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

bayer australia ltd - praziquantel, quantity: 600 mg - tablet, film coated - excipient ingredients: hypromellose; sodium lauryl sulfate; povidone; titanium dioxide; microcrystalline cellulose; macrogol 4000; magnesium stearate; maize starch - infections due to various types of blood fluke (eg, schistosoma haematobiium, s. japonicum, s. mekongi, s. mansoni)

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

bayer australia ltd - larotrectinib sulfate, quantity: 30.7 mg - capsule, hard - excipient ingredients: gelatin; propylene glycol; dimethicone 12500; brilliant blue fcf aluminium lake; titanium dioxide; shellac; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

Australia - English - 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 - English - 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 - English - 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 - English - 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 - English - 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 - English - 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).