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


chenodeoxycholic acid

This medicine is authorised for use in the European Union.


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 15/12/2021

Authorisation details

Product details
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Agency product number
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
Additional monitoringAdditional 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 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.


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
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Liebherrstrasse 22
80538 München

Product information

09/12/2021 Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) - EMEA/H/C/004061 - R/0018

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

Related content

How useful was this page?

Add your rating
2 ratings
1 rating