Drug and vaccine authorizations for COVID-19: List of applications received
Date published: 2021-07-30
Under the interim order, a company can submit an application for a drug or vaccine for use in COVID-19 that:
- has never been approved in Canada
- was previously approved in Canada for another use
- has been approved by a trusted foreign regulatory authority
An applicant can also file a new drug submission under the Food and Drug Regulations.
The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the interim order and those received under the Food and Drug Regulations. The current status of each application is also noted.
Information for each application includes the:
- applicant (name of the company that submitted the application)
- medicinal ingredient(s)
- therapeutic area (using the World Health Organization's coding system)
- date we received the application
- outcome of the application
- date of outcome ("not applicable" means the application is still in progress)
In the "outcome of application" column, there are 4 possible scenarios:
- Pending
- Authorized
- Rejected (by Health Canada)
- Cancelled (by the company)
Consult the Drug and health product submissions under review (SUR) list and the Generic submissions under review list to access submissions under review that are not related to the COVID-19 pandemic.
| Applicant | Medicinal ingredient(s) | Therapeutic area | Date application was received | Outcome of application | Date of decision/outcome |
|---|---|---|---|---|---|
| AstraZeneca Canada Inc | Adenovirus vaccine vector (ChAdOx1-S [recombinant]) | Vaccines, for human use | 2020-10-01 | Authorized (with terms and conditions) | 2021-02-26 |
| Celltrion HealthCare Co Ltd | Regdanvimab | Immune sera and immunoglobulins, for human use | 2021-05-21 | Under review | n/a |
| Eli Lilly Canada Inc | Bamlanivimab (LY-CoV555) | Immune sera and immunoglobulins, for human use | 2020-10-12 | Authorized (with terms and conditions) | 2020-11-20 |
| Gilead Sciences Canada Inc | Remdesivir | Antivirals for systemic use, for human use | 2020-06-19 | Authorized (with conditions) | 2020-07-27 |
| ModernaTX, Inc | mRNA-1273 SARS-CoV-2 |
Vaccines, for human use | 2020-10-12 | Authorized (with terms and conditions) | 2020-12-23 |
| ModernaTX, Inc | mRNA-1273 SARS-CoV-2 |
Vaccines, for human use | 2021-06-04 | Pediatric indication (ages 12-17) – Under review | n/a |
| Pfizer Canada ULC/BioNTech SE | Tozinameran (mRNA vaccine, BNT162b2) | Vaccines, for human use | 2020-10-09 | Authorized (with terms and conditions) | 2020-12-09 |
| Pfizer Canada ULC/BioNTech SE | Tozinameran (mRNA vaccine, BNT162b2) | Vaccines, for human use | 2021-04-16 | Pediatric indication (ages 12-15) - Authorized (with terms and conditions) | 2021-05-05 |
| Janssen Inc | Ad26.COV2.S (recombinant) | Vaccines, for human use | 2020-11-30 | Authorized (with terms and conditions) | 2021-03-05 |
| Dr Reddys Laboratories Ltd | Favipiravir | Antivirals for systemic use, for human use | 2020-12-18 | Under review | n/a |
| Pendopharm Division of Pharmascience Inc | ColchicineFootnote * | Antigout preparations, for human use | 2021-01-25 | Cancelled by sponsor | 2021-06-07 |
| Verity Pharmaceuticals Inc/Serum Institute of India (in partnership with AstraZeneca Canada Inc) | Adenovirus vaccine vector (ChAdOx1-S [recombinant]) |
Vaccines, for human use | 2021-01-23 | Authorized (with terms and conditions) | 2021-02-26 |
| Novavax Inc. | NVX-CoV2373 | Vaccines, for human use | 2021-01-29 | Under review | n/a |
| Eli Lilly Canada Inc | Bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) | Immune sera and immunoglobulins, for human use | 2021-02-16 | Under review | n/a |
| Hoffmann-La Roche Limited | Casirivimab and imdevimab | Immune sera and immunoglobulins, for human use | 2021-02-24 | Authorized (with conditions) | 2021-06-09 |
| CytoDyn, Inc. | Leronlimab | Immune sera and immunoglobulins, for human use | 2021-03-23 | Under review | n/a |
| GlaxoSmithKline Inc | Sotrovimab | Immune sera and immunoglobulins, for human use | 2021-04-01 | Authorized (with conditions) | 2021-07-30 |
| Medicago Inc | Coronavirus-like particle (CoVLP) | Vaccines, for human use | 2021-04-19 | Under review | n/a |
| Eli Lilly Canada Inc | BaricitinibFootnote * | Antivirals for systemic use, for human use | 2021-05-13 | Under review | n/a |
| Sanofi Pasteur Limited | SARS-CoV-2 prefusion spike delta TM protein, recombinant | Vaccines, for human use | 2021-07-21 | Under review | n/a |
| Sanotize Research & Development Corp. | Nitric oxideFootnote * | Other nervous system drugs, for human use | 2021-06-15 | Under review | n/a |
| Vaccigen Ltd | Whole virion inactivated corona virus | Vaccines, for human use | 2021-06-30 | Under review | n/a |
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