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Community register of orphan medicinal products


Product information

Glyceryl tri-(4-phenylbutyrate)

EU orphan designation number: EU/3/10/734   
Active ingredient: Glyceryl tri-(4-phenylbutyrate)
Indication: Treatment of ornithine carbamoyltransferase deficiency
Sponsor: Horizon Therapeutics Limited
90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ravicti on with the number EU/1/15/1062

   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/002/10 (2010)3904 of 10/06/2010
23/01/2014 Change of address of sponsor
22/06/2015 Change of address of sponsor