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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
J05AE07
ATC Item
fosamprenavir
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| fosamprenavir calcium | N/A | Fosamprenavir |
EMA Name
Telzir
Medicine Name
Telzir
Aliases
N/ANo risk management plan link.
