欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Cimzia
适用类别Human
治疗领域Arthritis, Rheumatoid
通用名/非专利名称certolizumab pegol
活性成分Certolizumab pegol
产品号EMEA/H/C/001037
患者安全信息No
许可状态Authorised
ATC编码L04AB05
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
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2009/10/01
上市许可开发者/申请人/持有人UCB Pharma
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2009/06/25
欧盟委员会决定日期2023/04/26
修订号35
治疗适应症Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Cimzia 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 MTX. Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis (AS) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis without radiographic evidence of AS Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. Psoriatic arthritis Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
适用物种
兽用药物ATC编码
首次发布日期2018/07/19
最后更新日期2024/08/22
产品说明书https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cimzia
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