Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Carglumic acid

EU orphan designation number: EU/3/08/575   
Active ingredient: Carglumic acid
Indication: Treatment of isovaleric acidaemia
Sponsor: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Carbaglu on 24/01/2003 with the number EU/1/02/246

   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
13/11/2008 Orphan designation EMEA/OD/107/07 (2008)6862 of 07/11/2008