欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Benlysta
适用类别Human
治疗领域Lupus Erythematosus, Systemic
通用名/非专利名称belimumab
活性成分belimumab
产品号EMEA/H/C/002015
患者安全信息No
许可状态Authorised
ATC编码L04AG04
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2011/07/13
上市许可开发者/申请人/持有人GlaxoSmithKline (Ireland) 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2011/05/19
欧盟委员会决定日期2025/07/18
修订号37
治疗适应症Benlysta is indicated as add-on therapy in adult patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.
适用物种
兽用药物ATC编码
首次发布日期2017/11/10
最后更新日期2025/07/30
产品说明书https://www.ema.europa.eu/en/documents/product-information/benlysta-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/benlysta
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