Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Sorafenib tosylate

EU orphan designation number: EU/3/13/1200   
Active ingredient: Sorafenib tosylate
Indication: Treatment of papillary thyroid cancer
Sponsor: Bayer Pharma AG
Müllerstrasse 178, 13353 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
15/11/2013 Orphan designation EMA/OD/093/13 (2013)8046 of 13/11/2013
14/05/2014 Other procedure
30/05/2014 Change of name and/or address of sponsor