Notice - Prescription Drug List (PDL): Esomeprazole

February 4, 2016
Our file number: 16-101151-272

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, 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 wording, which has not changed from what was proposed in the October 2, 2015 Notice of Consultation, is:

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: six months from date of this Notice

Consultation summary:

The proposal to amend the PDL was communicated to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations through a Notice of Consultation posted on Health Canada’s web-site on October 2, 2015.  The 75 day consultation period which ended December 16, 2015 has been completed.

There were no objections to this proposed switch only comments from one stakeholder. On December 7, 2015, the sponsor of the drug presented their request for nonprescription status to the National Drug Scheduling Advisory Committee (NDSAC) of the National Association of Regulatory Authorities (NAPRA).  Meeting minutes are available on NAPRA’s website. The committee expressed some concerns but tentatively recommended Schedule II status pending labelling revisions.

The non-prescription switch for Esomeprazole for the treatment of frequent heartburn will come into effect six months from the date of this Notice through a Notice of Amendment posted on the Health Canada web-site.

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
Phone: 613-957-1058
Fax: 613-941-1812