Review decisions
Showing 10 results of 680 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2024-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1732553847408
Product Type: Drug
Control Number: 278277
DIN(s): 02547392, 02547406
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-08-15
Issued / Original Publication Date: 2024-11-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1688740135719
Product Type: Drug
Control Number: 259302
DIN(s): 02533286
Manufacturer: VBI Vaccines Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-08
Issued / Original Publication Date: 2023-07-06
Decision / Authorization Date: 2022-12-06
Updated Date: 2024-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1698862620995
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-10-31
Decision / Authorization Date: 2023-09-12
Updated Date: 2024-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700495075939
Product Type: Drug
Control Number: 276302
DIN(s): 02541823, 02541831, 02541858, 02541866, 02552035, 02552078
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-11-22
Decision / Authorization Date: 2023-09-28
Updated Date: 2024-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1731445138060
Product Type: Drug
Control Number: 275762
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Issued / Original Publication Date: 2024-11-12
Decision / Authorization Date: 2024-11-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1725029128529
Product Type: Drug
Control Number: 275236
DIN(s): 02545713, 02545721
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-05-12
Issued / Original Publication Date: 2024-08-30
Decision / Authorization Date: 2024-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728656969053
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Issued / Original Publication Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730227073967
Product Type: Drug
Control Number: 274598
DIN(s): 02548909
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-21
Issued / Original Publication Date: 2024-10-29
Decision / Authorization Date: 2024-06-19