European Union - English - EMA (European Medicines Agency)

sandoz gmbh - infliximab - arthritis, psoriatic; psoriasis; crohn disease; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosuppressants - treatment of rheumatoid arthritis, crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - infliximab - powder for solution for infusion - 100mg

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.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen-biologics b.v., netherlands - infliximab - powder for concentrate for solution for infusion - 100 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazeera pharmaceutical industries (jpi), saudi arabia - infliximab - powder for concentrate for solution for infusion - 100 mg

Canada - English - Health Canada

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

Singapore - English - HSA (Health Sciences Authority)

celltrion healthcare singapore private limited - infliximab - injection, solution - infliximab 120mg/ml

Singapore - English - HSA (Health Sciences Authority)

celltrion healthcare singapore private limited - infliximab - injection, solution - infliximab 120mg/ml

Canada - English - Health Canada

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

Canada - English - Health Canada

celltrion healthcare co ltd - infliximab - kit - 120mg - infliximab 120mg - disease-modifying antirheumatic agents