Review decisions
Showing 50 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1765554392576
DIN(s): 02404508, 02420201, 02494809, 02494817, 02497026, 02497034, 02502690, 02502704, 02505762, 02505770, 02513781, 02513803, 02515563, 02515571, 02516047, 02516055, 02540746, 02540754
Issued / Original Publication Date: 2025-12-19
Updated Date: 2025-12-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766074543990
Product Type: Drug
Control Number: 296143
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2025-03-17
Decision / Authorization Date: 2025-12-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766085611036
Product Type: Drug
Control Number: 284571
DIN(s): 02456869
Manufacturer: Merck Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-01
Decision / Authorization Date: 2025-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765995575445
Product Type: Drug
Control Number: 281626
DIN(s): 02523760, 02523779, 02535076, 02535084, 02556596
Manufacturer: Celltrion Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-30
Decision / Authorization Date: 2025-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765893824566
Product Type: Drug
Control Number: 287986
Manufacturer: Chiesi Farmaceutici S.P.A
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-24
Decision / Authorization Date: 2025-12-09
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/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/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