Review decisions
Showing 50 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1743686266671
Product Type: Drug
Control Number: 284667
DIN(s): 02554429, 02554437
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-03-05
Issued / Original Publication Date: 2025-04-02
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1745520433225
Product Type: Drug
Control Number: 284436
DIN(s): 02556138
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-02-29
Issued / Original Publication Date: 2025-04-28
Decision / Authorization Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751029009341
Product Type: Drug
Control Number: 284373
DIN(s): 02557444, 02557452
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-28
Issued / Original Publication Date: 2025-06-27
Decision / Authorization Date: 2025-05-07
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/SBD1749131274419
Product Type: Drug
Control Number: 273870
DIN(s): 02556537, 02556545
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-02-25
Issued / Original Publication Date: 2025-06-03
Decision / Authorization Date: 2025-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1744031364691
Product Type: Drug
Control Number: 284125
DIN(s): 02555239
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-20
Issued / Original Publication Date: 2025-04-03
Decision / Authorization Date: 2025-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1747748736412
Product Type: Drug
Control Number: 283753
DIN(s): 02447967, 02448114, 02448122, 02448130, 02448149, 02448157
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-09
Issued / Original Publication Date: 2025-05-17
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/SBD1743623338530
Product Type: Drug
Control Number: 283206
DIN(s): 02554313
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-01-29
Issued / Original Publication Date: 2025-04-02
Decision / Authorization Date: 2025-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1746714399832
Product Type: Drug
Control Number: 283158
DIN(s): 02555735
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-01-26
Issued / Original Publication Date: 2025-05-08
Decision / Authorization Date: 2025-02-28