中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2015年
5期
279-281
,共3页
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
歐洲藥品管理跼%美沙酮口服液%高分子量聚維酮%暫停上市許可
구주약품관리국%미사동구복액%고분자량취유동%잠정상시허가
EMA%methadone oral solution%high molecular weight povidone%suspension of marketing authorisation
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。
2014年 EMA 經評價後認為含高分子量聚維酮 K90的美沙酮口服液的聚維酮貯積病風險超過受益，宣佈暫停該藥在歐盟的上市許可。通過介紹 EMA 的評價依據，以期對我國上市後藥品的再評價工作和相應管理製度等方麵有所啟示。
2014년 EMA 경평개후인위함고분자량취유동 K90적미사동구복액적취유동저적병풍험초과수익，선포잠정해약재구맹적상시허가。통과개소 EMA 적평개의거，이기대아국상시후약품적재평개공작화상응관리제도등방면유소계시。
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.
