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🇪🇺EU · EMAAuthorisedATC: J05AR03

Emtricitabine/Tenofovir disoproxil Krka(emtricitabine;tenofovir disoproxil succinate)

HIV Infections

Marketing Authorisation Holder: KRKA, d.d., Novo mesto

EMA Authorisation: 09/12/2016

INN: emtricitabine;tenofovir disoproxil

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.