EN Official Journal of the European Union C 277/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016

(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 277/01)

— 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 21.6.2016 Odefsey emtricitabine/rilpivirine/tenofovir alafenamide Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/16/1112 Film-coated tablet J05AR19 23.6.2016 24.6.2016 Ongentys opicapone Bial — Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/15/1066 Capsule, hard Pending 28.6.2016 24.6.2016 Zavicefta ceftazidime/avibactam AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/16/1109 Powder for concentrate for solution for infusion J01DD52 28.6.2016 29.6.2016 Enzepi pancreas powder APTALIS PHARMA SAS 5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France EU/1/16/1113 Capsule, hard, gastro-resistant A09AA02 1.7.2016

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 24.6.2016 Dropcys Lucane Pharma 172 rue de Charonne, 75011 Paris, France 28.6.2016

— 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 1.6.2016 Cotellic Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/15/1048 3.6.2016 1.6.2016 HyQvia Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich EU/1/13/840 6.6.2016 1.6.2016 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 3.6.2016 1.6.2016 Zinforo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/785 3.6.2016 2.6.2016 Adrovance Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364 6.6.2016 2.6.2016 Altargo Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/390 6.6.2016 2.6.2016 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300 6.6.2016 2.6.2016 Capecitabine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/762 6.6.2016 2.6.2016 Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France EU/1/09/558 6.6.2016 2.6.2016 Clopidogrel Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556 7.6.2016 2.6.2016 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika EU/1/09/541 6.6.2016 2.6.2016 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/13/825 6.6.2016 2.6.2016 Kineret Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/02/203 7.6.2016 2.6.2016 Kiovig Baxter AG Industriestrasse 67, A-1221 Wien, Österreich EU/1/05/329 6.6.2016 2.6.2016 Lonquex UAB ‘Sicor Biotech’ Molėtų pl. 5, LT-08409 Vilnius, Lietuva EU/1/13/856 6.6.2016 2.6.2016 Neuraceq Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom EU/1/13/906 6.6.2016 2.6.2016 Tasigna Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/422 6.6.2016 2.6.2016 Temozolomide Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/10/615 6.6.2016 2.6.2016 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 6.6.2016 9.6.2016 Cubicin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/328 13.6.2016 9.6.2016 Telmisartan Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/719 13.6.2016 9.6.2016 VPRIV Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646 13.6.2016 9.6.2016 Zyllt Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553 13.6.2016 13.6.2016 Gazyvaro Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/14/937 15.6.2016 16.6.2016 Advagraf Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/07/387 20.6.2016 16.6.2016 Avonex Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/97/033 20.6.2016 16.6.2016 Protopic Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/02/201 20.6.2016 16.6.2016 Tesavel Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 20.6.2016 16.6.2016 Xelevia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 20.6.2016 21.6.2016 Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Viale Shakespeare 47, 00144 Roma, Italia EU/1/11/716 23.6.2016 21.6.2016 Irbesartan Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/06/376 23.6.2016 21.6.2016 Karvea Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/97/049 23.6.2016 21.6.2016 Lemtrada Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom EU/1/13/869 23.6.2016 21.6.2016 Modigraf Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/523 23.6.2016 21.6.2016 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 23.6.2016 21.6.2016 Zometa Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/176 23.6.2016 24.6.2016 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 28.6.2016 24.6.2016 Advate Baxter AG Industriestrasse 67, A-1221 Wien, Österreich EU/1/03/271 28.6.2016 24.6.2016 Aprovel Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/97/046 28.6.2016 24.6.2016 Cubicin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/328 28.6.2016 24.6.2016 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 28.6.2016 24.6.2016 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/03/261 28.6.2016 24.6.2016 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 28.6.2016 24.6.2016 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 28.6.2016 24.6.2016 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 28.6.2016 24.6.2016 Januvia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 28.6.2016 24.6.2016 Rasilez Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/405 28.6.2016 24.6.2016 Rasilez HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/491 28.6.2016 24.6.2016 Relvar Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/13/886 28.6.2016 24.6.2016 Revinty Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/929 28.6.2016 24.6.2016 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 28.6.2016 24.6.2016 Tolura Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632 28.6.2016 24.6.2016 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 28.6.2016 24.6.2016 Zoledronic acid Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/12/800 28.6.2016 29.6.2016 Champix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/360 1.7.2016 29.6.2016 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 1.7.2016 29.6.2016 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/298 1.7.2016 29.6.2016 Kyprolis Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1060 1.7.2016 29.6.2016 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711 1.7.2016 29.6.2016 Memantine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/13/827 8.7.2016 29.6.2016 Mycamine Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/08/448 1.7.2016 29.6.2016 PegIntron Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/131 1.7.2016 29.6.2016 Revestive NPS Pharma Holdings Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/12/787 1.7.2016 29.6.2016 Tyverb Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/440 1.7.2016 29.6.2016 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/08/488 1.7.2016 29.6.2016 ViraferonPeg Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/132 4.7.2016 29.6.2016 Yondelis Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 1.7.2016 29.6.2016 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 1.7.2016 30.6.2016 Ceplene Meda AB Box 906, SE-170 09 Solna, Sverige EU/1/08/477 5.7.2016 30.6.2016 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 4.7.2016 30.6.2016 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 4.7.2016 30.6.2016 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 4.7.2016 30.6.2016 Filgrastim Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/08/496 4.7.2016 30.6.2016 Hycamtin Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/96/027 4.7.2016 30.6.2016 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 4.7.2016 30.6.2016 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/924 4.7.2016 30.6.2016 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 4.7.2016 30.6.2016 Toujeo Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 4.7.2016 30.6.2016 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 4.7.2016 30.6.2016 Yentreve Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/280 4.7.2016 30.6.2016 Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/08/495 4.7.2016

— 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 1.6.2016 Clopidogrel/Acetylsalicylic acid Teva Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/942 3.6.2016 21.6.2016 Capecitabine SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/13/831 23.6.2016 30.6.2016 Krystexxa Crealta Pharmaceuticals Ireland Limited Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland EU/1/12/810 4.7.2016 30.6.2016 Opgenra Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland EU/1/08/489 4.7.2016

— Issuing 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 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 21.6.2016 Sevocalm sevoflurane Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/16/196 Inhalation vapour, liquid Pending 24.6.2016

— 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 3.6.2016 Nobivac L4 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/12/143 7.6.2016 21.6.2016 Emdocam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, België EU/2/11/128 23.6.2016 21.6.2016 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/97/004 23.6.2016 22.6.2016 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/06/061 24.6.2016 24.6.2016 Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090 29.6.2016

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.