Isentress

RSS

raltegravir

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 14/11/2018

Authorisation details

Product details
Name
Isentress
Agency product number
EMEA/H/C/000860
Active substance
Raltegravir
International non-proprietary name (INN) or common name
raltegravir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX08
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
19/12/2007
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

24/10/2018 Isentress - EMEA/H/C/000860 - IG/0994

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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