This document is a summary of the European public assessment report (EPAR) for Telzir. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Telzir.
For practical information about using Telzir, patients should read the package leaflet or contact their doctor or pharmacist.
Telzir : EPAR - Summary for the public (PDF/99.73 KB)
First published: 15/05/2009
Last updated: 12/01/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
ViiV Healthcare BV
|Date of issue of marketing authorisation valid throughout the European Union||
28/09/2018 Telzir - EMEA/H/C/000534 - T/0093
- 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
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.
Antivirals for systemic use
Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products.
In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents.
In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied.
In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.