法规知识库 · EMA 集中审评
Tagrisso
osimertinib mesilate · EMEA/H/C/004124 · 已授权
获批上市许可
2016-02-01
欧委会决定日
2026-07-09
持有人 / 申请人
AstraZeneca AB
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：L01XE
治疗领域：Carcinoma, Non-Small-Cell Lung
药理分类：Other antineoplastic agents;Protein kinase inhibitors
修订号：25 · 最新影响 PI 的程序：VR/0000340013
适应症（原文）：Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
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。
2026-07-09 · 欧委会决定
2016-02-01 · 获批上市许可
2015-12-17 · 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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Tagrisso : EPAR - Risk management plan
rmp · 2026-09-10
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Tagrisso : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-18
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Tagrisso-H-C-4124-II-0019 : EPAR - Assessment Report - Variation
variation-report · 2026-02-05 · EMA/396618/2018
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Tagrisso : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-04
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Tagrisso : EPAR - Medicine overview
overview · 2025-01-24 · EMA/547447/2024
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Tagrisso-H-C-004124-II-0056 : EPAR - Assessment report - Variation
variation-report · 2025-01-09 · EMA/559416/2024
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Tagrisso-H-C-004124-II-0053 : EPAR - Assessment report - Variation
variation-report · 2024-07-23 · EMA/291598/2024
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Tagrisso-H-C-PSUSA-00010472-202111 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation - Annex IV
scientific-conclusion · 2022-10-03 · EMA/797953/2022
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Tagrisso-H-C-004124-II-0039-G : EPAR - Assessment Report - Variation
variation-report · 2021-07-01 · EMA/280219/2021
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Tagrisso : EPAR - Scientific conclusions
scientific-conclusion · 2020-02-25
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Tagrisso : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation - Annex IV
scientific-conclusion · 2019-10-23
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Tagrisso-H-C-4124-II-0009-G : EPAR - Assessment Report - Variation
variation-report · 2017-05-16 · EMA/CHMP/134310/2017
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Tagrisso : EPAR - Public assessment report
assessment-report · 2016-02-17 · EMA/CHMP/15445/20165
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。