Notice: Prescription Drug List: Multiple additions

July 4, 2018
Our file number: 18-107885-978

The purpose of this Notice of Amendment is to notify about the additions of Crisaborole and Ertugliflozin to the Human and/or Veterinary Prescription Drug Lists (PDL). These additions are effective at the time of posting.

Rationale:

A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.

EUCRISA (crisaborole ointment, 2%) is indicated for topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

STEGLATRO (ertugliflozin) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance.

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 on these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 343-998-9304
Facsimile: 613-941-1812
e-mail: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca