Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2013 to 31 January 2013 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2013-02-22
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013053EN.01000301.xml










22.2.2013   


EN


Official Journal of the European Union


C 53/3





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2013 to 31 January 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 53/03
—   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




8.1.2013


Imatinib Teva


imatinib







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/12/808


Capsule, hard
Film-coated tablet


L01XE01


10.1.2013




8.1.2013


Krystexxa


pegloticase







Savient Pharma Ireland Limited




Mespil House, Sussex Road, Dublin 4, Ireland






EU/1/12/810


Concentrate for solution for infusion


M04AX02


10.1.2013




14.1.2013


Amyvid


Florbetapir (18F)







Eli Lilly Nederland B.V.




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






EU/1/12/805


Solution for injection


V09AX05


17.1.2013




14.1.2013


Bexsero


Meningococcal group B Vaccine (rDNA, component, adsorbed)







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/12/812


Suspension for injection


J07AH09


18.1.2013




21.1.2013


BindRen


colestilan







Mitsubishi Pharma Europe Ltd.




Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom






EU/1/12/804


Film-coated tablet
Granules


Pending


23.1.2013




21.1.2013


Ryzodeg


Insulin degludec/insulin aspart







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/12/806


Solution for injection


Pending


23.1.2013




21.1.2013


Tresiba


Insulin degludec







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/12/807


Solution for injection


Pending


23.1.2013







—   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




14.1.2013


Abraxane







Celgene Europe Limited




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






EU/1/07/428


16.1.2013




14.1.2013


Entacapone Orion







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/11/708


17.1.2013




14.1.2013


Exelon







Novartis Europharm Limited




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






EU/1/98/066


16.1.2013




14.1.2013


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


16.1.2013




14.1.2013


Levodopa/Carbidopa/Entacapone Orion







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/11/706


17.1.2013




14.1.2013


Myocet







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/00/141


17.1.2013




14.1.2013


Neupro







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/05/331


17.1.2013




14.1.2013


Prepandrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/08/453


17.1.2013




14.1.2013


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/06/380


17.1.2013




14.1.2013


Stalevo







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/03/260


16.1.2013




14.1.2013


Tandemact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/06/366


17.1.2013




14.1.2013


Vectibix







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/07/423


17.1.2013




14.1.2013


Volibris







Glaxo Group Ltd




Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/08/451


17.1.2013




14.1.2013


Xagrid







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom






EU/1/04/295


17.1.2013




14.1.2013


Zebinix







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal






EU/1/09/514


17.1.2013




17.1.2013


Pradaxa







Boehringer Ingelheim International GmbH




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






EU/1/08/442


22.1.2013




17.1.2013


Revlimid







Celgene Europe Limited




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






EU/1/07/391


21.1.2013




21.1.2013


Cialis







Eli Lilly Nederland B.V.




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






EU/1/02/237


23.1.2013




21.1.2013


Levitra







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/03/248


23.1.2013




21.1.2013


Pradaxa







Boehringer Ingelheim International GmbH




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






EU/1/08/442


23.1.2013




21.1.2013


Rasilamlo







Novartis Europharm Limited




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






EU/1/11/686


23.1.2013




21.1.2013


Rasitrio







Novartis Europharm Limited




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






EU/1/11/730


23.1.2013




21.1.2013


Vivanza







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/03/249


23.1.2013




24.1.2013


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom






EU/1/04/276


29.1.2013




24.1.2013


Adcirca







Eli Lilly Nederland B.V.




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






EU/1/08/476


29.1.2013




24.1.2013


Comtess







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/98/082


29.1.2013




24.1.2013


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


29.1.2013




24.1.2013


Rasilez







Novartis Europharm Limited




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






EU/1/07/405


29.1.2013




28.1.2013


Olazax Disperzi







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika






EU/1/09/592


30.1.2013




28.1.2013


Rasilez HCT







Novartis Europharm Limited




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






EU/1/08/491


30.1.2013




28.1.2013


Trisenox







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/02/204


30.1.2013







—   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




24.1.2013


Riprazo







Novartis Europharm Limited




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






EU/1/07/409


29.1.2013







—   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




17.1.2013


Pelzont







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/460


18.1.2013




17.1.2013


Tredaptive







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/459


18.1.2013




17.1.2013


Trevaclyn







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/458


18.1.2013







—   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 Décision


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




28.1.2013


Kexxtone


Monensin sodium







Eli Lilly and Company Limited




Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom






EU/2/12/145


Continuous release intraruminal device


QA16QA06


30.1.2013







—   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




14.1.2013


Advocate







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/03/039


16.1.2013




14.1.2013


BLUEVAC BTV8







CZ Veterinaria, S.A.




La Relva s/n, P.O. Box 16, E-36400 Porriño, España






EU/2/11/122


16.1.2013




14.1.2013


Bovilis BTV8







Intervet International B.V.




Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland






EU/2/10/106


16.1.2013




14.1.2013


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/07/079


16.1.2013




21.1.2013


Panacur AquaSol







Intervet International B.V.




Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland






EU/2/11/135


23.1.2013




24.1.2013


Purevax RCP







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/04/052


29.1.2013




28.1.2013


Purevax RC







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/04/051


30.1.2013




28.1.2013


Purevax RCPCh







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/04/050


30.1.2013




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.

(2)  OJ L 136, 30.4.2004, p. 1.