Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - emtricitabine; tenofovir disoproxil - film-coated tablet - 200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - tenofovir disoproxil succinate - tablets - 245 milligram - nucleoside and nucleotide reverse transcriptase inhibitors

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: indigo carmine aluminium lake; magnesium stearate; croscarmellose sodium; titanium dioxide; triacetin; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; hypromellose - treatment of hiv-1 infection,truvada is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see clinical studies).

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

macleods pharmaceuticals limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, lamivudine and tenofovir disoproxil fumarate tablets is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients weighing at least 35 kg. 4.1 hypersensitivity efavirenz, lamivudine and tenofovir disoproxil fumarate tablets is contraindicated in patients: •with prior hypersensitivity reaction (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions)to efavirenz [see warnings and precautions (5.7)] , lamivudine, or tenofovir disoproxil fumarate. •when coadministered with elbasvir and grazoprevir [see warnings and precautions (5.2) and drug interactions (7.5)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate tabletsduring pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263.

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

direct rx - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - 1.1 treatment of hiv-1 infection emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)]. 1.2 hiv-1 pre-exposure prophylaxis (prep) emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that mo

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

sandoz pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil succinate, quantity: 300.6 mg - tablet, film coated - excipient ingredients: macrogol 3350; indigo carmine aluminium lake; magnesium stearate; isopropyl alcohol; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; lactose monohydrate; purified talc; croscarmellose sodium; purified water; pregelatinised maize starch - treatment of hiv-1 infection,tenofovir/emtricitabine sandoz is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis,tenofovir/emtricitabine sandoz is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see section 5.1 pharmacodynamic properties, clinical trials).

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

direct rx - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - 1.1 treatment of hiv-1 infection emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)]. 1.2 hiv-1 pre-exposure prophylaxis (prep) emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. 8.1 pregnancypregnancy exposure registry there is a pregnancy exposure registry that monitors pr

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

camber pharmaceuticals, inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. •  efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions ( 5.2)]. •  efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions ( 7.3) and clinical pharmacology ( 12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that m

Israel - English - Ministry of Health

gilead sciences israel ltd - tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg - tenofovir disoproxil - tenofovir disoproxil - viread is indicated for the treatment of :1. hiv 1 infected adults and pediatric patients 12 years of age and older in combination with other antiretroviral medicinal products for the treatment of hiv. 2. chronic hepatitis b in adults with: • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. • decompensated liver disease

Israel - English - Ministry of Health

gilead sciences israel ltd - tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg - tenofovir disoproxil - tenofovir disoproxil - viread is indicated for the treatment of :1. hiv 1 infected adults and pediatric patients 12 years of age and older in combination with other antiretroviral medicinal products for the treatment of hiv. 2. chronic hepatitis b in adults with: • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. • decompensated liver disease