Bacterial lysates-containing medicinal products indicated for respiratory conditions - referral

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.

Information for patients

• Bacterial lysate medicines should not be used to treat existing infections of the airways or to prevent pneumonia (a lung infection) because there are not enough data to show that they work for these uses.
• Bacterial lysate medicines can continue to be used to prevent infections of the airways (except pneumonia) from coming back in patients who regularly get infections.
• If you have an infection and are taking a bacterial lysate medicine to treat it, or if you are taking one of these medicines to prevent pneumonia, contact your doctor or pharmacist for advice on alternatives.
• If you have any questions or concerns about your medicine, discuss them with your doctor or pharmacist.

Information for healthcare professionals

• The indications of bacterial lysate medicines have been restricted to prophylaxis of recurrent respiratory tract infections, with the exception of pneumonia. Bacterial lysate medicines should not be prescribed for treatment of existing respiratory infections or for prophylaxis of pneumonia due to lack of efficacy data.
• The prescribing information of the medicines is being updated with the new indication and a warning against use for prevention of pneumonia.

More about the medicines

Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system to recognise and fight 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), inhaled through the nose (as a liquid) or given by injection into a muscle or under the skin.

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. They are sold under several brand names including 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 was initiated on 28 June 2018 at the request of Italy, under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 09 September 2019.

Bacterial lysate medicines Article 31 referral - Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections

Reference Number: EMA/502527/2019

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

Procedure started

Bacterial lysate medicines Article 31 referral - CHMP list of questions

Reference Number: EMA/CHMP/346196/2018

Bacterial lysate medicines Article 31 referral - Timetable for the procedure

Reference Number: EMA/CHMP/349538/2018 Rev. 2

Bacterial lysate medicines Article 31 referral - Notification

Reference Number: EMA/CHMP/346196/2018

Bacterial lysate medicines Article 31 referral - Review started

Reference Number: EMA/351982/2018

Opinion provided by Committee for Medicinal Products for human Use

Bacterial lysate medicines Article 31 referral - CHMP assessment report

Adopted Reference Number: EMA/457345/2019

Bacterial lysate medicines Article 31 referral - Annex IV

Bacterial lysate medicines Article 31 referral - Annex II

Bacterial lysate medicines Article 31 referral - Annex III

European Commission final decision

Bacterial lysate medicines Article 31 referral - Annex I

Adopted

Bacterial lysate medicines Article 31 referral - Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections

Reference Number: EMA/502527/2019

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.