Intelence

etravirine

Table of contents

Opinion

On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Intelence. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

The CHMP adopted an extension to the existing indication to include children from the age of 2 years.

The full indication for Intelence will be as follows1:

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 6 2 years of age (see sections 4.4, 4.5 and 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold, removed text as strikethrough

 

Key facts

Name
Intelence
Agency product number
EMEA/H/C/000900
International non-proprietary name (INN) or common name
  • etravirine
Active substance
  • Etravirine
Therapeutic area
HIV Infections
Date opinion adopted
26/03/2020
Company name
Janssen-Cilag International NV
Status
Positive
Application type
Post-authorisation

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