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: lactose; magnesium stearate; colloidal anhydrous silica; crospovidone; indigo carmine aluminium lake; macrogol 8000; purified talc; titanium dioxide; polyvinyl alcohol - 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 redcue the risk of sexually acquired hiv-1 in adutls 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)

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.

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.

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).

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).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - emtricitabine 200 mg; tenofovir disoproxil 245 mg - film-coated tablet - 200 mg - 245 mg - emtricitabine 200 mg; tenofovir disoproxil 245 mg - tenofovir disoproxil and emtricitabine

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)]

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

bryant ranch prepack - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are 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 tablets are 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 is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy  exposure  registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

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

bryant ranch prepack - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are 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 tablets are 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 is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy  exposure  registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

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

a-s medication solutions - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are 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 tablets are 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 for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2 )]. emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate ta