Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/02/102
Active ingredient: Mitotane
Indication: Treatment of adrenal cortical carcinoma
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 Lysodren on 28/04/2004 with the number EU/1/04/273

   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
14/06/2002 Orphan designation EMEA/OD/003/02 (2002)2228 of 12/06/2002
25/07/2005 Change of name and/or address of sponsor
30/04/2014 Removal of orphan designation from Community Register