法规知识库 · EMA 集中审评
Increlex
Mecasermin · EMEA/H/C/000704 · 已授权
获批上市许可
2007-08-02
欧委会决定日
2026-10-07
持有人 / 申请人
Esteve Pharmaceuticals, S.A.
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：H01AC03
治疗领域：Laron Syndrome
药理分类：Pituitary and hypothalamic hormones and analogues
修订号：30 · 最新影响 PI 的程序：N/0000380205
适应症（原文）：For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD is defined by: height standard deviation score ? -3.0 and; basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and; growth hormone (GH) sufficiency; exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
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。
2026-10-07 · 欧委会决定
2007-08-02 · 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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Increlex : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-08
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Increlex : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-18
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Increlex : EPAR - Risk-management-plan summary
rmp-summary · 2022-01-11
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Increlex-H-C-704-P46-054.1 : EPAR - Assessment Report
variation-report · 2015-08-06 · EMA/CHMP/433030/2015
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Increlex : EPAR - Summary for the public
overview · 2015-07-27
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Increlex-H-C-PSUSA-00001942-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-06-30
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Increlex-H-C-704-P46-050.2 : EPAR - Assessment Report
variation-report · 2015-04-13 · EMA/241222/2015
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Increlex : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2007-08-24
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Increlex : EPAR - Scientific Discussion
scientific-discussion · 2007-08-13
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Increlex : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-08-13
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。