Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications

Date published: 2021-09-16

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

In the list below, the entry for each authorized drug and vaccine includes the:

In the "authorization" column, there are 4 possible scenarios for each drug or vaccine:

List of authorized drugs, vaccines and expanded indications for COVID-19
Authorization holder Brand name, proper name or common name Therapeutic area Control number Date of authorization or expanded indication Authorization or expanded indication
GlaxoSmithKline Inc Sotrovimab
Sotrovimab for injection
Immune sera and immunoglobulins, for human use 251285 2021-07-30 Interim Order
Authorized with terms and conditions
BioNTech Manufacturing GmbH

Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine)

Tozinameran (mRNA vaccine, BNT162b2) suspension for injection

Vaccines, for human use 244906 2020-12-09 Interim Order
Authorized with terms and conditions
BioNTech Manufacturing GmbH

Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine)

Tozinameran (mRNA vaccine, BNT162b2) suspension for injection

Vaccines, for human use 251730 2021-05-05

Pediatric indication (ages 12-15)

Interim Order
Authorized with terms and conditions

BioNTech Manufacturing GmbH

Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine)

Tozinameran (mRNA vaccine, BNT162b2) suspension for injection

Vaccines, for human use 252736 2021-09-16 Food and Drug Regulations
Authorized with terms and conditions
Gilead Sciences Canada Inc. Veklury
Remdesivir solution for injection
Antivirals for systemic use, for human use 240551 2020-07-27 Food and Drug Regulations
Issued Notice of Compliance under the NOC/c Guidance
Eli Lilly Canada Inc Bamlanivimab
Bamlanivimab solution for injection
Immune sera and immunoglobulins, for human use 244947 2020-11-20 Interim Order
Authorized with terms and conditions
ModernaTX, Inc Spikevax (previously Moderna COVID-19 Vaccine)
Elasomeran
suspension for injection
Vaccines, for human use 244946 2020-12-23 Interim Order
Authorized with terms and conditions
ModernaTX, Inc Spikevax (previously Moderna COVID-19 Vaccine)
Elasomeran
suspension for injection
Vaccines, for human use 253430 2021-08-27

Pediatric indication (ages 12-17)

Interim Order Authorized with terms and conditions

ModernaTX,Inc

Spikevax (previously Moderna COVID-19 Vaccine)
Elasomeran
suspension for injection

Vaccines, for human use 252733 2021-09-16 Food and Drug Regulations
Authorized with terms and conditions

AstraZeneca Canada Inc Vaxzevria (previously AstraZeneca COVID-19 Vaccine)
ChAdOx1-S (recombinant)
solution for injection
Vaccines, for human use 244627 2021-02-26 Interim Order
Authorized with terms and conditions
Verity Pharmaceuticals Inc/Serum Institute of India (in partnership with AstraZeneca Canada Inc) Covishield
ChAdOx1-S (recombinant)
solution for injection
Vaccines, for human use 248651

2021-02-26

(expired 2021-09-16)

Interim Order
Authorized with terms and conditions
Janssen Inc Janssen COVID-19 Vaccine
AD26.COV2.S (recombinant)
suspension for injection
Vaccines, for human use 246758 2021-03-05 Interim Order
Authorized with terms and conditions
Hoffmann-La Roche Limited Casirivimab and imdevimab
Casirivimab and imdevimab solution for injection
Immune sera and immunoglobulins, for human use 249830 2021-06-09 Interim Order
Authorized with terms and conditions
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