US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Eviplera Gilead Sciences International Ltd · Authorised · authorised 27 Nov 2011 · ATC J05AR08
Therapeutic indication (EMA)
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.
Odefsey Gilead Sciences Ireland UC · Authorised · authorised 21 Jun 2016 · ATC J05AR19
Therapeutic indication (EMA)
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.
Therapeutic indication (EMA)
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).
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| COMPLERA | 02374129 | 200 MG; 25 MG; 300 MG | TABLET · ORAL | GILEAD SCIENCES CANADA INC |
| ODEFSEY | 02461463 | 25 MG; 200 MG; 25 MG | TABLET · ORAL | GILEAD SCIENCES CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | COMPLERA TABLET | $130.31417 | per EA | 23 Sep 2026 |
| US NADAC | ODEFSEY TABLET | $130.49198 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.