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

abbvie pty ltd - deoxycholic acid, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; hydrochloric acid - belkyra (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults

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

csl behring australia pty ltd - water for injections, quantity: 3 ml - injection, diluent for - excipient ingredients: - berinert iv is indicated for the treatment of acute attacks in patients with hereditary angioedema (hae).

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

csl behring australia pty ltd - water for injections, quantity: 10 ml - injection, diluent for - excipient ingredients: - berinert iv is indicated for the treatment of acute attacks in patients with hereditary angioedema (hae).

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

pfizer (perth) pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: sorbitol; water for injections; lactic acid - canada irinotecan hydrochloride injection usp (irinotecan hydrochloride trihydrate) is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride injection usp is also indicated as a single agent for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-fluorouracil-based therapy. egypt campto is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. campto is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

maxx pharma pty ltd - etanercept, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; glycine; sucrose; sodium citrate dihydrate; monobasic sodium phosphate dihydrate - nepexto 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). nepexto 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. etanercept 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 >= 4.,children and adolescents,children and adolescents weighing less than 62.5 kg should not receive nepexto. these patients should be accurately dosed on a mg/kg basis with other etanercept products.,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.,etanercept 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 psoriasis area and severity index (pasi) response is not achieved.

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

bayer australia ltd - radium (223ra) dichloride, quantity: 6600 kbq - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium citrate dihydrate - xofigo is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease.

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

takeda pharmaceuticals australia pty ltd - protein c, quantity: 1000 iu - injection, intravenous infusion - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

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

takeda pharmaceuticals australia pty ltd - protein c, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

Australia - English - 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.

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

astrazeneca pty ltd - palivizumab, quantity: 100 mg - injection, solution - excipient ingredients: histidine; glycine; water for injections - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd). (see clinical trials).