法规知识库 · EMA 集中审评
Fablyn
Lasofoxifene tartrate · EMEA/H/C/000977 · 已失效
获批上市许可
2009-02-24
欧委会决定日
2012-02-27
持有人 / 申请人
Dr. Friedrich Eberth Arzneimittel GmbH
终止日期字段
2012-02-27
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:G03
治疗领域:Osteoporosis, Postmenopausal
药理分类:Sex hormones and modulators of the genital system
修订号:2 · 最新影响 PI 的程序:T/0003
适应症(原文):Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
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。
2012-02-27 · 欧委会决定
2012-02-27 · 上市许可终止(撤市/失效/撤销等)
Lapsed
2009-02-24 · 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 ↗
Fablyn : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2012-06-22
- 打开官方文件 ↗
Fablyn : EPAR - Summary for the public
overview · 2012-06-22
- 打开官方文件 ↗
Fablyn : EPAR - Public assessment report
assessment-report · 2012-06-22
- 打开官方文件 ↗
Fablyn : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2012-06-21
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。