🇪🇺 Xenbilox in European Union

EMA authorised Xenbilox on 10 April 2017

Marketing authorisation

EMA — authorised 10 April 2017

  • Application: EMEA/H/C/004061
  • Marketing authorisation holder: Leadiant GmbH
  • Local brand name: Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)
  • 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.
  • Pathway: exceptional circumstances, orphan
  • Status: approved

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Other Other approved in European Union

Frequently asked questions

Is Xenbilox approved in European Union?

Yes. EMA authorised it on 10 April 2017.

Who is the marketing authorisation holder for Xenbilox in European Union?

Leadiant GmbH holds the EU marketing authorisation.