EN Official Journal of the European Union C 438/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2016 to 31 October 2016

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

(2016/C 438/01)

— 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 14.10.2016 Onivyde irinotecan Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich EU/1/16/1130 Concentrate for solution for infusion L01XX19 18.10.2016

— 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 decision Name of the medicinal product Holder of the marketing authorisation Number of the entry in the Community Register Date of notification 6.10.2016 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 10.10.2016 6.10.2016 Pregabalin Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1011 10.10.2016 6.10.2016 Replagal Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige EU/1/01/189 10.10.2016 14.10.2016 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604 18.10.2016 14.10.2016 Lixiana Daiichi Sankyo Europe GmbH Zielstattstrasse 48, D-81379 München, Deutschland EU/1/15/993 18.10.2016 14.10.2016 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 26.10.2016 14.10.2016 Ristempa Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/996 18.10.2016 14.10.2016 Stivarga Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 18.10.2016 14.10.2016 Zerbaxa Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1032 18.10.2016 21.10.2016 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 25.10.2016 21.10.2016 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/97/047 25.10.2016 21.10.2016 Blincyto Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1047 25.10.2016 21.10.2016 Cholib Mylan Products Limited 20 Station Close, Potters Bar, EN6 ITL, United Kingdom EU/1/13/866 25.10.2016 21.10.2016 Lynparza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/959 25.10.2016 21.10.2016 Metalyse Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/00/169 25.10.2016 21.10.2016 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119 25.10.2016 21.10.2016 Olanzapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/427 25.10.2016 21.10.2016 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 25.10.2016 24.10.2016 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/08/473 26.10.2016 24.10.2016 Raplixa ProFibrix BV (Mallinckrodt Pharmaceuticals) Darwinweg 24 2333 CR Leiden, Nederland EU/1/14/985 26.10.2016 24.10.2016 Somatropin Biopartners BioPartners GmbH Kaiserpassage 11, D-72764 Reutlingen, Deutschland EU/1/13/849 26.10.2016 24.10.2016 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/814 26.10.2016 27.10.2016 Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 31.10.2016 27.10.2016 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/08/446 31.10.2016 27.10.2016 Vitekta Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/883 31.10.2016 27.10.2016 Volibris Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/08/451 31.10.2016

— 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 3.10.2016 Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170 Amer (Girona), España EU/2/10/114 5.10.2016 3.10.2016 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/06/070 5.10.2016

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.