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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 331.2 mg - injection, powder for - excipient ingredients: polysorbate 80; arginine hydrochloride; histidine; sucrose; histidine hydrochloride monohydrate - ulcerative colitis,treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,crohn?s disease,treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,pouchitis,entyvio is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

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

merck healthcare pty ltd - cladribine, quantity: 10 mg - tablet, uncoated - excipient ingredients: hydroxypropylbetadex; sorbitol; magnesium stearate - mavenclad is indicated for the treatment of relapsing-remitting multiple sclerosis (rrms) to reduce the frequency of clinical relapses and to delay the progression of physical disability.,following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4. re-initiation of therapy after year 4 has not been studied.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - cladribine 10mg;   - tablet - 10 mg - active: cladribine 10mg   excipient: hydroxypropyl-beta-cyclodextrin magnesium stearate sorbitol water for injection - mavenclad is indicated for the treatment of relapsing-remitting multiple sclerosis (rrms) to reduce the frequency of clinical relapses and to delay the progression of physical disability. following completion of the two treatment courses, no further cladribine treatment is required in years three and four. re-initiation of therapy after year four has not been studied.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 119 mg - injection, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections - treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist. treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 119 mg - injection, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections - treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,treatment of adult patients with moderate to severe crohn's disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - vedolizumab 300mg;  ;   - powder for injection - 300 mg - active: vedolizumab 300mg     excipient: arginine hydrochloride histidine histidine hydrochloride monohydrate polysorbate 80 sucrose - treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf alpha) antagonist.

European Union - English - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selective immunosuppressants - ulcerative colitisentyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.crohn’s diseaseentyvio is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

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

ucb, inc. - certolizumab pegol (unii: umd07x179e) (certolizumab pegol - unii:umd07x179e) - certolizumab pegol 200 mg in 1 ml - cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (ra). cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (psa). cimzia is indicated for the treatment of adults with active ankylosing spondylitis (as). [see clinical studies (14.4)] cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation [see clinical studies (14.5)]. cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (pso) who are candidates for systemic therapy or phototherapy [see clinical studies (14.6)] cimzia is con

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

takeda uk ltd - vedolizumab - powder for solution for infusion - 300mg

Israel - English - Ministry of Health

takeda israel ltd - vedolizumab - powder for concentrate for solution for infusion - vedolizumab 300 mg/vial - vedolizumab - ulcerative colitis:entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.crohn’s disease:entyvio is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.