Prescription Drug List (PDL): Remdesivir (COVID-19) notice

Date published: July 28, 2020
Our file number: 20-110364-67

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

The new drug will be added to the PDL as the following:

Drugs containing any of the following Including (but not limited to) Qualifier
Remdesivir or its salts or derivatives 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 drug requires prescription status.

VEKLURY (remdesivir) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen.

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

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

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