Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2013-03-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013093EN.01000101.xml










28.3.2013   


EN


Official Journal of the European Union


C 93/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 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 93/01
—   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




1.2.2013


Lyxumia


lixisenatide







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/12/811


Solution for injection


Pending


5.2.2013




1.2.2013


ZALTRAP


aflibercept







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/12/814


Concentrate for solution for infusion


L01XX


5.2.2013




20.2.2013


Adasuve


loxapine







Alexza UK Ltd.




10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom






EU/1/13/823


Inhalation powder, pre-dispensed


N05AH01


25.2.2013




25.2.2013


Selincro


nalmefene







H. Lundbeck A/S




Ottiliavej 9, DK-2500 Valby, Danmark






EU/1/12/815


Film-coated tablet


N07BB


27.2.2013







—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




12.2.2013


Istodax







Celgene Europe Limited




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






—


14.2.2013




20.2.2013


Acrescent







H. Lundbeck A/S




Ottiliavej 9, DK-2500 Valby, Danmark






—


22.2.2013




20.2.2013


Balaxur







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100-104, D-60318 Frankfurt am Main, Deutschland






—


22.2.2013







—   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




1.2.2013


Ixiaro







Intercell AG




Campus Vienna Biocenter 3, A-1030 Wien, Österreich






EU/1/08/501


5.2.2013




8.2.2013


Aflunov







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/10/658


12.2.2013




8.2.2013


Vibativ







Theravance UK Limited




90 Fetter Lane London EC4A 1EQ United Kingdom






EU/1/11/705


12.2.2013




12.2.2013


Adcirca







Eli Lilly Nederland B.V.




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






EU/1/08/476


14.2.2013




13.2.2013


Cialis







Eli Lilly Nederland B.V.




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






EU/1/02/237


15.2.2013




13.2.2013


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vincilaan 15, B-1831 Diegem, België






EU/1/08/473


15.2.2013




13.2.2013


Forsteo







Eli Lilly Nederland B.V.




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






EU/1/03/247


15.2.2013




13.2.2013


Zostavax







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/06/341


15.2.2013




18.2.2013


Advagraf







Astellas Pharma Europe B.V.




Sylviusweg 62, NL-2333 BE Leiden, Nederland






EU/1/07/387


20.2.2013




18.2.2013


Aldurazyme







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/03/253


20.2.2013




18.2.2013


BeneFIX







Pfizer Limited




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






EU/1/97/047


20.2.2013




18.2.2013


Caprelsa







AstraZeneca AB




Building 411A, Floor 4, SE-151 85 Södertälje, Sverige






EU/1/11/749


20.2.2013




18.2.2013


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


20.2.2013




18.2.2013


Karvea







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/97/049


20.2.2013




18.2.2013


Karvezide







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/98/085


20.2.2013




18.2.2013


Komboglyze







Bristol-Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom






EU/1/11/731


20.2.2013




18.2.2013


Modigraf







Astellas Pharma Europe B.V.




Sylviusweg 62, NL-2333 BE Leiden, Nederland






EU/1/09/523


20.2.2013




18.2.2013


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


20.2.2013




18.2.2013


ProQuad







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/05/323


20.2.2013




18.2.2013


Rasilez







Novartis Europharm Limited




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






EU/1/07/405


20.2.2013




18.2.2013


Rasilez HCT







Novartis Europharm Limited




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






EU/1/08/491


20.2.2013




18.2.2013


Rasitrio







Novartis Europharm Limited




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






EU/1/11/730


20.2.2013




20.2.2013


Arzerra







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/625


22.2.2013




20.2.2013


Effentora







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/08/441


22.2.2013




20.2.2013


M-M-RVAXPRO







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/06/337


22.2.2013




25.2.2013


Humira







AbbVie Ltd




Maidenhead, SL6 4XE, United Kingdom






EU/1/03/256


27.2.2013




25.2.2013


Isentress







Merck Sharp & Dohme Limited




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






EU/1/07/436


27.2.2013




25.2.2013


Lumigan







Allergan Pharmaceuticals Ireland, (514125)




Castlebar Road, Westport, County Mayo, Ireland






EU/1/02/205


27.2.2013




25.2.2013


Rasilamlo







Novartis Europharm Limited




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






EU/1/11/686


27.2.2013




28.2.2013


DuoCover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/10/623


4.3.2013







—   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




13.2.2013


Semintra


Telmisartan







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/12/146


Oral solution


QC09CA07


15.2.2013




25.2.2013


Pexion


Imepitoin







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/12/147


Tablet


QN03AX90


27.2.2013







—   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




1.2.2013


Profender







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/05/054


5.2.2013




8.2.2013


Recocam







Cross Vetpharm Group, Ltd




Broomhill Road, Tallaght Dublin 24, Ireland






EU/2/11/133


12.2.2013




12.2.2013


Inflacam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/11/134


14.2.2013




13.2.2013


Onsior







Novartis Animal Health UK Ltd




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






EU/2/08/089


15.2.2013




13.2.2013


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/07/078


15.2.2013




20.2.2013


Zulvac 1 Bovis







Pfizer Limited




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






EU/2/11/130


22.2.2013




20.2.2013


Zulvac 1 Ovis







Pfizer Limited




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






EU/2/11/131


22.2.2013




25.2.2013


BTVPUR AlSap 2-4







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/10/108


27.2.2013




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.