أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; histidine; polysorbate 80; water for injections - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - golimumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: sorbitol; polysorbate 80; water for injections; histidine - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

كندا - الإنجليزية - Health Canada

pfizer canada ulc - tofacitinib (tofacitinib citrate) - tablet - 5mg - tofacitinib (tofacitinib citrate) 5mg - disease-modifying antirheumatic agents

كندا - الإنجليزية - Health Canada

sanofi-aventis canada inc - sarilumab - solution - 150mg - sarilumab 150mg - disease-modifying antirheumatic agents

كندا - الإنجليزية - Health Canada

sanofi-aventis canada inc - sarilumab - solution - 200mg - sarilumab 200mg - disease-modifying antirheumatic agents

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

genentech, inc. - tocilizumab (unii: i031v2h011) (tocilizumab - unii:i031v2h011) - tocilizumab 20 mg in 1 ml - actemra® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). actemra® (tocilizumab) is indicated for the treatment of giant cell arteritis (gca) in adult patients. actemra® (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. actemra® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. actemra® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. actemra® (tocilizumab) is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. actemra® (toci

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

u.s. pharmaceuticals - tofacitinib citrate (unii: o1ff4div0d) (tofacitinib - unii:87la6fu830) - tofacitinib 5 mg - xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (ra) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active psoriatic arthritis (psa) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc), who have an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz oral solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcjia) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more tnf

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - tofacitinib citrate (unii: o1ff4div0d) (tofacitinib - unii:87la6fu830) - tofacitinib 5 mg - xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (ra) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active psoriatic arthritis (psa) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have had an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz xr is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc), who have an inadequate response or intolerance to one or more tnf blockers. xeljanz/xeljanz oral solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcjia) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more tnf

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sarilumab (unii: nu90v55f8i) (sarilumab - unii:nu90v55f8i) - sarilumab 150 mg in 1.14 ml - kevzara® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (dmards). kevzara is indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. kevzara is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients [see warnings and precautions (5.5) and adverse reactions (6.1)] . risk summary the limited human data with kevzara in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see clinical considerations) . from animal data, and consistent with the mechanism of ac

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; water for injections; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).