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Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC

On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules do not outweigh their risks, and the marketing authorisation cannot be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.

The company requested a re-examination of the initial opinion. After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation cannot be granted.

What is Alcover granules?

Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption. The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gamma-aminobutyric acid (GABA), leading to a calming of the activity of these cells. Since it targets these receptors in the same way as alcohol, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.

Alcover syrup is available in Austria and Italy.

Why were Alcover granules reviewed?

Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States (the ‘concerned Member States’, in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).

However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.

The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules had not been clearly demonstrated and there are various risks including the risk of dependence, misuse and side effects.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules are insufficient and of inadequate quality to demonstrate that the medicine is effective in the proposed uses. Risk minimisation measures were proposed for the known risks. However, the CHMP concluded that, since the benefits of Alcover granules had not been clearly demonstrated, the marketing authorisation cannot be granted in the reference and concerned Member States.

After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.

This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.

Name Language First published Last updated
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) BG = bălgarski 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) ES = español 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) CS = čeština 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) DA = dansk 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) DE = Deutsch 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EL = elliniká 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EN = English 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) FR = français 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) IT = italiano 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) LV = latviešu valoda 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) LT = lietuvių kalba 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) HU = magyar 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) MT = Malti 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) NL = Nederlands 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) PL = polski 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) PT = português 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) RO = română 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) SK = slovenčina 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) SL = slovenščina 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) FI = suomi 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) SV = svenska 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) HR = Hrvatski 2017-06-23 2018-01-12

Key facts

Approved nameAlcover and associated names
International non-proprietary name (INN) or common name

sodium oxybate

Associated namesn/a
Class-
Reference numberEMEA/H/A-29(4)/1451
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date26/01/2017

All documents

Name Language First published Last updated
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) BG = bălgarski 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) ES = español 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) CS = čeština 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) DA = dansk 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) DE = Deutsch 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EL = elliniká 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EN = English 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) FR = français 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) IT = italiano 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) LV = latviešu valoda 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) LT = lietuvių kalba 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) HU = magyar 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) MT = Malti 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) NL = Nederlands 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) PL = polski 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) PT = português 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) RO = română 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) SK = slovenčina 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) SL = slovenščina 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) FI = suomi 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) SV = svenska 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) HR = Hrvatski 2017-06-23 2018-01-12
Alcover Article-29(4) referral - Annex I BG = bălgarski 2018-01-12  
Alcover Article-29(4) referral - Annex I ES = español 2018-01-12  
Alcover Article-29(4) referral - Annex I CS = čeština 2018-01-12  
Alcover Article-29(4) referral - Annex I DA = dansk 2018-01-12  
Alcover Article-29(4) referral - Annex I DE = Deutsch 2018-01-12  
Alcover Article-29(4) referral - Annex I ET = eesti keel 2018-01-12  
Alcover Article-29(4) referral - Annex I EL = elliniká 2018-01-12  
Alcover Article-29(4) referral - Annex I EN = English 2018-01-12  
Alcover Article-29(4) referral - Annex I FR = français 2018-01-12  
Alcover Article-29(4) referral - Annex I IT = italiano 2018-01-12  
Alcover Article-29(4) referral - Annex I LV = latviešu valoda 2018-01-12  
Alcover Article-29(4) referral - Annex I LT = lietuvių kalba 2018-01-12  
Alcover Article-29(4) referral - Annex I HU = magyar 2018-01-12  
Alcover Article-29(4) referral - Annex I MT = Malti 2018-01-12  
Alcover Article-29(4) referral - Annex I NL = Nederlands 2018-01-12  
Alcover Article-29(4) referral - Annex I PL = polski 2018-01-12  
Alcover Article-29(4) referral - Annex I PT = português 2018-01-12  
Alcover Article-29(4) referral - Annex I RO = română 2018-01-12  
Alcover Article-29(4) referral - Annex I SK = slovenčina 2018-01-12  
Alcover Article-29(4) referral - Annex I SL = slovenščina 2018-01-12  
Alcover Article-29(4) referral - Annex I FI = suomi 2018-01-12  
Alcover Article-29(4) referral - Annex I SV = svenska 2018-01-12  
Alcover Article-29(4) referral - Annex I HR = Hrvatski 2018-01-12  
Alcover Article-29(4) referral - Annex II BG = bălgarski 2018-01-12  
Alcover Article-29(4) referral - Annex II ES = español 2018-01-12  
Alcover Article-29(4) referral - Annex II CS = čeština 2018-01-12  
Alcover Article-29(4) referral - Annex II DA = dansk 2018-01-12  
Alcover Article-29(4) referral - Annex II DE = Deutsch 2018-01-12  
Alcover Article-29(4) referral - Annex II ET = eesti keel 2018-01-12  
Alcover Article-29(4) referral - Annex II EL = elliniká 2018-01-12  
Alcover Article-29(4) referral - Annex II EN = English 2018-01-12  
Alcover Article-29(4) referral - Annex II FR = français 2018-01-12  
Alcover Article-29(4) referral - Annex II IT = italiano 2018-01-12  
Alcover Article-29(4) referral - Annex II LV = latviešu valoda 2018-01-12  
Alcover Article-29(4) referral - Annex II LT = lietuvių kalba 2018-01-12  
Alcover Article-29(4) referral - Annex II HU = magyar 2018-01-12  
Alcover Article-29(4) referral - Annex II MT = Malti 2018-01-12  
Alcover Article-29(4) referral - Annex II NL = Nederlands 2018-01-12  
Alcover Article-29(4) referral - Annex II PL = polski 2018-01-12  
Alcover Article-29(4) referral - Annex II PT = português 2018-01-12  
Alcover Article-29(4) referral - Annex II RO = română 2018-01-12  
Alcover Article-29(4) referral - Annex II SK = slovenčina 2018-01-12  
Alcover Article-29(4) referral - Annex II SL = slovenščina 2018-01-12  
Alcover Article-29(4) referral - Annex II FI = suomi 2018-01-12  
Alcover Article-29(4) referral - Annex II SV = svenska 2018-01-12  
Alcover Article-29(4) referral - Annex II HR = Hrvatski 2018-01-12  
Alcover Article-29(4) referral - Assessment report (English only) 2018-01-12  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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