Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV-1) in adults and children from 2 years of age. HIV-1 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.
Intelence : EPAR - Summary for the public (PDF/124.74 KB)
First published: 07/08/2009
Last updated: 15/05/2020
Intelence : EPAR - Risk-management-plan summary (PDF/89.27 KB)
First published: 15/05/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
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Janssen-Cilag International NV
|Date of issue of marketing authorisation valid throughout the European Union||
28/04/2020 Intelence - EMEA/H/C/000900 - II/0058
- 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
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Non-nucleoside reverse transcriptase inhibitors
Antivirals for systemic use
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)27/03/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 201216/11/2012