Tanzania - English - Tanzania Medicinces & Medical Devices Authority

hetero laboratories limited, india - dolutegravir, lamivudine , tenofovir disoproxil fumarate tablets 50mg/300mg/300mg - oral tablet - 50/300/300

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

hetero laboratories limited, india - dolutegravir, lamivudine , tenofovir disoproxil fumarate tablets 50mg/300mg/300mg - oral tablet - 50/300/300

Zimbabwe - English - Medicines Control Authority

aurobindo pharma limited - dolutegravir; lamivudine; tenofovir disoproxil fumarate - tablet, coated; oral - 50; 300; 300mg

Uganda - English - National Drug Authority

macleods pharmaceuticals ltd - dolutegravir + lamivudine + tenofovir disoproxil fumarate - oral solid ordinary tablets - 50mg + 300mg + 300mg

Uganda - English - National Drug Authority

shanghai desano bio-pharmaceutical co., ltd - dolutegravir + lamivudine + tenofovir disoproxil fumarate - oral solid ordinary film-coated tablets - 50 mg + 300 mg + 300 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg;  ;  ;   - film coated tablet - 50 mg - active: dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg       excipient: mannitol microcrystalline cellulose opadry yellow 85f92461 povidone sodium starch glycolate sodium stearyl fumarate - tivicay is indicated for the treatment of human immunodeficiency virus (hiv) infection in combination with other antiretroviral agents in adults and children over 12 years of age and weighing 40 kg or more.

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - viread is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. viread is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 10 kg . none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to viread during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data). the rat

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

viiv healthcare company - dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663) - dolutegravir 50 mg - juluca is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults 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 juluca. juluca is contraindicated in patients:    •    with previous hypersensitivity reaction to dolutegravir or rilpivirine [see warnings and precautions (5.1)] .    •    receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see drug interactions (7)] .    •    receiving other coadministered drugs in table 1 that significantly decrease rilpivirine plasma concentrations [see drug interactions (7), clinical pharmacology (12.3)] . drug class contraindicated drugs in class clinical comment antia

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; triacetin - viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,viread is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,viread 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. viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults. viread is indicated for the treatment of chronic hepatitis b in adults with evidence of active viral replication and active liver inflammation.

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

sandoz pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; triacetin - tenofovir sandoz 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 sandoz is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir sandoz 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.