Notice: Multiple additions to the Prescription Drug List (PDL) [2026-06-25]
June 25, 2026
Our file number: 26-103595-74
The purpose of this Notice of Amendment is to announce the addition of donanemab, islatravir, and pegzilarginase to the Prescription Drug List (PDL) for human and veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Donanemab | n/a | n/a |
| Islatravir or its salts or derivatives | n/a | n/a |
| Pegzilarginase | n/a | n/a |
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.
Idvynso (doravirine/islatravir) is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
Kisunla (donanemab) is indicated for the treatment of adults with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease, who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, and who have confirmed amyloid pathology.
Loargys (pegzilarginase) is indicated for the treatment of hyperargininemia in adults and pediatric patients aged 2 years and older with arginase 1 deficiency (ARG1-D), in conjunction with dietary protein restriction.
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
Bureau of Policy, Science and International Programs
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca