| 商品名称 | Piasky |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hemoglobinuria, Paroxysmal |
| 通用名/非专利名称 | crovalimab |
| 活性成分 | |
| 产品号 | EMEA/H/C/006061 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AJ07 |
| 是否额外监管 | Yes |
| 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 | 2024/08/22 |
| 上市许可开发者/申请人/持有人 | Roche Registration GmbH |
| 人用药物治疗学分组 | Immunosuppressants, Complement inhibitors |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2024/06/27 |
| 欧盟委员会决定日期 | 2025/10/17 |
| 修订号 | 3 |
| 治疗适应症 | Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): In patients with haemolysis with clinical symptom(s) indicative of high disease activity. In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2024/06/28 |
| 最后更新日期 | 2025/10/21 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/piasky-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/piasky |