| 商品名称 | Valtropin |
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| 适用类别 | Human |
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| 治疗领域 | Turner Syndrome;Dwarfism, Pituitary |
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| 通用名/非专利名称 | somatropin |
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| 活性成分 | somatropin |
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| 产品号 | EMEA/H/C/000602 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | H01AC01 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | Yes |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2006/04/24 |
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| 上市许可开发者/申请人/持有人 | BioPartners GmbH |
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| 人用药物治疗学分组 | Pituitary and hypothalamic hormones and analogues |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2012/05/10 |
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| 修订号 | 5 |
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| 治疗适应症 | Paediatric poulation Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. Adult patients Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone 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-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2012/05/10 |
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| 最后更新日期 | 2012/08/14 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/valtropin-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/valtropin |
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