Notice of consultation: Proposed change to the veterinary omeprazole listing on the Prescription Drug List
Published: May 13, 2026
Our file number: 26-102596-785
On this page
- Overview
- How the omeprazole listing would change
- Why we are proposing this change
- How to participate
- Next steps
Overview
Health Canada is proposing a change to the listing for “omeprazole or its salts” on the veterinary use part of the Prescription Drug List (PDL) only.
The change would allow certain veterinary drugs that contain omeprazole to be sold without a prescription. Specifically, Health Canada would add a qualifier to the “omeprazole or its salts” listing to assign non-prescription status to drugs used to prevent gastric ulcers in horses at a dosage of less than 2 milligrams (mg) per kilogram (kg) per day.
How the omeprazole listing would change
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Omeprazole or its salts | Omeprazole, Omeprazole magnesium | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Omeprazole or its salts | Omeprazole, Omeprazole magnesium | except when sold for the prevention of gastric ulcers in horses at a dosage of less than 2 mg/kg/day |
Why we are proposing this change
Health Canada received a veterinary drug submission for an omeprazole product indicated to prevent gastric ulcers in horses at a dosage below 2 mg/kg/day. Omeprazole is a proton-pump inhibitor that can be used to lower stomach acid production in horses. Currently, all veterinary omeprazole drugs in Canada are available by prescription only.
We reviewed the safety and efficacy information included in the submission. Our assessment found that omeprazole, when used for this purpose and at this dosage, does not meet the criteria for prescription status outlined in section C.01.040.3 of the Food and Drug Regulations.
If this change goes forward, the sale of veterinary drugs containing omeprazole for this use and dosage would no longer need a prescription.
The following Drug Identification Number (DIN) products would be affected by this change:
- 02250349
- 02531674
Learn more:
How to participate
Please send your comments on the proposed change to the Prescription Drug List, preferably in electronic format, within 75 days from the date of this notice to:
Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address locator: 3106C
1600 Scott Street
Ottawa ON K1A 0K9
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
Next steps
Health Canada will consider all comments received about this Notice. Once we decide whether we will move forward with the change, we will publish a Notice of Intent. The Notice of Intent will inform stakeholders of Health Canada’s decision and provide a summary of the comments received.