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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Sorafenib tosylate

EU orphan designation number: EU/3/13/1199   
Active ingredient: Sorafenib tosylate
Indication: Treatment of follicular thyroid cancer
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
15/11/2013 Orphan designation EMA/OD/092/13 (2013)8045 of 13/11/2013
14/05/2014 Other procedure
30/05/2014 Change of name and/or address of sponsor
21/08/2017 Transfer of orphan designation EMA/OD/092/13/T/01 (2017)5796 of 17/08/2017