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


Indications restricted following review procedure under Article 31 of Directive 2001/83/EC as amended.

The European Medicines Agency has completed a review of the safety and effectiveness of modafinil. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of modafinil-containing medicines continue to outweigh their risks but that their use should be restricted to the treatment of narcolepsy. The CHMP also recommended further changes to the product information to ensure that the medicines are used appropriately, and asked the manufacturers to put in place risk minimisation measures.

After re-examination, the Committee confirmed these recommendations on 18 November 2010.

Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
Associated names
  • Modasomil
  • Modiodal
  • Provigil
  • Vigil
About this procedure
Current status
European Commission final decision
Reference number
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Key dates and outcomes
CHMP opinion date
EC decision date

All documents

  • List item

    Questions and answers on the review of medicines containing modafinil - Re-examination (PDF/70.01 KB)

    First published: 19/11/2010
    Last updated: 26/04/2011

  • List item

    Modafinil-H-A-31-1186: Article 31 Referral-Assessment report (PDF/554.02 KB)


    First published: 26/04/2011
    Last updated: 26/04/2011

  • List item

    Questions and answers on the review of medicines containing modafinil - Initial (PDF/61.53 KB)


    First published: 22/07/2010
    Last updated: 22/07/2010

  • List item

    Modafinil - Article 31 referral - Annex I, II, III, IV (PDF/261.31 KB)

    First published: 22/07/2010
    Last updated: 26/04/2011

  • 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.

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