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

Date published: 2021-12-01

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

The Interim order expired September 16, 2021 so all new submissions will now be filed 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:

In the "outcome of application" column, there are 5 possible scenarios:

The authorization dates below refer to decisions made under the interim order (IO) or the Food and Drug Regulations (FDR). Authorization of new uses (for example, pediatric use) and their authorization dates are also included.

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
AstraZeneca Canada Inc Adenovirus vaccine vector (ChAdOx1-S [recombinant]) Vaccines, for human use 2020-10-01 Authorized (with terms and conditions)

2021-02-26 (IO)

2021-11-19 (FDR)

AstraZeneca Canada Inc Cilgavimab and tixagevimab Immune sera and immunoglobulins, for human use 2021-11-03 Under review n/a
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 (IO)
Gilead Sciences Canada Inc Remdesivir Antivirals for systemic use, for human use 2020-06-19 Authorized (with conditions) 2020-07-27 (FDR)
ModernaTX, Inc Elasomeran Vaccines, for human use 2020-10-12 Authorized (with terms and conditions)

2020-12-23 (IO)

2021-08-27 (ages 12-17, IO)

2021-09-16 (FDR)

2021-11-12 (Booster dose, FDR)

ModernaTX, Inc Elasomeran Vaccines, for human use 2021-11-16 Pediatric dose (ages 6-11) - 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 (IO)

2021-05-05 (ages 12-15, IO)

2021-09-16 (FDR)

2021-11-09 (Booster dose, FDR)

2021-11-19 (ages 5-11, FDR)

Janssen Inc Ad26.COV2.S (recombinant) Vaccines, for human use 2020-11-30 Authorized (with terms and conditions)

2021-03-05 (IO)

2021-11-23 (FDR)

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 (IO)
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)

Expired

2021-02-26 (IO)

2021-09-16
(expired)

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 (IO)
CytoDyn, Inc. Leronlimab Immune sera and immunoglobulins, for human use 2021-03-23 Expired 2021-09-16
GlaxoSmithKline Inc Sotrovimab Immune sera and immunoglobulins, for human use 2021-04-01 Authorized (with conditions) 2021-07-30 (IO)
Medicago Inc Coronavirus-like particle (CoVLP) Vaccines, for human use 2021-04-19 Under review n/a
Merck Canada Inc Molnupiravir Antivirals for systemic use, for human use 2021-08-13 Under review n/a
Eli Lilly Canada Inc BaricitinibFootnote * Antivirals for systemic use, for human use 2021-05-13 Under review n/a
Pfizer Canada ULC PF-07321332 and ritonavir Antivirals for systemic use, for human use 2021-12-01 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 Cancelled by sponsor 2021-09-01 (IO)
Vaccigen Ltd Whole virion inactivated corona virus Vaccines, for human use 2021-06-30 Under review n/a
Footnote *

This product is approved in Canada for other uses.

Return to footnote * referrer

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