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

gilead sciences malaysia sdn. bhd. - emtricitabine; tenofovir alafenamide fumarate; elvitegravir; cobicistat on silicon dioxide -

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.,

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

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

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

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

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

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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.,

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg (as a blend with silicon dioxide);  ;  ;  ; elvitegravir 150mg;  ;  ; emtricitabine 200mg;  ;  ;  ;  ; tenofovir alafenamide 10mg (as tenofovir alafenamide fumarate 11.2mg);   - tablet - active: cobicistat 150mg (as a blend with silicon dioxide)       elvitegravir 150mg     emtricitabine 200mg         tenofovir alafenamide 10mg (as tenofovir alafenamide fumarate 11.2mg)   excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 85f110095 sodium laurilsulfate - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment-na?ve; or virologically suppressed (hiv-1 rna genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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

remedyrepack inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - genvoya is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of genvoya [see clinical studies (14)]. coadministration of genvoya is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of genvoya and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)]