EN Official Journal of the European Union C 243/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014

(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 243/01

— 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 30.6.2014 Mekinist trametinib Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/931 Film-coated tablet L01XE25 2.7.2014

— 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 3.6.2014 Adasuve Alexza UK Ltd. 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom EU/1/13/823 5.6.2014 3.6.2014 Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 5.6.2014 3.6.2014 Docetaxel Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/11/748 5.6.2014 3.6.2014 Docetaxel Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/611 6.6.2014 3.6.2014 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 5.6.2014 3.6.2014 Ibandronic acid Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/11/685 5.6.2014 3.6.2014 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 5.6.2014 3.6.2014 Kepivance Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/05/314 5.6.2014 3.6.2014 Kiovig Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/05/329 5.6.2014 3.6.2014 Lysodren Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/04/273 5.6.2014 3.6.2014 Macugen Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/325 5.6.2014 3.6.2014 Memantine LEK Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/13/826 5.6.2014 3.6.2014 Nevanac Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/07/433 5.6.2014 3.6.2014 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 5.6.2014 3.6.2014 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 5.6.2014 3.6.2014 Ristfor Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 5.6.2014 3.6.2014 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 5.6.2014 3.6.2014 Yondelis Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 5.6.2014 6.6.2014 Champix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/360 11.6.2014 6.6.2014 Edarbi Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/734 11.6.2014 6.6.2014 Gardasil Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 12.6.2014 6.6.2014 Resolor Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/09/581 11.6.2014 6.6.2014 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 13.6.2014 6.6.2014 Telmisartan Teva Pharma Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/719 12.6.2014 6.6.2014 Topotecan Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/09/536 11.6.2014 6.6.2014 Zutectra Biotest Pharma GmbH Landsteinerstrasse 5, D-63303 Dreieich, Deutschland EU/1/09/600 11.6.2014 12.6.2014 Imatinib Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/13/825 16.6.2014 19.6.2014 Celvapan Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/08/506 23.6.2014 19.6.2014 Enurev Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/789 23.6.2014 19.6.2014 Erivedge Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 23.6.2014 19.6.2014 GILENYA Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677 23.6.2014 19.6.2014 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564 23.6.2014 19.6.2014 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 23.6.2014 19.6.2014 Javlor Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France EU/1/09/550 23.6.2014 19.6.2014 Osseor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/287 23.6.2014 19.6.2014 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 23.6.2014 19.6.2014 Protelos Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/288 23.6.2014 19.6.2014 Remicade Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/99/116 23.6.2014 19.6.2014 Repaglinide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/530 23.6.2014 19.6.2014 Samsca Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/09/539 23.6.2014 19.6.2014 Seebri Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/788 23.6.2014 19.6.2014 Simponi Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/09/546 23.6.2014 19.6.2014 Topotecan Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/552 23.6.2014 19.6.2014 Tovanor Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/790 23.6.2014 19.6.2014 Valdoxan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/08/499 23.6.2014 19.6.2014 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/710 23.6.2014 23.6.2014 Angiox The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/04/289 25.6.2014 23.6.2014 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 25.6.2014 23.6.2014 Brilique AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/10/655 25.6.2014 23.6.2014 Diacomit Biocodex 7 avenue Gallieni, F-94250 Gentilly, France EU/1/06/367 25.6.2014 23.6.2014 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 25.6.2014 23.6.2014 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 25.6.2014 23.6.2014 Vfend Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/212 25.6.2014 23.6.2014 Yondelis Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 25.6.2014 23.6.2014 Zeffix Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/114 25.6.2014 27.6.2014 Amyvid Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/12/805 1.7.2014 27.6.2014 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543 1.7.2014 27.6.2014 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392 1.7.2014 27.6.2014 Esbriet InterMune UK Limited Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom EU/1/11/667 1.7.2014 27.6.2014 Foclivia Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/09/577 1.7.2014 27.6.2014 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678 1.7.2014 27.6.2014 Ibandronic Acid Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/642 2.7.2014 27.6.2014 Kineret Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/02/203 1.7.2014 27.6.2014 Orfadin Swedish Orphan Biovitrum International AB SE-112 76, Stockholm, Sverige EU/1/04/303 1.7.2014 27.6.2014 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 9.7.2014 27.6.2014 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 9.7.2014 27.6.2014 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 9.7.2014 27.6.2014 Topotecan Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/633 1.7.2014 27.6.2014 Xyrem UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312 1.7.2014 27.6.2014 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/814 1.7.2014 27.6.2014 Zoledronic acid Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/771 2.7.2014 30.6.2014 Arzerra Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/625 2.7.2014 30.6.2014 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300 2.7.2014 30.6.2014 Exforge HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569 9.7.2014 30.6.2014 Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 2.7.2014

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 6.6.2014 Vectra Felis dinotefuran, pyriproxyfen CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/14/165 Spot-on solution QP53AX73 11.6.2014

— 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 3.6.2014 Activyl Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/118 5.6.2014 6.6.2014 Cerenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/06/062 11.6.2014 6.6.2014 Leucofeligen FeLV/RCP Virbac 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France EU/2/09/097 11.6.2014 6.6.2014 Melovem Dopharma Research B.V. Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland EU/2/09/098 11.6.2014 6.6.2014 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/97/004 11.6.2014 6.6.2014 Suvaxyn PCV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/099 11.6.2014 12.6.2014 Leucogen Virbac 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France EU/2/09/096 16.6.2014 19.6.2014 Locatim Biokema Anstalt Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein EU/2/99/011 23.6.2014 19.6.2014 Previcox Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/045 23.6.2014 23.6.2014 Econor Novartis Tiergesundheit GmbH Zielstattstrasse 40, D-81379 München, Deutschland EU/2/98/010 25.6.2014 27.6.2014 Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/10/114 1.7.2014 27.6.2014 Zulvac 8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/105 1.7.2014 27.6.2014 Zulvac 8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/104 1.7.2014 30.6.2014 TruScient Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/11/136 2.7.2014

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, 30.4.04, p. 1.

(2) OJ L 136, 30.4.04, p. 1.