Review decisions
Showing 30 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1771610652206
Product Type: Drug
Control Number: 295190
DIN(s): 02529548, 02529556
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-02-13
Decision / Authorization Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770824778122
Product Type: Drug
Control Number: 289290
DIN(s): 02550245, 02550253, 02550261, 02558270
Manufacturer: Celltrion Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-08-02
Decision / Authorization Date: 2025-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770819331315
Product Type: Drug
Control Number: 286361
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-26
Decision / Authorization Date: 2025-04-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770827270935
Product Type: Drug
Control Number: 299521
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2025-06-30
Decision / Authorization Date: 2026-01-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770738107590
Product Type: Drug
Control Number: 288114
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-27
Decision / Authorization Date: 2025-07-03
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