Anpheros Search · Treatment

Etravirine

Also known as: Intelence

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In short

In the European Union, etravirine is indicated, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and paediatric patients from six years of age. In the United States, etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older. Etravirine is listed by the cited source as having an approved use for human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

From: Source: European Medicines Agency (EMA), Intelence — EPAR, 13/08/2024. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
475969 etravirine
EMA
EMEA/H/C/000900

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) etravirine

1 INDICATIONS AND USAGE Etravirine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14)] . Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older. (1)

Data provided by the U.S. Food and Drug Administration.

Document date: 20260113 · Official document →

EMA (EU) Intelence

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.

Source: European Medicines Agency (EMA), Intelence — EPAR, 13/08/2024. © European Medicines Agency.

Document date: 13/08/2024 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Etravirine approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Intelence — EPAR, 13/08/2024. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Intelence — EPAR, 13/08/2024. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →