Emtricitabine/Tenofovir disoproxil Krka (emtricitabine;tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- emtricitabine;tenofovir disoproxil
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 13 Oct 2016
- EU approval
- Fri 09 Dec 2016
- Designations
- Generic
- Application
- EMEA/H/C/004215
- ATC
- J05AR03
- Official record
- www.ema.europa.eu
Indication
Treatment of HIV-1 infection Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka 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 (see section 5.1 Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Krka 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
- 🇪🇺 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
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Atripla Withdrawn · Gilead Sciences Ireland UC
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