Review decisions

Showing 30 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770221056702
Product Type: Drug
Control Number: 290985
DIN(s): 02562219
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-11-01
Decision / Authorization Date: 2025-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770219862903
Product Type: Drug
Control Number: 286289
DIN(s): 02525267, 02525275, 02553619, 02553627
Manufacturer: UCB Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-24
Decision / Authorization Date: 2025-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770221966795
Product Type: Drug
Control Number: 279522
DIN(s): 02370050, 02370069, 02470489
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-09-28
Decision / Authorization Date: 2025-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771251043947
Product Type: Drug
Control Number: 296870
DIN(s): 02554283, 02554291, 02565420
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-04-07
Decision / Authorization Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770915388549
Product Type: Drug
Control Number: 295692
DIN(s): 02565382
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-02-28
Decision / Authorization Date: 2026-02-03
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