Eviplera

RSS

emtricitabine / rilpivirine / tenofovir disoproxil

Authorised
This medicine is authorised for use in the European Union.

Overview

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 22/08/2018

Authorisation details

Product details
Name
Eviplera
Agency product number
EMEA/H/C/002312
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
J05AR08
Publication details
Marketing-authorisation holder
Gilead Sciences International Ltd 
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
28/11/2011
Contact address
Gilead Sciences International Ltd
Cambridge
CB21 6GT
United Kingdom

Product information

19/07/2018 Eviplera - EMEA/H/C/002312 - WS/1351

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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