EMA 完成双氯芬酸钠/枸橼酸奥芬那君 PSUSA 定期安全性更新报告单次评估

PSUSA/00001045/202603

AI 导读

EMA 对含双氯芬酸钠/枸橼酸奥芬那君的欧盟上市药品完成 PSUSA 单次评估，程序编号 PSUSA/00001045/202603，监管结论为维持现状。PSUSA 是对欧盟已授权药品活性成分相关定期安全性更新报告（PSUR）的统一评估。

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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: diclofenac sodium / orphenadrine citrate
Procedure number: PSUSA/00001045/202603
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu