Intelence

RSS

etravirine

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

Overview

This is a summary of the European public assessment report (EPAR) for Intelence. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Intelence.

For practical information about using Intelence, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/10/2017

Authorisation details

Product details
Name
Intelence
Agency product number
EMEA/H/C/000900
Active substance
Etravirine
International non-proprietary name (INN) or common name
etravirine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AG04
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
27/08/2008
Contact address
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

13/07/2017 Intelence - EMEA/H/C/000900 - II/0050

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

Non nucleoside reverse transcriptase inhibitors

Therapeutic indication

Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.

This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.

Assessment history

How useful was this page?

Add your rating