Indehaveren af markedsføringstilladelsen meddelte, at cetirizins kliniske risk/ benefit- forhold ikke er blevet specifikt vurderet hos patienter med nedsat nyrefunktion, og at dosen derfor udelukkende er baseret på farmakokinetiske beregninger.
The MAH stated that the clinical benefit/ risk ratio of cetirizine has not been specifically evaluated in patients with renal impairment and that the dose is therefore based on pharmacokinetic calculations only.