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

PSUSA/00000230/202602

AI 导读

EMA 对活性物质 aprotinin 相关定期安全性更新报告（PSUR）完成单次评估（PSUSA/00000230/202602），监管结论为维持现状。PSUSA 是对欧盟已上市药品所含活性物质相关 PSUR 的单次评估，PSUR 由上市许可持有人在授权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: aprotinin
Procedure number: PSUSA/00000230/202602
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu