Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Cholic acid

EU orphan designation number: EU/3/09/683   
Active ingredient: Cholic acid
Indication: Treatment of inborn errors of primary bile acid synthesis responsive to treatment with cholic acid
Sponsor: Retrophin Europe Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Kolbam on 4/04/2014 with the number EU/1/13/895

   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
30/10/2009 Orphan designation EMEA/OD/080/09 (2009)8521 of 28/10/2009
13/12/2011 Transfer of orphan designation EMEA/OD/080/09/T/01 (2011)9424 of 9/12/2011
13/11/2014 Transfer of orphan designation EMA/OD/080/09/T/02 (2014)8535 of 11/11/2014
19/05/2015 Transfer of orphan designation EMA/OD/080/09/T/03 (2015)3437 of 13/05/2015
8/10/2015 Other procedure
21/12/2015 Change of name and/or address of sponsor
19/02/2016 Change of name and/or address of sponsor