Galantamine Stada

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

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Galantamine Stada. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: the Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain.

Key facts

About this medicine
Approved name
Galantamine Stada
International non-proprietary name (INN) or common name
galantamine
Associated names
  • Galantamina
  • Galantamine Tiefenbacher
  • Galantamina Ciclum
  • Galatnax xl
  • Galastad
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-29/001268
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
23/09/2010
EC decision date
21/02/2011

All documents

  • List item

    Questions and answers on Galantamine Stada and associated names (galantamine 8, 16 and 24 mg prolonged released tablets) (PDF/73.64 KB)

    Adopted

    First published: 24/09/2010
    Last updated: 08/06/2012
    EMA/594983/2010

  • List item

    Galantamine Stada - Article 29 referral - Annex I-II (PDF/77.41 KB)

    Adopted

    First published: 08/06/2012
    Last updated: 08/06/2012

  • 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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