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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - golimumab - solution for injection - 100mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - golimumab - solution for injection - 100mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - golimumab - solution for injection - 100mg/1ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

cilag ag - golimumab - solution for injection - 50mg/0.5ml

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - golimumab - injection, solution - golimumab 45mg/0.45ml

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - golimumab - injection, solution - 50 mg/0.5ml - golimumab 50 mg/0.5ml

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.

Canada - English - Health Canada

janssen inc - golimumab - solution - 50mg - golimumab 50mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

janssen inc - golimumab - solution - 50mg - golimumab 50mg - disease-modifying antirheumatic agents