Orphacol

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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 Orphacol. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Orphacol.

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

This EPAR was last updated on 06/10/2017

Authorisation details

Product details
Name
Orphacol
Agency product number
EMEA/H/C/001250
Active substance
cholic acid
International non-proprietary name (INN) or common name
cholic acid
Therapeutic area (MeSH)
  • Digestive System Diseases
  • 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
Laboratoires CTRS
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
12/09/2013
Contact address
Laboratoire CTRS
69, rue d'Aguesseau
92100 Boulogne-Billancourt
France

Product information

04/08/2017 Orphacol - EMEA/H/C/001250 - IA/0021

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 acid preparations

Therapeutic indication

Orphacol is indicated for the treatment of inborn errors in primary bile-acid synthesis due to 3β-hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults.

Assessment history

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