| 商品名称 | Optison |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Echocardiography |
| 通用名/非专利名称 | perflutren |
| 活性成分 | perflutren |
| 产品号 | EMEA/H/C/000166 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | V08DA01 |
| 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 | 1998/05/17 |
| 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 | Contrast media |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2022/05/19 |
| 修订号 | 19 |
| 治疗适应症 | This medicinal product is for diagnostic use only. Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation. Optison should only be used in patients where the study without contrast enhancement is inconclusive. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2014/05/08 |
| 最后更新日期 | 2022/06/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/optison-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/optison |