EMA 完成 nicorandil 定期安全性更新报告单次评估（PSUSA/00002152/202602）

PSUSA/00002152/202602

AI 导读

EMA 对欧盟已上市药品活性物质 nicorandil 的相关定期安全性更新报告（PSUR）完成单次评估，程序编号 PSUSA/00002152/202602，监管结论为维持现状（Maintenance）。PSUSA 是对欧盟授权药品所含活性物质相关 PSUR 的统一评估机制。

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: nicorandil
Procedure number: PSUSA/00002152/202602
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu