跳到正文
>hotmap_
只看一手#急诊与重症
11月6日周五
  1. EMA · What's New

    急诊与重症医学：Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Date of authorisation: 08/01/2007, Revision: 29, Status: Authorised

    原文摘录：Elaprase RSS Authorised This medicine is authorised for use in the European Union idursulfase Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment rep … This page was last updated on 06/11/2026

11月3日周二
  1. FDA · MedWatch Safety Alerts

    FDA早期预警：Compact Medical移除部分批次ButterflyBVM球囊面罩复苏器并更新使用说明

    FDA CDRH发布早期预警，通报潜在高风险器械问题：Compact Medical对部分批次ButterflyBVM一次性球囊面罩（BVM）复苏器发出紧急医疗器械召回通知，建议移除000109–000117批次，000081–000108批次须每次使用前完成使用前测试。

    关注理由：FDA CDRH以Early Alert标记该潜在高风险器械问题，区分需移除批次与仅需使用前测试的批次，可据此跟踪急救通气器械的受影响范围与后续监管更新。