Hopveus

sodium oxybate

Opinion

Update of 14 November 2019:: The applicant for Hopveus has requested a re-examination of EMA’s October 2019 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation. 

The European Medicines Agency has recommended the refusal of the marketing authorisation for Hopveus, a medicine intended for the treatment of alcohol dependence.

The Agency issued its opinion on 17 October 2019. The company that applied for authorisation, D&A Pharma, may ask for re-examination of the opinion within 15 days of receiving the opinion.

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
17/10/2019
Company name
D&a Pharma
Status
Negative
Application type
Initial authorisation

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