EMA 完成替诺昔康（tenoxicam）PSUSA 定期安全性更新报告单次评估，结论为维持现状

PSUSA/00002893/202602

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EMA 对活性物质替诺昔康（tenoxicam）完成 PSUSA 程序 PSUSA/00002893/202602 的单次评估，监管结论为维持（Maintenance）。PSUSA 是对欧盟已上市药品所含活性物质相关定期安全性更新报告（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。

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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: tenoxicam
Procedure number: PSUSA/00002893/202602
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu