Review decisions
Showing 320 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01087
Product Type: Drug
Control Number: 269939
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-12-16
Decision / Authorization Date: 2023-01-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01071
Product Type: Drug
Control Number: 263913
DIN(s): 02534673
Manufacturer: Pharmaris Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-03
Decision / Authorization Date: 2023-01-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01052
Product Type: Drug
Control Number: 262408
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-03-16
Decision / Authorization Date: 2023-01-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1709128914848
Product Type: Drug
Control Number: 271331
DIN(s): 02542293, 02542307
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-01-12
Issued / Original Publication Date: 2024-02-27
Decision / Authorization Date: 2023-10-13
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00737
Product Type: Drug
Control Number: 234655
DIN(s): 02503034
Manufacturer: Medunik Canada
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-20
Decision / Authorization Date: 2023-01-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01054
Product Type: Drug
Control Number: 265333
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-17
Decision / Authorization Date: 2023-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01055
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-24
Decision / Authorization Date: 2023-01-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1722001162962
Product Type: Drug
Control Number: 271065
DIN(s): 02543931
Manufacturer: Horizon Therapeutics Ireland DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-30
Issued / Original Publication Date: 2024-07-24
Decision / Authorization Date: 2023-12-15
Updated Date: 2024-11-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1698846935419
Product Type: Drug
Control Number: 271030
DIN(s): 02539888
Manufacturer: Mirum Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-12-28
Issued / Original Publication Date: 2023-10-27
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044, 02553120
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-24
Issued / Original Publication Date: 2024-06-12
Decision / Authorization Date: 2023-11-09
Updated Date: 2025-08-06