| 商品名称 | Ivabradine Anpharm |
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| 适用类别 | Human |
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| 治疗领域 | Angina Pectoris;Heart Failure |
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| 通用名/非专利名称 | ivabradine |
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| 活性成分 | ivabradine |
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| 产品号 | EMEA/H/C/004187 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | C01EB17 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2015/09/08 |
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| 上市许可开发者/申请人/持有人 | "Anpharm" Przedsiębiorstwo Farmaceutyczne S.A. |
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| 人用药物治疗学分组 | Other cardiac preparations |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2025/11/17 |
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| 修订号 | 11 |
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| 治疗适应症 | 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 contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal betablocker 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. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2018/01/11 |
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| 最后更新日期 | 2025/11/17 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ivabradine-anpharm-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ivabradine-anpharm |
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