Intelence
etravirine
Table of contents
Overview
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.
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List item
Intelence : EPAR - Summary for the public (PDF/124.74 KB)
First published: 07/08/2009
Last updated: 15/05/2020 -
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List item
Intelence : EPAR - Risk-management-plan summary (PDF/89.27 KB)
First published: 15/05/2020
Authorisation details
Product details | |
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Name |
Intelence
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Agency product number |
EMEA/H/C/000900
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Active substance |
Etravirine
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International non-proprietary name (INN) or common name |
etravirine
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AG04
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Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
25
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Date of issue of marketing authorisation valid throughout the European Union |
28/08/2008
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Contact address |
Turnhoutseweg, 30 |
Product information
28/04/2020 Intelence - EMEA/H/C/000900 - II/0058
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
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Non-nucleoside reverse transcriptase inhibitors
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Antivirals for systemic use
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
News
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27/03/2020
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
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23/10/2015
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16/11/2012