Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Sodium phenylbutyrate

EU orphan designation number: EU/3/11/948   
Active ingredient: Sodium phenylbutyrate
Indication: Treatment of 5q spinal muscular atrophy
Sponsor: GMP-Orphan SA
7 rue du Pasteur Wagner, F-75011 Paris, France

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
13/01/2012 Orphan designation EMA/OD/089/11 (2012)134 of 11/01/2012
20/07/2015 Change of name and/or address of sponsor EMA/OD/089/11