法规知识库 · EMA 集中审评
Temodal
temozolomide · EMEA/H/C/000229 · 已授权
获批上市许可
1999-01-26
欧委会决定日
2026-06-03
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01AX03
治疗领域：Glioma
药理分类：Antineoplastic agents
修订号：41 · 最新影响 PI 的程序：VR/0000337114
适应症（原文）：Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard 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。
2026-06-03 · 欧委会决定
1999-01-26 · 获批上市许可
1998-10-22 · 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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Temodal : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-18
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Temodal : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-22
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Temodal-H-C-PSUSA-00002886-201707 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-06-12 · EMA/392745/2018
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Temodal-H-C-PSUSA-00002886-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-07-29 · EMA/CHMP/252826/2015
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Temodal-H-C-229-A20-60 : EPAR - Assessment Report - Article 20
variation-report · 2013-03-12 · EMA/14060/2013
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Temodal : EPAR - Summary for the public
overview · 2012-03-01
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Temodal-H-C-229-II-21 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-12-08
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Temodal : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-12-13
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Temodal : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-12-13
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Temodal : EPAR - Scientific Discussion
scientific-discussion · 2005-12-13
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。