CPMP fandt, at resultaterne af undersøgelsen viste, at loratadin ikke fremkalder ændringer af udviklingen af tractus genitalis, herunder hypospadi, i F1- generationen hos rotter eksponeret gennem hele organogenesen og i den tidlige postnatale udvikling (indtil dag 4 post partum).
The CPMP considered that the results of this study demonstrated that loratadine did not affect the development of the male F1 genital tract, including hypospadias, in rats exposed throughout organogenesis and early postnatal development (up to day 4 post partum).