Notice: Prescription Drug List (PDL): Esomeprazole

August 18, 2016
Our file number: 16-109265-359

The purpose of this Notice of Amendment is to notify that Health Canada will switch certain uses of Esomeprazole to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific review of Esomeprazole against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The listing now reads:

Drugs containing the following: Esomeprazole or its salts

Including (but not limited to): Esomeprazole magnesium

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

Effective Date: Date of this Notice

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'ordonnance_des_drogues@hc-sc.gc.ca
Telephone: 613-957-1058
Facsimile: 613-941-1812

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