法规知识库 · EMA 集中审评
Beyfortus
nirsevimab · EMEA/H/C/005304 · 已授权
获批上市许可
2022-10-31
欧委会决定日
2026-03-12
持有人 / 申请人
Sanofi Winthrop Industrie
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
9
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J06BD08
治疗领域：—
药理分类：Immune sera and immunoglobulins
修订号：15 · 最新影响 PI 的程序：VR/0000319983
适应症（原文）：Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2026-03-12 · 欧委会决定
2022-10-31 · 获批上市许可
2022-09-15 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Beyfortus-PAM-0000303330 : EPAR - Assessment report
variation-report · 2026-04-24 · EMADOC-1700519818-2500371
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Beyfortus : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-01
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Beyfortus : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-24
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Beyfortus : EPAR - Risk management plan
rmp · 2024-10-07
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Beyfortus-H-C-005304-II-0005 : EPAR - Assessment report - Variation
variation-report · 2024-09-24 · EMA/355992/2024
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Beyfortus : EPAR - Medicine Overview
overview · 2024-09-04 · EMA/776857/2022
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Beyfortus : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2024-06-05 · EMA/182502/2024
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Beyfortus-H-C-005304-P46-006 : EPAR - Assessment Report
variation-report · 2024-01-15
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Beyfortus : EPAR - Public assessment report
assessment-report · 2022-11-15 · EMA/786523/2022
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。