欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Carvykti
适用类别Human
治疗领域Multiple Myeloma
通用名/非专利名称ciltacabtagene autoleucel
活性成分ciltacabtagene autoleucel
产品号EMEA/H/C/005095
患者安全信息no
授权状态Authorised
ATC编码L01XL05
是否额外监管yes
是否仿制药no
是否生物类似药no
是否附条件批准yes
是否特殊情形no
是否加速审评no
是否罕用药yes
批准上市日期2022/05/25
上市许可持有人/公司名称Janssen-Cilag International NV
审评意见发布日期2022/03/24
决定日期2023/07/25
修订号4
适应症Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
首次发布日期2022/03/25
修订日期2023/07/26
产品信息https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti
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