Australija - engleski - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards. psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Australija - engleski - 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.

Australija - engleski - 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.

Australija - engleski - 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.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - eculizumab, quantity: 300 mg - injection, intravenous infusion - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - soliris is indicated for the treatment of patients with: ? paroxysmal nocturnal haemoglobinuria (pnh) to reduce haemolysis. ? atypical haemolytic uraemic syndrome (ahus). ? adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin-4 (aqp4) antibody-positive. soliris is not intended for acute treatment of a nmosd relapse.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alemtuzumab, quantity: 30 mg - injection, intravenous infusion - excipient ingredients: disodium edetate; water for injections; polysorbate 80; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride - the treatment of patients with b-cell chronic lymphocytic leukaemia (cll) who have relapsed after failure of two prior therapies.,mabcampath is indicated for the treatment of patients with b-cell chronic lymphocytic leukaemia (b-cll).

Kenija - engleski - Pharmacy and Poisons Board

cadila healthcare limited zydus tower, satellite cross roads, ahmedabad 380 - bevacizumab - concentrate for solution for infusion - 100mg - bevacizumab

Kenija - engleski - Pharmacy and Poisons Board

cadila healthcare limited zydus tower, satellite cross roads, ahmedabad 380 - bevacizumab - concentrate for solution for infusion - 400 mg - bevacizumab

Kenija - engleski - Pharmacy and Poisons Board

trastuzumab - solution for infusion - 150mg - trastuzumab

Kenija - engleski - Pharmacy and Poisons Board

cadila healthcare limited zydus tower, satellite cross roads, ahmedabad 380 - trastuzumab - solution for infusion - 440 mg - trastuzumab