Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2013-09-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013282EN.01000101.xml










27.9.2013   


EN


Official Journal of the European Union


C 282/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013

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

2013/C 282/01
—   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




5.8.2013


Pomalidomide Celgene


Pomalidomide







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom






EU/1/13/850


Capsule, hard


L04AX06


8.8.2013




5.8.2013


Somatropin Biopartners


somatropin







BioPartners GmbH




Kaiserpassage 11, D-72764 Reutlingen, Deutschland






EU/1/13/849


Powder and solvent for prolonged-release suspension for injection


H01AC01


8.8.2013




12.8.2013


Voncento


human coagulation factor VIII/human von Willebrand factor


CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/13/857


Powder and solvent for solution for injection/infusion


B02BD06


14.8.2013




26.8.2013


AUBAGIO


Teriflunomide







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/13/838


Film-coated tablet


L04AA31


29.8.2013




26.8.2013


Cholib


fenofibrate/simvastatin


Abbott Healthcare Products Ltd
Mansbridge Road, West End Southampton, SO18 3JD, United Kingdom


EU/1/13/866


Film-coated tablet


C10BA04


28.8.2013




26.8.2013


Nexium Control


esomeprazole







AstraZeneca AB




SE-151 85 Södertälje, Sverige






EU/1/13/860


Gastro-resistant tablet


A02BC05


29.8.2013




26.8.2013


Stivarga


regorafenib







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/13/858


Film-coated tablet


L01XE21


29.8.2013




26.8.2013


Tafinlar


DABRAFENIB







GlaxoSmithKline Trading Services Limited




6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland






EU/1/13/865


Capsule, hard


L01XE23


29.8.2013







—   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




5.8.2013


Icandra







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/484


8.8.2013




5.8.2013


Marixino







Consilient Health Ltd.




Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland






EU/1/13/820


8.8.2013




5.8.2013


Rasilamlo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/11/686


8.8.2013




5.8.2013


Xarelto







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/08/472


8.8.2013




5.8.2013


Zomarist







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/483


8.8.2013




12.8.2013


Circadin







RAD Neurim Pharmaceuticals EEC Limited




One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom






EU/1/07/392


14.8.2013




12.8.2013


Pixuvri







CTI Life Sciences Ltd




Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom






EU/1/12/764


14.8.2013




12.8.2013


Signifor







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/12/753


14.8.2013




12.8.2013


Twynsta







Boehringer Ingelheim International GmbH




Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/10/648


14.8.2013




12.8.2013


Zavesca







Actelion Registration Ltd




Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom






EU/1/02/238


14.8.2013




14.8.2013


Conbriza







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/09/511


19.8.2013




14.8.2013


FLUENZ







MedImmune, LLC




Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland






EU/1/10/661


19.8.2013




14.8.2013


IOA







Organon N.V.




Kloosterstraat 6, NL-5349 AB Oss, Nederland






EU/1/11/689


19.8.2013




26.8.2013


ADCETRIS







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/12/794


28.8.2013




26.8.2013


Azarga







Alcon Laboratories (UK) Ltd.




Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom






EU/1/08/482


29.8.2013




26.8.2013


Ceplene







Meda AB




Box 906, SE-170 09 Solna, Sverige






EU/1/08/477


28.8.2013




26.8.2013


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


29.8.2013




26.8.2013


Eylea







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/12/797


28.8.2013




26.8.2013


Herceptin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/00/145


28.8.2013




26.8.2013


Hirobriz Breezhaler







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/594


29.8.2013




26.8.2013


Ifirmasta







Krka, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/480


29.8.2013




26.8.2013


Ilaris







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/564


28.8.2013




26.8.2013


Inlyta







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/12/777


29.8.2013




26.8.2013


Invega







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/07/395


28.8.2013




26.8.2013


Keppra







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/00/146


29.8.2013




26.8.2013


Onbrez Breezhaler







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/593


29.8.2013




26.8.2013


Oslif Breezhaler







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/586


28.8.2013




26.8.2013


Pramipexole Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/08/490


29.8.2013




26.8.2013


Tarceva







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/05/311


29.8.2013




26.8.2013


Tysabri







Biogen Idec Limited




Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom






EU/1/06/346


29.8.2013




26.8.2013


Ventavis







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/03/255


29.8.2013




26.8.2013


XALKORI







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/12/793


29.8.2013




26.8.2013


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/08/479


29.8.2013







—   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




5.8.2013


Econor







Novartis Animal Health Austria GmbH




Biochemiestrasse 10, A-6250 Kundl, Österreich






EU/2/98/010


9.8.2013




12.8.2013


Trocoxil







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/08/084


14.8.2013




14.8.2013


Cerenia







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/06/062


19.8.2013




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.