An overview of Isentress and why it is authorised in the EU
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
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp & Dohme B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
24/10/2018 Isentress - EMEA/H/C/000860 - IG/0994
- 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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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 in adults, adolescents, children, toddlers and infants from the age of 4 weeks.