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

janssen biotech, inc. - ustekinumab (unii: fu77b4u5z0) (ustekinumab - unii:fu77b4u5z0) - ustekinumab 45 mg in 0.5 ml - stelara® is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. stelara® is indicated for the treatment of patients 6 years or older with active psoriatic arthritis. stelara® is indicated for the treatment of adult patients with moderately to severely active crohn's disease. stelara® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. stelara® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients [see warnings and precautions (5.5)]. risk summary limited data on the use of stelara® in pregnant women are insufficient to inform a drug associated risk [see data] . in animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximu

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - solution for injection - ustekinumab 45 mg / 0.5 ml - ustekinumab - ustekinumab - *plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus u.v (puva) paediatric plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, othersystemic therapies or phototherapies.psoriatic arthritis (psa)stelara, alone or in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (dmard) therapy has been inadequatecrohn’s diseasestelara 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 tnfα antagonist or have medical contraindications to such therapies.ulcerative colitisstelara 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 biologic or have medical contraindications to such therapies

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - solution for injection - ustekinumab 45 mg / 0.5 ml - ustekinumab - ustekinumab - plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus u.v (puva) paediatric plaque psoriasisstelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, othersystemic therapies or phototherapies.psoriatic arthritis (psa)stelara, alone or in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (dmard) therapy has been inadequatecrohn’s diseasestelara 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 tnfα antagonist or have medical contraindications to such therapies.ulcerative colitisstelara 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 biologic or have medical contraindications to such therapies

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

janssen-cilag pty ltd - ustekinumab, quantity: 135 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; polysorbate 80; methionine; disodium edetate; water for injections; histidine - crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

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

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medic

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

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medic

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

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: water for injections; sucrose; polysorbate 80; histidine; histidine hydrochloride monohydrate - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medic

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

janssen-cilag pty ltd - ustekinumab -

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - concentrate for solution for infusion - ustekinumab 5 mg / 1 ml - ustekinumab - crohn’s disease :stelara 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 tnfα antagonist or have medical contraindications to such therapies.ulcerative colitis :stelara 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 biologic or have medical contraindications to such therapies

Israel - English - Ministry of Health

j-c health care ltd - ustekinumab - solution for injection - ustekinumab 45 mg / 0.5 ml - ustekinumab - * pque poriasis stelara is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, or have contraindication to or who are intolerant to other systemic therapies including ciclosporin, methotrexate or psoralen plus u.v (puva).* psoriatic arthritisstelara, alone or in combination with mtx, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (dmard) therapy has been inadequatepediatric plaque psoriasis:stelara is indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* crohn’s disease:stelara 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 tnfα antagonist or have medical contraindications to such therapies.