| 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 |
| 授权状态 | Authorised |
| ATC编码 | C03DA01 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2023/05/26 |
| 上市许可持有人/公司名称 | Nova Laboratories Ireland Limited |
| 人用药物治疗分组 | Antihypertensives and diuretics in combination |
| 决定日期 | 2023/05/26 |
| 修订号 | |
| 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). |
| 首次发布日期 | 2023/07/25 |
| 产品信息 | 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 |