EMA 完成胱氨酸/盐酸吡哆醇定期安全性更新报告单次评估，结论为维持现状

PSUSA/00000910/202603

AI 导读

EMA 对含胱氨酸/盐酸吡哆醇的欧盟上市药品完成 PSUSA 单次评估，程序编号 PSUSA/00000910/202603，监管结论为维持（Maintenance）。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: cystine / pyridoxine hydrochloride
Procedure number: PSUSA/00000910/202603
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu