| 商品名称 | Clopidogrel Acino Pharma |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Peripheral Vascular Diseases;Stroke;Myocardial Infarction |
| 通用名/非专利名称 | clopidogrel |
| 活性成分 | clopidogrel |
| 产品号 | EMEA/H/C/001172 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | B01AC04 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2009/09/21 |
| 上市许可开发者/申请人/持有人 | Acino Pharma GmbH |
| 人用药物治疗学分组 | Antithrombotic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2012/02/09 |
| 修订号 | 1 |
| 治疗适应症 | Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. For further information please refer to section 5.1. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2012/02/09 |
| 最后更新日期 | 2012/07/26 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/clopidogrel-acino-pharma-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/clopidogrel-acino-pharma |