| 商品名称 | Leqvio |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hypercholesterolemia;Dyslipidemias |
| 通用名/非专利名称 | inclisiran |
| 活性成分 | inclisiran |
| 产品号 | EMEA/H/C/005333 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | C10AX |
| 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 | 2020/12/09 |
| 上市许可开发者/申请人/持有人 | Novartis Europharm Limited |
| 人用药物治疗学分组 | Lipid modifying agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2020/10/15 |
| 欧盟委员会决定日期 | 2025/07/30 |
| 修订号 | 9 |
| 治疗适应症 | Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/01/06 |
| 最后更新日期 | 2025/09/18 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/leqvio-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio |