Eviplera (emtricitabine;rilpivirine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;rilpivirine;tenofovir disoproxil
- Company
- Gilead Sciences International Ltd
- Status
- Authorised
- Therapeutic area
- HIV Infections
- EU approval
- Sun 27 Nov 2011
- Application
- EMEA/H/C/002312
- ATC
- J05AR08
- Official record
- www.ema.europa.eu
Indication
Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ? 100,000 HIV-1 RNA copies/mL. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.
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.