European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil krka 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 krka prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of 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 efavirenz/emtricitabine/tenofovir disoproxil.no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil mylan 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 mylan prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of 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 efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

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

teva uk ltd - efavirenz; tenofovir disoproxil fumarate; emtricitabine - tablet - 600mg ; 245mg ; 200mg

Canada - English - Health Canada

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

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - efavirenz, emtricitabine, tenofovir disoproxil fumarate - hiv infections - antivirals for systemic use - atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. it is indicated for the treatment of human-immunodeficiency-virus-1 (hiv-1) infection in adults 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 atripla prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of atripla 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 atripla.no data are currently available from clinical studies with atripla in treatment-naive or in heavily pretreated patients.no data are available to support the combination of atripla and other antiretroviral agents.

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

mylan - efavirenz; tenofovir disoproxil fumarate; emtricitabine - tablet - 600mg ; 245mg ; 200mg

Canada - English - Health Canada

pharmascience inc - 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

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - tenofovir disoproxil succinate 300,6 mg - eq. tenofovir disoproxil 245 mg; efavirenz 600 mg; emtricitabine 200 mg - film-coated tablet - 600 mg - 200 mg - 245 mg - efavirenz 600 mg; emtricitabine 200 mg; tenofovir disoproxil succinate 300.6 mg - emtricitabine, tenofovir disoproxil and efavirenz

Israel - English - Ministry of Health

abic marketing ltd, israel - efavirenz; emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - efavirenz 600 mg; emtricitabine 200 mg; tenofovir disoproxil as fumarate 245 mg - emtricitabine, tenofovir disoproxil and efavirenz - tri-teva 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.