法规知识库 · EMA 集中审评
Libtayo
cemiplimab · EMEA/H/C/004844 · 已授权
获批上市许可
2019-06-28
欧委会决定日
2025-11-17
持有人 / 申请人
Regeneron Ireland Designated Activity Company (DAC)
终止日期字段
无
从产品到官方文件
文件记录
17
官方索引 17
EPAR / 审评
15
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XC33
治疗领域：Carcinoma, Squamous Cell
药理分类：Antineoplastic agents
修订号：22 · 最新影响 PI 的程序：VR/0000264999
适应症（原文）：Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
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。
2025-11-17 · 欧委会决定
2019-06-28 · 获批上市许可
2019-04-26 · 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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Libtayo : EPAR - Medicine overview
overview · 2026-01-20 · EMA/101482/2023
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Libtayo : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-10
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Libtayo-VR-0000264999 : Assessment report - Variation
variation-report · 2025-12-10 · EMADOC-1700519818-2492896
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Libtayo : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-10
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Libtayo : EPAR - Risk management plan
rmp · 2025-12-10
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Libtayo-H-C-PSUSA-00010780-202409 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-10-22 · EMA/206745/2025
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Libtayo-H-C-PSUSA-00010780-202209: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-07-18 · EMA/327048/2023
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Libtayo-H-C-004844-II-0028 : EPAR - Assessment report - Variation
variation-report · 2023-05-17 · EMA/CHMP/118736/2023
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Libtayo-H-C-004844-II-0026 : EPAR - Assessment report - Variation
variation-report · 2023-04-12 · EMA/862705/2022
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Libtayo-H-C-004844-R-0029 : EPAR - Assessment report - Renewal
variation-report · 2022-09-22 · EMA/665912/2022
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Libtayo-H-C-PSUSA-00010780-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-28 · EMA/33062/2022
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Libtayo-H-C-004844-II-0011 : EPAR - Assessment report - variation
variation-report · 2021-07-02 · EMA/319413/2021
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Libtayo-H-C-004844-II-0012 : EPAR - Assessment report - variation
variation-report · 2021-07-02 · EMA/319415/2021
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Libtayo-H-C-PSUSA-00010780-201909 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-07-21 · EMA/371795/2020
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Libtayo : EPAR - Public assessment report
assessment-report · 2019-07-05 · EMA/CHMP/368468/2019
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。