法规知识库 · EMA 集中审评
Verzenios
abemaciclib · EMEA/H/C/004302 · 已授权
获批上市许可
2018-09-26
欧委会决定日
2026-08-25
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
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：L01EF03
治疗领域：Breast Neoplasms
药理分类：Antineoplastic agents
修订号：20 · 最新影响 PI 的程序：N/0000365494
适应症（原文）：Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.
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。
2026-08-25 · 欧委会决定
2018-09-26 · 获批上市许可
2018-07-25 · 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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Verzenios : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-25
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Verzenios : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-05-27 · EMADOC-1700519818-3051385
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Verzenios : EPAR - Risk management plan
rmp · 2026-02-25
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Verzenios-VR-0000282650 : EPAR - Assessment report - Variation
variation-report · 2025-11-27 · EMADOC-1700519818-2266337
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Verzenios-PAM-0000253564 : EPAR - Assessment report
variation-report · 2025-06-02 · EMADOC-1700519818-1913499
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Verzenios-H-C-PSUSA-00010724-202309 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-08-23 · EMA/169761/2024
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Verzenios : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-08-23
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Verzenios-H-C-004302-II-0013: EPAR - Assessment report - Variation
variation-report · 2022-04-21 · EMA/156033/2022
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Verzenios : EPAR - Medicine overview
overview · 2022-04-21 · EMA/521639/2018
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Verzenios : EPAR - Risk-management-plan summary
rmp-summary · 2018-10-29
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Verzenios : EPAR - Public assessment report
assessment-report · 2018-10-29 · EMA/551438/2018
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。