法规知识库 · EMA 集中审评
Faslodex
fulvestrant · EMEA/H/C/000540 · 已授权
获批上市许可
2004-03-09
欧委会决定日
2025-05-14
持有人 / 申请人
AstraZeneca AB
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
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L02BA03
治疗领域：Breast Neoplasms
药理分类：Endocrine therapy;Anti-estrogens
修订号：26 · 最新影响 PI 的程序：VR/0000248153
适应症（原文）：Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
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。
2025-05-14 · 欧委会决定
2004-03-09 · 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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Faslodex : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-06-08
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Faslodex : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-15
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Faslodex : EPAR - Risk management plan
rmp · 2023-12-08
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Faslodex : EPAR - Public assessment report
assessment-report · 2020-07-10
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Faslodex-H-C-540-II-0059 : EPAR - Assessment Report - Variation
variation-report · 2018-12-07 · EMA/53381/2018
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Faslodex : EPAR - Summary for the public
overview · 2018-01-27
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Faslodex-H-C-540-II-0057 : EPAR - Assessment Report - Variation
variation-report · 2017-10-02 · EMA/490887/2017
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Faslodex-H-C-540-II-0018 : EPAR - Assessment Report - Variation
variation-report · 2010-11-16
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Faslodex : EPAR - Scientific Discussion
scientific-discussion · 2006-01-09
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Faslodex : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-01-09
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。