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
许可状态Authorised
ATC编码H01AC03
是否额外监管Yes
是否仿制药或hybrid药物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
上市许可日期2007/08/02
上市许可开发者/申请人/持有人Esteve Pharmaceuticals, S.A.
人用药物治疗学分组Pituitary and hypothalamic hormones and analogues
兽用药物治疗学分组
欧盟委员会决定日期2025/11/06
修订号28
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2017/09/14
最后更新日期2025/11/06
产品说明书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
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase