法规知识库 · EMA 集中审评
Poherdy
pertuzumab · EMEA/H/C/006583 · 已授权
获批上市许可
2026-04-23
欧委会决定日
2026-09-29
持有人 / 申请人
Organon N.V.
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01FD02
治疗领域:Breast Neoplasms
药理分类:Antineoplastic agents
修订号:2 · 最新影响 PI 的程序:VR/0000358569
适应症(原文):Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrenceMetastatic breast cancerPoherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
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。
2026-09-29 · 欧委会决定
2026-04-23 · 获批上市许可
2026-02-26 · 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 ↗
Poherdy : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-14
- 打开官方文件 ↗
Poherdy : EPAR - Medicine overview
overview · 2026-05-26 · EMA/52186/2026
- 打开官方文件 ↗
Poherdy : EPAR - Risk management plan
rmp · 2026-05-26
- 打开官方文件 ↗
Poherdy : EPAR - Public assessment report
assessment-report · 2026-05-26 · EMA/69263/2026
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。