Review decisions
Showing 30 results of 2586 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765217625791
Product Type: Drug
Control Number: 282235
DIN(s): 00466085
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-19
Decision / Authorization Date: 2024-12-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765205479281
Product Type: Drug
Control Number: 290364
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-09-23
Decision / Authorization Date: 2025-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768243878335
Product Type: Drug
Control Number: 284373
DIN(s): 02557444, 02557452
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-28
Decision / Authorization Date: 2025-05-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768236073374
Product Type: Drug
Control Number: 280995
DIN(s): 00297763, 02555093
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-10
Decision / Authorization Date: 2025-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769626224845
Product Type: Drug
Control Number: 288417
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-07-11
Decision / Authorization Date: 2025-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769177568104
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
Decision / Authorization Date: 2025-02-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770235707072
Product Type: Drug
Control Number: 276366
DIN(s): 02556812
Manufacturer: Amicus Therapeutics Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-03-08
Decision / Authorization Date: 2025-04-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770829277785
Product Type: Drug
Control Number: 269568
DIN(s): 02558912, 02558920, 02558939
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-10
Decision / Authorization Date: 2025-07-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765391179751
Product Type: Drug
Control Number: 298213
DIN(s): 02551284, 02551292, 02551306, 02551314
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-05-20
Decision / Authorization Date: 2025-12-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764967113004
Product Type: Drug
Control Number: 279915
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608, 02528509, 02528517, 02528525, 02528533, 02528541, 02552698
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-13
Decision / Authorization Date: 2024-11-25