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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Sorafenib tosylate

EU orphan designation number: EU/3/04/207
Active ingredient: Sorafenib tosylate
Indication: Treatment of renal cell carcinoma
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
02/08/2004 Orphan designation EMEA/OD/032/04 (2004)3001 of 29/07/2004
24/04/2009 Transfer of orphan designation EMEA/OD/032/04/T/01 (2009)3194 of 22/04/2009
21/10/2011 Change of name and/or address of sponsor
21/07/2016 Removal of orphan designation from Community Register