Notice of Amendment: Revision of Brimonidine on the Prescription Drug List (PDL)

May 16, 2022
Our file number: 22-105587-718

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing of "brimonidine or its salts" on the Prescription Drug List (PDL). Note that both the human and veterinary parts of the PDL were revised with the addition of a qualifier. Health Canada has conducted a scientific review of brimonidine tartrate against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations (FDR) that led to this decision.

With the addition of a qualifier, the revised listing for brimonidine now reads:

Drugs containing any of the following Including (but not limited to) Qualifier Effective Date
Brimonidine or its salts - except when sold as brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, used for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue for adults of 18 years and older 2022-05-16

Rationale

Brimonidine tartrate is a highly selective imidazoline alpha-2 adrenergic receptor agonist, a chemical class known to cause vasoconstriction (narrowing of blood vessels). Currently, drug products containing brimonidine or its salts as a medicinal ingredient require a prescription for human and veterinary use. Health Canada received a new drug submission for a brimonidine tartrate ophthalmic solution 0.025% (weight-volume, w/v), for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue, for adults 18 years and older.

Health Canada's review of the submission's safety, efficacy and quality evidence revealed that none of the PDL criteria outlined in section C.01.040.3 of the FDR apply to brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, used for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue for adults of 18 years and older. It should be noted that the use of brimonidine tartrate products in children will continue to require a prescription.

A summary of how brimonidine tartrate ophthalmic solution 0.025% does not meet any of the prescription criteria can be found in the consultation notice.

Next steps

This PDL amendment takes effect today May 16, 2022. Currently, there are no marketed products that would be affected by this amendment.

Sponsors seeking market authorizations for brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, for the indication included in the qualifier, can submit an application with safety and efficacy evidence to the Natural and Non-Prescription Health Products Directorate (NNHPD) for a full assessment.

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.

Should you have any questions regarding this notice, please contact:

Health Canada
Pharmaceutical Drugs Directorate
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca

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