Intelence

RSS

etravirine

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

Overview

Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV 1) in adults and children from 6 years of age. HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).

Intelence is only used in patients who have been treated for their HIV infection before and it must be used together with other HIV medicines that include a ‘boosted protease inhibitor’.

It contains the active substance etravirine.

This EPAR was last updated on 05/08/2019

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
24
Date of issue of marketing authorisation valid throughout the European Union
28/08/2008
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

23/08/2018 Intelence - EMEA/H/C/000900 - R/0052

Contents

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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

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