News

NDSAC Interim Recommendations on cetirizine for use in children 2 to 11 years

National Drug Schedule

A meeting of the National Drug Scheduling Advisory Committee (NDSAC) was held on December 2, 2024, with the following interim recommendations made:

  • 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.

Any objections to these interim recommendations must be received by the NAPRA office by end of day January 9, 2025. Questions or comments should be directed to the NDSAC Secretariat via email at ndsac@napra.ca.

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.