| 商品名称 | Synagis |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Respiratory Syncytial Virus Infections |
| 通用名/非专利名称 | palivizumab |
| 活性成分 | palivizumab |
| 产品号 | EMEA/H/C/000257 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J06BD01 |
| 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 | 1999/08/13 |
| 上市许可开发者/申请人/持有人 | AstraZeneca AB |
| 人用药物治疗学分组 | Immune sera and immunoglobulins |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 1999/05/19 |
| 欧盟委员会决定日期 | 2023/09/14 |
| 修订号 | 46 |
| 治疗适应症 | Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season; children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months; children less than two years of age and with haemodynamically significant congenital heart disease. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/05/08 |
| 最后更新日期 | 2023/10/11 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/synagis |