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法规知识库 · EMA 集中审评

Zirabev

bevacizumab · EMEA/H/C/004697 · 已授权

生物类似药额外监测

获批上市许可

2019-02-14

欧委会决定日

2026-03-25

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

10

官方索引 10

EPAR / 审评

7

assessment / overview 等

产品信息

3

PI / presentations

其他

0

RMP / PIP 等

ATC:L01XC07

治疗领域:Colorectal Neoplasms;Breast Neoplasms;Carcinoma, Non-Small-Cell Lung;Carcinoma, Renal Cell;Uterine Cervical Neoplasms

药理分类:Antineoplastic agents

修订号:19 · 最新影响 PI 的程序:N/0000337578

适应症(原文):Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

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。

  1. 2026-03-25 · 欧委会决定

  2. 2019-02-14 · 获批上市许可

  3. 2018-12-13 · 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 7产品信息 3其他 0

EPAR / 审评资料

  • Zirabev : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-03-25

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  • Zirabev-PSUSA-00000403-202502 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2026-01-28 · EMADOC-1700519818-2470418

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  • Zirabev : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-06-10

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  • Zirabev-H-C-PSUSA-00000403-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

    scientific-conclusion · 2023-01-05 · EMA/921971/2022

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  • Zirabev : EPAR - Medicine overview

    overview · 2020-02-11 · EMA/11276/2020

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  • Zirabev : EPAR - Risk-management-plan summary

    rmp-summary · 2019-04-16

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  • Zirabev : EPAR - Public assessment report

    assessment-report · 2019-04-16 · EMA/97237/2019

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产品信息

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。