Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
chenodeoxycholic acid
Table of contents
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.
Authorisation details
Product details | |
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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) |
|
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 | |
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Marketing-authorisation holder |
Leadiant GmbH
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
10/04/2017
|
Contact address |
Liebherrstrasse 22
80538 München Germany |
Product information
09/12/2021 Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) - EMEA/H/C/004061 - R/0018
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.