Notice: Prescription Drug List (PDL): Omeprazole

September 16, 2014
Our file number: 14-111102-429

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for omeprazole on the Prescription Drug List (PDL). Only the Human part of the PDL was revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of omeprazole against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which remains unchanged from what was proposed in the November 5, 2013 Notice of Consultation, is:

Drugs containing any of the following: Omeprazole or its salts

Including (but not limited to): omeprazole, omeprazole magnesium

Qualifier: except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20 milligrams

Effective Date: September 17, 2014

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9
Email: drug_prescription_status-statut_d'
Phone: 613-957-1058
Fax: 613-941-5035

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