Notice: Prescription Drug List (PDL): Esomeprazole
Notice to the reader:
The online consultation is now closed.
October 2, 2015
Our file number: 15-110627-76
The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch certain uses of Esomeprazole to non-prescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged. Health Canada has conducted a scientific assessment of this switch against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. Currently, Esomeprazole is listed on the Human Prescription Drug List as Esomeprazole or its salts without a Qualifier.
The proposed wording of the new listing on the Human List 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: to be determined
Rationale
Esomeprazole (Esomeprazole magnesium) is a proton pump inhibitor (PPI) that functions to stop acid production in the stomach. Esomeprazole is the S-isomer of Omeprazole, a racemic mixture of the S- and R-isomers. Omeprazole was switched to non-prescription status in 2014 at the same dose for the same indication and directions for use. Since the R-isomer is transformed into the S-isomer after ingestion, the amount of active ingredient in both drugs is equivalent.
Comments on this proposed change to the Prescription Drug List should be provided to Health Canada in writing, preferably in electronic format, within 75 days from the date of this notice.
Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Please send your comments to:
Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9
or
Telephone: 613-957-1058
or
Facsimile: 613-941-5035
or
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
If all comments not in favour of this switch can be addressed, a Notice of Intent to Amend will be posted on the Health Canada website. This Notice will address these comments and inform stakeholders of Health Canada's intention to revise the PDL. The actual revision to the PDL would be made six months from the date of the Notice of Intent to Amend and communicated to stakeholders through a Notice of Amendment.