法规知识库 · EMA 集中审评
Tepkinly
epcoritamab · EMEA/H/C/005985 · 已授权
获批上市许可
2023-09-22
欧委会决定日
2026-07-02
持有人 / 申请人
AbbVie Deutschland GmbH & Co. KG
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FX27
治疗领域：Lymphoma, Large B-Cell, Diffuse
药理分类：Antineoplastic agents
修订号：8 · 最新影响 PI 的程序：VR/0000311043
适应症（原文）：Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two 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。
2026-07-02 · 欧委会决定
2023-09-22 · 获批上市许可
2023-07-20 · 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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Tepkinly-VR-0000311043 : EPAR - Assessment report - Variation
variation-report · 2026-08-06 · EMADOC-1700519818-3104033
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Tepkinly : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-06
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Tepkinly : EPAR - Medicine overview
overview · 2026-08-06 · EMADOC-1829012207-55191
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Tepkinly : EPAR - Risk management plan
rmp · 2026-08-06
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Tepkinly-PSUSA-00000107-202503 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-06-09 · EMADOC-1700519818-2902250
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Tepkinly : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-19
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Tepkinly : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-09-03
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Tepkinly-H-C-005985-II-0001 : EPAR - Assessment report - Variation
variation-report · 2024-09-18 · EMA/369446/2024
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Tepkinly : Orphan designation withdrawal assessment report - post authorisation
orphan-maintenance-report-post · 2024-09-18 · EMA/OD/0000157895
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Tepkinly : EPAR - Public assessment report
assessment-report · 2023-10-05 · EMA/CHMP/419797/2023
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Tepkinly : Orphan maintenance assessment report - initial authorisation
orphan-maintenance-report · 2023-10-05 · EMA/OD/0000104478
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。