Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications
This page has been archived. Refer to the Lists of Drug and Health Product Submissions Under Review and the COVID-19 Vaccines and Treatments Portal for more information.
Date published: 2024-07-15
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:
- authorization holder
- brand name, proper name or common name, linked to the rationale for authorizing the product for use against COVID-19
- medicinal ingredient(s), strength, dosage form and route of administration
- drug identification number (DIN), linked to the entry for the product in the Drug Product Database, which includes the product monograph
- therapeutic area (using the World Health Organization's coding system)
- Health Canada's control number for the application
- date of authorization
- how the drug or vaccine was authorized
In the "authorization" column, there are 4 possible scenarios for each drug or vaccine:
- The product was submitted by the company to Health Canada and authorized under the Food and Drug Regulations
- The product was submitted by the company for review under section 3 of the interim order (IO) Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and authorized
- The product was submitted by the company for review under section 4 of the interim order and authorized
- The product was added to the List of new drugs for expanded indication in relation to the COVID-19 pandemic by Health Canada, under section 15 of the interim order
| 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 Omicron XBB.1.5 Raxtozinameran suspension for injection |
Vaccines, for human use | 276302 | 2023-09-28 | Food and Drug Regulations Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax XBB.1.5 Andusomeran dispersion for injection |
Vaccines, for human use | 275936 | 2023-09-12 | Food and Drug Regulations Authorized with terms and conditions |
| BioNTech Manufacturing GmbH | Comirnaty Original & Omicron BA.4/BA.5 Tozinameran, famtozinameran suspension for injection |
Vaccines, for human use | 275559 | 2023-08-31 (cancelled by sponsor 2024-05-03) |
Primary series (ages 6 months to < 5 years) Food and Drug Regulations Authorized with terms and conditions |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.1 Tozinameran, riltozinameran suspension for injection |
Vaccines, for human use | 266189 | 2022-10-21 (cancelled by sponsor 2024-05-03) |
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 (cancelled by sponsor 2024-05-03) |
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 (cancelled by sponsor 2024-03-27) |
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 (cancelled by sponsor 2024-03-27) |
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 (cancelled by sponsor 2023-03-31) | Food and Drug Regulations Authorized with terms and conditions |
| Medicago Inc | Covifenz Virus-like particles (VLP) of SARS-CoV-2 spike protein emulsion for injection |
Vaccines, for human use | 267448 | 2023-03-30 (cancelled by sponsor 2023-03-31) | Ages 65 years and older 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 (Authorization by interim order revoked 2024-04-29) |
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 (cancelled by sponsor 2024-05-03) |
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 (cancelled by sponsor 2024-05-03) |
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 (cancelled by sponsor 2024-05-03) |
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 (cancelled by sponsor 2024-05-03) |
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 (cancelled by sponsor 2024-05-03) |
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) |
Vaccines, for human use |
2022-06-01 |
First booster dose (ages 16-17 years) |
|
BioNTech Manufacturing GmbH |
Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) |
Vaccines, for human use |
2022-08-19 |
First booster dose (ages 5-11 years) |
|
| 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 |
| Gilead Sciences Canada Inc. | Veklury Remdesivir solution for injection |
Antivirals for systemic use, for human use | 266313 | 2023-06-15 | Ages older than 28 days-11 years Food and Drug Regulations Authorized |
| BioNTech Manufacturing GmbH | Comirnaty Original & Omicron BA.4/BA.5 Tozinameran, famtozinameran suspension for injection |
Vaccines, for human use | 268826 | 2022-12-09 (cancelled by sponsor 2024-05-03) |
Bivalent booster (ages 5-11 years) Food and Drug Regulations Authorized with terms and conditions |
| BioNTech Manufacturing GmbH | Comirnaty Original & Omicron BA.4/BA.5 |
Vaccines, for human use | 274152 | 2023-07-06 (cancelled by sponsor 2024-05-03) |
Primary series |
| BioNTech Manufacturing GmbH | Comirnaty Original & Omicron BA.4/BA.5 |
Vaccines, for human use | 267502 | 2022-10-07 (cancelled by sponsor 2024-05-03) |
Bivalent booster (ages 12 years and over) |
| Eli Lilly Canada Inc | Bamlanivimab Bamlanivimab solution for injection |
Immune sera and immunoglobulins, for human use | 244947 | 2020-11-20 (cancelled by sponsor 2023-02-13) | Interim Order Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) Elasomeran suspension for injection |
Vaccines, for human use | 244946 | 2020-12-23 (cancelled by sponsor 2024-01-19) | Interim Order Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) Elasomeran suspension for injection |
Vaccines, for human use | 253430 | 2021-08-27 (cancelled by sponsor 2024-01-19) | Pediatric indication (ages 12-17 years) Interim Order Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) Elasomeran suspension for injection |
Vaccines, for human use | 252733 | 2021-09-16 (cancelled by sponsor 2024-01-19) | Food and Drug Regulations Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) Elasomeran suspension for injection |
Vaccines, for human use | 257293 | 2021-11-12 (cancelled by sponsor 2024-01-19) | First booster dose Food and Drug Regulations Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) Elasomeran suspension for injection |
Vaccines, for human use | 258658 | 2022-03-17 (cancelled by sponsor 2024-01-19) | 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 (cancelled by sponsor 2023-12-19) | 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 |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) |
Vaccines, for human use | 2023-01-12 (cancelled by sponsor 2024-01-19) | First booster dose (ages 12-17 years) |
|
| Moderna Biopharma Canada Corporation | Spikevax Bivalent Elasomeran, imelasomeran dispersion for injection |
Vaccines, for human use | 265656 | 2022-09-01 (cancelled by sponsor 2024-01-19) | Bivalent booster (ages 18 years and over) Food and Drug Regulations Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax Bivalent |
Vaccines, for human use | 269428 | 2023-02-17 (cancelled by sponsor 2024-01-19) | Bivalent booster (ages 6-17 years) |
| Moderna Biopharma Canada Corporation | Spikevax Bivalent (Original / Omicron BA.4/5) Elasomeran, davesomeran dispersion for injection |
Vaccines, for human use | 267589 | 2022-11-03 (cancelled by sponsor 2024-01-19) | Bivalent booster (ages 18 years and over) Food and Drug Regulations Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax Bivalent (Original / Omicron BA.4/5) Elasomeran, davesomeran dispersion for injection |
Vaccines, for human use | 273747 | 2023-05-18 (cancelled by sponsor 2024-01-19) | Bivalent booster (ages 6-17 years) 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 (cancelled by sponsor 2024-02-29) | 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 (cancelled by sponsor 2024-02-29) | First booster dose 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 | 265342 | 2022-12-06 (cancelled by sponsor 2024-02-29) | Adolescent dose (ages 12-17 years) Food and Drug Regulations |
| Novavax Inc. | Nuvaxovid XBB.1.5 SARS-CoV-2 recombinant spike protein suspension for injection |
Vaccines, for human use | 278519 | 2023-12-05 | 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 (cancelled by sponsor 2023-06-30) |
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 (cancelled by sponsor 2023-06-30) |
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 | 2022-05-12 (cancelled by sponsor 2023-06-30) |
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 (Authorization by interim order revoked 2024-06-21) |
Interim Order Authorized with terms and conditions |
| Moderna Biopharma Canada Corporation | Spikevax (previously Moderna COVID-19 Vaccine) |
Vaccines, for human use | 263775 | 2022-07-14 (cancelled by sponsor 2024-01-19) | Pediatric indication (ages 6 months-5 years) |
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