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

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - emtricitabine, quantity: 200 mg; efavirenz, quantity: 600 mg; tenofovir disoproxil maleate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium metabisulfite; hyprolose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; ferric oxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - tenofovir disoproxil/ emtricitabine/ efavirenz mylan 300/200/600 is indicated for the treatment of hiv infected adults over the age of 18 years.,this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts in controlled studies of viread, emtriva and stocrin in treatment-na?ve and treatment experienced adults.

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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg - film coated tablet - 300 mg - active: tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg excipient: colloidal silicon dioxide hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry blue 32k505018 - tenofovir disoproxil mylan is indicated for the treatment of chronic hepatitis b in adults and paediatric patients 12 years of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - tenofovir disoproxil maleate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hyprolose; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - tenofovir disoproxil viatris in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil viatris is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil viatris is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - efavirenz 600mg;  ; emtricitabine 200mg;  ; tenofovir disoproxil maleate 300mg equivalent to 245 mg tenofovir disoproxil - film coated tablet - active: efavirenz 600mg   emtricitabine 200mg   tenofovir disoproxil maleate 300mg equivalent to 245 mg tenofovir disoproxil excipient: colloidal silicon dioxide croscarmellose sodium hyprolose low-substituted hydroxypropylcellulose, lh 11 iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 85f540043 sodium metabisulfite - indicated for the treatment of hiv infected adults over the age of 18 years, alone or in combination with other antiretroviral agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil maleate, quantity: 300 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; iron oxide red; microcrystalline cellulose; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow; brilliant blue fcf aluminium lake - treatment of hiv-1 infection: tenofovir disoproxil emtricitabine mylan 300/200 is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents. pre-exposure prophylaxis: tenofovir disoproxil emtricitabine mylan 300/200 is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see clinical studies).

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).