Telzir
Withdrawn
This medicine's authorisation has been withdrawn
fosamprenavir
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:IG1531
19/08/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 useTherapeutic 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
News on Telzir
Tópicos
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