Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/10/765   
Active ingredient: Midostaurin
Indication: Treatment of mastocytosis
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
6/08/2010 Orphan designation EMA/OD/016/10 (2010)5532 of 4/08/2010
29/08/2014 Change of name and/or address of sponsor
16/05/2018 Transfer of orphan designation EMA/OD/016/10/T/01 (2018)3039 of 8/05/2018