| 商品名称 | Respreeza |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Genetic Diseases, Inborn;Lung Diseases |
| 通用名/非专利名称 | alpha1-proteinase inhibitor (human) |
| 活性成分 | human alpha1-proteinase inhibitor |
| 产品号 | EMEA/H/C/002739 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | B02AB02 |
| 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 | 2015/08/20 |
| 上市许可开发者/申请人/持有人 | CSL Behring GmbH |
| 人用药物治疗学分组 | Antihemorrhagics |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2015/06/25 |
| 欧盟委员会决定日期 | 2025/03/26 |
| 修订号 | 15 |
| 治疗适应症 | Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/02/22 |
| 最后更新日期 | 2025/03/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/respreeza-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/respreeza |