🇪🇺 Sofosbuvir + Simeprevir in European Union

EMA authorised Sofosbuvir + Simeprevir on 14 May 2014

Marketing authorisation

EMA — authorised 14 May 2014

  • Application: EMEA/H/C/002777
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Olysio
  • Indication: Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity.
  • Status: withdrawn

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Other Virology/Hepatology approved in European Union

Frequently asked questions

Is Sofosbuvir + Simeprevir approved in European Union?

Yes. EMA authorised it on 14 May 2014.

Who is the marketing authorisation holder for Sofosbuvir + Simeprevir in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.