Isentress
raltegravir
Table of contents
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.
Authorisation details
Product details | |
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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 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 | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
Revision |
37
|
Date of issue of marketing authorisation valid throughout the European Union |
19/12/2007
|
Contact address |
Product information
27/10/2020 Isentress - EMEA/H/C/000860 - IB/0092
Contents
- 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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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
News
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23/02/2018
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19/05/2017
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27/06/2014
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 201219/10/2012