EMA 完成 ethosuximide 定期安全性更新报告单次评估，结论为维持现状

PSUSA/00001316/202603

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EMA 对 ethosuximide 的定期安全性更新报告完成单次评估（PSUSA/00001316/202603），监管结论为维持现状。该程序针对欧盟已上市药品所含活性成分的相关 PSUR 进行统一评估，PSUR 由上市许可持有人在授权后规定时间点定期提交。

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About

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.

Key facts

Active substance(s) in scope of the PSUSA procedure: ethosuximide
Procedure number: PSUSA/00001316/202603
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu