Review decisions
Showing 110 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715623184650
Product Type: Drug
Control Number: 272785
DIN(s): 02544040
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-27
Issued / Original Publication Date: 2024-05-10
Decision / Authorization Date: 2023-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707490019947
Product Type: Drug
Control Number: 272688
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-02-24
Issued / Original Publication Date: 2023-02-08
Decision / Authorization Date: 2024-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734618875973
Product Type: Drug
Control Number: 272660
DIN(s): 02549123, 02549131
Manufacturer: Eli Lilly Canada Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-22
Issued / Original Publication Date: 2024-12-18
Decision / Authorization Date: 2024-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729522137894
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-03-01
Updated Date: 2024-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1729523262756
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Issued / Original Publication Date: 2024-10-17
Decision / Authorization Date: 2024-02-16
Updated Date: 2024-10-17
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/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/SBD1724254451412
Product Type: Drug
Control Number: 271038
DIN(s): 02544903
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-28
Issued / Original Publication Date: 2024-08-21
Decision / Authorization Date: 2024-08-21
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