Agenerase (amprenavir)
- Region
- 🇪🇺 EU
- Active substance
- amprenavir
- Company
- Glaxo Group Ltd.
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- EU approval
- Fri 20 Oct 2000
- Application
- EMEA/H/C/000264
- ATC
- J05AE05
- Official record
- www.ema.europa.eu
Indication
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Telzir Withdrawn · ViiV Healthcare BV
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.