Review decisions

Showing 20 results of 2322 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774274878641
Product Type: Drug
Control Number: 281503
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-14
Decision / Authorization Date: 2026-02-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773080980602
Product Type: Drug
Control Number: 293336
DIN(s): 02565706
Manufacturer: Macleods Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-02-03
Decision / Authorization Date: 2026-02-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771512890256
Product Type: Drug
Control Number: 295245
DIN(s): 02497859, 02509474
Manufacturer: Teva Canada Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-02-18
Decision / Authorization Date: 2026-01-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773939928773
Product Type: Drug
Control Number: 295025
DIN(s): 02531917, 02531925, 02564726
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-02-10
Decision / Authorization Date: 2026-01-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771857891846
Product Type: Drug
Control Number: 282961
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-01-19
Decision / Authorization Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771856549838
Product Type: Drug
Control Number: 295777
DIN(s): 02434806
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-03-04
Decision / Authorization Date: 2026-01-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774537650545
Product Type: Drug
Control Number: 289506
DIN(s): 02559714
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-08-13
Decision / Authorization Date: 2025-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773943231326
Product Type: Drug
Control Number: 297894
DIN(s): 02563886
Manufacturer: Theratechnologies Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-05-09
Decision / Authorization Date: 2025-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771010886138
Product Type: Drug
Control Number: 298079
DIN(s): 02565226
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-05-16
Decision / Authorization Date: 2026-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770907424396
Product Type: Drug
Control Number: 296499
DIN(s): 02564610
Manufacturer: Jazz Pharmaceuticals Ireland Limited
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-04-04
Decision / Authorization Date: 2026-01-15