🇪🇺 sofosbubir/velpatasvir in European Union

EMA authorised sofosbubir/velpatasvir on 6 July 2016

Marketing authorisation

EMA — authorised 6 July 2016

  • Application: EMEA/H/C/004210
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Epclusa
  • Indication: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
  • Pathway: accelerated assessment
  • Status: approved

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Other Virology/Hepatology approved in European Union

Frequently asked questions

Is sofosbubir/velpatasvir approved in European Union?

Yes. EMA authorised it on 6 July 2016.

Who is the marketing authorisation holder for sofosbubir/velpatasvir in European Union?

Gilead Sciences Ireland UC holds the EU marketing authorisation.