Kolbam

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cholic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Kolbam. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kolbam.

For practical information about using Kolbam, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 05/01/2017

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Retrophin Europe Ltd
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address
Palmerston House
Fenian Street
Dublin 2
Ireland

Product information

07/12/2016 Kolbam - EMEA/H/C/002081 - IB/0019

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

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