法规知识库 · EMA 集中审评
Rybrevant
amivantamab · EMEA/H/C/005454 · 已授权
获批上市许可
2021-12-09
欧委会决定日
2026-02-20
持有人 / 申请人
未知
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
11
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FX18
治疗领域：Carcinoma, Non-Small-Cell Lung
药理分类：Antineoplastic agents
修订号：11 · 最新影响 PI 的程序：X/0000268898
适应症（原文）：Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based 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。
2026-02-20 · 欧委会决定
2021-12-09 · 获批上市许可
2021-10-14 · 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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Rybrevant-X-0000268898 : EPAR - Assessment report - Variation
variation-report · 2026-07-16 · EMADOC-1700519818-2846450
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Rybrevant: EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-16
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Rybrevant : EPAR - Risk management plan
rmp · 2026-07-16
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Rybrevant-PSUSA-00010977-202411 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-10-29 · EMADOC-1700519818-2198127
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Rybrevant: EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-19
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Rybrevant-H-C-005454-X-0014 : EPAR - Assessment report - Variation
variation-report · 2025-06-12 · EMA/61503/2025
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Rybrevant-H-C-005454-II-0013 : EPAR - Assessment report - Variation
variation-report · 2025-03-11 · EMA/580043/2024
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Rybrevant : EPAR - Medicine Overview
overview · 2025-03-11 · EMA/547740/2024
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Rybrevant-H-C-005454-II-0011: EPAR - Assessment report - Variation
variation-report · 2024-09-13 · EMA/373005/2024
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Rybrevant-H-C-005454-II-0010 : EPAR - Assessment report
variation-report · 2024-07-17 · EMA/CHMP/111303/2024
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Rybrevant : EPAR - Public Assessment Report
assessment-report · 2022-02-01 · EMA/629045/2021
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。