EN Official Journal of the European Union C 135/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017

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

(2017/C 135/01)

— 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 3.3.2017 Ledaga chlormethine Actelion Registration Ltd Chiswick Tower, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/16/1171 Gel L01AA05 7.3.2017 20.3.2017 Rolufta umeclidinium GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1174 Inhalation powder, pre-dispensed R03BB07 22.3.2017 22.3.2017 AMGEVITA adalimumab Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/16/1164 Solution for injection L04AB04 24.3.2017 22.3.2017 Daptomycin Hospira daptomycin Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/17/1175 Powder for solution for injection or infusion J01XX09 24.3.2017 22.3.2017 SOLYMBIC adalimumab Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/16/1163 Solution for injection L04AB04 24.3.2017 22.3.2017 Tadalafil Lilly tadalafil Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/17/1177 Film-coated tablet G04BE08 24.3.2017 22.3.2017 Xeljanz Tofacitinib Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/17/1178 Film-coated tablet L04AA29 24.3.2017 22.3.2017 Yargesa miglustat JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom EU/1/17/1176 Capsule, hard A16AX06 24.3.2017 29.3.2017 Jylamvo methotrexate Therakind Ltd 314 Regents Park Road, London N3 2JX, United Kingdom EU/1/17/1172 Oral solution L01BA01 31.3.2017

— 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 3.3.2017 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343 7.3.2017 3.3.2017 Combivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/98/058 7.3.2017 3.3.2017 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, D-80636 München, Deutschland EU/1/13/875 7.3.2017 3.3.2017 Gardasil 9 MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 7.3.2017 3.3.2017 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 7.3.2017 9.3.2017 Ziagen ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/99/112 13.3.2017 17.3.2017 Fortacin Plethora Solutions Limited Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom EU/1/13/881 21.3.2017 17.3.2017 Tybost Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/872 21.3.2017 20.3.2017 Benlysta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/700 22.3.2017 20.3.2017 Entacapone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/665 22.3.2017 20.3.2017 Repso Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/674 22.3.2017 20.3.2017 Telmisartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/610 22.3.2017 20.3.2017 Unituxin United Therapeutics Europe Ltd Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom EU/1/15/1022 22.3.2017 20.3.2017 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/11/671 22.3.2017 22.3.2017 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/97/047 23.3.2017 22.3.2017 Betaferon Bayer AG D-51368 Leverkusen, Deutschland EU/1/95/003 24.3.2017 22.3.2017 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 24.3.2017 22.3.2017 Cosentyx Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/980 24.3.2017 22.3.2017 Fluenz Tetra AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/887 24.3.2017 22.3.2017 Ilaris Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/564 24.3.2017 22.3.2017 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 24.3.2017 22.3.2017 Latuda Sunovion Pharmaceuticals Europe Ltd First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom EU/1/14/913 24.3.2017 22.3.2017 Pixuvri CTI Life Sciences Ltd Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 24.3.2017 22.3.2017 TAGRISSO AstraZeneca AB Gärtunavägen, SE-151 85 Södertälje, Sverige EU/1/16/1086 24.3.2017 22.3.2017 Zyclara Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige EU/1/12/783 24.3.2017 24.3.2017 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 28.3.2017 24.3.2017 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011 28.3.2017 24.3.2017 Genvoya Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/15/1061 28.3.2017 24.3.2017 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 28.3.2017 24.3.2017 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 28.3.2017 24.3.2017 Nemdatine Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/13/824 28.3.2017 24.3.2017 Nevirapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/598 28.3.2017 24.3.2017 NULOJIX Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694 28.3.2017 24.3.2017 Odefsey Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/16/1112 28.3.2017 24.3.2017 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 28.3.2017 24.3.2017 Pandemic influenza vaccine H5N1 BAXTER Nanotherapeutics UK Limited 10 Chiswell Street, London, EC1Y 4UQ, United Kingdom EU/1/09/571 28.3.2017 24.3.2017 Truvada Gilead Sciences International Ltd Cambridge, CB21 6GT, United Kingdom EU/1/04/305 28.3.2017 24.3.2017 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 28.3.2017 27.3.2017 Mekinist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/931 29.3.2017 29.3.2017 Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 31.3.2017 29.3.2017 Descovy Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/16/1099 31.3.2017 29.3.2017 EVARREST Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/13/868 31.3.2017 29.3.2017 Iressa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/526 31.3.2017 29.3.2017 Levitra Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/248 31.3.2017 29.3.2017 Plavix Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/069 31.3.2017 29.3.2017 Tafinlar Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/865 31.3.2017

— 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 20.3.2017 Unituxin United Therapeutics Europe Ltd Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom EU/1/15/1022 22.3.2017

— 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 6.3.2017 Rabigen SAG2 VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France EU/2/00/021 8.3.2017 13.3.2017 Nobivac L4 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/12/143 15.3.2017 29.3.2017 Dexdomitor Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/2/02/033 31.3.2017 29.3.2017 Porcilis ColiClos Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/12/141 31.3.2017

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.