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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Sodium phenylbutyrate

EU orphan designation number: EU/3/15/1581   
Active ingredient: Sodium phenylbutyrate
Indication: Treatment of pyruvate dehydrogenase complex deficiency
Sponsor: Fondazione Telethon
Via Varese 16b, 00185 Roma, Italia

   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
13/11/2015 Orphan designation EMA/OD/141/15 (2015)8031 of 11/11/2015