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.

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

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

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

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection:the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla ® , complera ® , descovy ® , genvoya ® , odefsey ® , stribild ® , truvada ® , or vemlidy ® [ see warnings and precautions ( 5.4) ]. tenofovir disoproxil fumarate tablets should not be used in combination with atripla ® , complera ® , descovy ® , gen

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

teva pharmaceuticals usa, inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla® , complera® , descovy® , genvoya® , odefsey® , stribild® , truvada® , or vemlidy® [see warnings and precautions (5.4) ]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hbv infection: - the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced w

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir alafenamide fumarate, quantity: 28 mg (equivalent: tenofovir alafenamide, qty 25 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - treatment of hiv-1 infection: descovy is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25kg. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of descovy (see section 5.1 pharmacodynamic properties).,hiv-1 pre-exposure prophylaxis: descovy is indicated for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.

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

remedyrepack inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - odefsey is indicated as a complete regimen for the treatment of hiv-1 infection in adult and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with hiv-1 rna less than or equal to 100,000 copies per ml or - to replace a stable antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of odefsey [see microbiology (12.4) and clinical studies (14)]. : limitations of use : - more rilpivirine-treated subjects with no antiretroviral treatment history with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥ 50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14.2, 14.3)]. more rilpivirine-treated subjects with no antiretroviral t

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

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: hyprolose; hypromellose; indigo carmine aluminium lake; lactose; colloidal anhydrous silica; calcium stearate; titanium dioxide; crospovidone; macrogol 8000 - tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

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

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; hypromellose; hyprolose; indigo carmine aluminium lake; titanium dioxide; calcium stearate; macrogol 8000 - tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - emtricitabine/tenofovir disoproxil krka d.d. is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka d.d. is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.