Table 1

Additional suitability criteria for paediatric oral dosage forms aside from the EMA matrix7

TabletsA single dose may involve two tablets at the maximum
A single dose may involve a halved tablet, if 1) the tablet contains a score line; 2) the SmPC does not state that the scoring line is for esthetical reasons only; 3) the SPC does not state that the tablet may only be broken to facilitate the intake of the full dose.
Oral liquid preparationsThe maximum dosing volume is 5 mL for children aged below 5 years.
The maximum dosing is 10 mL for children aged from 5 to 10 years.
The minimum single dosing is 0.2 mL.
  • SmPC, Summary of Product Characteristics.