Drug and vaccine authorizations for COVID-19: List of applications received

Date published: 2020-11-20

Under the interim order, a company can submit an application for a drug for use in COVID-19 that:

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 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:

In the "outcome of application" column, there are 4 possible scenarios:

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.

Applications received related to the COVID-19 pandemic
Applicant Medicinal ingredient(s) Therapeutic area Date application was received Outcome of application Date of decision/outcome
Moderna Therapeutics Inc mRNA-1273 vaccine Vaccines, for human use 2020-10-12 Pending 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
Pfizer Canada ULC/BioNTech SE mRNA vaccine BNT162b2 Vaccines, for human use 2020-10-09 Pending n/a
AstraZeneca Canada Inc. Adenovirus vaccine vector (ChAdOx1) Vaccines, for human use 2020-10-01 Pending n/a
Gilead Sciences Canada Inc. Remdesivir Antivirals for systemic use, for human use 2020-06-19 Authorized (with conditions) 2020-07-27
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