Australien - Englisch - 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).

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions (5.2)] . - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and ten

Irland - Englisch - 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

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - emtricitabine, quantity: 200 mg; efavirenz, quantity: 600 mg; tenofovir disoproxil maleate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium metabisulfite; hyprolose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; ferric oxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - tenofovir disoproxil/ emtricitabine/ efavirenz mylan 300/200/600 is indicated for the treatment of hiv infected adults over the age of 18 years.,this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts in controlled studies of viread, emtriva and stocrin in treatment-na?ve and treatment experienced adults.

Israel - Englisch - Ministry of Health

gilead sciences israel ltd - efavirenz; emtricitabine; tenofovir disoproxil as - film coated tablets - tenofovir disoproxil as 245 mg; emtricitabine 200 mg; efavirenz 600 mg - tenofovir disoproxil - atripla is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults.

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Kanada - Englisch - Health Canada

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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

macleods pharmaceuticals limited - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 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 populati

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - 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 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

Kanada - Englisch - Health Canada

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