法规知识库 · EMA 集中审评
NutropinAq
somatropin · EMEA/H/C/000315 · 已授权
获批上市许可
2001-02-15
欧委会决定日
2023-07-20
持有人 / 申请人
Ipsen Pharma
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
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：20 · 最新影响 PI 的程序：N/0079
适应症（原文）：Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.
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。
2023-07-20 · 欧委会决定
2001-02-15 · 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
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NutropinAq : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2023-07-20
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NutropinAq-H-C-PSUSA-00002772-202003 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-03-22
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NutropinAq-H-C-PSUSA-00002772-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-03-06 · EMA/140871/2018
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NutropinAq : EPAR - Summary for the public
overview · 2015-06-06
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NutropinAq : EPAR - Scientific Discussion
scientific-discussion · 2006-07-12
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NutropinAq : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-07-12
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。