| 商品名称 | Sapropterin Dipharma |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Phenylketonurias |
| 通用名/非专利名称 | sapropterin |
| 活性成分 | sapropterin dihydrochloride |
| 产品号 | EMEA/H/C/005646 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | A16AX07 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2022/02/16 |
| 上市许可开发者/申请人/持有人 | Dipharma Arzneimittel GmbH |
| 人用药物治疗学分组 | Other alimentary tract and metabolism products |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2021/12/16 |
| 欧盟委员会决定日期 | 2025/02/20 |
| 修订号 | 6 |
| 治疗适应症 | Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/12/14 |
| 最后更新日期 | 2025/10/17 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sapropterin-dipharma-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sapropterin-dipharma |