欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Abrysvo
适用类别Human
治疗领域Respiratory Syncytial Virus Infections
通用名/非专利名称Respiratory syncytial virus vaccine (bivalent, recombinant)
活性成分Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein
产品号EMEA/H/C/006027
患者安全信息No
许可状态Authorised
ATC编码J07BX05
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Yes
是否罕用药No
上市许可日期2023/08/23
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG
人用药物治疗学分组Vaccines
兽用药物治疗学分组
审评意见日期2023/07/20
欧盟委员会决定日期2024/11/14
修订号6
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.
适用物种
兽用药物ATC编码
首次发布日期2023/07/17
最后更新日期2024/11/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo
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