法规知识库 · EMA 集中审评
Somatropin Biopartners
somatropin · EMEA/H/C/002196 · 已失效
获批上市许可
2013-08-05
欧委会决定日
2017-03-13
持有人 / 申请人
BioPartners GmbH
终止日期字段
2017-11-09
从产品到官方文件
文件记录
5
官方索引 5
EPAR / 审评
3
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:H01AC01
治疗领域:Growth
药理分类:Somatropin and somatropin agonists;Pituitary and hypothalamic hormones and analogues
修订号:3 · 最新影响 PI 的程序:IAIN/0010
适应症(原文):Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.
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。
2017-11-09 · 上市许可终止(撤市/失效/撤销等)
Lapsed
2017-03-13 · 欧委会决定
2013-08-05 · 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 ↗
Somatropin Biopartners : EPAR - Summary for the public
overview · 2017-12-01 · EMA/338086/2013
- 打开官方文件 ↗
Somatropin Biopartners : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2017-04-27
- 打开官方文件 ↗
Somatropin Biopartners : EPAR - Public assessment report
assessment-report · 2013-09-09 · EMA/CHMP/229458/2013
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。