Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris (emtricitabine;rilpivirine;tenofovir alafenamide)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;rilpivirine;tenofovir alafenamide
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Tue 19 Aug 2025
- Designations
- Generic
- Application
- EMEA/H/C/006491
- ATC
- J05AR19
- Official record
- www.ema.europa.eu
Indication
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-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 (see sections 4.2, 4.4 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Odefsey 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.