Bacterial lysates-containing medicinal products indicated for respiratory conditions

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

Overview

Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections

On 27 June 2019, EMA recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This followed a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes.

In the review, EMA’s human medicines committee (CHMP) considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases.

Although data are limited, the review found some evidence of effectiveness of these medicines in the prevention of recurrent respiratory tract infections and the safety profile is in line with what is expected for this type of product. The CHMP therefore recommended that use of the medicines for prevention can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026.

Key facts

About this medicine
Approved name
Bacterial lysates-containing medicinal products indicated for respiratory conditions
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1465
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.

Authorisation model
Nationally authorised product(s)
Key dates and outcomes
CHMP opinion date
27/06/2019
EC decision date
09/09/2019

All documents

  • List item

    Bacterial lysate medicines Article 31 referral - CHMP assessment report (PDF/430.83 KB)

    Adopted

    First published: 16/09/2019
    EMA/457345/2019

  • List item

    Bacterial lysate medicines Article 31 referral - Annex IV (PDF/13.44 KB)


    First published: 16/09/2019

  • List item

    Bacterial lysate medicines Article 31 referral - Annex II (PDF/44.85 KB)


    First published: 16/09/2019

  • Procedure started

    Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Bacterial lysate medicines Article 31 referral - Annex III (PDF/20.08 KB)


    First published: 28/06/2019
    Last updated: 16/09/2019

  • European Commission final decision

  • List item

    Bacterial lysate medicines Article 31 referral - Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections (PDF/83.18 KB)


    First published: 28/06/2019
    Last updated: 16/09/2019
    EMA/502527/2019

  • List item

    Bacterial lysate medicines Article 31 referral - Annex I (PDF/103.09 KB)

    Adopted

    First published: 04/07/2018
    Last updated: 16/09/2019

  • 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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