Flixabi European Union - English - EMA (European Medicines Agency)

flixabi

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).

Inflectra European Union - English - EMA (European Medicines Agency)

inflectra

pfizer europe ma eeig - infliximab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; psoriasis; crohn disease; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritisinflectra, 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 diseaseinflectra 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 diseaseinflectra 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 colitisinflectra 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 colitisinflectra 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 spondylitisinflectra is indicated for treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisinflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.inflectra 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.psoriasisinflectra 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).

Remicade European Union - English - EMA (European Medicines Agency)

remicade

janssen biologics b.v.  - infliximab - spondylitis, ankylosing; arthritis, rheumatoid; psoriasis; crohn disease; arthritis, psoriatic; colitis, ulcerative - immunosuppressants - rheumatoid arthritisremicade, 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 diseaseremicade 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 diseaseremicade 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. remicade has been studied only in combination with conventional immunosuppressive therapy.ulcerative colitisremicade 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 colitisremicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients 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 spondylitisremicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.psoriatic arthritisremicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.remicade should be administered: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.psoriasisremicade 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 ultraviolet a (puva).

Remsima European Union - English - EMA (European Medicines Agency)

remsima

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).

REMICADE POWDER FOR SOLUTION Canada - English - Health Canada

remicade powder for solution

janssen inc - infliximab - powder for solution - 100mg - infliximab 100mg - disease-modifying antirheumatic agents

INFLECTRA POWDER FOR SOLUTION Canada - English - Health Canada

inflectra powder for solution

celltrion healthcare co ltd - infliximab - powder for solution - 100mg - infliximab 100mg - disease-modifying antirheumatic agents

REMSIMA POWDER FOR SOLUTION Canada - English - Health Canada

remsima powder for solution

celltrion healthcare co ltd - infliximab - powder for solution - 100mg - infliximab 100mg - disease-modifying antirheumatic agents

RENFLEXIS POWDER FOR SOLUTION Canada - English - Health Canada

renflexis powder for solution

samsung bioepis co., ltd - infliximab - powder for solution - 100mg - infliximab 100mg - disease-modifying antirheumatic agents