法规知识库 · EMA 集中审评
Aclasta
zoledronic acid · EMEA/H/C/000595 · 已授权
获批上市许可
2005-04-15
欧委会决定日
2026-04-16
持有人 / 申请人
Sandoz Pharmaceuticals d.d.
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
14
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：M05BA08
治疗领域：Osteoporosis;Osteitis Deformans;Osteoporosis, Postmenopausal
药理分类：Drugs for treatment of bone diseases
修订号：36 · 最新影响 PI 的程序：N/0000341352
适应症（原文）：Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture. Treatment of Paget's disease of the bone.
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。
2026-04-16 · 欧委会决定
2005-04-15 · 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
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Aclasta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-20
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Aclasta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-04-20
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Aclasta : EPAR - Risk-management-plan
rmp · 2024-03-04
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Aclasta-H-C-595-P46-036 : EPAR - Assessment Report
variation-report · 2018-12-18 · EMA/873947/2018
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Aclasta-H-C-PSUSA-00009334-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-07-28 · EMA/CHMP/373034/2015
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Aclasta : EPAR - Summary for the public
overview · 2015-07-28
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Aclasta-H-C-595-PSUV-0047 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-12-05 · EMA/CHMP/753938/2014
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Aclasta : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2012-06-07
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Aclasta-H-C-595-A20-0026 : EPAR - Assessment Report - Article 20
variation-report · 2011-09-13 · EMA/543438/2011
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Aclasta-H-C-595-II-0017 : EPAR - Assessment Report - Variation
variation-report · 2009-07-08 · EMEA/CHMP/358213/2009
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Aclasta-H-C-595-II-0016 : EPAR - Assessment Report - Variation
variation-report · 2008-10-21 · EMEA/CHMP/483357/2008
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Aclasta-H-C-595-II-10 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-10-23
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Aclasta : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-04-03
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Aclasta : EPAR - Scientific Discussion
scientific-discussion · 2006-04-03
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。