EN Official Journal of the European Union C 447/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 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 447/01)

— 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 10.11.2017 Cyltezo adalimumab Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/17/1240 Solution for injection L04AB04 14.11.2017 10.11.2017 Miglustat Gen.Orph Miglustat Gen.Orph 100 rue Louis Blanc, TSA/Bâtiment Copenhague, 60160 Montataire, France EU/1/17/1232 Capsule, hard A16AX06 14.11.2017 10.11.2017 Nyxoid naloxone Mundipharma Corporation Limited Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom EU/1/17/1238 Nasal spray, solution V03AB15 14.11.2017 10.11.2017 Ritonavir Mylan ritonavir Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1242 Film-coated tablet J05AE03 14.11.2017 10.11.2017 TOOKAD padeliporfin Steba Biotech S.A 7 Place du Théâtre, 2613 Luxembourg, Luxembourg EU/1/17/1228 Powder for solution for injection L01XD07 14.11.2017 10.11.2017 Tremfya Guselkumab Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1234 Solution for injection L04AC 14.11.2017 10.11.2017 VeraSeal human fibrinogen / human thrombin Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa EU/1/17/1239 Solutions for sealant B02BC 14.11.2017 10.11.2017 Zubsolv buprenorphine / naloxone Mundipharma Corporation Limited Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom EU/1/17/1233 Sublingual tablet N07BC51 14.11.2017 15.11.2017 Elebrato Ellipta fluticasone furoate/umeclidinium/vilanterol GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1237 Inhalation powder, pre-dispensed Pending 17.11.2017 15.11.2017 Imatinib Teva B.V. imatinib Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/17/1243 Capsule, hard Film-coated tablet L01XE01 17.11.2017 15.11.2017 Ontruzant trastuzumab Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom EU/1/17/1241 Powder for concentrate for solution for infusion L01XC03 17.11.2017 15.11.2017 Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/17/1236 Inhalation powder, pre-dispensed Pending 17.11.2017 16.11.2017 Zejula niraparib TESARO UK LIMITED 55 Baker Street, London W1U 7EU, United Kingdom EU/1/17/1235 Capsule, hard L01XX54 20.11.2017

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 16.11.2017 Adlumiz Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland — 20.11.2017

— 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 10.11.2017 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 14.11.2017 10.11.2017 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/05/315 14.11.2017 10.11.2017 Benlysta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/700 16.11.2017 10.11.2017 BYDUREON AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/696 14.11.2017 10.11.2017 ellaOne Laboratoire HRA Pharma 15 rue Béranger, 75003 Paris, France EU/1/09/522 14.11.2017 10.11.2017 Emtricitabine /Tenofovir disoproxil Krka d.d. Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1182 14.11.2017 10.11.2017 Exjade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/356 14.11.2017 10.11.2017 Exviera AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom EU/1/14/983 14.11.2017 10.11.2017 Faslodex AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom EU/1/03/269 14.11.2017 10.11.2017 Glubrava Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/07/421 14.11.2017 10.11.2017 Humira AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom EU/1/03/256 14.11.2017 10.11.2017 Iblias Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1077 14.11.2017 10.11.2017 Kolbam Retrophin Europe Limited Palmerstown House, Fenian Street, Dublin 2, Ireland EU/1/13/895 14.11.2017 10.11.2017 Kovaltry Bayer AG D-51368 Leverkusen, Deutschland EU/1/15/1076 14.11.2017 10.11.2017 Mepact Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France EU/1/08/502 14.11.2017 10.11.2017 NexoBrid MediWound Germany GmbH Eisenstraße 5, 65428 Ruesselsheim, Deutschland EU/1/12/803 14.11.2017 10.11.2017 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165 15.11.2017 10.11.2017 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 14.11.2017 10.11.2017 Plegridy Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/14/934 14.11.2017 10.11.2017 Revatio Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/318 14.11.2017 10.11.2017 Selincro H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/12/815 14.11.2017 10.11.2017 Tandemact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/366 14.11.2017 10.11.2017 Teysuno Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/11/669 14.11.2017 10.11.2017 Valdoxan Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/08/499 14.11.2017 15.11.2017 Aripiprazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1045 17.11.2017 15.11.2017 Bortezomib SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/16/1102 17.11.2017 15.11.2017 Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/16/1151 17.11.2017 15.11.2017 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, 3490 Kvistgaard, Danmark EU/1/13/855 17.11.2017 15.11.2017 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 17.11.2017 15.11.2017 Lemtrada Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom EU/1/13/869 17.11.2017 15.11.2017 NovoEight Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/13/888 17.11.2017 15.11.2017 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 20.11.2017 15.11.2017 ReFacto AF Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/103 17.11.2017 15.11.2017 Savene Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/06/350 17.11.2017 15.11.2017 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/15/992 17.11.2017 15.11.2017 Tasigna Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/422 17.11.2017 15.11.2017 Viekirax AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom EU/1/14/982 17.11.2017 15.11.2017 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/13/857 17.11.2017 15.11.2017 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/714 17.11.2017 16.11.2017 ATryn Laboratoire français du Fractionnement et des Biotechnologies 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France EU/1/06/355 20.11.2017 16.11.2017 Cubicin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/328 20.11.2017 16.11.2017 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, 92165 Antony CEDEX, France EU/1/07/384 20.11.2017 16.11.2017 Elocta Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/15/1046 20.11.2017 16.11.2017 Helixate NexGen Bayer AG D-51368 Leverkusen, Deutschland EU/1/00/144 20.11.2017 16.11.2017 KOGENATE Bayer Bayer AG D-51368 Leverkusen, Deutschland EU/1/00/143 20.11.2017 16.11.2017 Levemir Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/04/278 20.11.2017 16.11.2017 Levetiracetam Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/712 20.11.2017 16.11.2017 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, 92165 Antony CEDEX, France EU/1/95/002 20.11.2017 16.11.2017 Zydelig Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/938 20.11.2017 24.11.2017 Advate Baxter AG Industriestraße 67, 1221 Wien, Österreich EU/1/03/271 28.11.2017 24.11.2017 Nuwiq Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/14/936 28.11.2017 28.11.2017 Entacapone Orion Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/708 30.11.2017 28.11.2017 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/453 30.11.2017 28.11.2017 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/08/446 30.11.2017 30.11.2017 Zepatier Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/16/1119 4.12.2017

— 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 10.11.2017 Prevenar Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/00/167 14.11.2017 15.11.2017 EVARREST Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, 1831 Diegem, België EU/1/13/868 17.11.2017

— 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 23.11.2017 Optimark Guerbet 15 rue des Vanesses, 93420, Villepinte, France EU/1/07/398 27.12.2017

— 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 6.11.2017 Nobivac LeuFel Feline leukaemia vaccine (inactivated) Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/17/217 Suspension for injection QI06AA01 8.11.2017 21.11.2017 Bovilis Blue-8 Bluetongue virus vaccine (inactivated) serotype 8 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/218 Suspension for injection QI02AA08 QI04AA02 23.11.2017

— 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 14.11.2017 SevoFlo Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/02/035 16.11.2017 15.11.2017 Contacera Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/144 16.11.2017 21.11.2017 Circovac Ceva-Phylaxia Zrt. Szállás u. 5, 1107 Budapest, Magyarország EU/2/07/075 23.11.2017 21.11.2017 Pexion Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/147 23.11.2017

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.