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

Date published: 2022-11-17

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
BioNTech Manufacturing GmbH Comirnaty Original/Omicron BA.1
Tozinameran, riltozinameran suspension for injection
Vaccines, for human use 266189 2022-10-21 Bivalent booster (ages 12 years and over)
Food and Drug Regulations
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 265483 2022-09-09 Pediatric indication (ages 6 months-5 years)
Food and Drug Regulations
Authorized with terms and conditions
AstraZeneca Canada Inc Evusheld
Cilgavimab and tixagevimab solution for injection
Immune sera and immunoglobulins, for human use 258295 2022-04-14 Food and Drug Regulations
Authorized with terms and conditions
AstraZeneca Canada Inc

Evusheld Cilgavimab and tixagevimab solution for injection

Immune sera and immunoglobulins, for human use 265382 2022-10-18 Expanded indication Food and Drug Regulations Authorized
Medicago Inc Covifenz
Virus-like particles (VLP) of SARS-CoV-2 spike protein
emulsion for injection
Vaccines, for human use 254598 2022-02-24 Food and Drug Regulations
Authorized with terms and conditions
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 years)
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
BioNTech Manufacturing GmbH Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine)
Tozinameran (mRNA vaccine, BNT162b2) suspension for injection
Vaccines, for human use 257162 2021-11-09 First booster dose
Food and Drug Regulations

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 257698 2021-11-19 Pediatric indication (ages 5-11 years)
Food and Drug Regulations
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

261729

2022-06-01

First booster dose (ages 16-17 years)
Food and Drug Regulations
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

264621

2022-08-19

First booster dose (ages 5-11 years)
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
Gilead Sciences Canada Inc. Veklury
Remdesivir solution for injection
Antivirals for systemic use, for human use 250151 2022-04-22 Expanded indication
Food and Drug Regulations
Authorized
BioNTech Manufacturing GmbH

Comirnaty Original & Omicron BA.4/BA.5
Tozinameran, famtozinameran suspension for injection

Vaccines, for human use 267502 2022-10-07

Bivalent booster (ages 12 years and over)
Food and Drug Regulations
Authorized with terms and conditions

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 years)
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
ModernaTX, Inc Spikevax (previously Moderna COVID-19 Vaccine)
Elasomeran suspension for injection
Vaccines, for human use 257293 2021-11-12 First booster dose
Food and Drug Regulations
Authorized with terms and conditions
ModernaTX, Inc Spikevax (previously Moderna COVID-19 Vaccine)
Elasomeran suspension for injection
Vaccines, for human use 258658 2022-03-17 Pediatric indication (ages 6-11 years)
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
AstraZeneca Canada Inc Vaxzevria (previously AstraZeneca COVID-19 Vaccine)
ChAdOx1-S (recombinant)
solution for injection
Vaccines, for human use 253700 2021-11-19 Food and Drug Regulations
Authorized with terms and conditions
ModernaTX, Inc Spikevax Bivalent
Elasomeran, imelasomeran
dispersion for injection
Vaccines, for human use 265656 2022-09-01 Bivalent booster (ages 18 years and over)
Food and Drug Regulations
Authorized with terms and conditions
ModernaTX, Inc Spikevax Bivalent (Original / Omicron BA.4/5)
Elasomeran, davesomeran dispersion for injection
Vaccines, for human use 267589 2022-11-03 Bivalent booster (ages 18 years and over)
Food and Drug Regulations
Authorized with terms and conditions
Novavax Inc. Nuvaxovid
SARS-CoV-2 recombinant spike protein
suspension for injection
Vaccines, for human use 255370 2022-02-17 Food and Drug Regulations
Authorized with terms and conditions
Novavax Inc. Nuvaxovid
SARS-CoV-2 recombinant spike protein suspension for injection
Vaccines, for human use 266285 2022-11-17 First booster dose
Food and Drug Regulations
Authorized with terms and conditions
Pfizer Canada ULC Paxlovid
Nirmatrelvir and ritonavir tablets for oral administration
Antivirals for systemic use, for human use 259186 2022-01-17 Food and Drug Regulations
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 Jcovden (previously 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
Janssen Inc Jcovden (previously Janssen COVID-19 Vaccine)
AD26.COV2.S (recombinant)
suspension for injection
Vaccines, for human use 253702 2021-11-23 Food and Drug Regulations
Authorized with terms and conditions
Janssen Inc Jcovden (previously Janssen COVID-19 Vaccine)
AD26.COV2.S (recombinant) suspension for injection
Vaccines, for human use 259715 2022-05-11 First booster dose
Food and Drug Regulations
Authorized with terms and conditions
Hoffmann-La Roche Limited Actemra
Tocilizumab solution for injection
Immunosuppressants, for human use 261220 2022-10-13 Expanded indication
Food and Drug Regulations
Authorized
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
ModernaTX, Inc

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

Vaccines, for human use 263775 2022-07-14

Pediatric indication (ages 6 months-5 years)
Food and Drug Regulations
Authorized with terms and conditions

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