European Union - English - 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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - efavirenz; tenofovir disoproxil fumarate; emtricitabine - tablet - 600mg ; 245mg ; 200mg

European Union - English - 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 - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - efavirenz, emtricitabine, tenofovir disoproxil - film-coated tablet - efavirenz 600 mg emtricitabine 200 mg tenofovir disoproxil 245 mg - antivirals for systemic use

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - tenofovir disoproxil, efavirenz, emtricitabine - film-coated tablet - tenofovir disoproxil 245 mg efavirenz 600 mg emtricitabine 200 mg - antivirals for systemic use

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Canada - English - Health Canada

gilead sciences, llc - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

Canada - English - Health Canada

teva canada limited - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

Canada - English - Health Canada

mylan pharmaceuticals ulc - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

Canada - English - Health Canada

apotex inc - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors