Table of contents
Isentress is an HIV medicine that is used in combination with other HIV medicines to treat patients who are infected with human immunodeficiency virus (HIV‑1), a virus that causes acquired immune deficiency syndrome (AIDS).
Isentress contains the active substance raltegravir.
Isentress : EPAR - Medicine overview (PDF/88.67 KB)
First published: 18/09/2009
Last updated: 23/04/2018
Isentress : EPAR - Risk-management-plan summary (PDF/93.35 KB)
First published: 17/08/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
Merck Sharp & Dohme B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
17/10/2022 Isentress - EMEA/H/C/000860 - IB/0103
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antivirals for systemic use
Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.