🇪🇺 Livmarli in European Union

EMA authorised Livmarli on 9 December 2022

Marketing authorisations

EMA — authorised 9 December 2022

  • Application: EMEA/H/C/005857
  • Marketing authorisation holder: Mirum Pharmaceuticals International B.V.
  • Local brand name: Livmarli
  • Indication: Livmarli is indicated for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older, Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older. Livmarli tablets is indicated in adults and adolescents 12 years and older for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS), Progressive familial intrahepatic cholestasis (PFIC).
  • Pathway: exceptional circumstances, orphan
  • Status: approved

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EMA

  • Application: EMEA/H/C/005551
  • Marketing authorisation holder: FGK Representative Service GmbH
  • Local brand name: Livmarli
  • Indication: Treatment of progressive familial intrahepatic cholestasis type 2 (PFIC2)
  • Pathway: orphan
  • Status: withdrawn

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Livmarli in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is Livmarli approved in European Union?

Yes. EMA authorised it on 9 December 2022; EMA has authorised it.

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

Mirum Pharmaceuticals International B.V. holds the EU marketing authorisation.