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

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: titanium dioxide; colloidal anhydrous silica; crospovidone; indigo carmine aluminium lake; macrogol 8000; lactose; polyvinyl alcohol; purified talc; magnesium stearate - tenofovir/emtricitabine 300/200 arx 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 300/200 arx 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.

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: indigo carmine aluminium lake; magnesium stearate; croscarmellose sodium; titanium dioxide; triacetin; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; hypromellose - treatment of hiv-1 infection,truvada is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis truvada 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).

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg; rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; croscarmellose sodium; polysorbate 20; povidone; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; iron oxide red; macrogol 3350; indigo carmine aluminium lake - eviplera is indicated for the treatment of hiv infection in treatment-na?ve adult patients with plasma hiv-1 rna =< 100,000 copies/ml at the start of therapy. eviplera is also indicated in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of resistance to any of the components of eviplera (tenofovir df, emtricitabine or rilpivirine).

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.

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

unimed sdn bhd - efavirenz; lamivudine; tenofovir disoproxil fumarate -

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

gilead sciences, llc - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside 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

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - viread is 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. viread is 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 viread 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 population of the metropolitan atlanta congenital defects program (macdp) (see data). the rat

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

gilead sciences, inc - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - viread™ is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 12 years of age and older. viread is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to viread during pregnancy. healthcare providers are encouraged to register patients on the worldwide antiretroviral pregnancy register (apr) at www.apregistry.com/. 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 population of the metropolitan atlanta congenital defects program (macdp) (see data). the rate of miscarriage for individual drugs is