法规知识库 · EMA 集中审评
Tecartus
autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) · EMEA/H/C/005102 · 已授权
获批上市许可
2020-12-14
欧委会决定日
2026-04-23
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：L01X
治疗领域：Lymphoma, Mantle-Cell
药理分类：Antineoplastic agents
修订号：18 · 最新影响 PI 的程序：VR/0000308229
适应症（原文）：Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
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。
2026-04-23 · 欧委会决定
2020-12-14 · 获批上市许可
2020-10-15 · CHMP 意见通过
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Tecartus-PSUSA-00010903-202507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-05-19 · EMADOC-1700519818-3026217
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Tecartus : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-19
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Tecartus : EPAR - Risk management plan
rmp-summary · 2026-05-19
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Tecartus-PSUSA-00010903-202501 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-11-20 · EMADOC-1700519818-2426618
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Tecartus : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-20
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Tecartus-H-C-PSUSA-00010903-202307 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-04-24 · EMA/121570/2024
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Tecartus-H-C-PSUSA-00010903-202301 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-11-28 · EMA/536113/2023
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Tecartus-H-C-005102-II-0008-G : EPAR - Assessment report - Variation
variation-report · 2022-12-02 · EMA/683619/2022
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Tecartus : Orphan maintenance assessment report (post authorisation)
orphan-maintenance-report-post · 2022-12-02 · EMA/OD/0000063560
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Tecartus : EPAR - Medicine overview
overview · 2022-12-02 · EMA/712397/2022
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Tecartus : EPAR - Public assessment report
assessment-report · 2021-01-25 · EMA/588798/2020
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Tecartus : Orphan maintenance assessment report (initial authorisation)
orphan-maintenance-report · 2021-01-25 · EMADOC-1700519818-577467
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。