Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - baloxavir marboxil, quantity: 20 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.

Australië - Engels - 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.

Australië - Engels - 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

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - ocrelizumab, quantity: 300 mg - injection, concentrated - excipient ingredients: sodium acetate trihydrate; polysorbate 20; glacial acetic acid; water for injections; trehalose dihydrate - ocrevus is indicated for the treatment of patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and to reduce the frequency of relapse.,ocrevus is indicated for the treatment of patients with primary progressive multiple sclerosis (ppms) to delay the progression of physical disability

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - levodopa, quantity: 100 mg; benserazide hydrochloride, quantity: 28.5 mg (equivalent: benserazide, qty 25 mg) - tablet, uncoated - excipient ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; docusate sodium; iron oxide red; calcium hydrogen phosphate; magnesium stearate; ethylcellulose; mannitol - parkinson's disease and parkinsonian symptoms including post- encephalitic and toxic forms, but excluding drug induced parkinsonism.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - vemurafenib, quantity: 800 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; croscarmellose sodium; titanium dioxide; magnesium stearate; iron oxide red; hyprolose; purified talc; polyvinyl alcohol; macrogol 3350 - zelboraf is indicated for the treatment of unresectable stage iiic or stage iv metastatic melanoma positive for a braf v600 mutation.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - tocilizumab, quantity: 200 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate dihydrate; water for injections; polysorbate 80; sucrose; dibasic sodium phosphate dodecahydrate - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate. polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - tocilizumab, quantity: 80 mg - injection, concentrated - excipient ingredients: polysorbate 80; sucrose; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dodecahydrate; water for injections - rheumatoid arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations), intravenous formulation, actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - tocilizumab, quantity: 400 mg - injection, concentrated - excipient ingredients: sucrose; polysorbate 80; monobasic sodium phosphate dihydrate; water for injections; dibasic sodium phosphate dodecahydrate - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards. actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx. in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate. polyarticular juvenile idiopathic arthritis (iv and sc formulations), actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations), intravenous formulation, actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. subcutaneous formulation actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.actemra iv and sc can be given alone or in combination with methotrexate (mtx).,cytokine release syndrome (crs) (iv formulation only), actemra is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. coronavirus disease 2019 (covid-19) (iv formulation only),actemra has provisional approval for the treatment of coronavirus disease 2019 (covid-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. provisional approval has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - oseltamivir phosphate, quantity: 7.88 mg/ml (equivalent: oseltamivir, qty 6 mg/ml) - oral liquid, powder for - excipient ingredients: saccharin sodium; sodium benzoate; sodium dihydrogen citrate; sorbitol; titanium dioxide; xanthan gum; flavour - tamiflu is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,tamiflu is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.