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

roche products pty ltd - epoetin beta, quantity: 6666.66 iu/ml - injection - excipient ingredients: calcium chloride dihydrate; dibasic sodium phosphate dodecahydrate; water for injections; glutamic acid; isoleucine; urea; monobasic sodium phosphate; polysorbate 20; glycine; phenylalanine; leucine; sodium chloride; threonine - neorecormon is indicated for the treatment of anaemia associated with chronic kidney disease (ckd) in patients on dialysis and symptomatic patients not yet undergoing dialysis. to increase the yield of autologous blood from patients in pre-donation programme initiated to avoid the use of homologous blood. for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks. for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate.

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

roche products pty ltd - entrectinib, quantity: 200 mg - capsule, hard - excipient ingredients: propylene glycol; indigo carmine aluminium lake; magnesium stearate; hypromellose; lactose; shellac; sunset yellow fcf; tartaric acid; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; titanium dioxide; strong ammonia solution - non-small cell lung cancer (nsclc),rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) whose tumours are ros1-positive. solid tumours,rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with 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 have no satisfactory alternative therapy.,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

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

roche products pty ltd - entrectinib, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; tartaric acid; strong ammonia solution; crospovidone; shellac; iron oxide yellow; lactose; colloidal anhydrous silica; titanium dioxide; hypromellose; propylene glycol; microcrystalline cellulose; indigo carmine aluminium lake - non-small cell lung cancer (nsclc),rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) whose tumours are ros1-positive. solid tumours,rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with 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 have no satisfactory alternative therapy.,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

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

roche products pty ltd - emicizumab, quantity: 60 mg - injection, solution - excipient ingredients: poloxamer; arginine; aspartic acid; water for injections; histidine - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 30 mg - injection, solution - excipient ingredients: arginine; water for injections; histidine; aspartic acid; poloxamer - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 150 mg - injection, solution - excipient ingredients: aspartic acid; histidine; arginine; poloxamer; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 105 mg - injection, solution - excipient ingredients: arginine; poloxamer; aspartic acid; histidine; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - interferon alfa-2a -

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

roche products pty ltd - interferon alfa-2a -

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

roche products pty ltd - pirfenidone, quantity: 267 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; gelatin; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide yellow; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (ipf)