Review decisions
Showing 70 results of 633 total
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/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/RDS1755022842278
Product Type: Drug
Control Number: 284185
DIN(s): 02473232, 02496135
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-22
Decision / Authorization Date: 2025-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1756129266390
Product Type: Drug
Control Number: 288497
DIN(s): 02322285
Manufacturer: Alexion Pharma GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-07-11
Decision / Authorization Date: 2025-08-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759938964937
Product Type: Drug
Control Number: 264421
DIN(s): 02510219, 02510227, 02558947, 02558955
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-19
Decision / Authorization Date: 2025-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753294235039
Product Type: Drug
Control Number: 288709
DIN(s): 02478579
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-07-18
Decision / Authorization Date: 2025-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759759362199
Product Type: Drug
Control Number: 280615
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-01
Decision / Authorization Date: 2024-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760541328782
Product Type: Drug
Control Number: 282593
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-01-08
Decision / Authorization Date: 2024-12-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753284914670
Product Type: Drug
Control Number: 285395
DIN(s): 02557320
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2025-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758566878414
Product Type: Drug
Control Number: 285745
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-08
Decision / Authorization Date: 2025-04-10