Review decisions
Showing 40 results of 2627 total
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/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/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/RDS1772570025345
Product Type: Drug
Control Number: 293525
DIN(s): 02563487
Manufacturer: Searchlight Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-12-17
Decision / Authorization Date: 2025-12-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773424794723
Product Type: Drug
Control Number: 289987
DIN(s): 02563304
Manufacturer: Orimed Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-08-30
Decision / Authorization Date: 2025-11-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770822495415
Product Type: Drug
Control Number: 290103
DIN(s): 02563525, 02563533, 02563541
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-09-04
Decision / Authorization Date: 2025-12-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773671356247
Product Type: Drug
Control Number: 291745
DIN(s): 02562782
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-11-27
Decision / Authorization Date: 2025-11-14
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