| 商品名称 | Nplate |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Purpura, Thrombocytopenic, Idiopathic |
| 通用名/非专利名称 | romiplostim |
| 活性成分 | romiplostim |
| 产品号 | EMEA/H/C/000942 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | B02BX04 |
| 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 | 2009/02/04 |
| 上市许可开发者/申请人/持有人 | Amgen Europe B.V. |
| 人用药物治疗学分组 | Antihemorrhagics |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2008/11/20 |
| 欧盟委员会决定日期 | 2025/09/04 |
| 修订号 | 30 |
| 治疗适应症 | Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/04 |
| 最后更新日期 | 2025/10/15 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/nplate-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/nplate |