EN Official Journal of the European Union C 410/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2017 to 31 October 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 410/01)

— 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 3.10.2017 Beromun Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/99/097 5.10.2017 3.10.2017 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 5.10.2017 3.10.2017 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 5.10.2017 3.10.2017 Synflorix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/09/508 5.10.2017 3.10.2017 Toujeo Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 5.10.2017 3.10.2017 Zoely Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/690 5.10.2017 4.10.2017 Empliciti Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/16/1088 6.10.2017 4.10.2017 Twinrix Adult GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/96/020 6.10.2017 9.10.2017 Ambirix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/02/224 11.10.2017 9.10.2017 Erivedge Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 11.10.2017 13.10.2017 Amlodipine/Valsartan Mylan Mylan S.A.S 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1092 17.10.2017 13.10.2017 Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1148 17.10.2017 13.10.2017 JETREA ThromboGenics NV Gaston Geenslaan 1, 3001 Leuven, België EU/1/13/819 17.10.2017 13.10.2017 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/97/029 17.10.2017 13.10.2017 Ulunar Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/917 17.10.2017 13.10.2017 Wakix Bioprojet Pharma 9 rue Rameau, 75002 Paris, France EU/1/15/1068 17.10.2017 19.10.2017 Emend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262 24.10.2017 19.10.2017 Firazyr Shire Orphan Therapies GmbH Friedrichstraße 149, 10117 Berlin, Deutschland EU/1/08/461 23.10.2017 19.10.2017 Humalog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/007 23.10.2017 19.10.2017 Mozobil Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland EU/1/09/537 23.10.2017 19.10.2017 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 23.10.2017 19.10.2017 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442 23.10.2017 19.10.2017 Revestive Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/12/787 23.10.2017 19.10.2017 Stribild Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/830 23.10.2017 19.10.2017 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 23.10.2017 19.10.2017 Yondelis Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España EU/1/07/417 23.10.2017 23.10.2017 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/13/879 25.10.2017 23.10.2017 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 25.10.2017 23.10.2017 Levetiracetam Actavis Group Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/738 25.10.2017 23.10.2017 Liprolog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/01/195 25.10.2017 23.10.2017 Olanzapine Glenmark Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom EU/1/09/587 25.10.2017 23.10.2017 Olanzapine Glenmark Europe Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom EU/1/09/588 25.10.2017 23.10.2017 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 25.10.2017 30.10.2017 Competact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/354 1.11.2017 30.10.2017 Epclusa Gilead Sciences International Ltd Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom EU/1/16/1116 1.11.2017 30.10.2017 Firdapse BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom EU/1/09/601 1.11.2017 30.10.2017 Fortacin Recordati Ireland Ltd Raheens East, Ringaskiddy, Co. Cork, Ireland EU/1/13/881 1.11.2017 30.10.2017 Ibandronic Acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/642 2.11.2017 30.10.2017 Multaq Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/09/591 2.11.2017 30.10.2017 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311 1.11.2017 30.10.2017 Ultibro Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/862 1.11.2017 30.10.2017 Venclyxto AbbVie Ltd Vanwall Road, Maidenhead, SL6 4UB, United Kingdom EU/1/16/1138 1.11.2017

— 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 5.10.2017 Equisolon Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/14/161 10.10.2017 10.10.2017 Simparica Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/191 12.10.2017 19.10.2017 Bovela Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/14/176 23.10.2017 24.10.2017 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 26.10.2017 24.10.2017 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 26.10.2017 31.10.2017 Pexion Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/147 6.11.2017

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.