Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2013-04-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013121EN.01000201.xml










26.4.2013   


EN


Official Journal of the European Union


C 121/2





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 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 121/02
—   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




4.3.2013


Perjeta


pertuzumab







Roche Registration Limited




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






EU/1/13/813


Concentrate for solution for infusion


L01XC13


6.3.2013




13.3.2013


Actelsar HCT


telmisartan/hydrochlorothiazide







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland






EU/1/13/817


Tablet


C09DA07


15.3.2013




13.3.2013


JETREA


OCRIPLASMIN







ThromboGenics NV




Gaston Geenslaan 1, B-3001 Leuven, België






EU/1/13/819


Concentrate for solution for injection


Pending


15.3.2013




13.3.2013


Tolucombi


telmisartan/hydrochlorothiazide







Krka, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/13/821


Tablet


C09DA07


15.3.2013




22.3.2013


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


26.3.2013




27.3.2013


Bosulif


Bosutinib







Pfizer Limited




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






EU/1/13/818


Film-coated tablet


L01XE14


2.4.2013







—   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




6.3.2013


Byetta







Bristol-Myers Squibb/AstraZeneca EEIG




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






EU/1/06/362


8.3.2013




6.3.2013


Intelence







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/468


8.3.2013




6.3.2013


Ozurdex







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/10/638


8.3.2013




6.3.2013


Ranexa







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg






EU/1/08/462


8.3.2013




11.3.2013


Champix







Pfizer Limited




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






EU/1/06/360


13.3.2013




11.3.2013


Qutenza







Astellas Pharma Europe B.V.




Sylviusweg 62, NL-2333 BE Leiden, Nederland






EU/1/09/524


13.3.2013




11.3.2013


Victoza







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/09/529


13.3.2013




13.3.2013


BYDUREON







Bristol-Myers Squibb/AstraZeneca EEIG




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






EU/1/11/696


15.3.2013




13.3.2013


Efficib







Merck Sharp & Dohme Limited




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






EU/1/08/457


15.3.2013




13.3.2013


Firazyr







Shire Orphan Therapies GmbH




Friedrichstrasse 149, D-10117 Berlin, Deutschland






EU/1/08/461


15.3.2013




13.3.2013


Firdapse







BioMarin Europe Ltd




164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom






EU/1/09/601


15.3.2013




13.3.2013


Ganfort







Allergan Pharmaceuticals Ireland, (514125)




Castlebar Road, Westport, County Mayo, Ireland






EU/1/06/340


15.3.2013




13.3.2013


Iscover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/98/070


15.3.2013




13.3.2013


Janumet







Merck Sharp & Dohme Limited




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






EU/1/08/455


15.3.2013




13.3.2013


Optimark







Mallinckrodt Deutschland GmbH




Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland






EU/1/07/398


15.3.2013




13.3.2013


Pegasys







Roche Registration Limited




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






EU/1/02/221


15.3.2013




13.3.2013


Privigen







CSL Behring GmbH




Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland






EU/1/08/446


15.3.2013




13.3.2013


Velmetia







Merck Sharp & Dohme Limited




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






EU/1/08/456


15.3.2013




13.3.2013


Vidaza







Celgene Europe Limited




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






EU/1/08/488


15.3.2013




22.3.2013


Daliresp







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/668


26.3.2013




22.3.2013


DaTSCAN







GE Healthcare Limited




Little Chalfont, Bucks HP7 9NA, United Kingdom






EU/1/00/135


26.3.2013




22.3.2013


Daxas







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/10/636


26.3.2013




22.3.2013


Emend







Merck Sharp & Dohme Limited




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






EU/1/03/262


26.3.2013




22.3.2013


Ivemend







Merck Sharp & Dohme Limited




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






EU/1/07/437


26.3.2013




22.3.2013


Libertek







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/666


26.3.2013




22.3.2013


Pixuvri







CTI Life Sciences Ltd




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






EU/1/12/764


26.3.2013




26.3.2013


Combivir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/98/058


28.3.2013




26.3.2013


Daliresp







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/668


28.3.2013




26.3.2013


Daxas







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/10/636


28.3.2013




26.3.2013


Epivir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/96/015


28.3.2013




26.3.2013


Kivexa







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/04/298


28.3.2013




26.3.2013


Libertek







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/666


28.3.2012




26.3.2013


Privigen







CSL Behring GmbH




Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland






EU/1/08/446


28.3.2013




26.3.2013


Telzir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/04/282


28.3.2013




26.3.2013


Trizivir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/00/156


28.3.2013




26.3.2013


Ziagen







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/99/112


28.3.2013




27.3.2013


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/07/419


29.3.2013







—   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




27.3.2013


Bondenza







Roche Registration Limited




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






EU/1/03/266


2.4.2013




27.3.2013


Possia







AstraZeneca AB




SE-151 85 Södertälje, Sverige






EU/1/10/656


2.4.2013







—   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




22.3.2013


Pelzont







Merck Sharp & Dohme Limited




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






EU/1/08/460


26.3.2013




22.3.2013


Tredaptive







Merck Sharp & Dohme Limited




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






EU/1/08/459


26.3.2013




22.3.2013


Trevaclyn







Merck Sharp & Dohme Limited




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






EU/1/08/458


26.3.2013







—   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




6.3.2013


Loxicom







Norbrook Laboratories Ltd




Station Works, Newry, Co. Down, BT35 6JP, United Kindgom






EU/2/08/090


8.3.2013




6.3.2013


ProteqFlu







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/03/037


8.3.2013




6.3.2013


ProteqFlu-Te







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/03/038


8.3.2013




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.