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

bayer australia ltd - acarbose -

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

bayer australia ltd - acarbose -

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

bayer australia ltd - nifedipine -

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

bayer australia ltd - nimodipine, quantity: 30 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; maize starch; crospovidone; magnesium stearate; hypromellose; macrogol 4000; iron oxide yellow; titanium dioxide - prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus (eg hunt and hess grades i-iii).

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

bayer australia ltd - ethinylestradiol, quantity: 30 microgram; levonorgestrel, quantity: 150 microgram - tablet, sugar coated - excipient ingredients: sucrose; macrogol 6000; povidone; lactose monohydrate; glycol montanate; maize starch; purified talc; calcium carbonate; magnesium stearate - for the control of conception.

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

bayer australia ltd - levonorgestrel, quantity: 0.05 mg; ethinylestradiol, quantity: 0.03 mg - tablet, sugar coated - excipient ingredients: purified talc; glycol montanate; lactose monohydrate; povidone; magnesium stearate; sucrose; calcium carbonate; maize starch; macrogol 6000 - oral contraception.

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

bayer australia ltd - cyproterone acetate, quantity: 2 mg; ethinylestradiol, quantity: 35 microgram - tablet, sugar coated - excipient ingredients: povidone; calcium carbonate; maize starch; sucrose; lactose monohydrate; macrogol 6000; purified talc; magnesium stearate; glycol montanate - diane-35 ed is indicated for: the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. diane-35 will also provide effective oral contraception in this patient group. it should not be used in combination with other hormonal contraceptives (see contraindications).,if the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis.

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

bayer australia ltd - estradiol valerate, quantity: 2 mg - tablet, sugar coated - excipient ingredients: magnesium stearate; macrogol 6000; sucrose; glycol montanate; calcium carbonate; povidone; maize starch; lactose monohydrate; purified talc - indications as at 19 july 2004: short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness. progynova has also a favourable influence on bladder irritation (a not infrequent occurrence in the climacteric), signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age.

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

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate dihydrate; hydroxypropylbetadex; purified water; flavour; sorbitol; methyl hydroxybenzoate; citric acid; sucrose; glycerol; monobasic sodium phosphate; potassium sorbate - 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: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate; hydroxypropylbetadex; purified water; sucralose; sodium benzoate; citric acid; flavour - 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.