EN Official Journal of the European Union C 290/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 290/01

— 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 18.7.2014 Envarsus tacrolimus Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 Prolonged-release tablet L04AD02 22.7.2014 18.7.2014 Plegridy peginterferon beta-1a Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/14/934 Solution for injection L03AB13 23.7.2014 18.7.2014 Simbrinza Brinzolamide/Brimonidine tartrate Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/14/933 Ear drops, suspension Pending 23.7.2014 22.7.2014 Nuwiq simoctocog alfa Octapharma AB Elersvägen 40 Stockholm 11275 Sweden EU/1/14/936 Powder and solvent for solution for injection B02BD02 24.7.2014 23.7.2014 Gazyvaro obinutuzumab Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/14/937 Concentrate for solution for infusion L01 24.7.2014 31.7.2014 Translarna ataluren PTC Therapeutics, Limited Lakeside House, Office G33a, 1 Furzeground Way, Stockley Park E. Uxbridge, UB11 1BD, United Kingdom EU/1/13/902 Granules for oral suspension Pending 5.8.2014

— 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 4.7.2014 Masican AB Science S.A. 3 avenue George V, F-75008 Paris, France 8.7.2014 23.7.2014 Masiviera AB Science S.A. 3 avenue George V, F-75008 Paris, France 24.7.2014

— 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 4.7.2014 Copalia HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/575 11.7.2014 4.7.2014 Dafiro HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/574 11.7.2014 4.7.2014 Efavirenz Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/742 9.7.2014 4.7.2014 Flebogamma DIF Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa EU/1/07/404 8.7.2014 4.7.2014 Fuzeon Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/252 8.7.2014 4.7.2014 Optison GE Healthcare AS Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge EU/1/98/065 8.7.2014 11.7.2014 Riluzole Zentiva Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/12/768 15.7.2014 11.7.2014 Rivastigmine HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/09/589 15.7.2014 11.7.2014 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/09/599 15.7.2014 14.7.2014 Docetaxel Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/611 17.7.2014 14.7.2014 Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077 16.7.2014 18.7.2014 Adjupanrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/578 22.7.2014 18.7.2014 CellCept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005 22.7.2014 18.7.2014 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 23.7.2014 18.7.2014 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198 22.7.2014 18.7.2014 Irbesartan Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/576 23.7.2014 18.7.2014 Nimenrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/12/767 22.7.2014 18.7.2014 Omnitrope Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/06/332 22.7.2014 18.7.2014 Onglyza Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545 22.7.2014 18.7.2014 SANCUSO ProStrakan Limited Galabank Business Park, Galashiels TD1 1QH, United Kingdom EU/1/12/766 23.7.2014 18.7.2014 Savene Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/06/350 22.7.2014 18.7.2014 Tasmar Meda AB Pipers väg 2A, S-170 09 Solna, Sverige EU/1/97/044 22.7.2014 18.7.2014 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3, D-20354 Hamburg, Deutschland EU/1/09/605 22.7.2014 18.7.2014 Tesavel Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 22.7.2014 18.7.2014 Ventavis Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/255 22.7.2014 18.7.2014 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/710 23.7.2014 18.7.2014 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 23.7.2014 18.7.2014 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 23.7.2014 22.7.2014 Rapiscan Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom EU/1/10/643 24.7.2014 23.7.2014 Fabrazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/01/188 24.7.2014 28.7.2014 Arzerra Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/625 30.7.2014 28.7.2014 Byetta AstraZeneca AB S-151 85 Södertälje, Sverige EU/1/06/362 30.7.2014 28.7.2014 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 30.7.2014 28.7.2014 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126 29.7.2014 28.7.2014 Kalydeco Vertex Pharmaceuticals (U.K.) Limited Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom EU/1/12/782 30.7.2014 28.7.2014 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614 29.7.2014 28.7.2014 Olanzapine Apotex Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland EU/1/10/635 29.7.2014 28.7.2014 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/08/452 30.7.2014 28.7.2014 Stivarga Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 30.7.2014 28.7.2014 Xelevia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 29.7.2014 31.7.2014 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300 4.8.2014 31.7.2014 BYDUREON Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/696 4.8.2014 31.7.2014 Colobreathe Forest Laboratories UK Ltd Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom EU/1/11/747 1.8.2014 31.7.2014 Xarelto Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/08/472 4.8.2014

— 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 8.7.2014 Olanzapine Cipla Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom EU/1/07/426 10.7.2014 31.7.2014 Doribax Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/467 4.8.2014 31.7.2014 IOA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/689 4.8.2014

— 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 4.7.2014 ERYSENG Inactivated Erysipelothrix rhusiopathiae, strain R32E11 Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/14/166 Suspension for injection QI09AB03 8.7.2014 4.7.2014 Versican Plus DHPPi Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza type 2 virus Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/14/169 Lyophilisate and solvent for suspension for injection QI07AD04 8.7.2014 4.7.2014 Versican Plus Pi Canine parainfluenza type 2 virus Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/14/168 Lyophilisate and solvent for suspension for injection QI07AD08 8.7.2014 8.7.2014 ERYSENG PARVO Inactivated porcine parvovirus, strain NADL-2/Inactivated Erysipelothrix rhusiopathiae, strain R32E11 Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/14/167 Suspension for injection QI09AL01 10.7.2014 31.7.2014 Osurnia terbinafine/florfenicol/betamethasone acetate Novartis Santé Animale S.A.S. 10 Rue Blériot, 92 500 Rueil-Malmaison, France EU/2/14/170 Ear gel QS02CA90 1.8.2014 31.7.2014 Versican Plus L4 Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089 Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090 Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091 Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/14/171 Suspension for injection QI07AB01 5.8.2014 31.7.2014 Versican Plus Pi/L4 Canine parainfluenza type 2 virus Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089 Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090 Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091 Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/14/172 Lyophilisate for suspension for spray vaccination QI07AI08 4.8.2014

— 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 8.7.2014 Draxxin Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/03/041 10.7.2014 8.7.2014 SevoFlo Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom EU/2/02/035 10.7.2014 11.7.2014 ProteqFlu Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/03/037 15.7.2014 11.7.2014 ProteqFlu-Te Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/03/038 15.7.2014 28.7.2014 Poulvac E. coli Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/140 29.7.2014 31.7.2014 Palladia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/09/100 4.8.2014

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 30, Churchill Place, Canary Wharf UK — LONDON E14 5EU

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

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