法规知识库 · EMA 集中审评
Xtandi
enzalutamide · EMEA/H/C/002639 · 已授权
获批上市许可
2013-06-21
欧委会决定日
2026-07-28
持有人 / 申请人
Astellas Pharma Europe B.V.
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
13
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L02BB04
治疗领域：Prostatic Neoplasms
药理分类：Endocrine therapy
修订号：29 · 最新影响 PI 的程序：N/0000362594
适应症（原文）：Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel 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。
2026-07-28 · 欧委会决定
2013-06-21 · 获批上市许可
2013-04-26 · 拒绝上市许可
2013-04-25 · 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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Xtandi : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-29
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Xtandi : EPAR - Risk management plan
rmp · 2026-07-02
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Xtandi-H-C-002639-X-0029: EPAR - Assessment report - Variation
variation-report · 2025-10-02 · EMA/CHMP/432249/2017
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Xtandi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-31
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Xtandi-H-C-PSUSA-00010095-202308 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2024-06-27 · EMA/158390/2024
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Xtandi : EPAR - Medicine overview
overview · 2024-06-03 · EMA/186470/2021
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Xtandi-H-C-002639-II-0063: EPAR - Assessment report - Variation
variation-report · 2024-04-25 · EMA/CHMP/147735/2024
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Xtandi-H-C-PSUSA-00010095-202008 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2021-06-23 · EMA/285965/2021
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Xtandi-H-C-2639-II-0047-G : EPAR - Assessment Report - Variation
variation-report · 2021-05-12 · EMA/202601/2021
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Xtandi-H-C-2639-II-0039-G : EPAR - Assessment Report - Variation
variation-report · 2019-01-25 · EMA/41918/2019
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Xtandi-H-C-PSUSA-00010095-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-05-28 · EMA/212233/2015
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Xtandi-H-C-2639-II-0008 : EPAR - Assessment Report - Variation
variation-report · 2015-01-20 · EMA/CHMP/607459/2014
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Xtandi : EPAR - Public assessment report
assessment-report · 2013-07-02 · EMA/CHMP/383457/2013
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。