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

janssen biotech, inc. - golimumab (unii: 91x1klu43e) (golimumab - unii:91x1klu43e) - golimumab 50 mg in 4 ml - simponi aria, in combination with methotrexate (mtx), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. simponi aria is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. simponi aria is indicated for the treatment of adult patients with active ankylosing spondylitis. simponi aria is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pjia) in patients 2 years of age and older. none. risk summary there are no adequate and well-controlled trials of simponi aria in pregnant women. monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. there are clinical considerations for the use of simponi aria in pregnant women [see clinical considerations] . in an animal reproductive study, golimumab administered by the subcutaneous route to pregnant mo

Australia - English - 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).

Australia - English - 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).

Australia - English - 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).

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; histidine; 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).

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

janssen biotech, inc. - golimumab (unii: 91x1klu43e) (golimumab - unii:91x1klu43e) - golimumab 50 mg in 0.5 ml - simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. simponi, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis. simponi is indicated for the treatment of adult patients with active ankylosing spondylitis. simponi is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for: - inducing and maintaining clinical response - improving endoscopic appearance of the mucosa during induction - inducing clinical remission - achieving and sustaining clinical remission in induction responders [see clinical studies (14.4)]. none. risk summary there are no adequate and well-controlled trials of simponi in pregnant women. monocl

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - solution - excipient ingredients: water for injections; histidine; histidine hydrochloride monohydrate; sorbitol; polysorbate 80 - simponi iv,rheumatoid arthritis (ra),simponi iv, 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 iv has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi iv, 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.,ankylosing spondylitis (as),simponi iv is indicated for:,the treatment of active ankylosing spondylitis in adult patients

Israel - English - Ministry of Health

j-c health care ltd - golimumab - solution for injection - golimumab 50 mg / 0.5 ml - golimumab - golimumab - rheumatoid arthritis :simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drug (dmard) therapy including mtx has been inadequate.juvenile idiopathic arthritis: polyarticular juvenile idiopathic arthritis (pjia)simponi in combination with mtx is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with mtx.simponi 100 mg is not recommended in children aged less than 18.psoriatic arthritis :simponi, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate.ankylosing spondylitis :simponi is indicated for the treatment of adult patients with severe active ankylosing spondylitis who have responded inadequately to conventional therapy.non-radiographic axial spondyloarthritis (nr-axial spa):simponi is indicated for the treatment of adults with severe, 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 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.

European Union - English - EMA (European Medicines Agency)

janssen biologics b.v. - golimumab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; arthritis, rheumatoid - immunosuppressants - rheumatoid arthritis (ra)simponi, in combination with methotrexate (mtx), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (dmard) therapy including mtx has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx.simponi, in combination with mtx, has been shown to reduce the rate of progression of joint damage as measured by x ray and to improve physical function.for information regarding the polyarticular juvenile idiopathic arthritis indication, please see the simponi 50 mg smpc.psoriatic arthritis (psa)simponi, alone or in combination with mtx, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate. simponi 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 (see section 5.1) and to improve physical function.axial spondyloarthritisankylosing spondylitis (as)simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.non radiographic axial spondyloarthritis (nr axial spa)simponi is indicated for the treatment of adults with severe, 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 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.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritis (pjia)simponi in combination with methotrexate (mtx) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with mtx.rheumatoid arthritis (ra)simponi, in combination with methotrexate (mtx), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (dmard) therapy including mtx has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx.simponi, in combination with mtx, has been shown to reduce the rate of progression of joint damage as measured by x ray and to improve physical function.juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritis (pjia)simponi in combination with mtx is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with mtx.psoriatic arthritis (psa)simponi, alone or in combination with mtx, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate. simponi 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 (see section 5.1) and to improve physical function.axial spondyloarthritisankylosing spondylitis (as)simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.non radiographic axial spondyloarthritis (nr axial spa)simponi is indicated for the treatment of adults with severe, 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 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).