ESPL Regulatory Consulting


Regulatory News and Updates

EMA - Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections

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.

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Ian Abernethy