🇪🇺 rilpivirina + emtricitabina + tenofovir in European Union

EMA authorised rilpivirina + emtricitabina + tenofovir on 27 November 2011

Marketing authorisation

EMA — authorised 27 November 2011

  • Application: EMEA/H/C/002312
  • Marketing authorisation holder: Gilead Sciences International Ltd
  • Local brand name: Eviplera
  • Indication: Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ? 100,000 HIV-1 RNA copies/mL. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.
  • Status: approved

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Other Infectious Disease / Virology approved in European Union

Frequently asked questions

Is rilpivirina + emtricitabina + tenofovir approved in European Union?

Yes. EMA authorised it on 27 November 2011.

Who is the marketing authorisation holder for rilpivirina + emtricitabina + tenofovir in European Union?

Gilead Sciences International Ltd holds the EU marketing authorisation.