Pharmaceuticals - Community Register


Community 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: ASK Pharmaceuticals GmbH
Heimeranstraße 35, D-80339 München, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Kolbam on 04/04/2014 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 Centralised Orphan - Designation EMEA/OD/080/09 (2009)8521 of 28/10/2009
13/12/2011 Centralised Orphan - Transfer of orphan designation EMEA/OD/080/09/T/01 (2011)9424 of 09/12/2011
13/11/2014 Centralised Orphan - Transfer of orphan designation EMA/OD/080/09/T/02 (2014)8535 of 11/11/2014