EMA对含高分子量聚维酮美沙酮口服液的评价

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (5): 279-281.

EMA对含高分子量聚维酮美沙酮口服液的评价

王玉珠,萧惠来

国家食品药品监督管理总局药品审评中心，北京 100038

发布日期:2015-06-08
通讯作者: 萧惠来，男，教授，药品技术审评。
作者简介:王玉珠，女，博士，副研究员，药品技术审评。

Evaluation on Methadone Oral Solution Containing High Melocular Weight Povidone by EMA

WANG Yu-zhu ,XIAO Hui-lai

Center for Drug Evaluation, CFDA, Beijing 100038, China

Published:2015-06-08

摘要/Abstract

摘要： 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。

关键词: 欧洲药品管理局, 美沙酮口服液, 高分子量聚维酮, 暂停上市许可

Abstract: 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.

Key words: EMA, methadone oral solution, high molecular weight povidone, suspension of marketing authorisation

中图分类号:

R965

王玉珠,萧惠来. EMA对含高分子量聚维酮美沙酮口服液的评价[J]. 中国药物警戒, 2015, 12(5): 279-281.

WANG Yu-zhu ,XIAO Hui-lai. Evaluation on Methadone Oral Solution Containing High Melocular Weight Povidone by EMA[J]. Chinese Journal of Pharmacovigilance, 2015, 12(5): 279-281.