Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/12/965   
Active ingredient: Ketoconazole
Indication: Treatment of Cushing’s syndrome
Sponsor: Laboratoire HRA Pharma
15 rue Béranger, 75003 Paris, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ketoconazole HRA on 19/11/2014 with the number EU/1/14/965

   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
26/04/2012 Orphan designation EMA/OD/125/11 (2012)2897 of 23/04/2012
9/10/2014 Other procedure