Austrália - inglês - 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.

Israel - inglês - Ministry of Health

j-c health care ltd - infliximab - powder for concentrate for infusion - infliximab 100.0 mg/vial - infliximab - infliximab - - adult :- crohn's disease: treatment of moderate to severe active crohn's disease in patients who have not responded despite of a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant. treatment of fistulising crohn's disease in patients who have not responded despite of a full and adequate course of therapy with conventional treatment. - paediatric crohn's disease: remicade is indicated for: treatment of severe active crohn's disease in paediatric patients aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid an immunomodulator and primary nutrition therapy or who are intolerant to or have contraindications for such therapies. remicade has been studied only in combination with conventional immunosuppressive therapy - ankylosing spondylitis: remicade is indicated for: treatment of ankylosing spondylitis in patients who have severe axial symptoms elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. - psoriatic arthritis : remicade is indicated for : treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. remicade should be administered : either in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. - remicade has been shown to improve physical function in patients with psoriatic arthritis and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease. - rheumatoid arthritis: remicade in combination with methotrexate is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: patients with active disease when the response to disease-modifying drugs including methotrexate has been inadequate. patients with severe active and progressive disease not previously treated with methotrexate or other dmards. in this these patient populations a reduction in the rate of the progression of joint damage as measured by x-ray has been demonstrated - psoriasis: remicade is indicated for: treatment of moderate to severe plaque psoriasis in adults who failed to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine methotrexate or puva. - ulcerative colitis: remicade is indicated for: treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to convential therapy including corticosteroids and 6-mp or aza or who are intolerant to or have medical contraindications for such therapies.- paediatric ulcerative colitis: remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 mp or aza, or who are intolerant to or have medical contraindications for such therapies

Estados Unidos - inglês - NLM (National Library of Medicine)

janssen biotech, inc. - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab is indicated for: - reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn's disease (cd) who have had an inadequate response to conventional therapy. - reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing cd. infliximab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active cd who have had an inadequate response to conventional therapy. infliximab is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response to conventional therapy. infliximab is indicated for reducing signs and symptoms and inducing and maintaining clini

Japão - inglês - すりの適正使用協議会 RAD-AR Council, Japan

nichi-iko pharmaceutical co.,ltd - infliximab(genetical recombination)[infliximab biosimilar 2] - injection

Japão - inglês - すりの適正使用協議会 RAD-AR Council, Japan

pfizer pharmaceuticals inc. - infliximab(genetical recombination)[infliximab biosimilar3] - injection

Japão - inglês - すりの適正使用協議会 RAD-AR Council, Japan

celltrion healthcare japan k.k - infliximab(genetical recombination)[infliximab biosimilar 1] - injection

Japão - inglês - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - infliximab(genetical recombination)[ infliximab biosimilar 1] - injection

Austrália - inglês - 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.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima 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.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima 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. remsima may be administered in combination with methotrexate.,psoriasis remsima 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 remsima 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 remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima 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.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima 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. remsima may be administered in combination with methotrexate.,psoriasis remsima 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 remsima 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 remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.