法规知识库 · EMA 集中审评
Ibandronic acid Accord
ibandronic acid · EMEA/H/C/002638 · 已授权
获批上市许可
2012-11-18
欧委会决定日
2025-09-25
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
6
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：M05BA06
治疗领域：Wounds and Injuries;Breast Diseases;Neoplastic Processes;Calcium Metabolism Disorders;Water-Electrolyte Imbalance
药理分类：Drugs for treatment of bone diseases
修订号：17 · 最新影响 PI 的程序：VR/0000300801
适应症（原文）：Ibandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour induced hypercalcaemia with or without metastases. Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
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。
2025-09-25 · 欧委会决定
2012-11-18 · 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 ↗
Ibandronic acid Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-09-26
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - Risk management plan
rmp · 2025-03-04
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-04
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - Summary for the public
overview · 2017-10-30 · EMEA/H/C/002638
- 打开官方文件 ↗
Ibandronic acid Accord-H-C-2638-X-0006 : EPAR - Assessment Report - Extension
variation-report · 2015-05-26 · EMA/198447/2015
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - Public assessment report
assessment-report · 2012-12-06 · EMA/711044/2012
产品信息
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - Product information - tracked changes
product-information-tracked-changes · 2025-09-26
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - Product Information
product-information · 2025-09-26
- 打开官方文件 ↗
Ibandronic acid Accord : EPAR - All Authorised presentations
all-authorised-presentations · 2015-05-26
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。