Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Cholic acid

EU orphan designation number: EU/3/02/127   
Active ingredient: Cholic acid
Indication: Treatment of inborn errors in primary bile acid synthesis
Sponsor: Laboratoires CTRS
63 rue de l'Est, 92100 Boulogne-Billancourt, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Orphacol on 12/09/2013 with the number EU/1/13/870

   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
19/12/2002 Orphan designation EMEA/OD/036/02 (2002)5453 of 18/12/2002
3/08/2007 Transfer of orphan designation EMEA/OD/036/02/T/01 (2007)3642 of 24/07/2007
7/04/2008 Change of name and/or address of sponsor
12/01/2011 Other procedure
11/01/2016 Change of name and/or address of sponsor