Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/12/1063   
Active ingredient: Panobinostat
Indication: Treatment of multiple myeloma
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 Farydak on 28/08/2015 with the number EU/1/15/1023

   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
12/11/2012 Orphan designation EMA/OD/113/12 (2012)8196 of 8/11/2012
26/08/2014 Change of name and/or address of sponsor
16/07/2015 Other procedure
16/05/2018 Transfer of orphan designation EMA/OD/113/12/T/01 (2018)3041 of 8/05/2018