🇪🇺 Emtricitabine (FTC) in European Union

EMA authorised Emtricitabine (FTC) on 24 October 2003

Marketing authorisation

EMA — authorised 24 October 2003

  • Application: EMEA/H/C/000533
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Emtriva
  • Indication: Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the tr
  • Status: approved

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Other Infectious Disease / Virology approved in European Union

Frequently asked questions

Is Emtricitabine (FTC) approved in European Union?

Yes. EMA authorised it on 24 October 2003.

Who is the marketing authorisation holder for Emtricitabine (FTC) in European Union?

Gilead Sciences Ireland UC holds the EU marketing authorisation.