Review decisions
Showing 90 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1737492567696
Product Type: Drug
Control Number: 276757
DIN(s): 02549220, 02549239, 02549247
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-06-30
Issued / Original Publication Date: 2025-01-21
Decision / Authorization Date: 2024-07-11
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: 2025-08-22
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: 2025-08-21
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/SBD1736954230750
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2025-01-15
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733496891004
Product Type: Drug
Control Number: 274338
DIN(s): 02550040, 02550059
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-31
Issued / Original Publication Date: 2024-12-06
Decision / Authorization Date: 2024-07-19
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
Updated Date: 2025-06-30
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
Decision / Authorization Date: 2024-01-26
Updated Date: 2025-06-20
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