欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Sarclisa
适用类别Human
治疗领域Multiple Myeloma
通用名/非专利名称isatuximab
活性成分Isatuximab
产品号EMEA/H/C/004977
患者安全信息No
许可状态Authorised
ATC编码L01XC38
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2020/05/30
上市许可开发者/申请人/持有人Sanofi Winthrop Industrie
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2020/03/26
欧盟委员会决定日期2025/07/18
修订号13
治疗适应症SARCLISA is indicated:  In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
适用物种
兽用药物ATC编码
首次发布日期2020/06/12
最后更新日期2025/08/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa
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