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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Sodium phenylbutyrate

EU orphan designation number: EU/3/12/950
Active ingredient: Sodium phenylbutyrate
Indication: Treatment of ornithine transcarbamylase deficiency
Sponsor: Lucane Pharma SA
172 rue de Charonne, 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
13/02/2012 Orphan designation EMA/OD/097/11 (2012)876 of 9/02/2012
9/07/2013 Removal of orphan designation from Community Register
28/08/2013 Change of name and/or address of sponsor