商品名称 | Procoralan |
---|---|
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/000597 |
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 |
人用药物治疗分组 | Cardiac therapy |
决定日期 | 2021/09/30 |
修订号 | 22 |
适应症 | Symptomatic treatment of chronic stable angina pectoris Ivabradine 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 failure Ivabradine 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/procoralan-epar-product-information_en.pdf |
公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/procoralan |