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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Sorafenib tosylate

EU orphan designation number: EU/3/06/364
Active ingredient: Sorafenib tosylate
Indication: Treatment of hepatocellular carcinoma
Sponsor: Bayer AG
D-51368 Leverkusen, 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 of name and/or address of sponsor
30/08/2017 Transfer of orphan designation EMEA/OD/109/05/T/02 (2017)5981 of 28/08/2017
01/11/2017 Removal of orphan designation from Community Register