Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - pralsetinib, quantity: 100 mg - capsule, hard - excipient ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue fcf; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - non-small cell lung cancer (nsclc),gavreto has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (ret) fusion-positive non-small cell lung cancer (nsclc). the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor) in single-arm trials. continued approval of this indication depends on verification and description of benefit in confirmatory trials. ret-fusion positive thyroid cancer,gavreto has provisional approval in australia for the treatment of adult patients with advanced or metastatic ret-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - baloxavir marboxil, quantity: 80 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; purified talc; hypromellose; titanium dioxide - treatment of influenza,xofluza is indicated for the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:,? otherwise healthy, or,? at high risk of developing influenza complications.,prophylaxis of influenza,xofluza is indicated for the post-exposure prophylaxis of influenza in patients aged 12 years of age and older following contact with an individual who has confirmed influenza.,vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - aspirin 505.4mg; caffeine 168.5mg; salicylamide 168.5mg - powder for oral solution - 505.4/168.5/168.5mg - active: aspirin 505.4mg caffeine 168.5mg salicylamide 168.5mg

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab 120 mg/ml - solution for injection - 600 mg/5ml - active: trastuzumab 120 mg/ml excipient: histidine histidine hydrochloride monohydrate hyaluronidase methionine polysorbate 20 trehalose dihydrate water for injection - herceptin sc is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Avstralija - angleščina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

grochem australia pty ltd - copper (cu) present as tribasic copper sulphate - suspension concentrate - copper (cu) present as tribasic copper sulphate mineral-copper active 190.0 g/l - fungicide - almond | apple | apricot | avocado | banana | bean | brassica vegetables | capsicum or pepper | carrot | celery | cherry | citru - algae | angular leaf spot on cucurbit | angular leaf spot-p. syringae pv. tabaci | anthracnose | anthracnose on mango | ascochyta blight | bacterial black spot | bacterial brown spot | bacterial canker - c. michiganense | bacterial canker on tomato | bacterial gummosis | bacterial leaf spot - x. campestris | bacterial soft rot | bacterial speck | bacterial spot | bacterial spot - xanthomonas vesicatoria | black rot on cole crop/brassica | black spot | black spot or speckled blotch on citrus | cercospora leaf spot - banana | chocolate spot on bean | citrus melanose | citrus scab | common blight | crown top rot | downy mildew | downy mildew - peronospora farinosa | downy mildew - peronospora parasitica | downy mildew on allium (onion, garlic) | downy mildew on rhubarb | freckle or scab on stone fruit | halo blight | late blight or irish blight | leaf curl | leaf spot - alternaria cercospora | parasitic algae on lychee | peppery leaf spot | phytophthora stem canker | ring spot on brassica/cole crop | rust - urom

Avstralija - angleščina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

grochem australia pty ltd - copper present as copper sulfate pentahydrate - water dispersible granule - copper present as copper sulfate pentahydrate mineral-copper active 250.0 g/kg - molluscicide - flooded rice crops - aquatic snail

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - midazolam maleate 10.2mg equivalent to 7.5 mg midazolam;   - tablet - 7.5 mg - active: midazolam maleate 10.2mg equivalent to 7.5 mg midazolam   excipient: hypromellose lactose magnesium stearate microcrystalline cellulose purified talc starch titanium dioxide - short-term treatment of insomnia. benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - alectinib hydrochloride 161.33mg equivalent to alectinib 150mg - capsule - 150 mg - active: alectinib hydrochloride 161.33mg equivalent to alectinib 150mg excipient: black ink (alecensa) carmellose calcium carnauba wax carrageenan hyprolose hypromellose lactose monohydrate magnesium stearate maize starch potassium chloride sodium laurilsulfate titanium dioxide - alecensa is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive, locally advanced or metastatic non-small cell lung cancer (nsclc).

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - entrectinib 100mg;   - capsule - 100 mg - active: entrectinib 100mg   excipient: colloidal silicon dioxide crospovidone hypromellose     iron oxide yellow   lactose magnesium stearate microcrystalline cellulose tartaric acid tekprint blue sb-6018 titanium dioxide   - solid tumours rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (ntrk) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. this indication was approved based on objective response rate and response duration in single-arm trials. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. non-small cell lung cancer (nsclc) rozlytrek is indicated for the treatment of adult patients with ros1-positive, locally advanced or metastatic nsclc.

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - entrectinib 200mg;   - capsule - 200 mg - active: entrectinib 200mg   excipient: colloidal silicon dioxide crospovidone hypromellose     lactose magnesium stearate microcrystalline cellulose sunset yellow aluminium lake   tartaric acid tekprint blue sb-6018 titanium dioxide   - solid tumours rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (ntrk) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. this indication was approved based on objective response rate and response duration in single-arm trials. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. non-small cell lung cancer (nsclc) rozlytrek is indicated for the treatment of adult patients with ros1-positive, locally advanced or metastatic nsclc.