Australia - English - 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.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - infliximab - powder for concentrate for solution for infusion - infliximab 100 mg - infliximab - rheumatoid arthritis:ixifi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:• adult patients with active disease when the response to disease modifying antirheumatic drugs (dmards),including methotrexate, has been inadequate.• adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards.in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x ray, has been demonstrated.* ankylosing spondylitis:ixifi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* psoriatic arthritis:ixifi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.* ixifi should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.infliximab 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.* psoriasis:ixifi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet a (puva)* adult crohn’s diseaseixifi is indicated for treatment :• of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.• treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).* ulcerative colitis• ixifi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab, license holder unspecified 100 mg in 10 ml - inflectra is indicated for: inflectra 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. inflectra 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. inflectra 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 uc who have had an inadequate response to conventional therapy. inflectra, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderatel

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - infliximab - solution for injection - infliximab 120 mg/ml - infliximab - rheumatoid arthritis: remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:•adult patients with active disease when the response to disease-modifying antirheumatic drugs (dmards),including methotrexate, has been inadequate. •adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards. in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x ray,has been demonstrated.crohn’s diseaseremsima is indicated for:• treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.• treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).ulcerative colitisremsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.ankylosing spondylitisremsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisremsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.remsima should be administered• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. infliximab 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.psoriasisremsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet a (puva).

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab, license holder unspecified 100 mg - renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn's disease who have had an inadequate response to conventional therapy. renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing crohn's disease. renflexis 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 crohn's disease who have had an inadequate response to conventional therapy. renflexis 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 who have had an inadequate response to conventional therapy. renflexis is indicated for reducing signs and symptoms

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

janssen-cilag pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose - rheumatoid arthritis in adults: remicade, 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. remicade should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate. ankylosing spondylitis: remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. psoriatic arthritis: remicade 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. remicade may be administered in combination with methotrexate. psoriasis: remicade 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 (6-17 years): remicade 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: remicade 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); remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - infliximab (unii: b72hh48flu) (infliximab - unii:b72hh48flu) - infliximab, license holder unspecified 100 mg in 10 ml - remicade 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. remicade 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. remicade 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. remicade is indicated for reducing signs and symptoms and inducing and maintaining clinical remi

European Union - English - EMA (European Medicines Agency)

samsung bioepis nl b.v. - infliximab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; arthritis, rheumatoid; crohn disease; psoriasis - immunosuppressants - rheumatoid arthritisflixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:adult patients with active disease when the response to disease-modifying antirheumatic drugs (dmards), including methotrexate, has been inadequate.dult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards.in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x-ray, has been demonstrated (see section 5.1).adult crohn’s diseaseflixabi is indicated for:reatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.reatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).paediatric crohn’s diseaseflixabi is indicated for treatment of severe, active crohn’s disease in children and adolescents 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. infliximab has been studied only in combination with conventional immunosuppressive therapy.ulcerative colitisflixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.paediatric ulcerative colitisflixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents 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.ankylosing spondylitisflixabiis indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisflixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.flixabi should be administered:in combination with methotrexateor alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.infliximab 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 (see section 5.1).psoriasisflixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet a (puva) (see section 5.1).

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - infliximab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; psoriasis; crohn disease; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritisremsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:adult patients with active disease when the response to disease‑modifying antirheumatic drugs (dmards), including methotrexate, has been inadequate;adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards.in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x‑ray, has been demonstrated.adult crohn’s diseaseremsima is indicated for:treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies;treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).paediatric crohn’s diseaseremsima is indicated for treatment of severe, active crohn’s disease in children and adolescents aged six 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. infliximab has been studied only in combination with conventional immunosuppressive therapy.ulcerative colitisremsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6‑mercaptopurine (6‑mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.paediatric ulcerative colitisremsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six 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.ankylosing spondylitisremsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisremsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.remsima should be administered:in combination with methotrexate;or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.infliximab 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.psoriasisremsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet a (puva).

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

celltrion healthcare australia pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: sucrose; monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; polysorbate 80 - 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 and in children and adolescents (6 to 17 years),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 and in children and adolescents (6 to 17 years),remsima is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.