| 商品名称 | SonoVue |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Ultrasonography;Echocardiography |
| 通用名/非专利名称 | sulphur hexafluoride |
| 活性成分 | sulphur hexafluoride |
| 产品号 | EMEA/H/C/000303 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | V08DA05 |
| 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 | 2001/03/26 |
| 上市许可开发者/申请人/持有人 | Bracco International B.V. |
| 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 | 2022/11/10 |
| 修订号 | 21 |
| 治疗适应症 | This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio. SonoVue should only be used in patients where study without contrast enhancement is inconclusive. Echocardiography SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation. Doppler of macrovasculature SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio. SonoVue increases the quality of the Doppler flow image and the duration of clinically useful signal enhancement in portal vein assessment in adult patients. Doppler of microvasculature SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation. Ultrasonography of excretory urinary tract SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/04/26 |
| 最后更新日期 | 2025/11/24 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sonovue-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sonovue |