Ireland - English - HPRA (Health Products Regulatory Authority)

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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-na?ve adults. stribild is also indicated in certain virologically suppressed (hiv1 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 treatment failure or known mutations associated with resistance to the antiretroviral components of stribild (tenofovir df, emtricitabine or elvitegravir). stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

laurus labs limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adult and pediatric patients weighing at least 35 kg. efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are contraindicated: - in patients with a previous hypersensitivity reaction (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components contained in the formulation [see warnings and precautions (5.8)] . - when coadministered with elbasvir and grazoprevir [see warnings and precautions (5.3) and drug interactions (7.5)]. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and 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: there are r

Zimbabwe - English - Medicines Control Authority

strides arcolab ltd - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet; oral - 600; 200; 300mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - emtricitabine , tenofovir disoproxil fumarate - tablets - 300 + 200

Kenya - English - Pharmacy and Poisons Board

strides pharma science limited no 36/7, suragajakkanahalli, lndlavadi cross, - efavirenz emtricitabine tenofovir disoproxil… - tablet - efavirenz 600mg emtricitabine 200mg tenofovir… - antivirals for systemic use: combinations of

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

unimed sdn bhd - emtricitabine; tenofovir disoproxil fumarate -

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.