Bacterial lysates-containing medicinal products indicated for respiratory conditions

Current status:
Under evaluation

Overview

The European Medicines Agency (EMA) has started a review of bacterial lysate medicines, which are authorised in some EU member states for treatment or prevention of respiratory tract infections (infections of the airways and lungs) and for chronic (long-term) respiratory conditions.

Recent studies have cast doubt on the effectiveness of bacterial lysate medicines in reducing the number and severity of respiratory infections in adults and children who experience repeated infections. In addition, in very rare cases, these medicines are known to cause serious side effects related to the immune system (the body's natural defences).

This review has been requested by the Italian medicines agency (AIFA). EMA will now review the available information and recommend whether the marketing authorisations for the medicines should be maintained, varied or suspended across the EU.

Key facts

Approved name
Bacterial lysates-containing medicinal products indicated for respiratory conditions
International non-proprietary name (INN) or common name

Haemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis

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.

Status
Under evaluation
Opinion date
28/06/2018

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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