Review decisions
Showing 10 results of 741 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1761315404285
Product Type: Drug
Control Number: 294637
DIN(s): 02560771
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-01-28
Issued / Original Publication Date: 2025-10-23
Decision / Authorization Date: 2025-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1759323925454
Product Type: Drug
Control Number: 293441
DIN(s): 02560178
Manufacturer: Gilead Sciences Canada, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-12-16
Issued / Original Publication Date: 2025-09-29
Decision / Authorization Date: 2025-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1759755218605
Product Type: Drug
Control Number: 293019
DIN(s): 02560232
Manufacturer: Iovance Biotherapeutics, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-12-03
Issued / Original Publication Date: 2025-10-03
Decision / Authorization Date: 2025-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750255396960
Product Type: Drug
Control Number: 289990
DIN(s): 02557347
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-08-30
Issued / Original Publication Date: 2025-06-18
Decision / Authorization Date: 2025-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1748527113506
Product Type: Drug
Control Number: 289541
DIN(s): 02556219
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-08-13
Issued / Original Publication Date: 2025-05-29
Decision / Authorization Date: 2025-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1760450740287
Product Type: Drug
Control Number: 289506
DIN(s): 02559714
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-08-13
Issued / Original Publication Date: 2025-10-12
Decision / Authorization Date: 2025-07-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1753452540480
Product Type: Drug
Control Number: 288150
DIN(s): 02558351, 02558378
Manufacturer: Daiichi Sankyo Pharma Canada Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-28
Issued / Original Publication Date: 2025-07-24
Decision / Authorization Date: 2025-06-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1758215873791
Product Type: Drug
Control Number: 281029
DIN(s): 02559676, 02559684
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-27
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1746715804692
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
Issued / Original Publication Date: 2025-05-08
Decision / Authorization Date: 2025-02-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751981071024
Product Type: Drug
Control Number: 287772
DIN(s): 02557010
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-19
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-04-25