Canada - English - Health Canada

gilead sciences canada inc - bictegravir (bictegravir sodium); emtricitabine; tenofovir alafenamide (tenofovir alafenamide hemifumarate) - tablet - 50mg; 200mg; 25mg - bictegravir (bictegravir sodium) 50mg; emtricitabine 200mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 25mg - hiv integrase inhibitors

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - bictegravir, emtricitabine, tenofovir alafenamide, fumarate - hiv infections - antivirals for systemic use - biktarvy is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)

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

gilead sciences international ltd - emtricitabine; tenofovir alafenamide fumarate; bictegravir - tablet - 200mg ; 25mg ; 50mg

Israel - English - Ministry of Health

gilead sciences israel ltd - bictegravir as sodium; emtricitabine; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; bictegravir as sodium 50 mg - emtricitabine, tenofovir alafenamide and bictegravir - biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (hiv 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Israel - English - Ministry of Health

gilead sciences israel ltd - bictegravir as sodium; emtricitabine; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; bictegravir as sodium 50 mg - emtricitabine, tenofovir alafenamide and bictegravir - biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (hiv 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Singapore - English - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - bictegravir sodium 52.45mg eqv bictegravir; emtricitabine; tenofovir alafenamide fumarate 28.04mg eqv tenofovir alafenamide - tablet, film coated - bictegravir sodium 52.45mg eqv bictegravir 50mg; emtricitabine 200mg; tenofovir alafenamide fumarate 28.04mg eqv tenofovir alafenamide 25mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية بيتا - beta drug store - emtricitabine 200 mg, tenofovir alafenamide 25 mg, bictegravir 50 mg - 200 mg, 25 mg, 50 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - bictegravir sodium 52.45mg equivalent to to 50 mg bictegravir;  ; emtricitabine 200mg;  ;  ;  ;  ; tenofovir alafenamide fumarate 28.04mg equivalent to to 25 mg tenofovir alafenamide;   - film coated tablet - active: bictegravir sodium 52.45mg equivalent to to 50 mg bictegravir   emtricitabine 200mg         tenofovir alafenamide fumarate 28.04mg equivalent to to 25 mg tenofovir alafenamide   excipient: croscarmellose sodium magnesium stearate microcrystalline cellulose opadry brown 85f165072 - biktarvy is indicated for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy (art)-na?ve or to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of biktarvy.

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

gilead sciences pty ltd - bictegravir sodium, quantity: 52.45 mg (equivalent: bictegravir, qty 50 mg); tenofovir alafenamide fumarate, quantity: 28.04 mg (equivalent: tenofovir alafenamide, qty mg); emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - biktarvy is indicated for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy (art)-na?ve or to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of biktarvy.

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

gilead sciences pty ltd - bictegravir sodium, quantity: 52.45 mg (equivalent: bictegravir, qty 50 mg); tenofovir alafenamide fumarate, quantity: 28.04 mg (equivalent: tenofovir alafenamide, qty mg); emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - biktarvy is indicated for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy (art)-na?ve or to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of biktarvy.