Kolbam

RSS

cholic acid

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Kolbam has been withdrawn at the request of the marketing-authorisation holder.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
Name
Kolbam
Agency product number
EMEA/H/C/002081
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
A05AA03
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
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
20/11/2015
Contact address
Palmerston House
Fenian Street
Dublin 2
Ireland

Product information

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

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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
Average
1 rating