| 商品名称 | Ablavar (previously Vasovist) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Magnetic Resonance Angiography |
| 通用名/非专利名称 | gadofosveset trisodium |
| 活性成分 | gadofosveset trisodium |
| 产品号 | EMEA/H/C/000601 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | V08CA |
| 是否额外监管 | no |
| 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 | no |
| 是否加速审评 | no |
| 是否罕用药 | no |
| 批准上市日期 | 2005/10/03 |
| 上市许可持有人/公司名称 | TMC Pharma Services Ltd. |
| 人用药物治疗分组 | Contrast media |
| 决定日期 | 2011/05/15 |
| 修订号 | 10 |
| 适应症 | This medicinal product is for diagnostic use only.Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease. |
| 首次发布日期 | 2011/05/15 |
| 修订日期 | 2011/11/14 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/ablavar-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ablavar-previously-vasovist |