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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
A05AA01
ATC Item
chenodeoxycholic acid
Pharmacotherapeutic Group
Bile and liver therapy
Active Substance (Summary)
INN / Common Names
EMA Name
Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Medicine Name
Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)
Aliases
N/ANo risk management plan link.
