法规知识库 · EMA 集中审评
Yescarta
axicabtagene ciloleucel · EMEA/H/C/004480 · 已授权
获批上市许可
2018-08-23
欧委会决定日
2026-06-08
持有人 / 申请人
Kite Pharma EU B.V.
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XX70
治疗领域：Lymphoma, Follicular;Lymphoma, Large B-Cell, Diffuse
药理分类：Antineoplastic agents
修订号：24 · 最新影响 PI 的程序：VR/0000350867
适应症（原文）：Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2026-06-08 · 欧委会决定
2018-08-23 · 获批上市许可
2018-06-28 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Yescarta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-06-08
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Yescarta : EPAR - Risk management plan
rmp · 2026-05-19
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Yescarta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-20
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Yescarta-H-C-004480-II-0046 : EPAR - Assessment report - Variation
variation-report · 2022-12-16 · EMA/804955/2022
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Yescarta : EPAR - Orphan Maintenance Assessment Report (post-authorisation)
orphan-maintenance-report-post · 2022-12-16 · EMADOC-1700519818-943901
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Yescarta : EPAR - Medicine overview
overview · 2022-12-16 · EMA/854121/2022
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Yescarta-H-C-PSUSA-00010703-202110 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-12-12 · EMA/936726/2022
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Yescarta : EPAR - Orphan Maintenance Assessment Report (post authorisation)
orphan-maintenance-report-post · 2022-07-12 · EMA/OD/0000068456
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Yescarta-H-C-004480-II-0042 : EPAR - Assessment report - Variation
variation-report · 2022-07-12 · EMA/622447/2022
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Yescarta-H-C-PSUSA-00010703-201904 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-02-03 · EMA/52410/2020
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Yescarta : EPAR - Public assessment report
assessment-report · 2018-09-10 · EMA/481168/2018
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Yescarta : Orphan maintenance assessment report (initial authorisation)
orphan-maintenance-report · 2018-09-10 · EMA/511556/2018
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。