Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use, - genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.,

Canada - English - Health Canada

gilead sciences canada inc - emtricitabine; elvitegravir; tenofovir alafenamide (tenofovir alafenamide hemifumarate); cobicistat - tablet - 200mg; 150mg; 10mg; 150mg - emtricitabine 200mg; elvitegravir 150mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 10mg; cobicistat 150mg - hiv integrase inhibitors

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Singapore - English - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - cobicistat on silicon dioxide 288.5mg eqv cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate 11.2mg eqv tenofovir alafenamide fumarate free base - tablet, film coated - cobicistat on silicon dioxide 288.5mg eqv cobicistat 150mg; elvitegravir 150.0mg; emtricitabine 200.0mg; tenofovir alafenamide fumarate 11.2mg eqv tenofovir alafenamide fumarate free base 10.0mg

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

gilead sciences international ltd - tenofovir alafenamide; emtricitabine; cobicistat; elvitegravir - tablet - 10mg ; 200mg ; 150mg ; 150mg