🇪🇺 Cholic Acids in European Union

EMA authorised Cholic Acids on 12 September 2013

Marketing authorisations

Application: EMEA/H/C/001250
Marketing authorisation holder: Theravia
Local brand name: Orphacol
Indication: Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency ininfants, children and adolescents aged 1 month to 18 years and adults.
Pathway: exceptional circumstances
Status: approved

Application: EMEA/H/C/002081
Marketing authorisation holder: Retrophin Europe Ltd
Local brand name: Kolbam
Indication: Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects: sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency; 2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency; cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.
Pathway: exceptional circumstances
Status: withdrawn

Is Cholic Acids approved in European Union?

Yes. EMA authorised it on 12 September 2013; EMA authorised it on 20 November 2015.

Who is the marketing authorisation holder for Cholic Acids in European Union?

Theravia holds the EU marketing authorisation.