EN Official Journal of the European Union C 318/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015

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

(2015/C 318/01)

— 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 14.8.2015 Odomzo sonidegib Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1030 Capsule, hard L01XX48 18.8.2015 14.8.2015 Unituxin dinutuximab United Therapeutics Europe Ltd Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom EU/1/15/1022 Concentrate for solution for infusion L01XC16 18.8.2015 20.8.2015 Aripiprazole Sandoz Aripiprazole Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1029 Tablet N05AX12 24.8.2015 20.8.2015 Duloxetine Zentiva duloxetine Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1028 Gastro-resistant capsule, hard N06AX21 25.8.2015 20.8.2015 Respreeza human alpha1-proteinase inhibitor CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/15/1006 Powder and solvent for solution for infusion B02AB02 25.8.2015 28.8.2015 Docetaxel Hospira UK Limited docetaxel Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/15/1017 Concentrate for solution for infusion L01CD02 1.9.2015 28.8.2015 Farydak panobinostat Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1023 Capsule, hard L01XX42 1.9.2015 28.8.2015 Kanuma sebelipase alfa Synageva BioPharma Ltd 1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom EU/1/15/1033 Concentrate and solvent for solution for infusion Pending 1.9.2015 28.8.2015 Pregabalin Accord pregabalin Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1027 Capsule, hard N03AX16 1.9.2015 28.8.2015 Strensiq asfotase alfa Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/15/1015 Solution for injection Pending 1.9.2015

— 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 6.8.2015 Aerius Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/160 10.8.2015 6.8.2015 Azomyr Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/157 10.8.2015 6.8.2015 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507 10.8.2015 6.8.2015 Intanza Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/08/505 10.8.2015 12.8.2015 Cyanokit SERB S.A. Avenue Louise 480, 1050 Brussels, Belgique EU/1/07/420 14.8.2015 12.8.2015 Retacrit Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/07/431 14.8.2015 14.8.2015 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/02/237 18.8.2015 14.8.2015 Komboglyze AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/731 18.8.2015 14.8.2015 Norvir AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/96/016 18.8.2015 20.8.2015 Adcirca Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/476 24.8.2015 20.8.2015 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/97/047 24.8.2015 20.8.2015 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 24.8.2015 20.8.2015 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 24.8.2015 20.8.2015 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573 24.8.2015 20.8.2015 Fareston Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/96/004 24.8.2015 20.8.2015 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/00/152 1.9.2015 20.8.2015 Invokana Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/884 24.8.2015 20.8.2015 Kalydeco Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/12/782 27.8.2015 20.8.2015 Keppra UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/00/146 24.8.2015 20.8.2015 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/924 24.8.2015 20.8.2015 Qutenza Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/09/524 24.8.2015 20.8.2015 Stayveer Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland EU/1/13/832 24.8.2015 20.8.2015 Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 24.8.2015 20.8.2015 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/10/648 24.8.2015 20.8.2015 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 24.8.2015 25.8.2015 Adasuve Ferrer Internacional S.A. Gran Via Carlos III, 94 08028 Barcelona Spain EU/1/13/823 27.8.2015 25.8.2015 Biopoin Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/565 27.8.2015 25.8.2015 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507 27.8.2015 25.8.2015 Intanza Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/08/505 27.8.2015 25.8.2015 Mekinist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/931 27.8.2015 25.8.2015 Optaflu Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 27.8.2015 25.8.2015 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 27.8.2015 25.8.2015 Tafinlar Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/865 27.8.2015 25.8.2015 Temozolomide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/606 27.8.2015 25.8.2015 Zykadia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/999 27.8.2015 28.8.2015 Fluenz Tetra MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/13/887 1.9.2015

— Issuing 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 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 28.8.2015 Porcilis PCV ID Porcine circovirus type 2 ORF2 subunit antigen Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/15/187 Emulsion for injection QI09AA07 1.9.2015

— 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 6.8.2015 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 10.8.2015 20.8.2015 Eurican Herpes 205 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/01/029 24.8.2015 28.8.2015 Equilis StrepE Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/04/043 1.9.2015 28.8.2015 Fevaxyn Pentofel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/96/002 1.9.2015

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.