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

gilead sciences pty ltd - cobicistat, quantity: 150 mg - tablet - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - tybost is indicated as a pharmacokinetic enhancer of appropriate hiv-1 protease inhibitors in adults (see dosage and administration).

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

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

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

bristol-myers squibb australia pty ltd - cobicistat, quantity: 150 mg; atazanavir, quantity: 300 mg - tablet, film coated - excipient ingredients: stearic acid; croscarmellose sodium; hyprolose; crospovidone; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide red - evotaz is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults.

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-na?ve adults. stribild is also indicated in certain virologically suppressed (hiv1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of stribild (tenofovir df, emtricitabine or elvitegravir). stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Zimbabwe - English - Medicines Control Authority

mylan laboratories limited - cobicistat; darunavir - tablet, coated; oral - 800; 150mg

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg;  ;  ;   - film coated tablet - 150 mg - active: cobicistat 150mg       excipient: colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose opadry orange 85f93642 - tybost is indicated as a pharmacokinetic enhancer of appropriate hiv-1 protease inhibitors in adults

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - hiv infections - antivirals for systemic use - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat - stribild is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat - stribild is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.