Review decisions
Showing 10 results of 2572 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769539407691
Product Type: Drug
Control Number: 286429
DIN(s): 02563665, 02563673
Manufacturer: Galderma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-05-01
Decision / Authorization Date: 2025-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770218138447
Product Type: Drug
Control Number: 290788
DIN(s): 02564653, 02564661, 02564688
Manufacturer: BioMarin International Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-10-01
Decision / Authorization Date: 2026-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768234416024
Product Type: Drug
Control Number: 289989
DIN(s): 02536552, 02536560
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-08-30
Decision / Authorization Date: 2025-08-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1767626541718
Product Type: Drug
Control Number: 286477
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-30
Decision / Authorization Date: 2025-10-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768246014820
Product Type: Drug
Control Number: 293878
Manufacturer: BeOne Medicines I GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-12-30
Decision / Authorization Date: 2025-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766500484485
Product Type: Drug
Control Number: 296767
DIN(s): 02550520, 02550539, 02550547, 02562987, 02562995, 02563002
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-04-02
Decision / Authorization Date: 2025-11-21
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