| 商品名称 | Vueway |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Magnetic Resonance Imaging |
| 通用名/非专利名称 | gadopiclenol |
| 活性成分 | Gadopiclenol |
| 产品号 | EMEA/H/C/006172 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | V08CA12 |
| 是否额外监管 | Yes |
| 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 | 2023/12/07 |
| 上市许可开发者/申请人/持有人 | Bracco Imaging S.p.A. |
| 人用药物治疗学分组 | Paramagnetic contrast media |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2023/10/12 |
| 欧盟委员会决定日期 | 2026/01/22 |
| 修订号 | 4 |
| 治疗适应症 | This medicinal product is for diagnostic use only.Vueway is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2023/10/13 |
| 最后更新日期 | 2026/03/12 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vueway-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vueway |