Augmentin

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

Overview

The European Medicines Agency has completed a review of Augmentin. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Augmentin in the European Union (EU).

The review was carried out under an 'Article 30' referral1.

1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by Member States

Key facts

About this medicine
Approved name
Augmentin
International non-proprietary name (INN) or common name
  • amoxicillin
  • clavulanic acid
Class
-
About this procedure
Current status
European Commission final decision
Reference number
CHMP/97898/2009
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes
CHMP opinion date
19/01/2009
EC decision date
19/10/2009

All documents

  • List item

    Questions and answers on the referral for Augmentin (amoxicillin and clavulanic acid) (PDF/228.24 KB)

    Adopted

    First published: 25/06/2009
    Last updated: 18/11/2013
    EMEA/CHMP/97898/2009

  • List item

    Augmentin - Article 30 - Annex III (PDF/994.08 KB)

    Adopted

    First published: 25/06/2009
    Last updated: 18/11/2013

  • European Commission final decision

  • List item

    Augmentin - Article 30 - Annex I (PDF/222.66 KB)


    First published: 18/11/2013
    Last updated: 18/11/2013

  • List item

    Augmentin - Article 30 - Annex II (PDF/143.25 KB)


    First published: 18/11/2013
    Last updated: 18/11/2013

  • 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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