Bacterial lysates-containing medicinal products indicated for respiratory conditions

• 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.

• 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.

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.

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.