Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

RSS

chenodeoxycholic 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 Chenodeoxycholic acid Leadiant. 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 Chenodeoxycholic acid Leadiant.

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

This EPAR was last updated on 24/11/2017

Authorisation details

Product details
Name
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Agency product number
EMEA/H/C/004061
Active substance
Chenodeoxycholic acid
International non-proprietary name (INN) or common name
chenodeoxycholic acid
Therapeutic area (MeSH)
  • Xanthomatosis, Cerebrotendinous
  • Metabolism, Inborn Errors
Anatomical therapeutic chemical (ATC) code
A05AA01
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
Leadiant GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
09/04/2017
Contact address
Liebherrstrasse 22
80538 München
Germany

Product information

28/09/2017 Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) - EMEA/H/C/004061 - IB/0003/G

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

Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.

Assessment history

How useful was this page?

Add your rating