, Mid- Solution for injec- dlesex, HA1 4HF, United Kingdom tion 14.1.2016 Benepali etanercept Samsung Bioepis UK Limited EU/1/15/1074 Solution for injec- L04AB01 18.1.2016 Off 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, tion icial United Kingdom Jour nal 14.1.2016 Briviact brivaracetam UCB Pharma S.A. EU/1/15/1073 Film-coated tablet N03AX23 18.1.2016 Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Oral solution of Researchdreef 60, 1070 Brussel, België Solution for injec- the tion or infusion European 14.1.2016 Episalvan birch bark ex- Birken AG EU/1/15/1069 Gel Pending 18.1.2016 tract Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Uni Deutschland on 14.1.2016 Lopinavir/Ritonavir lopinavir/ritona- Mylan S.A.S EU/1/15/1067 Film-coated tablet J05AR10 18.1.2016 Mylan vir 117 allée des Parcs, F-69800 Saint Priest, France 14.1.2016 Oncaspar pegaspargase Baxalta Innovations GmbH EU/1/15/1070 Powder and solvent L01XX24 18.1.2016 Industriestrasse 67, A-1221 Vienna, Österreich for solution for in- jection/infusion 14.1.2016 Spectrila asparaginase medac Gesellschaft für klinische Spezialpräparate mbH EU/1/15/1072 Powder for concen- L01XX02 18.1.2016 Theaterstr. 6, D-22880 Wedel, Deutschland trate for solution for infusion 26.2.2016 26.2.2016 INN (International Number of the entry in ATC code (Anatomi- Date of the Name of the medicinal Date of noti- Non-Proprietary Holder of the marketing authorisation the Community Regis- Pharmaceutical form cal Therapeutic Che- decision product fication Name) ter mical Code) 18.1.2016 Pemetrexed Accord pemetrexed Accord Healthcare Limited EU/1/15/1071 Powder for concen- L01BA04 20.1.2016 EN Sage House, 319 Pinner Road, North Harrow, Mid- trate for solution for dlesex, HA1 4HF, United Kingdom infusion 18.1.2016 Pemetrexed Actavis pemetrexed Actavis Group PTC ehf. EU/1/15/1063 Concentrate for so- L01BA04 21.1.2016 Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland lution for infusion Off icial Jour nal of the European Uni on C 76/3 C 76/4 EN Official Journal of the European Union 26.2.2016 — 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 Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication 7.1.2016 Bosulif Pfizer Limited EU/1/13/818 11.1.2016 Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom 7.1.2016 Kuvan BioMarin International Limited EU/1/08/481 11.1.2016 Shanbally, Ringaskiddy, County Cork, Ireland 7.1.2016 Sildenafil Teva Teva B.V. EU/1/09/584 11.1.2016 Swensweg 5, 2031 GA Haarlem, Nederland 7.1.2016 Sirturo Janssen-Cilag International NV EU/1/13/901 11.1.2016 Turnhoutseweg 30, B-2340 Beerse, België 11.1.2016 Cometriq TMC Pharma Services Ltd EU/1/13/890 13.1.2016 Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom 11.1.2016 Latuda Takeda Pharma A/S EU/1/14/913 13.1.2016 Dybendal Alle 10, 2630 Taastrup, Danmark 11.1.2016 Sivextro Merck Sharp & Dohme Limited EU/1/15/991 13.1.2016 Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom 11.1.2016 Yellox PharmaSwiss Česká republika s.r.o. EU/1/11/692 13.1.2016 Jankovcova 1569/2c 17000 Praha 7 Česká republika 11.1.2016 Zinforo AstraZeneca AB EU/1/12/785 13.1.2016 SE-151 85 Södertälje, Sverige 12.1.2016 Atriance Novartis Europharm Limited EU/1/07/403 14.1.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom 12.1.2016 Cervarix GlaxoSmithKline Biologicals S.A. EU/1/07/419 14.1.2016 rue de l’Institut 89, 1330 Rixensart, Belgique 12.1.2016 Gardasil Sanofi Pasteur MSD SNC EU/1/06/357 14.1.2016 162 avenue Jean Jaurès, 69007 Lyon, France 12.1.2016 Gardasil 9 Sanofi Pasteur MSD SNC EU/1/15/1007 14.1.2016 162 avenue Jean Jaurès, 69007 Lyon, France 12.1.2016 Silgard Merck Sharp & Dohme Limited EU/1/06/358 14.1.2016 Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom 14.1.2016 Bronchitol Pharmaxis Pharmaceuticals Limited EU/1/12/760 18.1.2016 25 Moorgate, London, EC2R 6AY, United King- dom. 14.1.2016 Caprelsa AstraZeneca AB EU/1/11/749 18.1.2016 SE-151 85 Södertälje, Sverige 26.2.2016 EN Official Journal of the European Union C 76/5 Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication 14.1.2016 Eliquis Bristol-Myers Squibb/Pfizer EEIG EU/1/11/691 18.1.2016 Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom 14.1.2016 Evoltra Genzyme Europe B.V. EU/1/06/334 18.1.2016 Gooimeer 10, NL-1411 DD Naarden, Nederland 14.1.2016 Glivec Novartis Europharm Limited EU/1/01/198 18.1.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom 14.1.2016 Leganto UCB Manufacturing Ireland Ltd EU/1/11/695 19.1.2016 Shannon Industrial Estate, Co, Clare, Ireland 14.1.2016 Lumigan Allergan Pharmaceuticals Ireland EU/1/02/205 18.1.2016 Castlebar Road, Westport, County Mayo, Ireland 14.1.2016 Pravafenix LABORATOIRES SMB SA EU/1/11/679 18.1.2016 26-28 rue de la Pastorale/26-28 Herderslied- straat, 1080 Brussel/Bruxelles, Belgique/België 14.1.2016 Rotarix GlaxoSmithKline Biologicals S.A. EU/1/05/330 18.1.2016 rue de l’Institut 89, 1330 Rixensart, Belgique 14.1.2016 Torisel Pfizer Limited EU/1/07/424 18.1.2016 Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom 14.1.2016 Trobalt Glaxo Group Ltd EU/1/11/681 18.1.2016 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom 14.1.2016 VELCADE Janssen-Cilag International NV EU/1/04/274 18.1.2016 Turnhoutseweg 30, B-2340 Beerse, België 14.1.2016 Xeloda Roche Registration Limited EU/1/00/163 18.1.2016 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom 18.1.2016 Repso Teva B.V. EU/1/11/674 20.1.2016 Swensweg 5, 2031 GA Haarlem, Nederland 18.1.2016 Xagrid Shire Pharmaceutical Contracts Ltd EU/1/04/295 20.1.2016 Hampshire International Business Park, Chine- ham, Basingstoke, Hampshire RG24 8EP, United Kingdom 18.1.2016 Xiapex Swedish Orphan Biovitrum AB (publ) EU/1/11/671 20.1.2016 SE-112 76 Stockholm, Sverige 22.1.2016 Clopidogrel Teva Teva B.V. EU/1/09/561 26.1.2016 Pharma Swensweg 5, 2031 GA Haarlem, Nederland C 76/6 EN Official Journal of the European Union 26.2.2016 Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication 22.1.2016 Kadcyla Roche Registration Limited EU/1/13/885 26.1.2016 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom 22.1.2016 Levitra Bayer Pharma AG EU/1/03/248 26.1.2016 D-13342 Berlin, Deutschland 22.1.2016 Levodopa/Carbido- Orion Corporation EU/1/11/706 26.1.2016 pa/Entacapone Or- Orionintie 1, FI-02200 Espoo, Suomi ion 22.1.2016 Neupro UCB Manufacturing Ireland Ltd EU/1/05/331 26.1.2016 Shannon Industrial Estate, Co, Clare, Ireland 22.1.2016 Nplate Amgen Europe B.V. EU/1/08/497 26.1.2016 Minervum 7061, NL-4817 ZK Breda, Nederland 22.1.2016 Ofev Boehringer Ingelheim International GmbH EU/1/14/979 26.1.2016 Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland 22.1.2016 Optaflu Novartis Influenza Vaccines Marburg GmbH EU/1/07/394 26.1.2016 Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland 22.1.2016 Topotecan Actavis Actavis Group PTC ehf.