法规知识库 · EMA 集中审评
Zometa
zoledronic acid;zoledronic acid monohydrate · EMEA/H/C/000336 · 已授权
获批上市许可
2001-03-20
欧委会决定日
2024-09-05
持有人 / 申请人
Phoenix Labs Unlimited Company
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：M05BA08
治疗领域：Cancer;Fractures, Bone
药理分类：Drugs for treatment of bone diseases
修订号：40 · 最新影响 PI 的程序：II/0103/G
适应症（原文）：Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).
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。
2024-09-05 · 欧委会决定
2001-03-20 · 获批上市许可
2000-12-14 · 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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Zometa : EPAR - Risk management plan
rmp · 2025-08-11
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Zometa : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-10-29
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Zometa-H-C-PSUSA-00003149-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-06-20 · EMA/321878/2017
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Zometa-H-C-PSUSA-00003149/-01508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-06-28 · EMA/CHMP/356759/2016
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Zometa : EPAR - Summary for the public
overview · 2015-11-24
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Zometa-H-C-PSUSA-00003149-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-09-01 · EMA/CHMP/300110/2015
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Zometa-H-C-336-P46-0040 : EPAR - Assessment report
variation-report · 2015-06-08 · EMA/CHMP/383288/2015
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Zometa-H-C-336-A20-0036 : EPAR - Assessment Report – Article 20
variation-report · 2011-09-29 · EMA/543437/2011
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Zometa-H-C-336-II-0031 : EPAR - Assessment Report - Variation
variation-report · 2010-03-01 · EMA/35729/2010
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Zometa : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
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Zometa : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
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Zometa : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-21
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。