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

gilead sciences malaysia sdn. bhd. - emtricitabine; tenofovir alafenamide fumarate -

Canada - English - Health Canada

laboratoire riva inc. - efavirenz; emtricitabine; tenofovir disoproxil fumarate - tablet - 600mg; 200mg; 300mg - efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

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

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera® is indicated as a complete regimen for the treatment of hiv-1 infection in adults 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/ml at the start of therapy or - to replace a stable antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of complera [see microbiology (12.4) and clinical studies (14)] . limitations of use : - more rilpivirine-treated subjects 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)] . complera is contraindicated when coadministered with the following

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

remedyrepack inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera ® is indicated as a complete regimen for the treatment of hiv-1 infection in adults 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/ml at the start of therapy or - to replace a stable antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of complera [see microbiology (12.4) and clinical studies (14)] . limitations of use : - more rilpivirine-treated subjects 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

Israel - English - Ministry of Health

gilead sciences israel ltd - tenofovir alafenamide - film coated tablets - tenofovir alafenamide 25 mg - tenofovir alafenamide - vemlidy is indicated for the treatment of chronic hepatitis b in adults and adolescents (aged 12 years and older with body weight at least 35 kg)

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - emtricitabine 200mg;  ; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg; emtricitabine 200mg; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg - film coated tablet - 200 mg/300 mg - active: emtricitabine 200mg   tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 31k510010 active: emtricitabine 200mg tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 32k510087 - treatment of hiv-1 infection tenofovir disoproxil emtricitabine viatris is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

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

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - descovy is indicated, in combination with other antiretroviral agents, for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg. descovy is indicated, in combination with other antiretroviral agents other than protease inhibitors that require a cyp3a inhibitor, for the treatment of hiv-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg. descovy is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of hiv-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. individuals must have a negative hiv-1 test immediately prior to initiating descovy for hiv-1 prep [see dosage and administration (2.2) and warnings and precautions (5.2)]. limitations of use: the indication does not include use of descovy in individuals at risk of hiv-1 from receptive vaginal sex because effectiveness in this population has not been evaluated [see clinical studies

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

gilead sciences pty ltd - efavirenz,emtricitabine,tenofovir disoproxil fumarate -

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.