Malta - Kiingereza - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - tenofovir disoproxil - film-coated tablet - tenofovir disoproxil 245 mg - antivirals for systemic use

Kanada - Kiingereza - Health Canada

laboratoire riva inc. - tenofovir disoproxil fumarate - tablet - 300mg - tenofovir disoproxil fumarate 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

Umoja wa Ulaya - Kiingereza - 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

Malta - Kiingereza - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - emtricitabine, tenofovir disoproxil - film-coated tablet - emtricitabine 200 mg tenofovir disoproxil 245 mg - antivirals for systemic use

Ayalandi - Kiingereza - 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

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

rowex ltd - tenofovir disoproxil - film-coated tablet - 245 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

teva b.v. - tenofovir disoproxil - film-coated tablet - 245 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

accord healthcare limited - tenofovir disoproxil - film-coated tablet - 245 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - emtricitabine/tenofovir disoproxil krka d.d. is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka d.d. is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.

Australia - Kiingereza - 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).