Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Sodium oxybate

EU orphan designation number: EU/3/02/131
Active ingredient: Sodium oxybate
Indication: Treatment of narcolepsy
Sponsor: UCB Pharma Ltd
208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Xyrem on 13/10/2005 with the number EU/1/05/312

   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
06/02/2003 Orphan designation EMEA/OD/051/02 (2003)470 of 03/02/2003
13/02/2004 Transfer of orphan designation EMEA/OD/051/02/T/01 (2004)329 of 11/02/2004
05/08/2005 Change of name and/or address of sponsor EMEA/OD/051/02
11/01/2010 Removal of orphan designation from Community Register EMEA/OD/051/02