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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, 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
24/05/2017 Removal of orphan designation from Community Register