| 商品名称 | Elaprase |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Mucopolysaccharidosis II |
| 通用名/非专利名称 | idursulfase |
| 活性成分 | idursulfase |
| 产品号 | EMEA/H/C/000700 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | A16AB09 |
| 是否额外监管 | yes |
| 是否仿制药 | no |
| 是否生物类似药 | no |
| 是否附条件批准 | no |
| 是否特殊情形 | yes |
| 是否加速审评 | no |
| 是否罕用药 | no |
| 批准上市日期 | 2007/01/08 |
| 上市许可持有人/公司名称 | Takeda Pharmaceuticals International AG Ireland Branch |
| 人用药物治疗分组 | Other alimentary tract and metabolism products, |
| 决定日期 | 2022/12/14 |
| 修订号 | 25 |
| 适应症 | Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials. |
| 首次发布日期 | 2018/06/21 |
| 修订日期 | 2022/12/15 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/elaprase-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/elaprase |