Methylphenidate Hexal

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

Overview

On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Hexal. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Hexal outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.

Key facts

About this medicine
Approved name
Methylphenidate Hexal
International non-proprietary name (INN) or common name
methylphenidate hydrochloride
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-29/1360
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
25/07/2013
EC decision date
09/10/2013

All documents

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Questions and answers on Methylphenidate Hexal (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 mg) - Outcome of a procedure under Article 29 of Directive 2001/83/EC (PDF/66.21 KB)


    First published: 26/07/2013
    Last updated: 05/12/2013
    EMEA/H/A-29/1360

  • European Commission final decision

  • List item

    Methylphenidate Hexal Article-29 referral - Annex I (PDF/55.26 KB)


    First published: 05/12/2013
    Last updated: 05/12/2013

  • List item

    Methylphenidate Hexal Article-29 referral - Annex II (PDF/60.36 KB)


    First published: 05/12/2013
    Last updated: 05/12/2013

  • List item

    Methylphenidate Hexal Article-29 referral - Annex III (PDF/43.92 KB)


    First published: 05/12/2013
    Last updated: 05/12/2013

  • List item

    Methylphenidate Hexal Article-29 referral - Assessment report (PDF/285.53 KB)

    Adopted

    First published: 05/12/2013
    Last updated: 05/12/2013
    EMA/596773/2013

  • 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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