EN Official Journal of the European Union C 29/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013

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

2014/C 29/01

— 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 4.12.2013 Fluenz Tetra Influenza Virus Type A, H1N1 / Influenza Virus Type A, H3N2 / Influenza Virus Type B (Victoria lineage) / Influenza Virus, Type B (Yamagata lineage) MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/13/887 Nasal spray, suspension J07BB03 6.12.2013 4.12.2013 Memantine Accord memantine Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/880 Film-coated tablet N06DX01 6.12.2013 18.12.2013 Brintellix vortioxetine H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/13/891 Film-coated tablet Oral drops, solution N06AX26 20.12.2013 20.12.2013 Opsumit macitentan Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/13/893 Film-coated tablet C02KX04 27.12.2013





— 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 3.12.2013 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 6.12.2013 3.12.2013 Bondronat Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/012 6.12.2013 3.12.2013 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328 6.12.2013 3.12.2013 Dynastat Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/209 6.12.2013 3.12.2013 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389 6.12.2013 3.12.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 6.12.2013 3.12.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 6.12.2013 3.12.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 6.12.2013 3.12.2013 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672 6.12.2013 3.12.2013 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 6.12.2013 4.12.2013 Synagis AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/99/117 6.12.2013 4.12.2013 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222 6.12.2013 9.12.2013 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603 11.12.2013 13.12.2013 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/11/733 16.12.2013 13.12.2013 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/06/378 17.12.2013 13.12.2013 Irbesartan / Hydrochlorothiazide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/583 18.12.2013 13.12.2013 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 17.12.2013 13.12.2013 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292 17.12.2013 13.12.2013 Revatio Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/318 17.12.2013 13.12.2013 Temozolomide HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616 17.12.2013 13.12.2013 Tracleer Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/02/220 17.12.2013 17.12.2013 Benlysta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/700 19.12.2013 17.12.2013 Esbriet InterMune UK Limited Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom EU/1/11/667 19.12.2013 17.12.2013 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 19.12.2013 17.12.2013 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 19.12.2013 17.12.2013 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165 20.12.2013 18.12.2013 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229 20.12.2013 18.12.2013 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230 20.12.2013 18.12.2013 Aflunov Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658 20.12.2013 18.12.2013 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253 23.12.2013 18.12.2013 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/05/315 2.1.2014 18.12.2013 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265 20.12.2013 18.12.2013 Bronchitol Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom EU/1/12/760 23.12.2013 18.12.2013 Buccolam ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België EU/1/11/709 19.12.2013 18.12.2013 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 23.12.2013 18.12.2013 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/317 23.12.2013 18.12.2013 Dexdor Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/718 23.12.2013 18.12.2013 Efient Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/503 23.12.2013 18.12.2013 Emend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262 20.12.2013 18.12.2013 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573 20.12.2013 18.12.2013 Erbitux Merck KGaA 64271 Darmstadt EU/1/04/281 23.12.2013 18.12.2013 Esmya Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/12/750 23.12.2013 18.12.2013 Extavia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/454 20.12.2013 18.12.2013 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269 23.12.2013 18.12.2013 GILENYA Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677 23.12.2013 18.12.2013 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145 23.12.2013 18.12.2013 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/11/687 23.12.2013 18.12.2013 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 20.12.2013 18.12.2013 Kaletra AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/01/172 23.12.2013 18.12.2013 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/741 23.12.2013 18.12.2013 Lojuxta Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom EU/1/13/851 23.12.2013 18.12.2013 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155 23.12.2013 18.12.2013 Mepact Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France EU/1/08/502 23.12.2013 18.12.2013 Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/333 23.12.2013 18.12.2013 Nivestim Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/631 20.12.2013 18.12.2013 Norvir AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/96/016 20.12.2013 18.12.2013 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006 23.12.2013 18.12.2013 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 2.1.2014 18.12.2013 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/316 23.12.2013 18.12.2013 ProQuad Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/05/323 20.12.2013 18.12.2013 Protopic Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/02/201 23.12.2013 18.12.2013 Removab Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland EU/1/09/512 20.12.2013 18.12.2013 Repaglinide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/530 24.12.2013 18.12.2013 Ribavirin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/10/634 20.12.2013 18.12.2013 Soliris Alexion Europe SAS 25 boulevard de l'Amiral Bruix, F-75016 Paris, France EU/1/07/393 23.12.2013 18.12.2013 Temodal Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/98/096 23.12.2013 18.12.2013 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 23.12.2013 18.12.2013 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 23.12.2013 18.12.2013 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 23.12.2013 18.12.2013 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 23.12.2013 18.12.2013 Yondelis Pharma Mar S.A. Polígono Industrial La Mina, Avda de los Reyes 1, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 23.12.2013 18.12.2013 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 23.12.2013 20.12.2013 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 30.12.2013 20.12.2013 Advate Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/03/271 6.1.2014 20.12.2013 Atriance Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/403 2.1.2014 20.12.2013 Caprelsa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/749 27.12.2013 20.12.2013 Comtan Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/081 2.1.2014 20.12.2013 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 24.12.2013 20.12.2013 Iclusig ARIAD Pharma Ltd Brooklands Business Park, Wellington Way, Weybridge, KT13 0TT, United Kingdom EU/1/13/839 27.12.2013 20.12.2013 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437 2.1.2014 20.12.2013 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 27.12.2013 20.12.2013 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 2.1.2014 20.12.2013 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231 27.12.2013 20.12.2013 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 24.12.2013 20.12.2013 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 27.12.2013 20.12.2013 Pioglitazone Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/722 24.12.2013 20.12.2013 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 24.12.2013 20.12.2013 Sabervel Pharmathen S.A. Dervenakion 6, 15351 Pallini Attiki, Ελλάδα EU/1/12/765 24.12.2013 20.12.2013 Tasigna Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422 2.1.2014 20.12.2013 Vizarsin Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 24.12.2013 20.12.2013 VPRIV Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646 24.12.2013 20.12.2013 Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727 24.12.2013





— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): 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 4.12.2013 BROADLINE Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/157 Spot-on solution QP54AA54 6.12.2013 4.12.2013 Vectra 3D dinotefuran, pyriproxyfen, permethrin CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/13/156 Spot-on solution QP53AC54 6.12.2013





— 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 3.12.2013 Emdocam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, België EU/2/11/128 6.12.2013 3.12.2013 Meloxidolor Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/13/148 6.12.2013 4.12.2013 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 6.12.2013 9.12.2013 Acticam Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, België EU/2/08/088 11.12.2013 13.12.2013 Porcilis PCV Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/08/091 17.12.2013 13.12.2013 Prac-Tic Novartis Sanidad Animal S.L. Calle de la Marina, 206, E-08013 Barcelona, España EU/2/06/066 17.12.2013 18.12.2013 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/06/070 20.12.2013

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.

(2) OJ L 136, 30.4.2004, p. 1.