EN Official Journal of the European Union C 428/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 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 428/01)

— 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 21.10.2014 IMBRUVICA Ibrutinib Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/945 Capsule, hard L01XE27 23.10.2014

— 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 1.10.2014 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285 6.10.2014 1.10.2014 Bexsero Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 3.10.2014 1.10.2014 BYDUREON AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/696 3.10.2014 1.10.2014 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 3.10.2014 1.10.2014 Iscover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/070 3.10.2014 1.10.2014 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/01/195 3.10.2014 1.10.2014 Plavix Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/069 3.10.2014 1.10.2014 Voriconazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/835 3.10.2014 1.10.2014 Zoledronic acid Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/771 3.10.2014 3.10.2014 Forxiga AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/795 7.10.2014 3.10.2014 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030 7.10.2014 3.10.2014 Jakavi Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/773 7.10.2014 3.10.2014 Xigduo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/900 7.10.2014 8.10.2014 Krystexxa Crealta Pharmaceuticals Ireland Limited Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland EU/1/12/810 13.10.2014 8.10.2014 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311 10.10.2014 8.10.2014 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/280 10.10.2014 10.10.2014 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/283 14.10.2014 10.10.2014 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 14.10.2014 10.10.2014 Keppra UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/00/146 14.10.2014 10.10.2014 Translarna PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/13/902 14.10.2014 15.10.2014 Atosiban SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/13/852 17.10.2014 15.10.2014 Komboglyze AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/731 20.10.2014 15.10.2014 Onglyza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/545 17.10.2014 15.10.2014 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/297 17.10.2014 20.10.2014 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/296 23.10.2014 21.10.2014 Clopidogrel Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/561 23.10.2014 22.10.2014 Lyxumia Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/811 24.10.2014 22.10.2014 Nevirapine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/598 24.10.2014 22.10.2014 Privigen CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/08/446 24.10.2014 27.10.2014 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 29.10.2014 27.10.2014 BindRen Mitsubishi Tanabe Pharma Europe Ltd Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom EU/1/12/804 29.10.2014 27.10.2014 Entacapone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/665 29.10.2014 27.10.2014 Fasturtec Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/00/170 29.10.2014 27.10.2014 Hexyon Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/13/829 29.10.2014 27.10.2014 Invanz Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216 29.10.2014 27.10.2014 Myclausen Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, D-14167 Berlin, Deutschland EU/1/10/647 29.10.2014 27.10.2014 Synflorix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/09/508 29.10.2014 27.10.2014 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/08/488 29.10.2014 27.10.2014 Zavesca Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/02/238 29.10.2014 30.10.2014 Elonva Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/609 3.11.2014 30.10.2014 Hexacima Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/13/828 3.11.2014 30.10.2014 Mycophenolate mofetil Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/07/439 4.11.2014 30.10.2014 Myfenax Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/07/438 4.11.2014 30.10.2014 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 3.11.2014 30.10.2014 Zinforo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/785 3.11.2014

— 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 1.10.2014 FLUENZ MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/10/661 3.10.2014 1.10.2014 Topotecan Eagle Eagle Laboratories Limited The Clock House, Station Approach, Marlow, Bucks SL7 1NT, United Kingdom EU/1/11/744 3.10.2014 21.10.2014 Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/649 23.10.2014 27.10.2014 Ipreziv Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/735 29.10.2014

— 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 21.10.2014 Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090 23.10.2014 27.10.2014 Apoquel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 29.10.2014

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.