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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Glyceryl tri-(4-phenylbutyrate)

EU orphan designation number: EU/3/10/739   
Active ingredient: Glyceryl tri-(4-phenylbutyrate)
Indication: Treatment of citrullinaemia type 2
Sponsor: Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

   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
15/06/2010 Orphan designation EMA/OD/007/10 (2010)3910 of 10/06/2010
23/01/2014 Change of name and/or address of sponsor
22/06/2015 Change of name and/or address of sponsor
02/02/2016 Transfer of orphan designation EMA/OD/007/10/T/01 (2016)677 of 29/01/2016