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Crohn Disease
通用名/非专利名称certolizumab pegol
活性成分Certolizumab pegol
产品号EMEA/H/C/000740
患者安全信息No
许可状态Refused
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
拒绝上市许可日期2008/05/21
上市许可开发者/申请人/持有人UCB Pharma SA
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2008/03/19
欧盟委员会决定日期2008/03/20
修订号
治疗适应症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 (DMARD) including methotrexate, has been inadequate.Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.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 methotrexate.
适用物种
兽用药物ATC编码
首次发布日期2008/03/20
最后更新日期2008/03/20
产品说明书
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/cimzia-0
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