Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/214   
Active ingredient: Midostaurin
Indication: Treatment of acute myeloid leukaemia
Sponsor: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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     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/028/04 (2004)3094 of 29/07/2004
29/08/2014 Change of name and/or address of sponsor
16/05/2018 Transfer of orphan designation EMEA/OD/028/04/T/01 (2018)3032 of 08/05/2018