EN Official Journal of the European Union C 439/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2015 to 30 November 2015

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

(2015/C 439/01)

— 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 9.11.2015 Edistride dapagliflozin AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1052 Film-coated tablet A10BX09 12.11.2015 11.11.2015 Obizur susoctocog alfa Baxalta Innovations GmbH Industriestrasse 67, A-1221 Vienna, Österreich EU/1/15/1035 Powder and solvent for solution for injection B02BD14 13.11.2015 16.11.2015 Aripiprazole Accord aripiprazole Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1045 Tablet N05AX12 19.11.2015 16.11.2015 Ebymect dapagliflozin/metfomin AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1051 Film-coated tablet A10BD15 18.11.2015 16.11.2015 Votubia Everolimus Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/710 Tablet L01XE10 23.11.2015 19.11.2015 Cinacalcet Mylan cinacalcet Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/15/1054 Film-coated tablet H05BX01 23.11.2015 19.11.2015 Elocta efmoroctocog alfa Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/15/1046 Powder and solvent for solution for injection Pending 23.11.2015 19.11.2015 Entresto sacubitril/valsartan Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1058 Film-coated tablet C09DX04 23.11.2015 19.11.2015 Genvoya elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/15/1061 Film-coated tablet J05AR18 23.11.2015 19.11.2015 IONSYS fentanyl Incline Therapeutics Europe Ltd 21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom EU/1/15/1050 Transdermal system N02AB03 23.11.2015 19.11.2015 Kyprolis carfilzomib Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1060 Powder for solution for infusion L01XX45 23.11.2015 19.11.2015 Numient levodopa/carbidopa Impax Laboratories (Netherlands) BV WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland EU/1/15/1044 Modified-release capsule, hard N04BA02 23.11.2015 19.11.2015 Orkambi Lumacaftor/Ivacaftor Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/15/1059 Film-coated tablet R07AX30 24.11.2015 20.11.2015 Cotellic cobimetinib Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/15/1048 Film-coated tablet Pending 24.11.2015 20.11.2015 Kolbam cholic acid Retrophin Europe Limited 25/28 North Wall Quay, Dublin 1, Ireland EU/1/13/895 Capsule, hard A05AA03 24.11.2015 20.11.2015 Pemetrexed Hospira pemetrexed Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/15/1057 Powder for concentrate for solution for infusion L01BA04 24.11.2015 20.11.2015 Praxbind idarucizumab Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1056 Powder and solvent for solution for injection/infusion V03AB 24.11.2015 23.11.2015 Blincyto blinatumomab Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1047 Powder for concentrate for solution for infusion L01XC19 25.11.2015 27.11.2015 Pemetrexed medac Pemetrexed medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/15/1038 Powder for concentrate for solution for infusion L01BA04 1.12.2015 27.11.2015 Ravicti Glycerol phenylbutyrate Horizon Therapeutics Limited 90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom EU/1/15/1062 Oral liquid A16AX09 1.12.2015

— 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 3.11.2015 Dexdor Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/718 5.11.2015 3.11.2015 Ventavis Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/255 5.11.2015 6.11.2015 Relvar Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/13/886 10.11.2015 6.11.2015 Vedrop Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/09/533 10.11.2015 10.11.2015 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland EU/1/02/226 12.11.2015 11.11.2015 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185 13.11.2015 11.11.2015 Comtan Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/081 13.11.2015 11.11.2015 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 13.11.2015 11.11.2015 Revestive NPS Pharma Holdings Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/12/787 13.11.2015 11.11.2015 Ristfor Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 13.11.2015 16.11.2015 Imatinib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/845 18.11.2015 16.11.2015 Kalydeco Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/12/782 19.11.2015 16.11.2015 Suboxone Indivior UK Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom EU/1/06/359 18.11.2015 19.11.2015 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 23.11.2015 19.11.2015 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/290 23.11.2015 19.11.2015 Carbaglu Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/02/246 23.11.2015 19.11.2015 Colobreathe Forest Laboratories UK Ltd Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom EU/1/11/747 23.11.2015 19.11.2015 Cosentyx Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/980 23.11.2015 19.11.2015 Cubicin Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/05/328 23.11.2015 19.11.2015 Cystadane Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/06/379 23.11.2015 19.11.2015 Entacapone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/665 23.11.2015 19.11.2015 Exelon Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/066 23.11.2015 19.11.2015 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 23.11.2015 19.11.2015 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678 23.11.2015 19.11.2015 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 23.11.2015 19.11.2015 Ifirmacombi Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 23.11.2015 19.11.2015 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 23.11.2015 19.11.2015 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 23.11.2015 19.11.2015 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 23.11.2015 19.11.2015 Krystexxa Crealta Pharmaceuticals Ireland Limited Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin, Ireland EU/1/12/810 23.11.2015 19.11.2015 Lamivudine/Zidovudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/663 23.11.2015 19.11.2015 Macugen PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/05/325 24.11.2015 19.11.2015 Mirvaso Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 23.11.2015 19.11.2015 NovoNorm Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/98/076 23.11.2015 19.11.2015 Optimark Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland EU/1/07/398 23.11.2015 19.11.2015 Prandin Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/162 23.11.2015 19.11.2015 Prometax Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/092 23.11.2015 19.11.2015 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/462 23.11.2015 19.11.2015 Simulect Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/084 23.11.2015 19.11.2015 Teysuno Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/11/669 23.11.2015 19.11.2015 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 23.11.2015 19.11.2015 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 23.11.2015 19.11.2015 Valdoxan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France EU/1/08/499 23.11.2015 19.11.2015 Vfend Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212 23.11.2015 19.11.2015 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 23.11.2015 19.11.2015 Xenical Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/071 23.11.2015 20.11.2015 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/736 24.11.2015 20.11.2015 Volibris Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/08/451 25.11.2015 23.11.2015 alli Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/401 25.11.2015 23.11.2015 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 25.11.2015 23.11.2015 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 25.11.2015 23.11.2015 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 25.11.2015 23.11.2015 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/11/671 25.11.2015 27.11.2015 CellCept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005 1.12.2015 27.11.2015 Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 1.12.2015 27.11.2015 Pandemic influenza vaccine H5N1 BAXTER Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika EU/1/09/571 1.12.2015 27.11.2015 Quinsair Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland EU/1/14/973 1.12.2015 27.11.2015 Rapamune Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/01/171 2.12.2015 27.11.2015 Revinty Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/929 1.12.2015 27.11.2015 Rivastigmine HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/09/589 30.11.2015 27.11.2015 Rivastigmine Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/09/599 2.12.2015 27.11.2015 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 1.12.2015 30.11.2015 Celvapan Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika EU/1/08/506 2.12.2015 30.11.2015 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland EU/1/09/585 2.12.2015 30.11.2015 Vepacel Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika EU/1/12/752 2.12.2015

— 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 30.11.2015 Nivolumab BMS Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1026 2.12.2015

— Suspension of a marketing authorisation (Article 20 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 20.11.2015 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland EU/1/02/226 24.11.2015

— Issuing 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 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 6.11.2015 Simparica sarolaner Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/191 Chewable tablet QP53BX06 10.11.2015 6.11.2015 Suvaxyn Circo + MH RTU Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated) Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/15/190 Emulsion for injection QI09AL 10.11.2015 6.11.2015 Zycortal desoxycortone Dechra Limited Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom EU/2/15/189 Suspension for injection QH02AA03 10.11.2015

— 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 6.11.2015 Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170 Amer (Girona), España EU/2/10/114 10.11.2015 9.11.2015 Nobivac Bb Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/02/034 11.11.2015 19.11.2015 Zolvix Novartis Healthcare A/S Edvard Thomsens Vej 14, DK-2300 København S, Danmark EU/2/09/101 23.11.2015 20.11.2015 Leucofeligen FeLV/RCP Virbac 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France EU/2/09/097 24.11.2015 27.11.2015 Leucogen Virbac 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France EU/2/09/096 1.12.2015

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.