其 他 安 全 警 示
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| European Union: Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections (English only) |
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European Medicines Agency (EMA) is recommending 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 follows 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.
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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/bacterial-lysate-medicines-respiratory-conditions-be-used-only-prevention-recurrent-infections
In Hong Kong, the above mentioned bacterial lysate medicines are not registered pharmaceutical products.
Ends/ Saturday, June 29, 2019
Issued at HKT 12:30
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