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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

N-carbamyl-L-glutamic acid

EU orphan designation number: EU/3/00/007
Active ingredient: N-carbamyl-L-glutamic acid
Indication: Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Sponsor: Orphan Europe S.A.R.L.
Immeuble "Le Guillaumet", 92046 Paris La Défense, 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
13/11/2000 Orphan designation EMEA/OD/002/00 (2000)3023 of 18/10/2000
28/01/2013 Removal of orphan designation from Community Register