Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;tenofovir disoproxil
- Company
- Zentiva k.s.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 15 Sep 2016
- EU approval
- Wed 09 Nov 2016
- Designations
- Generic
- Application
- EMEA/H/C/004137
- ATC
- J05AR03
- Official record
- www.ema.europa.eu
Indication
Treatment of HIV-1 infection Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents. Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents 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
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Truvada Authorised · Gilead Sciences Ireland UC
- 🇪🇺 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- 🇪🇺 Atripla Withdrawn · Gilead Sciences Ireland UC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.