法规知识库 · EMA 集中审评
Cimzia
certolizumab pegol · EMEA/H/C/001037 · 已授权
获批上市许可
2009-10-01
欧委会决定日
2026-04-16
持有人 / 申请人
UCB Pharma
终止日期字段
无
从产品到官方文件
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0
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EPAR / 审评
0
assessment / overview 等
产品信息
0
PI / presentations
其他
0
RMP / PIP 等
ATC:L04AB05
治疗领域:Arthritis, Rheumatoid
药理分类:Immunosuppressants
修订号:41 · 最新影响 PI 的程序:VR/0000310696
适应症(原文):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.
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2026-04-16 · 欧委会决定
2009-10-01 · 获批上市许可
2009-06-25 · CHMP 意见通过
说明书、EPAR 与其他文件
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