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法规知识库 · EMA 集中审评

Enzalutamide Viatris

enzalutamide · EMEA/H/C/006299 · 已授权

仿制药

获批上市许可

2024-08-22

欧委会决定日

2026-06-18

持有人 / 申请人

Viatris Limited

终止日期字段

无

从产品到官方文件

文件记录

8

官方索引 8

EPAR / 审评

6

assessment / overview 等

产品信息

2

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:6 · 最新影响 PI 的程序:VR/0000350515

适应症(原文):Enzalutamide Viatris is indicated:• 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);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for 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);• for 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。

  1. 2026-06-18 · 欧委会决定

  2. 2024-08-22 · 获批上市许可

  3. 2024-06-27 · 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 6产品信息 2其他 0

EPAR / 审评资料

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

    procedural-steps-after · 2026-10-20

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

    procedural-steps-after · 2026-06-23

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  • Enzalutamide Viatris-H-C-006299-X-0003 : EPAR - Assessment report

    variation-report · 2026-01-23 · EMA/CHMP/246017/2025

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  • Enzalutamide Viatris : EPAR - Medicine overview

    overview · 2024-10-09 · EMA/320757/2024

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  • Enzalutamide Viatris : EPAR - Risk management plan

    rmp · 2024-10-09

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  • Enzalutamide Viatris : EPAR - Public assessment report

    assessment-report · 2024-10-09 · EMA/338096/2024

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产品信息

  • Enzalutamide Viatris : EPAR - Product information

    product-information · 2026-06-23

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  • Enzalutamide Viatris : EPAR - All authorised presentations

    all-authorised-presentations · 2025-12-09

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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。