EMA 完成 cyproterone acetate / estradiol valerate 定期安全性更新报告单次评估

PSUSA/00000907/202603

AI 导读

EMA 对含 cyproterone acetate / estradiol valerate 的欧盟上市药品完成 PSUSA 单次评估，程序编号 PSUSA/00000907/202603，监管结论为维持现状（Maintenance）。该评估基于上市许可持有人按期提交的定期安全性更新报告（PSUR）。

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: cyproterone acetate / estradiol valerate
Procedure number: PSUSA/00000907/202603
Regulatory outcome: Maintenance

来源：EMA What's New · ema.europa.eu