Emtriva (emtricitabine)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- HIV Infections
- EU approval
- Fri 24 Oct 2003
- Application
- EMEA/H/C/000533
- ATC
- J05AF09
- Official record
- www.ema.europa.eu
Indication
Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens. When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Symtuza Authorised · Janssen-Cilag International
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- 🇪🇺 Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Genvoya Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris Authorised · Viatris Limited
- 🇪🇺 Emtricitabine / Tenofovir alafenamide Viatris Authorised · Viatris Limited
- 🇪🇺 Biktarvy Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Eviplera Authorised · Gilead Sciences International Ltd
- 🇪🇺 Descovy Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Truvada Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Stribild Authorised · Gilead Sciences Ireland UC
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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.