EMA 完成硝基呋喃妥因 PSUSA 定期安全性更新报告单次评估，结论为维持现状

PSUSA/00002174/202602

AI 导读

EMA 对硝基呋喃妥因及硝基呋喃妥因/盐酸吡哆醇相关 PSUR 完成单次评估（程序号 PSUSA/00002174/202602），监管结论为维持。该评估针对欧盟已上市药品所含活性物质的定期安全性更新报告。

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: nitrofurantoin, nitrofurantoin / pyridoxine hydrochloride
Procedure number: PSUSA/00002174/202602
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu