After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Hopveus. The medicine was intended for the treatment of alcohol dependence.
The Agency issued its opinion after re-examination on 30 April 2020. The Agency had issued its initial opinion on 17 October 2019. The company that applied for authorisation of Hopveus is D&A Pharma.
Questions and answers on the refusal of the marketing authorisation for Hopveus (sodium oxybate) (PDF/103.43 KB) (updated)Adopted
First published: 30/04/2020
Last updated: 13/07/2020
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