오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sorbitol; polysorbate 20; water for injections; histidine; histidine hydrochloride monohydrate - rheumatoid arthritis: hadlima 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. hadlima can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hadlima 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 antirheumatic drugs (dmards). hadlima can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hadlima 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 hadlima 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 hadlima is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) hadlima 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 hadlima 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 section 5.1 pharmacodynamic properties- clinical trials for ulcerative colitis).,psoriasis in adults and children hadlima is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,hadlima 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),hadlima is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativatherapy.,uveitis hadlima 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.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sorbitol; polysorbate 20; water for injections; histidine; histidine hydrochloride monohydrate - rheumatoid arthritis: hadlima 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. hadlima can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hadlima 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 antirheumatic drugs (dmards). hadlima can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hadlima 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 hadlima 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 hadlima is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) hadlima 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 hadlima 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 section 5.1 pharmacodynamic properties- clinical trials for ulcerative colitis).,psoriasis in adults and children hadlima is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,hadlima 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),hadlima is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativatherapy.,uveitis hadlima 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.

말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -

말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -

뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - infliximab 100mg;   - powder for injection - 100 mg - active: infliximab 100mg   excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate monohydrate polysorbate 80 sucrose - rheumatoid arthritis remicade is a ?disease-controlling anti-rheumatic therapy" (dcart) indicated for: · the reduction of signs and symptoms · prevention of structural joint damage (erosions and joint space narrowing) · improvement in physical function in patients with active disease. remicade should be given in combination with methotrexate.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose - rheumatoid arthritis in adults: remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: patients with active disease despite treatment with methotrexate; patients with active disease who have not previously received methotrexate. remicade should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate. ankylosing spondylitis: remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. psoriatic arthritis: remicade is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remicade may be administered in combination with methotrexate. psoriasis: remicade is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established. crohn's disease in adults and in children and adolescents (6-17 years): remicade is indicated for the treatment of moderate to severe crohn's disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. refractory fistulising crohn's disease: remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. ulcerative colitis in adults and in children and adolescents (6 to 17 years); remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

이스라엘 - 영어 - Ministry of Health

neopharm (israel)1996 ltd - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - • rheumatoid arthritis: idacio 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. idacio 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.• axial spondyloarthritis:-ankylosing spondylitis (as): idacio 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 as: idacio 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.• psoriatic arthritis: idacio 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.• psoriasis: idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• hidradenitis suppurativa (hs): idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.• crohn’s disease: idacio 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. idacio 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. • ulcerative colitis: idacio 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. • uveitis:idacio 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.• intestinal behcet's disease: idacio is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - adalimumab -

이스라엘 - 영어 - Ministry of Health

abbvie biopharmaceuticals ltd, israel - adalimumab - solution for injection - adalimumab 100 mg / 1 ml - adalimumab - • rheumatoid arthritis:humira 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.humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.humira 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.• polyarticular juvenile idiopathic arthritis:humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. humira has not been studied in patients aged less than 2 years.• enthesitis-related arthritis:humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.• axial spondyloarthritis :humira 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 as:humira 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. • psoriatic arthritis:humira 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. humira 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.• psoriasis:humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• paediatric plaque psoriasis:humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.• hidradenitis suppurativa (hs):humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy.• crohn’s disease:humira 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. humira 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 disease:humira 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 colitis:humira 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. • uveitis:humira 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.• intestinal behcet's disease:humira is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.• paediatric uveitishumira is indicated for the treatment of chronic non-infectious uveitis in paediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.• paediatric ulcerative colitis humira is indicated for the treatment of moderately to severely active ulcerative colitis in pediatric 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

이스라엘 - 영어 - Ministry of Health

padagis israel agencies ltd, israel - infliximab - solution for injection - infliximab 120 mg/ml - infliximab - rheumatoid arthritis: remsima, 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.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).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.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 ciclosporin, methotrexate or psoralen ultra-violet a (puva).