EN Official Journal of the European Union C 380/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2013 to 30 November 2013

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

2013/C 380/01

— 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 11.11.2013 Levodopa-Carbidopa-Entacapone Sandoz levodopa / carbidopa / entacapone Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/13/859 Film-coated tablet N04BA03 13.11.2013 13.11.2013 NovoEight turoctocog alfa Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/13/888 Powder and solvent for solution for injection B02BD02 15.11.2013 13.11.2013 Relvar Elllipta fluticasone furoate/vilanterol trifenatate Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/13/886 Inhalation powder, pre-dispensed R03AK10 14.11.2013 13.11.2013 Vitekta elvitegravir Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/883 Film-coated tablet J05AX11 14.11.2013 13.11.2013 Xofigo Radium Ra 223 dichloride Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/873 Solution for injection V10XX03 14.11.2013 15.11.2013 ABILIFY MAINTENA Aripiprazole Otsuka Pharmaceutical Europe Ltd. Gallions Wexham Springs, Framewood Road, Wexham, Slough, Berkshire SL3 6PJ, United Kingdom EU/1/13/882 Powder and solvent for prolonged-release suspension for injection N05AX12 19.11.2013 15.11.2013 Invokana canagliflozin Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 Film-coated tablet A10BX11 19.11.2013 15.11.2013 Kadcyla Trastuzumab emtansine Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/885 Powder for concentrate for solution for infusion L01XC14 19.11.2013 15.11.2013 Lidocaine/Prilocaine Plethora lidocaine / prilocaine Plethora Solutions Limited Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom EU/1/13/881 Cutaneous spray, solution N01BB20 19.11.2013 20.11.2013 Intelence etravirine Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 Tablet J05AG04 22.11.2013





— 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 8.11.2013 Xeljanz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/874 12.11.2013





— 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 11.11.2013 Edarbi Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/11/734 12.11.2013 11.11.2013 Ipreziv Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/11/735 12.11.2013 11.11.2013 Oprymea Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 13.11.2013 11.11.2013 Rapamune Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/01/171 13.11.2013 13.11.2013 Actos Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/00/150 15.11.2013 13.11.2013 Competact Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/06/354 14.11.2013 13.11.2013 Efient Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/503 15.11.2013 13.11.2013 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126 15.11.2013 13.11.2013 Filgrastim Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/08/496 15.11.2013 13.11.2013 Firmagon Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark EU/1/08/504 15.11.2013 13.11.2013 Firmagon Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark EU/1/08/504 15.11.2013 13.11.2013 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/12/776 15.11.2013 13.11.2013 Glubrava Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/07/421 15.11.2013 13.11.2013 Glustin Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/00/151 15.11.2013 13.11.2013 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026 15.11.2013 13.11.2013 Jakavi Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/773 15.11.2013 13.11.2013 Kuvan Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/08/481 15.11.2013 13.11.2013 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/462 22.11.2013 13.11.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 15.11.2013 13.11.2013 ReFacto AF Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/103 15.11.2013 13.11.2013 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 15.11.2013 13.11.2013 Silodyx Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/607 15.11.2013 13.11.2013 Tandemact Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/06/366 15.11.2013 13.11.2013 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 15.11.2013 13.11.2013 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 15.11.2013 13.11.2013 Urorec Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/608 15.11.2013 13.11.2013 Valdoxan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/08/499 15.11.2013 13.11.2013 Valdoxan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/08/499 15.11.2013 13.11.2013 Vidaza Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom EU/1/08/488 15.11.2013 13.11.2013 Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/08/495 15.11.2013 15.11.2013 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/290 19.11.2013 15.11.2013 Azilect Teva Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/04/304 19.11.2013 15.11.2013 Bretaris Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/781 18.11.2013 15.11.2013 Ecansya Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 19.11.2013 15.11.2013 Eklira Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/778 18.11.2013 15.11.2013 Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691 18.11.2013 15.11.2013 Kineret Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/02/203 19.11.2013 15.11.2013 Multaq Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/09/591 19.11.2013 15.11.2013 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227 19.11.2013 15.11.2013 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 19.11.2013 15.11.2013 Rapiscan Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom EU/1/10/643 19.11.2013 15.11.2013 Sutent Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/347 19.11.2013 15.11.2013 Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/336 19.11.2013 15.11.2013 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/710 19.11.2013 20.11.2013 Angiox The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/04/289 22.11.2013 20.11.2013 Beromun Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/99/097 22.11.2013 20.11.2013 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/08/473 22.11.2013 20.11.2013 Fasturtec Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/00/170 22.11.2013 20.11.2013 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678 25.11.2013 20.11.2013 Hycamtin SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/027 22.11.2013 20.11.2013 Kalydeco Vertex Pharmaceuticals (U.K.) Limited Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom EU/1/12/782 22.11.2013 20.11.2013 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 25.11.2013 20.11.2013 Opgenra Olympus Biotech International Limited Raheen Business Park, Limerick, Ireland EU/1/08/489 25.11.2013 20.11.2013 Plenadren ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België EU/1/11/715 21.11.2013 20.11.2013 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 22.11.2013 20.11.2013 Rotarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/05/330 22.11.2013 20.11.2013 Telzir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/282 22.11.2013 20.11.2013 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424 22.11.2013 20.11.2013 Zoledronic acid Teva Pharma Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/772 22.11.2013 25.11.2013 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 27.11.2013 25.11.2013 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/06/365 27.11.2013 25.11.2013 GILENYA Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677 27.11.2013 25.11.2013 Pandemic influenza vaccine H5N1 BAXTER Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/09/571 27.11.2013 25.11.2013 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 27.11.2013 25.11.2013 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508 27.11.2013 25.11.2013 Vepacel Baxter Innovations GmbH Industriestraße 67, A-1221 Wien, Österreich EU/1/12/752 27.11.2013 28.11.2013 Jalra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485 29.11.2013 28.11.2013 Xiliarx Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486 29.11.2013 29.11.2013 Arixtra Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/02/206 2.12.2013 29.11.2013 Busilvex Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France EU/1/03/254 3.12.2013 29.11.2013 Eviplera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/11/737 4.12.2013 29.11.2013 Preotact NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland EU/1/06/339 3.12.2013 29.11.2013 Prevenar Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/00/167 3.12.2013 29.11.2013 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 3.12.2013





— 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 8.11.2013 Onsior Novartis Animal Health UK Ltd Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom EU/2/08/089 13.11.2013 8.11.2013 Zulvac 1+8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/139 13.11.2013 11.11.2013 Easotic VIRBAC S.A. 1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, France EU/2/08/085 13.11.2013 13.11.2013 Comfortis Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/10/115 15.11.2013 20.11.2013 CERTIFECT Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/11/125 22.11.2013

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.