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

celltrion healthcare australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections - rheumatoid arthritis,yuflyma is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. yuflyma can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,yuflyma in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,yuflyma is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (6 years and older),yuflyma is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or,,? who have lost response to or are intolerant to infliximab,ulcerative colitis,yuflyma is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties - clinical trials).,psoriasis in adults and children,yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,yuflyma is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

celltrion healthcare australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections - rheumatoid arthritis,yuflyma is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. yuflyma can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,yuflyma in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,yuflyma is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (6 years and older),yuflyma is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or,,? who have lost response to or are intolerant to infliximab,ulcerative colitis,yuflyma is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties - clinical trials).,psoriasis in adults and children,yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,yuflyma is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

celltrion healthcare australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; glycine; polysorbate 80; water for injections - rheumatoid arthritis,yuflyma is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. yuflyma can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,yuflyma in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,yuflyma is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (6 years and older),yuflyma is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or,,? who have lost response to or are intolerant to infliximab,ulcerative colitis,yuflyma is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties - clinical trials).,psoriasis in adults and children,yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,yuflyma is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - adalimumab - solution for injection - adalimumab 100 mg/ml - adalimumab - rheumatoid arthritis yuflyma in combination with methotrexate, is indicated for:• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years weighing weighing >=30 kg who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab has not been studied in patients aged less than 2 years.enthesitis-related arthritisyuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, weighing >= 30 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.axial spondyloarthritis• ankylosing spondylitis (as)yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.• axial spondyloarthritis without radiographic evidence of asyuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids).psoriatic arthritisyuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasisyuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age weighing >= 30 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.hidradenitis suppurativa (hs)yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age weighing >= 30 kg with an inadequate response to conventional systemic hs therapy.crohn’s diseaseyuflyma 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. yuflyma is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.paediatric crohn's diseaseyuflyma is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitisyuflyma 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 colitis yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisyuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.paediatric uveitisyuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age weighing >= 30 kg, who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.intestinal behcet's diseaseyuflyma is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo company, limited - adalimumab (genetical recombination) [adalimumab biosimilar 2] - injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo company, limited - adalimumab (genetical recombination) [adalimumab biosimilar 2] - injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo company, limited - adalimumab (genetical recombination) [adalimumab biosimilar 2] - injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo company, limited - adalimumab (genetical recombination) [adalimumab biosimilar 2] - injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sandoz k.k. - adalimumab(genetical recombination)[adalimumab biosimilar 1] - colorless to faintly yellowish brown and limpid or slightly white turbid injectable solution in prefilled syringe

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sandoz k.k. - adalimumab(genetical recombination)[adalimumab biosimilar 1] - colorless to faintly yellowish brown and limpid or slightly white turbid injectable solution in a prefilled syringe contained inside a pen device