Fuzeon (enfuvirtide)
- Region
- 🇪🇺 EU
- Active substance
- enfuvirtide
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- HIV Infections
- EU approval
- Tue 27 May 2003
- Application
- EMEA/H/C/000514
- ATC
- J05AX07
- Official record
- www.ema.europa.eu
Indication
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.
Regulatory milestones
No milestones recorded in the last year.
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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.