News

National Drug Schedules: Final Recommendations for cetirizine for use in children 2 to 11 years

National Drug Schedule

The interim recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on December 2, 2024 that:

  • Cetirizine or its salts, when sold in concentrations of 8.5 mg or less of cetirizine base per unit dose, in products labelled for use in children aged 2 to 11 years, in package sizes containing greater than 119 mg of cetirizine base, remain in Schedule III
  • Cetirizine or its salts, when sold in concentrations of 8.5 mg or less of cetirizine base per unit dose, in products labelled for use in children aged 2 to 11 years, in package sizes containing no more than 119 mg of cetirizine base, be granted Unscheduled status
  • Cetirizine or its salts, when sold in concentrations of 8.5 mg or less of cetirizine base per unit dose, in products labelled for use in individuals 12 years of age and older, remain Unscheduled

**Note: 8.5 mg of cetirizine base is approximately equivalent to 10 mg of cetirizine hydrochloride.

were finalized effective January 21, 2025. Final approval of the interim recommendations was made by NAPRA’s Board of Directors. In this case, NAPRA did not receive any comments during the 30-day consultation period. The National Drug Schedules will be revised accordingly.

Subscribe to Updates from NAPRA

Receive NAPRA updates of interest directly to your inbox: general NAPRA news, NDS updates and/or updates on practice resources.