Bisphosphonates

  • 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 bisphosphonate-containing medicines at the request of the United Kingdom and the European Commission, following reports of an increased risk of atypical stress fractures of the femur associated with these medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bisphosphonates continue to outweigh their risks but that warnings of the risk of atypical femoral fractures should be added to the prescribing information for all bisphosphonate-containing medicines in the European Union (EU).

Key facts

About this medicine
Approved name
Bisphosphonates
International non-proprietary name (INN) or common name
  • alendronic acid
  • clodronic acid
  • etidronic acid
  • ibandronic acid
  • neridronic acid
  • pamidronic acid
  • risedronic acid
  • tiludronic acid
  • zoledronic acid
Associated names
  • Actonel
  • Aredia
  • Bonefos
  • Didronel
  • Fosamax
  • Nerixia
  • Skelid
Class
Bisphosphonates
About this procedure
Current status
European Commission final decision
Reference number
EMA/288359/2011
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
14/04/2011
EC decision date
13/07/2011

All documents

  • List item

    Questions and answers on the review of bisphosphonates and atypical stress fractures (PDF/98.11 KB)

    Adopted

    First published: 15/04/2011
    Last updated: 28/10/2011
    EMA/288359/2011 Rev. 1

  • List item

    Bisphosphonates - Article 31 referral - Annex I (PDF/5.2 MB)

    Adopted

    First published: 28/10/2011
    Last updated: 28/10/2011

  • List item

    Bisphosphonates - Article 31 referral - Annex II (PDF/65.07 KB)

    Adopted

    First published: 28/10/2011
    Last updated: 28/10/2011

  • List item

    Bisphosphonates - Article 31 referral - Annex IV (PDF/44.66 KB)

    Adopted

    First published: 28/10/2011
    Last updated: 28/10/2011

  • List item

    Assessment report for bisphosphonates containing medicinal products (PDF/128.67 KB)

    Adopted

    First published: 28/10/2011
    Last updated: 28/10/2011
    EMA/725125/2011

  • List item

    Bisphosphonates - Article 31 - changes to product information (PDF/18.8 KB)


    First published: 15/04/2011
    Last updated: 15/04/2011

  • 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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