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

mylan laboratories limited - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet; oral - 600; 200; 300mg

Zimbabwe - English - Medicines Control Authority

aurobindo pharma limited - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet, coated; oral - 600; 200; 300 mg

Zimbabwe - English - Medicines Control Authority

macleods pharmaceuticals ltd - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet; oral - 600; 200; 300 mg

Uganda - English - National Drug Authority

aurobindo pharma ltd - efavirenz + emtricitabine + tenofovir disoproxil fumarate - oral solid ordinary film-coated tablets - 600mg +200mg + 300mg

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

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)

gilead sciences pty ltd - efavirenz,emtricitabine,tenofovir disoproxil fumarate -

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - emtricitabine 200mg; tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg;   - film coated tablet - active: emtricitabine 200mg tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg   excipient: croscarmellose sodium indigo carmine aluminium lake lactose monohydrate macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol pregelatinised maize starch purified talc purified water titanium dioxide - indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

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

aurobindo pharma limited - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 150 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 10 kg. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference popul