Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Midostaurin

EU orphan designation number: EU/3/04/214   
Active ingredient: Midostaurin
Indication: Treatment of acute myeloid leukaemia
Sponsor: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Rydapt on 20/09/2017 with the number EU/1/17/1218

   Public summary of scientific opinion    

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/028/04 (2004)3094 of 29/07/2004
29/08/2014 Change of name and/or address of sponsor