Review decisions
Showing 310 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722532649097
Product Type: Drug
Control Number: 281914
DIN(s): 02549891
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-12-08
Decision / Authorization Date: 2024-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1720539616626
Product Type: Drug
Control Number: 282374
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719926004455
Product Type: Drug
Control Number: 275762
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Decision / Authorization Date: 2024-06-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1753452540480
Product Type: Drug
Control Number: 288150
DIN(s): 02558351, 02558378
Manufacturer: Daiichi Sankyo Pharma Canada Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-28
Issued / Original Publication Date: 2025-07-24
Decision / Authorization Date: 2025-06-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1758215873791
Product Type: Drug
Control Number: 281029
DIN(s): 02559676, 02559684
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-27
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719422939290
Product Type: Drug
Control Number: 276501
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-23
Decision / Authorization Date: 2024-05-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1746715804692
Product Type: Drug
Control Number: 288071
DIN(s): 02555476, 02555484
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-26
Issued / Original Publication Date: 2025-05-08
Decision / Authorization Date: 2025-02-14
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719934782015
Product Type: Drug
Control Number: 272660
DIN(s): 02549123, 02549131
Manufacturer: Eli Lilly Canada, Inc.
Submission Type: New Drug Submission (New Active Submission)
Date Filed / Submission Date: 2022-02-22
Decision / Authorization Date: 2024-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766001787668
Product Type: Drug
Control Number: 287973
DIN(s): 02561824, 02561832
Manufacturer: PTC Therapeutics International Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-24
Issued / Original Publication Date: 2025-12-18
Decision / Authorization Date: 2025-10-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1770748625931
Product Type: Drug
Control Number: 287986
DIN(s): 02563568, 02563576
Manufacturer: Chiesi Farmaceutici S.P.A
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-24
Issued / Original Publication Date: 2026-02-09
Decision / Authorization Date: 2025-12-09