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法规知识库 · EMA 集中审评

Afinitor

everolimus · EMEA/H/C/001038 · 已授权

获批上市许可

2009-08-02

欧委会决定日

2025-11-20

持有人 / 申请人

Novartis Europharm Limited

终止日期字段

无

从产品到官方文件

文件记录

11

官方索引 11

EPAR / 审评

9

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:L01XE10

治疗领域:Carcinoma, Renal Cell;Breast Neoplasms;Pancreatic Neoplasms

药理分类:Antineoplastic agents

修订号:33 · 最新影响 PI 的程序:VR/0000310437

适应症(原文):Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted 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. 2025-11-20 · 欧委会决定

  2. 2009-08-02 · 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 9产品信息 2其他 0

EPAR / 审评资料

  • Afinitor : EPAR - Procedural steps taken and scientific information after authorisation (archived)

    procedural-steps-after · 2026-10-20

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

    procedural-steps-after · 2025-11-20

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  • Afinitor : EPAR - Risk-management-plan summary

    rmp-summary · 2021-12-07

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  • Afinitor : EPAR - Summary for the public

    overview · 2018-12-11 · EMA/44790/2013

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  • Afinitor-H-C-1038-II-0048 : EPAR - Assessment Report - Variation

    variation-report · 2016-07-21 · EMA/390543/2016

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  • Afinitor-H-C-1038-PSUV-0039 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

    scientific-conclusion · 2014-12-23 · EMA/794249/2014

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  • Afinitor-H-C-1038-II-0020 : EPAR - Assessment Report - Variation

    variation-report · 2012-08-07 · EMA/CHMP/438808/2012

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  • Afinitor-H-C-1038-II-0008: EPAR - Assessment Report - Variation

    variation-report · 2011-09-29 · EMA/723893/2011

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  • Afinitor : EPAR - Public assessment report

    assessment-report · 2009-09-02

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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。