Review decisions
Showing 10 results of 705 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740501914989
Product Type: Drug
Control Number: 285051
Manufacturer: Acadia Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-03-15
Issued / Original Publication Date: 2025-02-21
Decision / Authorization Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739203842068
Product Type: Drug
Control Number: 284351
DIN(s): 02552043
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-02-27
Issued / Original Publication Date: 2025-02-08
Decision / Authorization Date: 2024-09-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1738591726718
Product Type: Drug
Control Number: 283307
DIN(s): 02551284, 02551292, 02551306, 02551314
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-31
Issued / Original Publication Date: 2025-01-31
Decision / Authorization Date: 2024-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733494552846
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Issued / Original Publication Date: 2024-12-05
Decision / Authorization Date: 2024-08-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740062351552
Product Type: Drug
Control Number: 279053
DIN(s): 02553805, 02553813
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
Issued / Original Publication Date: 2025-02-19
Decision / Authorization Date: 2024-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740407272003
Product Type: Drug
Control Number: 282144
DIN(s): 02553996
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2024-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739374529873
Product Type: Drug
Control Number: 281963
DIN(s): 02551551, 02551578
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-12-11
Issued / Original Publication Date: 2025-02-11
Decision / Authorization Date: 2024-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734463856248
Product Type: Drug
Control Number: 281914
DIN(s): 02549891
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-12-08
Issued / Original Publication Date: 2024-12-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740491309253
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Issued / Original Publication Date: 2025-02-24
Decision / Authorization Date: 2024-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739886817493
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Issued / Original Publication Date: 2025-02-17
Decision / Authorization Date: 2024-10-11