Hopveus

sodium oxybate

Opinion

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.

Key facts

Name
Hopveus
Agency product number
EMEA/H/C/004962
International non-proprietary name (INN) or common name
  • sodium oxybate
Active substance
  • sodium oxybate
Therapeutic area
Substance Withdrawal Syndrome
Alcohol Abstinence
Date opinion adopted
30/04/2020
Company name
D&A Pharma
Status
Negative
Application type
Initial authorisation

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