法规知识库 · EMA 集中审评
Kisqali
ribociclib succinate · EMEA/H/C/004213 · 已授权
获批上市许可
2017-08-22
欧委会决定日
2026-07-23
持有人 / 申请人
Novartis Europharm Limited
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：L01EF02
治疗领域：Breast Neoplasms
药理分类：Antineoplastic agents
修订号：28 · 最新影响 PI 的程序：VR/0000325484
适应症（原文）：Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, 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。
2026-07-23 · 欧委会决定
2017-08-22 · 获批上市许可
2017-06-22 · 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 ↗
Kisqali : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-19
- 打开官方文件 ↗
Kisqali-VR-0000315309 : EPAR - Assessment report - Variation
variation-report · 2026-05-21 · EMADOC-1700519818-2738249
- 打开官方文件 ↗
Kisqali : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2026-05-21 · EMADOC-1700519818-3015561
- 打开官方文件 ↗
Kisqali-PSUSA-00010633-202503 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-01-26 · EMADOC-1700519818-2853524
- 打开官方文件 ↗
Kisqali : EPAR - Risk management plan
rmp · 2026-01-26
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Kisqali : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-25
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Kisqali : EPAR - Medicine overview
overview · 2025-02-05 · EMA/506621/2024
- 打开官方文件 ↗
Kisqali-H-C-004213-II-0045 : EPAR - Assessment report - Variation
variation-report · 2025-02-04 · EMA/512303/2024 corr.1
- 打开官方文件 ↗
Kisqali-H-C-PSUSA-00010633-202203 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-01-04 · EMA/942004/2022
- 打开官方文件 ↗
Kisqali-H-C-4213-II-0004 : EPAR - Assessment report - Variation
variation-report · 2019-01-30 · EMA/888562/2018
- 打开官方文件 ↗
Kisqali : EPAR - Public assessment report
assessment-report · 2017-08-31 · EMA/CHMP/506968/2017
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。