Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/09/671   
Active ingredient: pasireotide
Indication: Treatment of Cushing's disease
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 Signifor on 24/04/2012 with the number EU/1/12/753

   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
12/10/2009 Orphan designation EMEA/OD/052/09 (2009)7856 of 8/10/2009
8/02/2012 Other procedure
29/08/2014 Change of name and/or address of sponsor
16/05/2018 Transfer of orphan designation EMEA/OD/052/09/T/01 (2018)3037 of 8/05/2018