Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

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", F-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 Centralised Orphan - Designation EMEA/OD/003/00 (2001)1398 of 09/07/2001