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

viatris pty ltd - mesalazine, quantity: 250 mg - tablet, enteric coated - excipient ingredients: microcrystalline cellulose; povidone; sodium carbonate; purified talc; titanium dioxide; iron oxide red; colloidal anhydrous silica; calcium stearate; glycine; iron oxide yellow; methacrylic acid copolymer; macrogol 6000; triethyl citrate - indications as at 12 september 1990: treatment of acute inflammatory large bowel disease. maintenance therapy of crohns colitis and ulcerative colitis in patients sensitive to sulfasalazine.

Australia - English - 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.

Australia - English - 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.

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

samsung bioepis au pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: water for injections; sucrose; monobasic sodium phosphate monohydrate; polysorbate 80; dibasic sodium phosphate heptahydrate - renflexis is indicated for the treatment of:,rheumatoid arthritis in adults renflexis, 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.,renflexis should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate,ankylosing spondylitis renflexis is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis renflexis 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.,renflexis may be administered in combination with methotrexate.,psoriasis renflexis 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) renflexis 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 renflexis 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) renflexis is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

ferring pharmaceuticals pty ltd - budesonide, quantity: 9 mg - tablet, modified release - excipient ingredients: stearic acid; lecithin; microcrystalline cellulose; hyprolose; lactose monohydrate; silicon dioxide; magnesium stearate; methacrylic acid copolymer; purified talc; titanium dioxide; triethyl citrate - cortiment prolonged-release tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (uc) where 5-asa treatment is not sufficient or not tolerated.

Australia - English - 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.

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

ferring pharmaceuticals pty ltd - mesalazine, quantity: 4 g - granules, modified release - excipient ingredients: povidone; ethylcellulose - treatment of mild to moderate ulcerative colitis and crohn's disease and maintenance of remission.

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

dr falk pharma australia pty ltd - mesalazine, quantity: 3000 mg - granules, modified release - excipient ingredients: aspartame; carmellose sodium; microcrystalline cellulose; citric acid; hypromellose; magnesium stearate; methylcellulose; povidone; colloidal anhydrous silica; simethicone; sorbic acid; purified talc; titanium dioxide; triethyl citrate; methacrylic acid copolymer; flavour - salofalk granules granules are indicated in the treatment of acute ulcerative colitis of mild to moderate severity, and for the maintenance of remission and/or the long term treatment of ulcerative colitis.

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

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; histidine; polysorbate 80; water for injections - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; water for injections; histidine - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).