| 商品名称 | Macitentan Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hypertension, Pulmonary |
| 通用名/非专利名称 | macitentan |
| 活性成分 | macitentan |
| 产品号 | EMEA/H/C/006524 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | C02KX04 |
| 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 | 2025/09/24 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare |
| 人用药物治疗学分组 | Antihypertensives |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2025/07/24 |
| 修订号 | |
| 治疗适应症 | AdultsMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1). Paediatric populationMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHOFunctional Class (FC) II to III (see section 5.1). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2025/07/25 |
| 最后更新日期 | 2025/12/19 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/macitentan-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/macitentan-accord |