Alcover and associated names

Current status:
European Commission final decision

Overview

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.

Key facts

Approved name
Alcover and associated names
International non-proprietary name (INN) or common name
sodium oxybate
Associated names
n/a
Class
-
Reference number
EMEA/H/A-29(4)/1451
Type
Article 29(4) referrals

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

Status
European Commission final decision
Opinion date
26/01/2017
EC decision date
18/12/2017

All documents

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 havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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