Truvada (emtricitabine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;tenofovir disoproxil
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 18 Nov 2004
- EU approval
- Sun 20 Feb 2005
- Application
- EMEA/H/C/000594
- ATC
- J05AR03
- Official record
- www.ema.europa.eu
Indication
Treatment of HIV-1 infection: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. Pre-exposure prophylaxis (PrEP): Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Stribild Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Krka d.d. Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Atripla Withdrawn · Gilead Sciences Ireland UC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.