Vancomycin-containing medicines

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

Overview

EMA recommends changes to prescribing information for vancomycin antibiotics

Changes aim to ensure appropriate use in context of fight against antimicrobial resistance

On 19 May 2017, the European Medicines Agency (EMA) recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.

Vancomycin has been used since the 1950s and to this day it remains an important therapeutic option for the treatment of serious infections.The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data on vancomycin medicines given by infusion (drip) and injection and taken by mouth as part of its strategy to update the product information of old antibacterial agents in the context of the fight against antimicrobial resistance.

The CHMP concluded that infusion of vancomycin can continue to be used for the treatment of serious infections caused by certain bacteria including MRSA (meticillin-resistant Staphylococcus aureus) in patients of all ages. Vancomycin can also be used to prevent bacterial endocarditis (an infection in the heart) in patients undergoing surgery and to treat infections in patients undergoing a procedure called peritoneal dialysis. When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).

Because the available data do not adequately support the use of vancomycin in the treatment of staphylococcal enterocolitis (inflammation of the gut caused by S. aureus) and its use to clear the gut of bacteria in patients with a weakened immune (defence) system, the CHMP concluded that vancomycin should no longer be used for these indications.

In addition, the Committee reviewed the recommended dosage for vancomycin for the various indications and patient groups, and concluded that the starting dose of vancomycin by infusion should be calculated according to the age and weight of the patient. The updated recommendations are based on data which showed that the previously recommended dose often resulted in less than optimal levels of vancomycin in the blood, reducing the effectiveness of the antibiotic.

Key facts

About this medicine
Approved name
Vancomycin-containing medicines
International non-proprietary name (INN) or common name
vancomycin
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1440
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
18/05/2017
EC decision date
21/09/2017

All documents

Procedure started

  • List item

    Vancomycin Article-31 referral - Annex I (PDF/866.6 KB)


    First published: 11/04/2016
    Last updated: 17/11/2017
    EMA/258475/2016

  • List item

    Vancomycin Article-31 referral - Review started (PDF/75.55 KB)


    First published: 01/04/2016
    Last updated: 01/04/2016
    EMA/222696/2016

  • List item

    Vancomycin Article-31 referral - CHMP list of questions (PDF/74.08 KB)


    First published: 01/04/2016
    Last updated: 01/04/2016
    EMA/CHMP/224042/2016

  • List item

    Vancomycin Article-31 referral - Timetable for the procedure (PDF/73.65 KB)


    First published: 01/04/2016
    Last updated: 03/03/2017
    EMA/CHMP/224121/2016 Rev. 2

  • List item

    Vancomycin Article-31 referral - Notification (PDF/63.34 KB)


    First published: 01/04/2016
    Last updated: 01/04/2016
    EMA/CHMP/224121/2016

  • Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Vancomycin Article-31 referral - Annex III (PDF/331.79 KB)


    First published: 19/05/2017
    Last updated: 17/11/2017

  • European Commission final decision

  • List item

    Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics (PDF/88.91 KB)


    First published: 19/05/2017
    Last updated: 17/11/2017
    EMA/645879/2017

  • List item

    Vancomycin Article-31 referral - Assessment report (PDF/298.44 KB)


    First published: 17/11/2017
    Last updated: 17/11/2017
    EMA/645288/2017

  • List item

    Vancomycin Article-31 referral - Annex II (PDF/102.86 KB)


    First published: 17/11/2017
    Last updated: 17/11/2017

  • 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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