Edurant

RSS

rilpivirine

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

Overview

This is a summary of the European public assessment report (EPAR) for Edurant. 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 Edurant.

This EPAR was last updated on 07/06/2018

Authorisation details

Product details
Name
Edurant
Agency product number
EMEA/H/C/002264
Active substance
rilpivirine hydrochloride
International non-proprietary name (INN) or common name
rilpivirine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AG05
Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.   
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
27/11/2011
Contact address
Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

08/05/2018 Edurant - EMEA/H/C/002264 - T/0034

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

Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV‑1 RNA copies/ml.

As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant.

Assessment history

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