Bacterial lysate medicines

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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.

More about the medicines

Bacterial lysate medicines are used on their own or with other medicines to treat or prevent upper or lower respiratory tract infections or for the treatment of chronic respiratory conditions including chronic bronchitis (inflammation of the airways in the lungs) and chronic obstructive pulmonary disease (damage or blockage of the airways and air sacs in the lungs).

Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system to recognise and fight bacterial infections. These medicines are taken by mouth (as capsules, tablets, granules/powder for making up an oral mixture or drops), dissolved under the tongue (as tablets), or inhaled through the nose (as a liquid).

Bacterial lysate medicines have been authorised via national procedures. They are available in Austria, Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia and Slovenia in under several brand names including Biomunil, Broncho Munal, Broncho Vaxom, Buccalin, Immubron, Immucytal, Ismigen, Lantigen B, Luivac, Ommunal, Paspat, Pir-05, Polyvaccinum, Provax, Respivax and Ribomunyl.

More about the procedure

The review of bacterial lysate medicines has been initiated at the request of Italy, under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Name Language First published Last updated
Bacterial lysate medicines Article 31 referral - Review started (English only) 2018-06-29  

Key facts

Approved nameBacterial lysate medicines
International non-proprietary name (INN) or common name
Associated names
Class
Reference numberEMEA/H/A-31/1465
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusProcedure started
Opinion date28/06/2018

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
Procedure started

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