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

bayer australia ltd - darolutamide, quantity: 300 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; calcium hydrogen phosphate; macrogol 3350; titanium dioxide; povidone - nubeqa is indicated for the treatment of patients with: ? non-metastatic castration resistant prostate cancer (nmcrpc) ? metastatic hormone-sensitive prostate cancer (mhspc) in combination with docetaxel

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

bayer australia ltd - rivaroxaban, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; iron oxide red; macrogol 3350; titanium dioxide - ixarola is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe, ixarola, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

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

bayer australia ltd - rivaroxaban, quantity: 2.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; macrogol 3350; titanium dioxide; propylene glycol; purified talc; iron oxide yellow; macrogol 6000 - ixarola is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe, ixarola, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

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

bayer australia ltd - rivaroxaban, quantity: 15 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; iron oxide red; macrogol 3350; titanium dioxide - ixarola is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe, ixarola, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

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

bayer australia ltd - rivaroxaban, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; lactose monohydrate; iron oxide red; titanium dioxide; macrogol 3350; magnesium stearate - ixarola is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe, ixarola, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

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

gilead sciences pty ltd - lenacapavir sodium, quantity: 306.8 mg (equivalent: lenacapavir, qty 300 mg) - tablet, film coated - excipient ingredients: copovidone; poloxamer; mannitol; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - sunlenca, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

galen ltd - sodium; chloride; potassium; bicarbonate; macrogol '3350' - powder for oral solution - 65mmol/1litre ; 53mmol/1litre ; 5.4mmol/1litre ; 17mmol/1litre ; 105gram/1litre

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

abbvie pty ltd - lopinavir, quantity: 200 mg; ritonavir, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; macrogol 3350; hyprolose; macrogol 400; colloidal anhydrous silica; polysorbate 80; purified talc; copovidone; titanium dioxide; iron oxide yellow; hypromellose; sorbitan monolaurate - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).