Telzir

RSS

fosamprenavir

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

Overview

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.

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Telzir
Agency product number
EMEA/H/C/000534
Active substance
fosamprenavir calcium
International non-proprietary name (INN) or common name
fosamprenavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE07
Publication details
Marketing-authorisation holder
ViiV Healthcare BV
Revision
39
Date of issue of marketing authorisation valid throughout the European Union
12/07/2004
Contact address

Huis ter Heideweg 62
3705 LZ Zeist
The Netherlands

Product information

28/09/2018 Telzir - EMEA/H/C/000534 - T/0093

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

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.

Assessment history

Changes since initial authorisation of medicine

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