Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - emtricitabine; rilpivirine hcl 27.5mg eqv. to rilpivirine; tenofovir alafenamide fumarate 28.04mg eqv. to tenofovir alafenamide - tablet, film coated - emtricitabine 200mg; rilpivirine hcl 27.5mg eqv. to rilpivirine 25mg; tenofovir alafenamide fumarate 28.04mg eqv. to tenofovir alafenamide 25mg

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide - hiv infections - antivirals for systemic use - 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 known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml.,

Canada - English - Health Canada

gilead sciences canada inc - emtricitabine; rilpivirine (rilpivirine hydrochloride); tenofovir alafenamide (tenofovir alafenamide hemifumarate) - tablet - 200mg; 25mg; 25mg - emtricitabine 200mg; rilpivirine (rilpivirine hydrochloride) 25mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 25mg - nonnucleoside reverse transcriptase inhibitors

Kenya - English - Pharmacy and Poisons Board

gilead sciences, inc. 333 lakeside drive, foster city, ca 94404, usa - bictegravir, emtricitabine and tenofovir… - film-coated tablet - biktarvy 50 mg/200 mg/25 mg; bictegravir sodium… - emtricitabine tenofovir alafenamide and

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir alafenamide fumarate, quantity: 28.04 mg; rilpivirine hydrochloride, quantity: 27.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; povidone; croscarmellose sodium; polysorbate 20; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - odefsey is indicated as a complete regimen for the treatment of hiv-1 infection in adults and adolescents (12 years and older with body weight at least 35 kg) with plasma hiv-1 rna <= 100,000 copies/ml at the start of therapy. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of odefsey.

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

gilead sciences international ltd - tenofovir alafenamide fumarate; rilpivirine hydrochloride; emtricitabine - tablet - 25mg ; 25mg ; 200mg

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - emtricitabine 200mg;  ;  ;  ;  ; rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg;  ; tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25 mg;   - film coated tablet - 200mg/25mg/25mg - active: emtricitabine 200mg         rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg   tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25 mg   excipient: croscarmellose sodium opadry ii grey 85f17636 lactose monohydrate magnesium stearate microcrystalline cellulose polysorbate 20 povidone - indicated as a complete regimen for the treatment of hiv-1 infection in adults and adolescents (12 years and older with a body weight at least 35 kg) with plasma hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of odefsey.

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey 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 known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey 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 known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml