Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Sorafenib tosylate

EU orphan designation number: EU/3/06/364   
Active ingredient: Sorafenib tosylate
Indication: Treatment of hepatocellular carcinoma
Sponsor: Bayer Pharma AG
Müllerstrasse 178, D-13342 Berlin, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Nexavar on 19/07/2006 with the number EU/1/06/342

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
13/04/2006 Orphan Designation EMEA/OD/109/05 (2006)1645 of 11/04/2006
06/04/2009 Transfer of orphan designation EMEA/OD/109/05/T/01 (2009)2702 of 02/04/2009
21/10/2011 Change name of sponsor