Telzir

RSS

fosamprenavir

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

Overview

Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Telzir is used in combination with ritonavir and other HIV medicines. It contains the active substance fosamprenavir.

This EPAR was last updated on 20/08/2019

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
42
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

18/06/2019 Telzir - EMEA/H/C/000534 - II/0094/G

Contents

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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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