法规知识库 · EMA 集中审评
Zoledronic Acid Hospira
zoledronic acid monohydrate · EMEA/H/C/002365 · 已撤市
获批上市许可
2012-11-19
欧委会决定日
2021-10-01
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
2024-02-22
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：M05BA08
治疗领域：Hypercalcemia
药理分类：Drugs for treatment of bone diseases
修订号：19 · 最新影响 PI 的程序：N/0045
适应症（原文）：4 mg / 5 ml and 4 mg / 100 ml: 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). 5 mg / 100 ml: 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; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.
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。
2024-02-22 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2021-10-01 · 欧委会决定
2012-11-19 · 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
- 打开官方文件 ↗
Zoledronic Acid Hospira-H-C-PSUSA-3149-01608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2026-05-12 · EMA/321882/2017
- 打开官方文件 ↗
Zoledronic Acid Hospira : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-12
- 打开官方文件 ↗
Zoledronic Acid Hospira : EPAR - Public assessment report
assessment-report · 2026-05-12 · EMA/711812/2012
- 打开官方文件 ↗
Zoledronic Acid Hospira : EPAR - Summary for the public
overview · 2026-05-12 · EMA/623949/2012
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。