Notice Prescription Drug List (PDL): Bamlanivimab (COVID-19)
Date: November 20, 2020
Our file number: 20-116517-414
The purpose of this Notice of Amendment is to notify about the addition of bamlanivimab 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 |
|---|---|---|
| Bamlanivimab | 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.
Bamlanivimab is indicated for the treatment of adults and pediatric patients 12 years of age or older with mild to moderate coronavirus disease 2019 (COVID-19), who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
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
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