欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Increlex
适用类别Human
治疗领域Laron Syndrome
通用名/非专利名称mecasermin
活性成分Mecasermin
产品号EMEA/H/C/000704
患者安全信息no
授权状态Authorised
ATC编码H01AC03
是否额外监管yes
是否仿制药no
是否生物类似药no
是否附条件批准no
是否特殊情形yes
是否加速审评no
是否罕用药no
批准上市日期2007/08/02
上市许可持有人/公司名称Ipsen Pharma
人用药物治疗分组Pituitary and hypothalamic hormones and analogues
决定日期2021/11/11
修订号24
适应症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.
首次发布日期2017/09/14
修订日期2022/01/11
产品信息https://www.ema.europa.eu/en/documents/product-information/increlex-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/increlex
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