Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

cipla australia pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; pregelatinised starch; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection: cipla tenofovir + emtricitabine 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: cipla tenofovir + emtricitabine 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.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - emtricitabine, tenofovir disoproxil , efavirenz - tablets - tenofovir disoproxil fumarate / efavirenz/ emtricitabine 300 mg/600 mg and 200 mg

Kenya - English - Pharmacy and Poisons Board

mylan laboratories limited c/o surgilinks ltd mylan laboratories limited r&d centre plot no. - tenofovir disoproxil fumarate emtricitabine… - film-coated tablet - tenofovir disoproxil fumarate 300mg emtricitabine… - antivirals for systemic use: combinations of

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

sandoz pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; triacetin - tenofovir sandoz 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 sandoz is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir sandoz 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.

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.

Canada - English - Health Canada

laboratoire riva inc. - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

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

sandoz pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil succinate, quantity: 300.6 mg - tablet, film coated - excipient ingredients: macrogol 3350; indigo carmine aluminium lake; magnesium stearate; isopropyl alcohol; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; lactose monohydrate; purified talc; croscarmellose sodium; purified water; pregelatinised maize starch - treatment of hiv-1 infection,tenofovir/emtricitabine sandoz 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/emtricitabine sandoz 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 section 5.1 pharmacodynamic properties, clinical trials).

Zimbabwe - English - Medicines Control Authority

hetero drugs ltd - emtricitabine; tenofovir disoproxil fumarate - tablet, coated; oral - 200; 300mg

Zimbabwe - English - Medicines Control Authority

macleods pharmaceuticals ltd - emtricitabine; tenofovir disoproxil fumarate - tablet; oral - 200; 300 mg