EMA 完成呋喃妥因类活性物质 furazidine 的 PSUSA 定期安全性更新报告单次评估

PSUSA/00011098/202602

AI 导读

EMA 对欧盟已上市药品中的活性物质 furazidine 完成 PSUSA 程序 PSUSA/00011098/202602 的单次评估，监管结论为维持现状（Maintenance）。PSUSA 是对相关 PSUR 的单次评估，PSUR 由上市许可持有人在药品获批后规定时间点定期提交。

正文 · 原文

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: furazidine
Procedure number: PSUSA/00011098/202602
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu