USA - engelsk - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - 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 hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla® , complera® , descovy® , genvoya® , odefsey® , stribild® , truvada® , or vemlidy® [see warnings and precautions (5.4) ]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hbv infection: - the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced w

USA - engelsk - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - 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 12 years of age and older. pediatric use information is approved for gilead sciences, inc.'s viread ® (tenofovir disoproxil fumarate) tablets. however, due to gilead sciences, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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.

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

alphapharm pty ltd - emtricitabine,tenofovir disoproxil maleate -

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

Irland - engelsk - 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

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - emtricitabine; tenofovir disoproxil - film-coated tablet - 200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine

Irland - engelsk - HPRA (Health Products Regulatory Authority)

tillomed pharma gmbh - emtricitabine; tenofovir disoproxil fumarate - film-coated tablet - 200/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine

Irland - engelsk - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - emtricitabine; tenofovir disoproxil - film-coated tablet - 200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine

Australien - engelsk - 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).

Irland - engelsk - HPRA (Health Products Regulatory Authority)

teva b.v. - emtricitabine; tenofovir disoproxil - film-coated tablet - 200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine