Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

Sodium oxybate

Product name: Sodium oxybate
Active substance: Sodium oxybate
Indication: Indicated for the treatment of narcolepsy with cataplexy in adults.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/08/2015 PSUSA - Modification EMEA/H/C/PSUSA/2757/201410 (2015)6115 of 28/08/2015