法规知识库 · EMA 集中审评
Talzenna
talazoparib · EMEA/H/C/004674 · 已授权
获批上市许可
2019-06-20
欧委会决定日
2025-06-19
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01XK04
治疗领域:Breast Neoplasms
药理分类:Antineoplastic agents
修订号:11 · 最新影响 PI 的程序:X/0022
适应症(原文):Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.
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。
2025-06-19 · 欧委会决定
2019-06-20 · 获批上市许可
2019-04-26 · 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 ↗
Talzenna : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-29
- 打开官方文件 ↗
Talzenna : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-07-18
- 打开官方文件 ↗
Talzenna : EPAR - Risk management plan
rmp · 2024-09-11
- 打开官方文件 ↗
Talzenna-H-C-4674-X-0015-G : EPAR - Assessment report - Variation
variation-report · 2024-01-16 · EMA/570477/2023
- 打开官方文件 ↗
Talzenna : EPAR - Medicine overview
overview · 2024-01-16 · EMA/242902/2019
- 打开官方文件 ↗
Talzenna : EPAR - Public assessment report
assessment-report · 2019-07-08 · EMA/270498/2019
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。