Alcover and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision

Table of contents

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

About this medicine
Approved name
Alcover and associated names
International non-proprietary name (INN) or common name
sodium oxybate
Associated names
n/a
Class
-
About this procedure
Current status
European Commission final decision
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.
Key dates and outcomes
CHMP opinion date
26/01/2017
EC decision date
18/12/2017

All documents

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) (PDF/112.21 KB)


    First published: 23/06/2017
    Last updated: 12/01/2018
    EMA/391578/2017 Rev.1

    • European Commission final decision

  • List item

    Alcover Article-29(4) referral - Annex I (PDF/49.35 KB)


    First published: 12/01/2018
    Last updated: 12/01/2018

  • List item

    Alcover Article-29(4) referral - Annex II (PDF/65.81 KB)


    First published: 12/01/2018
    Last updated: 12/01/2018

  • List item

    Alcover Article-29(4) referral - Assessment report (PDF/351.52 KB)

    Adopted

    First published: 12/01/2018
    Last updated: 12/01/2018
    EMA/833636/2017

    • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

    News

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