574-581 It is acknowledged in the Add a new final guidance document that sentence: “In limited clinical data may be addition and where available in patients with robust preclinical pathogens that are BL-R data are available BL/BLI-S. Robust against specific data which includes species and enzyme confirmation of activity types, it may be across multiple strains and appropriate that the enzyme types could support SmPC reflect the extrapolation to other potential utility of pathogens. the combination by noting such activity data. 602 We would suggest including Suggest rewording the food-drug interaction as to food-drug and “... well. drug-drug...”
574-581 It is acknowledged in the guidance document that limited clinical data may be available in patients with pathogens that are BL-R BL/BLI-S. Robust data which includes confirmation of activity across multiple strains and enzyme types could support extrapolation to other pathogens. Add a new final sentence: “In addition and where robust preclinical data are available against specific species and enzyme types, it may be appropriate that the SmPC reflect the potential utility of the combination by noting such activity data. 602 We would suggest including the food-drug interaction as well. Suggest rewording to “... food-drug and drug-drug...”