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)

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)

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.

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

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

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)

arrotex pharmaceuticals pty ltd - perindopril erbumine, quantity: 8 mg - tablet, uncoated - excipient ingredients: lactose; magnesium stearate - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindopril have not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of nonfatal myocardial infarction or cardiac arrest.

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

arrotex pharmaceuticals pty ltd - perindopril erbumine, quantity: 4 mg - tablet, uncoated - excipient ingredients: lactose; magnesium stearate - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindopril have not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of nonfatal myocardial infarction or cardiac arrest.

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

arrotex pharmaceuticals pty ltd - perindopril erbumine, quantity: 2 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindopril have not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of nonfatal myocardial infarction or cardiac arrest.

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

arrotex pharmaceuticals pty ltd - perindopril arginine, quantity: 2.5 mg - tablet, film coated - excipient ingredients: titanium dioxide; hyprolose; magnesium stearate; isomalt; colloidal anhydrous silica; hypromellose; macrogol 8000 - treatment of hypertension and the treatment of heart failure. in such patients it is recommended that perindopril arginine be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindopril arginine has not been demonstrated for new york heart association category iv patients); and patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.