Table 2. Age groups according to ICH guideline (40).

Preterm newborn infants
Term newborn infants	0–27 days
Infants and toddlers	28 days–23 months
Children	2–11 years
Adolescents	12–16/18 years

Prescribing information commonly provides a further classification into infants (28 days to 11 months), toddlers (12 –23 months), preschool children (2–5 years) and school children (6–11 years).

ICH, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use