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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Betaine anhydrous

EU orphan designation number: EU/3/01/045
Active ingredient: Betaine anhydrous
Indication: Treatment of homocystinuria
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 Cystadane on 15/02/2007 with the number EU/1/06/379

   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
10/07/2001 Orphan designation EMEA/OD/003/00 (2001)1398 of 09/07/2001
19/02/2017 Removal of orphan designation from Community Register