欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Omnitrope
适用类别Human
治疗领域Turner Syndrome;Prader-Willi Syndrome;Dwarfism, Pituitary
通用名/非专利名称somatropin
活性成分somatropin
产品号EMEA/H/C/000607
患者安全信息No
许可状态Authorised
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Yes
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2006/04/12
上市许可开发者/申请人/持有人Sandoz GmbH
人用药物治疗学分组Pituitary and hypothalamic hormones and analogues
兽用药物治疗学分组
审评意见日期2003/06/26
欧盟委员会决定日期2025/08/05
修订号23
治疗适应症Infants, children and adolescents Growth disturbance due to insufficient secretion of growth hormone (GH). Growth disturbance associated with Turner syndrome. Growth disturbance associated with chronic renal insufficiency. Growth disturbance (current height standard-deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by four years of age or later. Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS < -2) 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2018/02/27
最后更新日期2025/08/05
产品说明书https://www.ema.europa.eu/en/documents/product-information/omnitrope-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope
©2006-2025 DrugFuture->European Medicines Agency Authorisation of Medicines DataBase