Telzir (fosamprenavir)
- Region
- 🇪🇺 EU
- Active substance
- fosamprenavir
- Company
- ViiV Healthcare BV
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- EU approval
- Mon 12 Jul 2004
- Application
- EMEA/H/C/000534
- ATC
- J05AE07
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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