法规知识库 · EMA 集中审评
Rubraca
rucaparib camsylate · EMEA/H/C/004272 · 已授权
获批上市许可
2018-05-23
欧委会决定日
2026-06-11
持有人 / 申请人
pharmaand GmbH
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：L01XX
治疗领域：Ovarian Neoplasms
药理分类：Antineoplastic agents
修订号：19 · 最新影响 PI 的程序：VR/0000332297
适应症（原文）：Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
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。
2026-06-11 · 欧委会决定
2018-05-23 · 获批上市许可
2017-11-06 · 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 ↗
Rubraca : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-19
- 打开官方文件 ↗
Rubraca : EPAR - Risk management plan
rmp · 2026-08-19
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Rubraca : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-27
- 打开官方文件 ↗
Rubraca-H-C-4272-II-0036 : Assessment report - Variation
variation-report · 2023-11-30 · EMA/CHMP/503870/2023
- 打开官方文件 ↗
Rubraca : EPAR - Medicine overview
overview · 2023-11-30 · EMA/469708/2023
- 打开官方文件 ↗
Rubraca-H-C-4272-II-0029 : EPAR - Assessment report - Variation
variation-report · 2022-11-25 · EMA/883431/2022
- 打开官方文件 ↗
Rubraca : EPAR - Scientific conclusions Annex IV
scientific-conclusion · 2022-11-09
- 打开官方文件 ↗
Rubraca-H-A-20-1518-C-4272-0033 : Assessment report
variation-report · 2022-11-09 · EMA/674344/2022
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Rubraca-H-C-PSUSA-00010694-202012 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-09-20 · EMA/526847/2021
- 打开官方文件 ↗
Rubraca-H-C-4272-II-0001 : EPAR - Assessment report - Variation
variation-report · 2019-02-19 · EMA/902679/2019
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Rubraca : Orphan designation withdrawal assessment report (post-authorisation)
orphan-maintenance-report-post · 2019-02-19 · EMA/22653/2019
- 打开官方文件 ↗
Rubraca : EPAR - Public assessment report
assessment-report · 2018-05-31 · EMA/CHMP/238139/2018
- 打开官方文件 ↗
Rubraca : Orphan designation withdrawal assessment report (initial authorisation)
orphan-maintenance-report · 2018-05-31 · EMA/272157/2018
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。