emtricitabine / rilpivirine / tenofovir disoproxil

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Eviplera. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eviplera.

This EPAR was last updated on 13/12/2022

Authorisation details

Product details
Agency product number
Active substance
  • emtricitabine
  • rilpivirine hydrochloride
  • tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
  • emtricitabine
  • rilpivirine
  • tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Gilead Sciences International Ltd 
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Gilead Sciences International Ltd
CB21 6GT
United Kingdom

Product information

12/12/2022 Eviplera - EMEA/H/C/002312 - IB/0111

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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.

Assessment history

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