Orlistat

  • 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 orlistat-containing medicines, following concerns about the possible risk of severe liver injury with these medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.

Key facts

About this medicine
Approved name
Orlistat
International non-proprietary name (INN) or common name
orlistat
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1318
Type
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
16/02/2012
EC decision date
24/04/2012

All documents

  • List item

    Orlistat - Article 31 referral - Annex III (PDF/51.43 KB)


    First published: 16/02/2012
    Last updated: 21/12/2012

  • European Commission final decision

  • List item

    Questions and answers on the review of orlistat-containing medicines (PDF/80.64 KB)

    Adopted

    First published: 16/02/2012
    Last updated: 21/12/2012
    EMA/CHMP/113837/2012 Rev.1

  • List item

    Orlistat - Article 31 referral - Annex I (PDF/112.57 KB)


    First published: 21/12/2012
    Last updated: 21/12/2012

  • List item

    Orlistat - Article 31 referral - Assessment report for orlistat-containing medicinal products (PDF/225.18 KB)

    Adopted

    First published: 21/12/2012
    Last updated: 21/12/2012
    EMA/276546/2012

  • List item

    Orlistat - Article 31 referral - Annex II (PDF/59.99 KB)


    First published: 21/12/2012
    Last updated: 21/12/2012

  • 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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