EMA What's New·· 3 小时前AI 评分12
EMA 额外监测药品清单更新：Cavoley 新增列入
List of medicines under additional monitoring
AI 导读
EMA 更新额外监测药品清单，2026 年 10 月新增 Cavoley 这一新生物制品，本月无药品移出清单，也无新增或移出的国家批准药品（NAP）。该清单涵盖 2011 年 1 月 1 日后欧盟未含新活性物质的药品、2011 年后获批的生物制品（含生物类似药）、需开展上市后安全性研究（PASS）的药品、附条件批准或特殊情形批准药品，以及带特定不良反应记录或监测义务的药品。
正文 · 原文
The list includes centrally and nationally authorised medicines (CAPs) in the following categories:
- medicines that contain a new active substance that was not contained in any authorised medicine in the EU on 1 January 2011;
- biological medicines authorised after 1 January 2011 - this applies to all biological medicines including biosimilars;
- medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS);
- medicines given conditional approval or authorised under exceptional circumstances and medicines authorised with specific obligations on the recording or monitoring of suspected adverse drug reactions.
Summary of changes in October 2026
The following CAPs have been added to the list:
- Cavoley - New biological
The following CAPs have been removed from the list:
- None
The following NAPs have been added to the list:
- None
The following NAPs have been removed from the list:
- None
来源：EMA What's New · ema.europa.eu