法规知识库 · EMA 集中审评
Ronapreve
casirivimab;imdevimab · EMEA/H/C/005814 · 已撤市
获批上市许可
2021-11-12
欧委会决定日
2025-04-03
持有人 / 申请人
Roche Registration GmbH
终止日期字段
2025-12-05
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J06BD07
治疗领域：COVID-19 virus infection
药理分类：Immune sera and immunoglobulins
修订号：9 · 最新影响 PI 的程序：VR/0000254621
适应症（原文）：Ronapreve is indicated for:- Treatment of COVID-19 in adults, adolescents and children aged 2 years and older weighing at least 10 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. - Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.Ronapreve should be used in accordance with official recommendations where available and based on information on the activity of casirivimab and imdevimab against presently circulating viral variants.
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。
2025-12-05 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2025-04-03 · 欧委会决定
2021-11-12 · 获批上市许可
2021-11-11 · 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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Ronapreve-H-C-005814-II-0017 : EPAR - Assessment report - Variation
variation-report · 2026-01-23 · EMA/CHMP/104963/2025
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Ronapreve : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-23
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Ronapreve-H-C-5814-II-0002 : EPAR - Assessment report
variation-report · 2026-01-23 · EMA/CHMP/68947/2023
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Ronapreve-H-C-5814-P46-015 : EPAR - Assessment report
variation-report · 2026-01-23 · EMA/CHMP/57023/2023
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Ronapreve-H-C-5814-P46-016 : EPAR - Assessment report
variation-report · 2026-01-23 · EMA/CHMP/57024/2023
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Ronapreve-H-C-5814-P46-017 : EPAR - Assessment report
variation-report · 2026-01-23 · EMA/CHMP/57025/2023
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Ronapreve-H-C-5814-P46-005 : EPAR - Assessment report
variation-report · 2026-01-23 · EMA/902731/2022
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Ronapreve : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-23
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Ronapreve : EPAR - Risk-management-plan
rmp · 2026-01-23
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Ronapreve : EPAR - Public assessment report
assessment-report · 2026-01-23 · EMA/680189/2021
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Ronapreve : EPAR - Medicine overview
overview · 2026-01-23 · EMA/47158/2025
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。