🇪🇺 Hepcludex in European Union

EMA authorised Hepcludex on 31 July 2020

Marketing authorisations

EMA — authorised 31 July 2020

  • Marketing authorisation holder: MYR GmbH
  • Status: approved

EMA — authorised 31 July 2020

  • Application: EMEA/H/C/004854
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Hepcludex
  • Indication: Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.
  • Pathway: orphan, PRIME
  • Status: approved

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Hepcludex in other countries

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

Other Infectious Disease approved in European Union

Frequently asked questions

Is Hepcludex approved in European Union?

Yes. EMA authorised it on 31 July 2020; EMA authorised it on 31 July 2020.

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

MYR GmbH holds the EU marketing authorisation.