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

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: hyprolose; hypromellose; indigo carmine aluminium lake; lactose; colloidal anhydrous silica; calcium stearate; titanium dioxide; crospovidone; macrogol 8000 - tenofovir disoproxil fumarate 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 fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate 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)

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; hypromellose; hyprolose; indigo carmine aluminium lake; titanium dioxide; calcium stearate; macrogol 8000 - tenofovir disoproxil fumarate 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 fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate 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.

Zimbabwe - English - Medicines Control Authority

hetero labs ltd - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet, coated; oral - 600; 200; 300mg

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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.

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)

lupin australia pty limited - emtricitabine, quantity: 200 mg; tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: mannitol; purified water; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection tenofovir emt gh 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 emt gh 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).

United States - English - NLM (National Library of Medicine)

macleods pharmaceuticals limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, lamivudine and tenofovir disoproxil fumarate tablets is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients weighing at least 35 kg. 4.1 hypersensitivity efavirenz, lamivudine and tenofovir disoproxil fumarate tablets is contraindicated in patients: •with prior hypersensitivity reaction (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions)to efavirenz [see warnings and precautions (5.7)] , lamivudine, or tenofovir disoproxil fumarate. •when coadministered with elbasvir and grazoprevir [see warnings and precautions (5.2) and drug interactions (7.5)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate tabletsduring pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263.

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

lupin australia pty limited - tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - tenofovir gh 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 gh is indicated for the treatment of chronic hepatitis b in adults (see clinical trials). tenofovir gh 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

dr reddy's laboratories (uk - efavirenz; tenofovir disoproxil fumarate; emtricitabine - tablet - 600mg ; 245mg ; 200mg