| 商品名称 | LeukoScan |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteomyelitis;Radionuclide Imaging |
| 通用名/非专利名称 | sulesomab |
| 活性成分 | sulesomab |
| 产品号 | EMEA/H/C/000111 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | VO4D |
| 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 | 1997/02/14 |
| 上市许可开发者/申请人/持有人 | Immunomedics GmbH |
| 人用药物治疗学分组 | Diagnostic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2017/01/18 |
| 修订号 | 7 |
| 治疗适应症 | This medicinal product is for diagnostic use only. LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers. LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/01/18 |
| 最后更新日期 | 2018/02/09 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/leukoscan-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/leukoscan |