欧盟 PSUSA 对格列齐特（gliclazide）的定期安全性更新报告单次评估结果：维持现状

PSUSA/00001532/202602

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欧盟 PSUSA 程序完成对活性物质格列齐特（gliclazide）相关定期安全性更新报告（PSUR）的单次评估，监管结论为维持现状（Maintenance）。该程序编号为 PSUSA/00001532/202602，评估对象为欧盟已授权药品中所含的该活性物质。

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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: gliclazide
Procedure number: PSUSA/00001532/202602
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu