Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

abbey laboratories pty ltd - ivermectin - topical solution/suspension - ivermectin anthelmintic active 10.0 g/l - parasiticides

Úc - Tiếng Anh - 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.

Úc - Tiếng Anh - 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.

Úc - Tiếng Anh - 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.

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

abbey laboratories pty ltd - ivermectin - parenteral liquid/solution/suspension - ivermectin anthelmintic active 10.0 mg/ml - parasiticides

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

abbey laboratories pty ltd - clorsulon; ivermectin - parenteral liquid/solution/suspension - clorsulon ungrouped active 100.0 mg/ml; ivermectin anthelmintic active 10.0 mg/ml - parasiticides

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

abbey laboratories pty ltd - levamisole hydrochloride - oral solution/suspension - levamisole hydrochloride anthelmintic active 80.0 g/l - parasiticides

New Zealand - Tiếng Anh - Ministry for Primary Industries

bayer new zealand limited - flufenacet; metribuzin - water dispersible granule - flufenacet 240 g/kg; metribuzin 175 g/kg - herbicide - herbicide

New Zealand - Tiếng Anh - Ministry for Primary Industries

bayer new zealand limited - prothioconazole; isoflucypram - prothioconazole 100 g/litre; isoflucypram 50 g/litre - fungicide - fungicide

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

beigene aus pty ltd - zanubrutinib, quantity: 80 mg - capsule - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; sodium lauryl sulfate; magnesium stearate; gelatin; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - waldenstr?m?s macroglobulinaemia (wm),brukinsa is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll),brukinsa is indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), including patients with deletion 17p and/or tp53 mutation. mantle cell lymphoma (mcl),brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.,this indication was approved via the provisional approval pathway, based on objective response rate. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.,marginal zone lymphoma (mzl),brukinsa is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one-prior anti-cd20-based therapy.,this indication was approved via the provisional approval pathway, based on objective response rate. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.