| 商品名称 | Uptravi |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hypertension, Pulmonary |
| 通用名/非专利名称 | selexipag |
| 活性成分 | selexipag |
| 产品号 | EMEA/H/C/003774 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | B01AC27 |
| 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 | 2016/05/12 |
| 上市许可开发者/申请人/持有人 | Janssen Cilag International NV |
| 人用药物治疗学分组 | Antithrombotic agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2016/01/28 |
| 欧盟委员会决定日期 | 2024/11/08 |
| 修订号 | 18 |
| 治疗适应症 | Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/04/09 |
| 最后更新日期 | 2025/05/22 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/uptravi-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/uptravi |