Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/071
Active ingredient: Stiripentol
Indication: Treatment of severe myoclonic epilepsy in infancy
Sponsor: Biocodex
7 avenue Gallieni, 94250 Gentilly, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Diacomit on 04/01/2007 with the number EU/1/06/367

   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
07/12/2001 Orphan designation EMEA/OD/030/01 (2001)4026 of 05/12/2001
14/03/2005 Change of name and/or address of sponsor
09/01/2017 Removal of orphan designation from Community Register