欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Gobivaz
适用类别Human
治疗领域Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloarthritis;Colitis, Ulcerative;Non-Radiographic Axial Spondyloarthritis
通用名/非专利名称golimumab
活性成分Golimumab
产品号EMEA/H/C/006560
患者安全信息No
许可状态Authorised
ATC编码L04AB06
是否额外监管Yes
是否仿制药或hybrid药物No
是否生物类似药Yes
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2025/11/17
上市许可开发者/申请人/持有人Advanz Pharma Limited
人用药物治疗学分组Immunosuppressants
兽用药物治疗学分组
审评意见日期2025/09/18
修订号
治疗适应症Rheumatoid arthritis (RA) Gobivaz, 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. Golimumab, 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 arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Gobivaz 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) Gobivaz, 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. Golimumab 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. Axial spondyloarthritis Ankylosing spondylitis (AS) Gobivaz 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) Gobivaz 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) Gobivaz 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.
适用物种
兽用药物ATC编码
首次发布日期2025/09/19
最后更新日期2025/11/20
产品说明书https://www.ema.europa.eu/en/documents/product-information/gobivaz-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/gobivaz
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