EMA 对含高分子量聚维酮美沙酮口服液的评价

摘要

Based on the estimated result that methadone oral solution containing high molecular weight povidone K90 induced more risk of 'povidone storage disease' than benefit, so EMA suspended marketing authorisation of this kind of drugs in European Union since 2014. The paper introduces the EMA's evaluation basis. It is expected to enlighten us on the work such as reevaluation on post-marketing drugs including methadone and the related management measures.%2014年 EMA 经评价后认为含高分子量聚维酮 K90的美沙酮口服液的聚维酮贮积病风险超过受益，宣布暂停该药在欧盟的上市许可。通过介绍 EMA 的评价依据，以期对我国上市后药品的再评价工作和相应管理制度等方面有所启示。