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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。

  1. 2017-11-09 · 上市许可终止(撤市/失效/撤销等)

    Lapsed

  2. 2017-03-13 · 欧委会决定

  3. 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 3产品信息 2其他 0

EPAR / 审评资料

  • Somatropin Biopartners : EPAR - Summary for the public

    overview · 2017-12-01 · EMA/338086/2013

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  • Somatropin Biopartners : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2017-04-27

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  • Somatropin Biopartners : EPAR - Public assessment report

    assessment-report · 2013-09-09 · EMA/CHMP/229458/2013

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产品信息

  • Somatropin Biopartners : EPAR - Product Information

    product-information · 2017-04-27

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  • Somatropin Biopartners : EPAR - All Authorised presentations

    all-authorised-presentations · 2013-09-09

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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。