| 商品名称 | Vizamyl |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Radionuclide Imaging;Alzheimer Disease |
| 通用名/非专利名称 | flutemetamol (18F) |
| 活性成分 | flutemetamol (18F) |
| 产品号 | EMEA/H/C/002557 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | V09AX04 |
| 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 | 2014/08/22 |
| 上市许可开发者/申请人/持有人 | GE Healthcare AS |
| 人用药物治疗学分组 | Diagnostic radiopharmaceuticals |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2014/06/26 |
| 欧盟委员会决定日期 | 2025/11/18 |
| 修订号 | 20 |
| 治疗适应症 | This medicinal product is for diagnostic use only. Vizamyl is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of ? amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Vizamyl should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/07/31 |
| 最后更新日期 | 2025/11/18 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vizamyl-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vizamyl |