| 商品名称 | Ongentys |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Parkinson Disease |
| 通用名/非专利名称 | opicapone |
| 活性成分 | opicapone |
| 产品号 | EMEA/H/C/002790 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N04 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | 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 |
| 上市许可日期 | 2016/06/24 |
| 上市许可开发者/申请人/持有人 | Bial - Portela Cª, S.A. |
| 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 | 2016/04/28 |
| 欧盟委员会决定日期 | 2024/07/11 |
| 修订号 | 10 |
| 治疗适应症 | Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/01/17 |
| 最后更新日期 | 2025/05/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ongentys-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ongentys |