| 商品名称 | Abrysvo |
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| 适用类别 | Human |
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| 治疗领域 | Respiratory Syncytial Virus Infections |
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| 通用名/非专利名称 | Respiratory syncytial virus vaccine (bivalent, recombinant) |
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| 活性成分 | Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein |
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| 产品号 | EMEA/H/C/006027 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | J07BX05 |
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| 是否额外监管 | Yes |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | Yes |
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| 是否罕用药 | No |
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| 上市许可日期 | 2023/08/23 |
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| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
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| 人用药物治疗学分组 | Vaccines |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2023/07/20 |
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| 欧盟委员会决定日期 | 2024/11/14 |
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| 修订号 | 6 |
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| 治疗适应症 | Abrysvo is indicated for: Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1. Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV. The use of this vaccine should be in accordance with official recommendations. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2023/07/17 |
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| 最后更新日期 | 2024/11/28 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo |
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