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法规知识库 · EMA 集中审评

Valtropin

somatropin · EMEA/H/C/000602 · 已撤市

生物类似药

获批上市许可

2006-04-24

欧委会决定日

2012-05-10

持有人 / 申请人

BioPartners GmbH

终止日期字段

2012-05-10

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:H01AC01

治疗领域:Turner Syndrome;Dwarfism, Pituitary

药理分类:Pituitary and hypothalamic hormones and analogues

修订号:5 · 最新影响 PI 的程序:A20/08

适应症(原文):Paediatric poulation Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. Adult patients Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) 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. 2012-05-10 · 欧委会决定

  2. 2012-05-10 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  3. 2006-04-24 · 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 5产品信息 2其他 0

EPAR / 审评资料

  • Valtropin-H-C-620-A20-08 : EPAR - Assessment Report - Variation

    variation-report · 2012-08-14

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

    procedural-steps-after · 2012-08-14

    打开官方文件 ↗
  • Valtropin : EPAR - Scientific Discussion

    scientific-discussion · 2012-08-14

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  • Valtropin : EPAR - Summary for the public

    overview · 2012-08-14

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  • Valtropin : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2012-08-14

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产品信息

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。