Kolbam

Withdrawn

This medicine's authorisation has been withdrawn

cholic acid

Overview

On 13 July 2020, the European Commission withdrew the marketing authorisation for Kolbam (cholic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Retrophin Europe Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Kolbam was granted marketing authorisation in the EU on 04 April 2014 for treatment of inborn errors of primary bile acid synthesis. The marketing authorisation was initially valid for a 5-year period. Patients currently treated with Kolbam will be transitioned to alternative treatments. 

The European Public Assessment Report (EPAR) for Kolbam is updated to indicate that the marketing authorisation is no longer valid.

Kolbam : EPAR - Summary for the public

Kolbam : EPAR - Risk-management-plan summary

Product information

Kolbam : EPAR - Product Information

Kolbam : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Kolbam
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002081
• Exceptional 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.

• Marketing authorisation holder:
  Retrophin Europe Ltd

  Palmerston House; Fenian Street; Dublin 2; Ireland

• Opinion adopted:
  21/11/2013
• Marketing authorisation issued:
  20/11/2015
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

Kolbam : EPAR - Procedural steps taken and scientific information after authorisation

Kolbam-H-C-PSUSA-00010182-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/685152/2019

Initial marketing authorisation documents

Kolbam : EPAR - Public assessment report

AdoptedReference Number: EMA/689761/2015

CHMP summary of opinion for Kolbam

AdoptedReference Number: EMA/627629/2015 Corr. 1

CHMP summary of positive opinion Kolbam

AdoptedReference Number: EMA/627629/2015