Review decisions
Showing 140 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758130283450
Product Type: Drug
Control Number: 285296
DIN(s): 02557061
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-25
Decision / Authorization Date: 2025-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758131354024
Product Type: Drug
Control Number: 285444
DIN(s): 02558262
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758027432801
Product Type: Drug
Control Number: 287534
Manufacturer: Neurim Pharmaceuticals Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-06-07
Decision / Authorization Date: 2025-09-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764951751376
Product Type: Drug
Control Number: 288056
DIN(s): 02502984
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-06-26
Decision / Authorization Date: 2025-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1757343054057
Product Type: Drug
Control Number: 293019
Manufacturer: Iovance Biotherapeutics Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-12-03
Decision / Authorization Date: 2025-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759435249086
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
Decision / Authorization Date: 2025-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1756137828906
Product Type: Drug
Control Number: 285056
DIN(s): 02463644
Manufacturer: ALK- Abello A/S
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-18
Decision / Authorization Date: 2025-03-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1756133878031
Product Type: Drug
Control Number: 288908
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-07-25
Decision / Authorization Date: 2025-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1756135291228
Product Type: Drug
Control Number: 289008
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-07-29
Decision / Authorization Date: 2025-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1756136476006
Product Type: Drug
Control Number: 294481
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2025-01-23
Decision / Authorization Date: 2025-08-11