🇪🇺 daily TDF/FTC in European Union

EMA authorised daily TDF/FTC on 20 February 2005

Marketing authorisation

EMA — authorised 20 February 2005

  • Application: EMEA/H/C/000594
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Truvada
  • Indication: Treatment of HIV-1 infection: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. Pre-exposure prophylaxis (PrEP): Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
  • Status: approved

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Other Infectious Disease / Virology approved in European Union

Frequently asked questions

Is daily TDF/FTC approved in European Union?

Yes. EMA authorised it on 20 February 2005.

Who is the marketing authorisation holder for daily TDF/FTC in European Union?

Gilead Sciences Ireland UC holds the EU marketing authorisation.