法规知识库 · EMA 集中审评
Votubia
everolimus · EMEA/H/C/002311 · 已授权
获批上市许可
2011-09-02
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
18
官方索引 18
EPAR / 审评
16
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XE10
治疗领域：Tuberous Sclerosis
药理分类：Antineoplastic agents
修订号：34 · 最新影响 PI 的程序：VR/0000310311
适应症（原文）：Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease?related symptoms, has not been demonstrated.
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。
2025-11-20 · 欧委会决定
2011-09-02 · 获批上市许可
2011-06-23 · 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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Votubia : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-20
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Votubia : EPAR - Procedural steps taken and scientific information after authorisation (Archived)
procedural-steps-after · 2024-12-06
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Votubia-H-C-002311-II-0089 : EPAR - Assessment report - Variation
variation-report · 2024-10-30 · EMA/442156/2024
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Votubia : EPAR - Risk management plan
rmp · 2024-10-30
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Votubia-H-C-2311-II-0061 : EPAR - Assessment Report - Variation
variation-report · 2020-09-16 · EMA/471889/2020
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Votubia-H-C-002311-X-0045 : EPAR - Assessment Report - Extension
variation-report · 2018-06-15 · EMA/221731/2018
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Votubia : EPAR - Medicine overview
overview · 2018-06-15 · EMA/528406/2011
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Votubia-H-C-2311-II-0041 : EPAR - Assessment Report - Variation
variation-report · 2017-02-24 · EMA/12340/2017
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Votubia-H-C-2311-P46-28: EPAR - Assessment Report
variation-report · 2016-06-21 · EMA/430409/2016
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Votubia-H-C-2311-P46-0026 : EPAR - Assessment report
variation-report · 2015-12-03 · EMA/817353/2015
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Votubia-H-C-2311-P46-0022.1: EPAR - Assessment Report
variation-report · 2015-06-30 · EMA/314770/2015
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Votubia-H-C-2311-PSUV-0025 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-12-23
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Votubia-H-C-2311-PSUV-0022 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-07-02 · EMA/382291/2014
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Votubia-H-C-2311-X-0008-G : EPAR - Assessment Report - Extension
variation-report · 2014-01-23 · EMA/CHMP/39285/2014
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Votubia-H-C-2311-II-0004 : EPAR - Assessment Report - Variation
variation-report · 2012-12-03 · EMA/686119/2012
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Votubia : EPAR - Public assessment report
assessment-report · 2011-09-19 · EMA/646111/2011
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。