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