EN Official Journal of the European Union C 35/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2015 to 31 December 2015

(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 035/01)

— 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 2.12.2015 Ciambra pemetrexed Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/15/1055 Powder for concentrate for solution for infusion L01BA04 4.12.2015 2.12.2015 Nucala mepolizumab GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/15/1043 Powder for solution for injection Pending 7.12.2015 16.12.2015 Imlygic talimogene laherparepvec Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1064 Solution for injection Pending 18.12.2015

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 21.12.2015 Heparesc Cytonet GmbH & Co. KG Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland — 23.12.2015

— 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 2.12.2015 Tadalafil Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/14/961 4.12.2015 2.12.2015 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/96/020 4.12.2015 2.12.2015 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/97/029 4.12.2015 2.12.2015 Zyclara Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige EU/1/12/783 4.12.2015 9.12.2015 Abasaglar Eli Lilly Regional Operations GmbH. Kölblgasse 8-10, 1030 Wien, Österreich EU/1/14/944 11.12.2015 9.12.2015 Voriconazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/835 11.12.2015 10.12.2015 Accofil Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/14/946 14.12.2015 10.12.2015 Amyvid Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/12/805 14.12.2015 10.12.2015 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419 14.12.2015 10.12.2015 Efient DAIICHI SANKYO EUROPE GmbH Zielstattstrasse 48, D-81379 München, Deutschland EU/1/08/503 14.12.2015 10.12.2015 Gardasil Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 14.12.2015 10.12.2015 Holoclar Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/987 14.12.2015 10.12.2015 Ifirmasta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 14.12.2015 10.12.2015 Remsima Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország EU/1/13/853 14.12.2015 10.12.2015 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 14.12.2015 10.12.2015 Starlix Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/174 14.12.2015 10.12.2015 Synagis AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/99/117 14.12.2015 10.12.2015 Vipidia Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/844 14.12.2015 10.12.2015 Votubia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/710 14.12.2015 10.12.2015 Zoledronic acid Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/12/759 14.12.2015 14.12.2015 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 16.12.2015 14.12.2015 Envarsus Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 16.12.2015 14.12.2015 Incruse Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/922 16.12.2015 14.12.2015 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 16.12.2015 14.12.2015 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/08/452 16.12.2015 14.12.2015 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 16.12.2015 16.12.2015 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253 18.12.2015 16.12.2015 Angiox The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/04/289 18.12.2015 16.12.2015 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/13/838 18.12.2015 16.12.2015 BYDUREON AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/696 18.12.2015 16.12.2015 Byetta AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/06/362 18.12.2015 16.12.2015 Caprelsa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/749 18.12.2015 16.12.2015 Cholestagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/268 18.12.2015 16.12.2015 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 18.12.2015 16.12.2015 Emend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262 18.12.2015 16.12.2015 Eucreas Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/425 18.12.2015 16.12.2015 Fuzeon Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/252 18.12.2015 16.12.2015 Galvus Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/414 18.12.2015 16.12.2015 Icandra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/484 18.12.2015 16.12.2015 Invokana Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 18.12.2015 16.12.2015 Jalra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/485 18.12.2015 16.12.2015 Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom EU/1/03/270 21.12.2015 16.12.2015 Lyrica Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/04/279 18.12.2015 16.12.2015 Nimenrix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/767 18.12.2015 16.12.2015 ProQuad Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/05/323 18.12.2015 16.12.2015 Protopic Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/02/201 18.12.2015 16.12.2015 Stivarga Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 18.12.2015 16.12.2015 Tecfidera Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/13/837 22.12.2015 16.12.2015 Vfend Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212 18.12.2015 16.12.2015 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 18.12.2015 16.12.2015 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672 18.12.2015 16.12.2015 Xiliarx Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/486 18.12.2015 16.12.2015 Zomarist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/483 18.12.2015 16.12.2015 Zutectra Biotest Pharma GmbH Landsteinerstrasse 5, D-63303 Dreieich, Deutschland EU/1/09/600 18.12.2015 18.12.2015 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 22.12.2015 18.12.2015 Zostavax Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/341 22.12.2015

— Withdrawal of a marketing authorisation (Article 13 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 16.12.2015 Osigraft Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland EU/1/01/179 21.12.2015

— 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 9.12.2015 Imrestor pegbovigrastim Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/15/193 Solution for injection QL03AA90 11.12.2015 9.12.2015 Velactis Cabergoline Ceva Santé Animale 10 av. de La Ballastière, 33500 Libourne, France EU/2/15/192 Solution for injection QG02CB03 11.12.2015

— 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 2.12.2015 Easotic VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France EU/2/08/085 4.12.2015 2.12.2015 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 4.12.2015 2.12.2015 Purevax Rabies Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/117 4.12.2015 18.12.2015 Equip WNV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/08/086 21.12.2015 18.12.2015 Novem Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/042 22.12.2015 18.12.2015 Purevax RC Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/051 22.12.2015

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 7, Westferry Circus, Canary Wharf UK — LONDON E14 4H

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