Canada - English - Health Canada

auro pharma inc - tenofovir disoproxil fumarate; emtricitabine - tablet - 300mg; 200mg - tenofovir disoproxil fumarate 300mg; emtricitabine 200mg - nucleoside and nucleotide reverse transcriptase inhibitors

Canada - English - Health Canada

mint pharmaceuticals inc - emtricitabine; tenofovir disoproxil fumarate - tablet - 200mg; 300mg - emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

Canada - English - Health Canada

teva canada limited - emtricitabine; tenofovir disoproxil fumarate - tablet - 200mg; 300mg - emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - emtricitabine 200mg;  ; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg; emtricitabine 200mg; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg - film coated tablet - 200 mg/300 mg - active: emtricitabine 200mg   tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 31k510010 active: emtricitabine 200mg tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 32k510087 - treatment of hiv-1 infection tenofovir disoproxil emtricitabine viatris is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - emtricitabine , tenofovir disoproxil fumarate - tablets - 200 mg/300 mg

Namibia - English - Namibia Medicines Regulatory Council

strides arcolab limited - efavirenz+emtricitabine+tenofovir disoproxil fumarate - tablet - each tablet contains efavirenz 600mg, 200mg emtricitabine and 300mg tenofovir disoproxil fumarate

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

camber pharmaceuticals, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies ( 14)] .  emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration ( 2.2), warnings and precautions ( 5.2)] . emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep are contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions ( 5.2)]

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - tenofovir disoproxil fumarate -

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

alphapharm pty ltd - emtricitabine,tenofovir disoproxil maleate -

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).