| 商品名称 | Qaialdo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Edema;Heart Failure;Liver Cirrhosis;Ascites;Nephrotic Syndrome;Hyperaldosteronism;Essential Hypertension |
| 通用名/非专利名称 | spironolactone |
| 活性成分 | spironolactone |
| 产品号 | EMEA/H/C/005535 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | C03DA01 |
| 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 | 2023/05/26 |
| 上市许可开发者/申请人/持有人 | Nova Laboratories Ireland Limited |
| 人用药物治疗学分组 | Antihypertensives and diuretics in combination |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/08/19 |
| 修订号 | 2 |
| 治疗适应症 | In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2023/07/25 |
| 最后更新日期 | 2025/08/20 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/qaialdo-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/qaialdo |