Review decisions
Showing 60 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774965255993
Product Type: Drug
Control Number: 290817
DIN(s): 02454130, 02519011, 02519038, 02561514
Manufacturer: Aralez Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-10-01
Decision / Authorization Date: 2025-10-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770829277785
Product Type: Drug
Control Number: 269568
DIN(s): 02558912, 02558920, 02558939
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-10
Decision / Authorization Date: 2025-07-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769626224845
Product Type: Drug
Control Number: 288417
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-07-11
Decision / Authorization Date: 2025-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769177568104
Product Type: Drug
Control Number: 288071
DIN(s): 02555476, 02555484
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-26
Decision / Authorization Date: 2025-02-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765391179751
Product Type: Drug
Control Number: 298213
DIN(s): 02551284, 02551292, 02551306, 02551314
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-05-20
Decision / Authorization Date: 2025-12-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764967113004
Product Type: Drug
Control Number: 279915
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608, 02528509, 02528517, 02528525, 02528533, 02528541, 02552698
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-13
Decision / Authorization Date: 2024-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1772730117045
Product Type: Drug
Control Number: 282015
DIN(s): 02560704
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-13
Decision / Authorization Date: 2025-08-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773947348229
Product Type: Drug
Control Number: 282456
DIN(s): 02415690, 02561069
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-29
Decision / Authorization Date: 2025-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769701234858
Product Type: Drug
Control Number: 292450
DIN(s): 02483084, 02483092
Manufacturer: Indivior UK Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-18
Decision / Authorization Date: 2025-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773082209708
Product Type: Drug
Control Number: 292802
DIN(s): 02563010
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-11-28
Decision / Authorization Date: 2025-11-21