欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Bimzelx
适用类别Human
治疗领域Psoriasis
通用名/非专利名称bimekizumab
活性成分bimekizumab
产品号EMEA/H/C/005316
患者安全信息No
许可状态Authorised
ATC编码L04AC
是否额外监管Yes
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2021/08/20
上市许可开发者/申请人/持有人UCB Pharma S.A.  
人用药物治疗学分组bimekizumab 
兽用药物治疗学分组
审评意见日期2021/06/24
欧盟委员会决定日期2025/04/28
修订号11
治疗适应症Plaque psoriasis Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Hidradenitis suppurativa (HS)Bimzelx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
适用物种
兽用药物ATC编码
首次发布日期2021/08/24
最后更新日期2025/04/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/bimzelx
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