欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Somatropin Biopartners
适用类别Human
治疗领域Growth
通用名/非专利名称somatropin
活性成分somatropin
产品号EMEA/H/C/002196
患者安全信息No
许可状态Lapsed
ATC编码H01AC01
是否额外监管No
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No
是否加速审评No
是否罕用药No
上市许可日期2013/08/05
上市许可开发者/申请人/持有人BioPartners GmbH
人用药物治疗学分组Somatropin and somatropin agonists;Pituitary and hypothalamic hormones and analogues
兽用药物治疗学分组
欧盟委员会决定日期2017/03/13
修订号3
治疗适应症Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.
适用物种
兽用药物ATC编码
首次发布日期2017/03/13
最后更新日期2017/12/01
产品说明书https://www.ema.europa.eu/en/documents/product-information/somatropin-biopartners-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/somatropin-biopartners
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