Table 1

Suitability of tablets according to the recent EMA/CHMP draft ‘Guideline on pharmaceutical development of medicines for paediatric use’6

Age categories (EMA/CHMP reflection paper)4AgeAcceptability of tablets
Neonates0–30 daysNone
Infants1–6 monthsNone
6–24 monthsNone; but powders, granules and pellets accepted
Preschool children2–5 yearsTablets 3–5 mm in diameter
School children6–11 yearsTablets ≤10 mm in diameter
12–18 yearsTablets ≤15 mm in diameter
  • CHMP, Committee for Medicinal Products for Human Use; EMA, European Medicines Agency.