法规知识库 · EMA 集中审评
Prevymis
Letermovir · EMEA/H/C/004536 · 已授权
获批上市许可
2018-01-08
欧委会决定日
2025-12-05
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J05
治疗领域：Cytomegalovirus Infections
药理分类：Antivirals for systemic use
修订号：18 · 最新影响 PI 的程序：N/0000304418
适应症（原文）：Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration should be given to official guidance on the appropriate use of antiviral agents.
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 · 欧委会决定
2018-01-08 · 获批上市许可
2017-10-12 · 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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Prevymis : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-12
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Prevymis-H-C-004536-X-0037-G : EPAR - Assessment report - Variation
variation-report · 2025-05-27 · EMA/CHMP/56610/2025
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Prevymis : EPAR - Risk management plan
rmp · 2025-05-27
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Prevymis : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-27
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Prevymis : EPAR - Medicine overview
overview · 2025-05-27 · EMA/80635/2025
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Prevymis-H-C-004536-II-0033-G : EPAR - Assessment report - Variation
variation-report · 2024-01-18 · EMA/525117/2023
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Prevymis : Orphan maintenance assessment report (post authorisation)
orphan-maintenance-report-post · 2024-01-18 · EMA/OD/0000133054
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Prevymis : Orphan maintenance assessment report (initial authorisation)
orphan-maintenance-report · 2018-01-17 · EMA/785410/2017
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Prevymis : EPAR - Public assessment report
assessment-report · 2018-01-17 · EMA/CHMP/490007/2017
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。