뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - infliximab 100mg;   - powder for injection - 100 mg - active: infliximab 100mg   excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate monohydrate polysorbate 80 sucrose - rheumatoid arthritis inflectra is a ?disease-controlling anti-rheumatic therapy" (dcart) indicated for: · the reduction of signs and symptoms · prevention of structural joint damage (erosions and joint space narrowing) · improvement in physical function in patients with active disease. inflectra should be given in combination with methotrexate.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 135 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; polysorbate 80; methionine; disodium edetate; water for injections; histidine - crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - mesalazine, quantity: 800 mg - tablet, enteric coated - excipient ingredients: lactose monohydrate; sodium starch glycollate type a; magnesium stearate; purified talc; povidone; methacrylic acid copolymer; triethyl citrate; iron oxide yellow; iron oxide red; macrogol 6000 - for the treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - mesalazine, quantity: 400 mg - tablet, enteric coated - excipient ingredients: lactose monohydrate; sodium starch glycollate type a; magnesium stearate; purified talc; povidone; methacrylic acid copolymer; triethyl citrate; iron oxide yellow; iron oxide red; macrogol 6000 - for the treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - azathioprine, quantity: 50 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; maize starch; purified talc; povidone; hypromellose; microcrystalline cellulose; peg-8 stearate - immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - allopurinol -

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - allopurinol -

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80 - rheumatoid arthritis in adults,inflectra in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in:,- patients with active disease despite treatment with methotrexate,- patients with active disease who have not previously received methotrexate.,inflectra should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis,inflectra is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis,inflectra is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. inflectra may be administered in combination with methotrexate.,psoriasis,inflectra is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults and in children and adolescents (6 to 17 years),inflectra is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease,inflectra is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults and in children and adolescents (6 to 17 years),inflectra is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 331.2 mg - injection, powder for - excipient ingredients: polysorbate 80; arginine hydrochloride; histidine; sucrose; histidine hydrochloride monohydrate - ulcerative colitis,treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,crohn?s disease,treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,pouchitis,entyvio is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - azathioprine, quantity: 50 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; macrogol 8000; hypromellose; macrogol 400 - azathioprine is used as an immunosuppressant anti-metabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effects may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids.,azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants.,azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: ,? severe rheumatoid arthritis;,? systemic lupus erythematosus;,? dermatomyositis / polymyositis;,? autoimmune chronic active hepatitis;,? pemphigus vulgaris;,? polyarteritis nodosa;,? autoimmune haemolytic anaemia; ,? chronic refractory idiopathic thrombocytopenic purpura.