“…It has been widely reported that information available for children in the SPC is inadequate, incomplete, and shows inconsistencies in many cases (17,18). There is usually no dosage recommendation according to weight, body surface, or age range, although it is widely recognized that extrapolation of pediatric dosages from the adult population is not always appropriate due to specific pharmacokinetics and pharmacodynamics in children (13,17). It is not infrequent to find that the widely accepted therapeutic recommendations or practice guidelines in children are not in accordance with the formally approved conditions of use in the SPC, even in cases in which good supporting scientific evidence is available.…”