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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Glyceryl tri-(4-phenylbutyrate)

EU orphan designation number: EU/3/10/735   
Active ingredient: Glyceryl tri-(4-phenylbutyrate)
Indication: Treatment of citrullinaemia type 1
Sponsor: Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ravicti on 27/11/2015 with the number EU/1/15/1062

   Public summary of scientific opinion     EPAR

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/003/10 (2010)3905 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
8/10/2015 Other procedure
2/02/2016 Transfer of orphan designation EMA/OD/003/10/T/01 (2016)673 of 29/01/2016