法规知识库 · EMA 集中审评
Perjeta
pertuzumab · EMEA/H/C/002547 · 已授权
获批上市许可
2013-03-04
欧委会决定日
2026-03-12
持有人 / 申请人
Roche Registration GmbH
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
9
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01FD02
治疗领域：Breast Neoplasms
药理分类：Antineoplastic agents;monoclonal antibodies and antibody drug conjugates
修订号：27 · 最新影响 PI 的程序：VR/0000307073
适应症（原文）：Metastatic Breast Cancer: Perjeta 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. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
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。
2026-03-12 · 欧委会决定
2013-03-04 · 获批上市许可
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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Perjeta : EPAR - Risk management plan
rmp · 2026-10-15
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Perjeta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-28
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Perjeta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-03
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Perjeta-H-C-PSUSA-00010125-201806 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-04-15 · EMA/219028/2019
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Perjeta-H-C-002547-II-0034 : EPAR - Assessment Report - Variation
variation-report · 2018-06-28 · EMA/CHMP/366182/2018
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Perjeta : EPAR - Medicine overview
overview · 2018-06-28 · EMA/824939/2012
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Perjeta-H-C-PSUSA-00010125-201412 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-10-08 · EMA/667576/2015
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Perjeta-H-C-2547-II-0010 : EPAR - Assessment Report - Variation
variation-report · 2015-08-14 · EMA/CHMP/285991/2015
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Perjeta : EPAR - Public assessment report
assessment-report · 2013-04-05 · EMA/17250/2013
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。