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The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing...

Treatment of HIV-1 infection Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). 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 (see sections 4.2, 4.4 and 5.1). 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 (see sections 4.2, 4.4 and 5.1).

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with combination efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Treatment of HIV-1 infection: Emtricitabine/ Tenofovir disoproxil is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1) Emtricitabine/ Tenofovir disoproxil 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 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 (see sections 4.4 and 5.1).

Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Glenmark is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Glenmark is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1).

Ictastan is a fixed dose combination of emtricitabine and tenofovir disoproxil succinate. It is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults aged 18 years and over. The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil in antiretroviral therapy is based solely on studies performed in treatment-naïve patients (see section 5.1).