EN Official Journal of the European Union C 91/2

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014

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

2014/C 91/02

— 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 20.2.2014 Izba travoprost Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/13/905 Eye drops, solution S01EE04 24.2.2014 20.2.2014 Neuraceq florbetaben (18F) Piramal Imaging GmbH Tegeler Strasse 6-7 13353 Berlin – Deutschland EU/1/13/906 Solution for injection V09AX06 24.2.2014 21.2.2014 Mirvaso brimonidine Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 Gel D11AX21 25.2.2014





— 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 6.2.2014 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 10.2.2014 6.2.2014 Humira AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 10.2.2014 6.2.2014 Repso Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/674 11.2.2014 6.2.2014 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/95/002 10.2.2014 11.2.2014 Pravafenix LABORATOIRES SMB SA 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België EU/1/11/679 13.2.2014 11.2.2014 Sycrest Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/10/640 13.2.2014 11.2.2014 Temozolomide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/606 14.2.2014 12.2.2014 Mozobil Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/537 13.2.2014 13.2.2014 Lyrica Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/04/279 17.2.2014 17.2.2014 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511 19.2.2014 17.2.2014 Modigraf Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/523 19.2.2014 17.2.2014 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 19.2.2014 20.2.2014 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 24.2.2014 20.2.2014 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 24.2.2014 20.2.2014 Capecitabine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/762 22.2.2014 20.2.2014 Capecitabine Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/761 25.2.2014 20.2.2014 Constella Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/801 24.2.2014 20.2.2014 Helixate NexGen Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/00/144 24.2.2014 20.2.2014 KOGENATE Bayer Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/00/143 24.2.2014 20.2.2014 Metalyse Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/00/169 24.2.2014 20.2.2014 Mycamine Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/08/448 24.2.2014 20.2.2014 Nevirapine Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/598 25.2.2014 20.2.2014 Zoledronic acid Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/12/759 24.2.2014 20.2.2014 Zoledronic acid Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/12/786 24.2.2014 21.2.2014 Celsentri ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/07/418 25.2.2014 21.2.2014 CONTROLOC Control Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/09/515 25.2.2014 21.2.2014 Fertavid Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/510 25.2.2014 21.2.2014 NeuroBloc Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/00/166 25.2.2014 21.2.2014 NovoThirteen Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/775 25.2.2014 21.2.2014 PANTECTA Control Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/09/518 25.2.2014 21.2.2014 PANTOLOC Control Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/09/519 25.2.2014 21.2.2014 PANTOZOL Control Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/09/517 25.2.2014 21.2.2014 SOMAC Control Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/09/516 25.2.2014 21.2.2014 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/494 25.2.2014 21.2.2014 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508 25.2.2014 21.2.2014 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 25.2.2014 28.2.2014 Adjupanrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578 4.3.2014 28.2.2014 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/802 4.3.2014 28.2.2014 Effentora Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/08/441 5.3.2014 28.2.2014 Instanyl Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/09/531 4.3.2014 28.2.2014 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich EU/1/08/501 4.3.2014 28.2.2014 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614 4.3.2014 28.2.2014 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/051 4.3.2014 28.2.2014 PecFent Archimedes Development Ltd Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom EU/1/10/644 4.3.2014 28.2.2014 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/453 4.3.2014 28.2.2014 Pumarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/10/664 3.3.2014 28.2.2014 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063 4.3.2014 28.2.2014 Samsca Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/09/539 4.3.2014 28.2.2014 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050 4.3.2014 28.2.2014 Temozolomide Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/615 4.3.2014 28.2.2014 Xolair Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/319 4.3.2014





— Withdrawal of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 17.2.2014 Onduarp Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/729 19.2.2014





— Lift of suspension of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 21.2.2014 Luminity Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom EU/1/06/361 25.2.2014





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 11.2.2014 Bravecto Fluralaner Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/13/158 Chewable tablet QP53BX 13.2.2014 11.2.2014 NexGard afoxolaner Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/159 Chewable tablet QP53BX04 13.2.2014





— 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 6.2.2014 Melovem Dopharma Research B.V. Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland EU/2/09/098 10.2.2014 10.2.2014 Startvac Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/08/092 12.2.2014 13.2.2014 Contacera Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/144 17.2.2014 13.2.2014 Melosus CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland EU/2/10/116 17.2.2014 20.2.2014 CaniLeish VIRBAC S.A. 1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, France EU/2/11/121 24.2.2014

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, 30.4.2004, p. 1.

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