EMA What's New·· 2 天前AI 评分22
EMA 修改已同意的人巨细胞病毒 mRNA 疫苗儿科研究计划（PIP）
EMA/PE/0000291645
AI 导读
EMA 就编码人巨细胞病毒 UL128、UL130、UL131A、gH、gB、gL 的 mRNA 疫苗作出修改已同意儿科研究计划（PIP）的决定，决定编号 EMA/PE/0000291645，决定日期 29/01/2026。该产品为注射用混悬液粉末，经肌内给药，适应症为预防巨细胞病毒感染，合规检查未完成。
正文 · 原文
Key facts
Active substance
- mRNA encoding Human cytomegalovirus UL128
- mRNA encoding Human cytomegalovirus UL130
- mRNA encoding Human cytomegalovirus UL131A
- mRNA encoding Human cytomegalovirus glycoprotein H
- mRNA encoding Human cytomegalovirus glycoprotein B
- mRNA encoding Human cytomegalovirus glycoprotein L
Therapeutic area
Infections and infestations
Decision number
EMA/PE/0000291645
PIP number
EMA/PE/0000291645
Pharmaceutical form(s)
Powder for suspension for injection
Condition(s) / indication(s)
Prevention of cytomegalovirus infection
Route(s) of administration
Intramuscular use
Contact for public enquiries
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
29/01/2026
Compliance check done
No
来源：EMA What's New · ema.europa.eu