Australia - engelsk - 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.

Australia - engelsk - 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.

Israel - engelsk - Ministry of Health

roche pharmaceuticals (israel) ltd - tocilizumab - concentrate for solution for infusion - tocilizumab 20 mg/ml - tocilizumab - tocilizumab - actemra (tocilizumab), is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one or more dmards(disease modifying anti-rheumatic drugs) or tnf antagonists or in whom dmards cannot be used. actemra can be used alone or in combination with methotrexate or other dmards. actemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. actemra in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. actemra in combination with methotrexate (mtx) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx.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 3 years of age and older.actemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; 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.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,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).

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; 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.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,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).

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

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; 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.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,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).

Singapore - engelsk - HSA (Health Sciences Authority)

roche singapore pte. ltd. - tocilizumab - injection, solution - tocilizumab 162 mg/0.9 ml

Panama - engelsk - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

f. hoffmann la roche s.a. - tocilizumab - tocilizumab....162 mg

Filippinene - engelsk - FDA (Food And Drug Administration)

roche (philippines), inc.; distributor: zuellig pharma corporation - tocilizumab - solution for injection (sc) - 162 mg/ 0.9 ml

Filippinene - engelsk - FDA (Food And Drug Administration)

zuellig pharma corporation - tocilizumab - solution for injection (sc) - 162mg + 0.9ml