EN Official Journal of the European Union C 199/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2014 to 31 May 2014

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

2014/C 199/01

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 2.5.2014 Revinty Ellipta fluticasone furoate/vilanterol trifenatate Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/929 Inhalation powder, pre-dispensed R03AK10 6.5.2014 8.5.2014 Anoro umeclidinium bromide/vilanterol trifenatate Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/898 Inhalation powder, pre-dispensed R03AL03 13.5.2014 8.5.2014 Laventair umeclidinium bromide/vilanterol trifenatate Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/899 Inhalation powder, pre-dispensed R03AL03 13.5.2014 14.5.2014 OLYSIO simeprevir Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/924 Capsule, hard J05AE14 16.5.2014 22.5.2014 Ebilfumin oseltamivir Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/14/915 Capsule, hard J05AH02 27.5.2014 22.5.2014 Entyvio vedolizumab Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 Powder for concentrate for solution for infusion L04AA33 27.5.2014 22.5.2014 Jardiance Empagliflozin Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 Film-coated tablet A10BX12 27.5.2014 22.5.2014 Sylvant siltuximab Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/928 Powder for concentrate for solution for infusion Pending 27.5.2014

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 2.5.2014 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026 6.5.2014 6.5.2014 NutropinAq Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/00/164 9.5.2014 6.5.2014 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland EU/1/09/585 8.5.2014 6.5.2014 Vyndaqel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/11/717 8.5.2014 7.5.2014 Tresiba Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/807 9.5.2014 7.5.2014 Trobalt Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 9.5.2014 8.5.2014 Clopidogrel Teva Pharma Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/561 14.5.2014 8.5.2014 Zylagren Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/558 13.5.2014 14.5.2014 Clopidogrel Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556 16.5.2014 14.5.2014 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland EU/1/02/226 16.5.2014 14.5.2014 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 16.5.2014 14.5.2014 Pandemic influenza vaccine H5N1 BAXTER Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/09/571 16.5.2014 14.5.2014 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 16.5.2014 14.5.2014 Zyllt Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553 16.5.2014 16.5.2014 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538 20.5.2014 16.5.2014 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 20.5.2014 16.5.2014 Clopidogrel Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/540 20.5.2014 16.5.2014 Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/649 20.5.2014 16.5.2014 Docetaxel Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/769 20.5.2014 16.5.2014 Javlor Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France EU/1/09/550 20.5.2014 16.5.2014 Vizarsin Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 20.5.2014 22.5.2014 Adjupanrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578 27.5.2014 22.5.2014 Busilvex Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France EU/1/03/254 27.5.2014 22.5.2014 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560 27.5.2014 22.5.2014 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/09/559 27.5.2014 22.5.2014 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika EU/1/09/541 27.5.2014 22.5.2014 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland EU/1/09/555 27.5.2014 22.5.2014 Docetaxel Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/12/770 27.5.2014 22.5.2014 Fampyra Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699 27.5.2014 22.5.2014 Grastofil Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland EU/1/13/877 27.5.2014 22.5.2014 Iasibon Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659 27.5.2014 22.5.2014 Ipreziv Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/735 27.5.2014 22.5.2014 Osseor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/287 27.5.2014 22.5.2014 PegIntron Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/131 27.5.2014 22.5.2014 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/453 27.5.2014 22.5.2014 Protelos Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/288 27.5.2014 22.5.2014 Selincro H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/12/815 27.5.2014 22.5.2014 Vaniqa Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/01/173 27.5.2014 22.5.2014 ViraferonPeg Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/132 27.5.2014 23.5.2014 Clopidogrel Acino Acino AG Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/532 27.5.2014 23.5.2014 GILENYA Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677 27.5.2014 23.5.2014 Invega Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/07/395 27.5.2014 23.5.2014 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 27.5.2014 23.5.2014 Nexavar Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/06/342 27.5.2014 23.5.2014 Suboxone RB Pharmaceuticals Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom EU/1/06/359 27.5.2014

— Withdrawal of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 16.5.2014 Preotact NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland EU/1/06/339 20.5.2014

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 7.5.2014 Versican Plus DHPPi/L4 Versican Plus DHPPi/L4 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/14/164 Lyophilisate and solvent for suspension for injection QI07AI02 9.5.2014 7.5.2014 Versican Plus DHPPi/L4R Versican Plus DHPPi/L4R Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/14/163 Lyophilisate and solvent for suspension for injection QI07AJ06 9.5.2014

— Modification of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 7.5.2014 Recocam Cross Vetpharm Group, Ltd Broomhill Road, Tallaght Dublin 24, Ireland EU/2/11/133 8.5.2014 16.5.2014 Circovac Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/07/075 20.5.2014

— Withdrawal of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 6.5.2014 Flexicam Dechra Veterinary Products A/S Mekuvej 9, DK-7171 Uldum, Danmark EU/2/06/058 8.5.2014

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.

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