cholic acid

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Kolbam has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 15/07/2020

Authorisation details

Product details
Agency product number
Active substance
cholic acid
International non-proprietary name (INN) or common name
cholic acid
Therapeutic area (MeSH)
Metabolism, Inborn Errors
Anatomical therapeutic chemical (ATC) code
Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Retrophin Europe Ltd
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Palmerston House
Fenian Street
Dublin 2

Product information

27/03/2020 Kolbam - EMEA/H/C/002081 - N/0033

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Bile and liver therapy

Therapeutic 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.

Assessment history

How useful was this page?

Add your rating
1 rating