法规知识库 · EMA 集中审评
Abraxane
paclitaxel · EMEA/H/C/000778 · 已授权
获批上市许可
2008-01-11
欧委会决定日
2026-01-20
持有人 / 申请人
Bristol-Myers Squibb Pharma EEIG
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01CD01
治疗领域：Breast Neoplasms;Pancreatic Neoplasms;Carcinoma, Non-Small-Cell Lung
药理分类：Antineoplastic agents
修订号：32 · 最新影响 PI 的程序：VR/0000311114
适应症（原文）：Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
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。
2026-01-20 · 欧委会决定
2008-01-11 · 获批上市许可
2007-10-18 · 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
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Abraxane : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-21
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Abraxane : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-21
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Abraxane : EPAR - Risk management plan
rmp · 2024-04-10
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Abraxane-H-C-778-II-0097 : EPAR - Assessment Report - Variation
variation-report · 2020-03-09 · EMA/116095/2020
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Abraxane-H-C-PSUSA-00010123-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-11-18 · EMA/564160/2019
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Abraxane-H-C-PSUSA-00010123-201601 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-11-23 · EMA/787208/2016
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Abraxane-H-C-II-0067 : EPAR - Assessment Report - Variation
variation-report · 2015-05-11 · EMA/76768/2015
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Abraxane : EPAR - Summary for the public
overview · 2015-05-11
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Abraxane-H-C-778-II-0055 : EPAR - Assessment Report - Variation
variation-report · 2014-01-30 · EMA/CHMP/627629/2013
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Abraxane : EPAR - Public assessment report
assessment-report · 2008-02-04
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。