Odefsey (emtricitabine;rilpivirine;tenofovir alafenamide)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;rilpivirine;tenofovir alafenamide
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 28 Apr 2016
- EU approval
- Tue 21 Jun 2016
- Application
- EMEA/H/C/004156
- ATC
- J05AR19
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris Authorised · Viatris Limited
Follow Odefsey
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.