Isentress

RSS

raltegravir

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

Overview

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 25/06/2019

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
Accelerated assessmentAccelerated assessment

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.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
36
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

21/05/2019 Isentress - EMEA/H/C/000860 - IB/0087

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating