Notice: Nirmatrelvir (COVID-19) added to Prescription Drug List (PDL)

January 17, 2022
Our file number: 22-100536-553

The purpose of this Notice of Amendment is to notify about the addition of nirmatrelvir to the Prescription Drug List (PDL) for human and veterinary use.

The new medicinal ingredient will be added to the PDL as the following:

Drugs containing any of the following Including (but not limited to) Qualifier
Nirmatrelvir N/A N/A

This addition is effective at the time of posting.

Rationale

A scientific review of this drug against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that this medicinal ingredient requires prescription status.

Paxlovid (nirmatrelvir tablets; ritonavir tablets*) is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

*Ritonavir is already listed on the human and veterinary parts of the PDL.

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 this amendment to the Prescription Drug List please contact:

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

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