European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - 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., 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 efavir

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil krka 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 krka prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of 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.no data are currently available from clinical studies with 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.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil mylan 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 mylan prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of 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 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - efavirenz; emtricitabine; tenofovir disoproxil - film-coated tablet - 600 mg/200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; emtricitabine, tenofovir disoproxil and efavirenz

Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - efavirenz; emtricitabine; tenofovir disoproxil - film-coated tablet - 600 mg/200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; emtricitabine, tenofovir disoproxil and efavirenz

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - 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., 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 efavir

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - efavirenz, emtricitabine, tenofovir disoproxil - film-coated tablet - efavirenz 600 mg emtricitabine 200 mg tenofovir disoproxil 245 mg - antivirals for systemic use

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - tenofovir disoproxil, efavirenz, emtricitabine - film-coated tablet - tenofovir disoproxil 245 mg efavirenz 600 mg emtricitabine 200 mg - antivirals for systemic use

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - emtricitabine/tenofovir disoproxil krka d.d. is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka d.d. 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.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5.1).emtricitabine/tenofovir disoproxil mylan 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 mylan 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).