Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

swedish orphan biovitrum pty ltd - anakinra, quantity: 100 mg - injection, solution - excipient ingredients: polysorbate 80; sodium citrate dihydrate; water for injections; disodium edetate; sodium chloride - kineret (anakinra) is indicated: -for the treatment of active adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more other disease modifying anti rheumatic drugs (dmards). kineret should be given in combination with methotrexate. - in adult and paediatric patients aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (caps) including neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca), muckle-wells syndrome (mws), and familial cold autoinflammatory syndrome (fcas). - for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 2 years and above who have failed to respond adequately to non-biological dmards

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; citric acid monohydrate; hydrochloric acid; water for injections; sodium hydroxide; polysorbate 80 - non-hodgkin?s lymphoma (nhl),riximyo (rituximab) is indicated for treatment of patients with:,? cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma,,? cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma,,? cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia (cll),riximyo (rituximab) is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,rheumatoid arthritis (ra),riximyo (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa),riximyo (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: water for injections; polysorbate 80; citric acid monohydrate; hydrochloric acid; sodium chloride; sodium hydroxide - non-hodgkin?s lymphoma (nhl),riximyo (rituximab) is indicated for treatment of patients with:,? cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma,,? cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma,,? cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia (cll),riximyo (rituximab) is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,rheumatoid arthritis (ra),riximyo (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa),riximyo (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - anifrolumab, quantity: 300 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; histidine; lysine hydrochloride - saphnelo (anifrolumab) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (sle), despite standard therapy.,the safety and efficacy of saphnelo have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - dexamethasone sodium phosphate - solution for injection - dexamethasone

Singapor - Ingliż - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - adalimumab - injection, solution - adalimumab 40mg/0.8ml

Singapor - Ingliż - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - adalimumab - injection, solution - adalimumab 40mg/0.8ml

Singapor - Ingliż - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - adalimumab - injection, solution - adalimumab 40mg/0.8ml

Singapor - Ingliż - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - dupilumab - injection, solution - dupilumab 300 mg/2ml

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - etanercept, quantity: 25 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; sucrose; sodium chloride; water for injections; arginine hydrochloride - enbrel is indicated for the treatment of: adults rheumatoid arthritis active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). enbrel can be used in combination with methotrexate. severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease. psoriatic arthritis the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. enbrel has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. plaque psoriasis adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy. ankylosing spondylitis the signs and symptoms of active ankylosing spondylitis in adults. non-radiographic axial spondyloarthritis treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids . * active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of greater than or equal to 4.,children and adolescents juvenile idiopathic arthritis active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more dmards. active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy. active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. enbrel has not been studied in children aged less than 2 years. paediatric plaque psoriasis chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant pasi response is not achieved.