法规知识库 · EMA 集中审评
Retsevmo
selpercatinib · EMEA/H/C/005375 · 已授权
获批上市许可
2021-02-11
欧委会决定日
2026-06-04
持有人 / 申请人
Eli Lilly Nederland B.V.
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EX22
治疗领域：Carcinoma, Non-Small-Cell Lung;Thyroid Neoplasms;Cancer
药理分类：Antineoplastic agents
修订号：21 · 最新影响 PI 的程序：VR/0000282012
适应症（原文）：Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. For biomarker-based patient selection, see section 4.2. Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . For biomarker-based patient selection, see section 4.2. advanced RET mutant medullary thyroid cancer (MTC) . For biomarker-based patient selection, see section 4.2. advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2.
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。
2026-06-04 · 欧委会决定
2021-02-11 · 获批上市许可
2020-12-10 · 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
- 打开官方文件 ↗
Retsevmo-VR-0000282012 : EPAR - Assessment report - Variation
variation-report · 2026-07-03 · EMADOC-1700519818-3080621
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Retsevmo : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-07-03
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Retsevmo : EPAR - Medicine overview
overview · 2026-07-03 · EMADOC-1829012207-49600
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Retsevmo : EPAR - Risk management plan
rmp · 2026-07-03
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Retsevmo-PSUSA-00010917-202505 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-02-12 · EMADOC-1700519818-2912670
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Retsevmo-H-C-005375-II-0022 : EPAR - Assessment report - Variation
variation-report · 2025-05-23 · EMA/CHMP/143891/2024
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Retsevmo : EPAR - Procedural steps taken and scientific information after the authorisation (archive)
procedural-steps-after · 2025-05-23
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Retsevmo-H-C-005375-X-0031 : EPAR - Assessment report - Variation
variation-report · 2025-04-30 · EMA/94274/2025
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Retsevmo-H-C-005375-II-0021 : EPAR - Assessment report - Extension
variation-report · 2024-03-14 · EMA/60663/2024
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Retsevmo-H-C-005375-II-0011 : EPAR - Assessment Report - Variation
variation-report · 2022-11-09 · EMA/583379/2022
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Retsevmo-H-C-005375-II-0014-G : EPAR - Assessment Report - Variation
variation-report · 2022-11-09 · EMA/681951/2022
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Retsevmo-H-C-PSUSA-00010917-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-03-14 · EMA/34538/2022
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Retsevmo : EPAR - Public assessment report
assessment-report · 2021-04-23 · EMA/9037/2021
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。