| 商品名称 | Pramipexole Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Parkinson Disease;Restless Legs Syndrome |
| 通用名/非专利名称 | pramipexole |
| 活性成分 | pramipexole dihydrochloride monohydrate |
| 产品号 | EMEA/H/C/002291 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | N04BC05 |
| 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 | 2011/09/29 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Anti-Parkinson drugs |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2011/07/21 |
| 欧盟委员会决定日期 | 2020/11/20 |
| 修订号 | 10 |
| 治疗适应症 | Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/10/24 |
| 最后更新日期 | 2024/03/11 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/pramipexole-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/pramipexole-accord |