| 商品名称 | Corlentor |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Angina Pectoris; Heart Failure |
| 通用名/非专利名称 | ivabradine |
| 活性成分 | ivabradine hydrochloride |
| 产品号 | EMEA/H/C/000598 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | C01EB17 |
| 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 | 2005/10/25 |
| 上市许可持有人/公司名称 | Les Laboratoires Servier |
| 决定日期 | 2021/09/30 |
| 修订号 | 26 |
| 适应症 | Symptomatic treatment of chronic stable angina pectorisIvabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. |
| 首次发布日期 | 2018/01/11 |
| 修订日期 | 2021/12/17 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/corlentor-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor |