Telzir

Withdrawn

This medicine's authorisation has been withdrawn

fosamprenavir

Overview

On 21 November 2025, the European Commission withdrew the marketing authorisation for Telzir (fosamprenavir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, ViiV Healthcare B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Telzir was granted marketing authorisation in the EU on 12 July 2004 for the treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2009. 

Telzir : EPAR - Medicine overview

Product information

Telzir : EPAR - Product Information

Telzir : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Telzir
• Active substance:
  fosamprenavir calcium
• International non-proprietary name (INN) or common name:
  fosamprenavir
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AE07

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000534
• Marketing authorisation holder:
  ViiV Healthcare BV

  Van Asch van Wijckstraat 55H; 3811 LP Amersfoort; The Netherlands

• Marketing authorisation issued:
  12/07/2004
• Withdrawal of marketing authorisation:
  21/11/2025
• Revision:
  48

Assessment history

Changes since initial authorisation of medicine

Telzir : EPAR - Procedural steps taken and scientific information after authorisation

CHMP post-authorisation summary of positive opinion for Telzir

Adopted Reference Number: EMA/156121/2016

Telzir-H-C-534-P46-0075 : EPAR - Assessment Report

Adopted Reference Number: EMA/642265/2014

Telzir-H-C-534-II-0074 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/339053/2014

Telzir-H-C-534-P46-0060 : EPAR - Assessment Report

Adopted Reference Number: EMA/131182/2013

Telzir-H-C-534-II-0058 : EPAR - Assessment Report - Variation

Adopted

Telzir-H-C-534-II-0041 : EPAR - Assessment Report - Variation

Reference Number: EMEA/CHMP/182021/2009

CHMP post-authorisation summary of positive opinion for Telzir on 19 February 2009

Adopted Reference Number: EMEA/109046/2009

Telzir-H-C-534-II-0018 : EPAR - Scientific Discussion - Variation

Adopted

Initial marketing authorisation documents

Telzir : EPAR - Scientific Discussion

Telzir : EPAR - Procedural steps taken before authorisation