| 商品名称 | NutropinAq |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Turner Syndrome;Dwarfism, Pituitary |
| 通用名/非专利名称 | somatropin |
| 活性成分 | somatropin |
| 产品号 | EMEA/H/C/000315 |
| 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 | 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 | 2001/02/15 |
| 上市许可开发者/申请人/持有人 | Ipsen Pharma |
| 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 | 2023/07/20 |
| 修订号 | 20 |
| 治疗适应症 | Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/02/22 |
| 最后更新日期 | 2023/07/20 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nutropinaq-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nutropinaq |