ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosuppressants - please refer to section 4.1 of the summary of product characteristics in the product information document.,

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosuppressants - please refer to section 4.1 of the summary of product characteristics in the product information document. ,

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 50 mg/ml;  ;   - solution for injection - 20mg/0.4ml - active: adalimumab 50 mg/ml     excipient: citric acid monohydrate dibasic sodium phosphate dihydrate mannitol monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride sodium citrate sodium hydroxide water for injection - humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients aged 2 years of age and older. humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 50 mg/ml;  ;   - solution for injection - 40 mg/0.8ml - active: adalimumab 50 mg/ml     excipient: citric acid monohydrate dibasic sodium phosphate dihydrate dimeticone mannitol monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - rheumatoid arthritis humira 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. humira can be used alone or in combination with methotrexate.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 50 mg/ml;  ;   - solution for injection - 40 mg/0.8ml - active: adalimumab 50 mg/ml     excipient: citric acid monohydrate dibasic sodium phosphate dihydrate dimeticone mannitol monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - rheumatoid arthritis humira 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. humira can be used alone or in combination with methotrexate.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 50 mg/ml;  ;   - solution for injection - 10 mg/0.2 ml - active: adalimumab 50 mg/ml     excipient: citric acid monohydrate dibasic sodium phosphate dihydrate mannitol monobasic sodium phosphate dihydrate polysorbate 80 sodium chloride sodium citrate sodium hydroxide water for injection - humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients aged 2 years of age and older. humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

abbvie limited - adalimumab 100 mg/ml;  ;  ;   - solution for injection - 40 mg/0.4ml - active: adalimumab 100 mg/ml       excipient: mannitol polysorbate 80 water for injection - 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. humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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.

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

abbvie pte. ltd. - adalimumab - injection - 40.0 mg - adalimumab 40.0 mg

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

pfizer europe ma eeig  - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppressants - rheumatoid arthritisamsparity 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.amsparity 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 arthritis amsparity 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). amsparity 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 arthritis amsparity 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 spondyloarthritisankylosing spondylitis (as) amsparity 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 amsparity is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids).psoriatic arthritisamsparity 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.psoriasisamsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.paediatric plaque psoriasisamsparity 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 suppurativaamsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (hs) (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy.crohn’s diseaseamsparity 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.paediatric crohn's diseaseamsparity 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 a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.ulcerative colitisamsparity 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.uveitisamsparity 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.adolescent hidradenitis suppurativaamsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (hs) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy.paediatric uveitisamsparity is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in 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.