Review decisions
Showing 30 results of 768 total
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/SBD1762969841968
Product Type: Drug
Control Number: 288908
DIN(s): 02559617, 02559625
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-07-25
Issued / Original Publication Date: 2025-11-10
Decision / Authorization Date: 2025-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763739725473
Product Type: Drug
Control Number: 288760
DIN(s): 02561042, 02561050
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-07-22
Issued / Original Publication Date: 2025-11-20
Decision / Authorization Date: 2025-09-12
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
Updated Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766001787668
Product Type: Drug
Control Number: 287973
DIN(s): 02561824, 02561832
Manufacturer: PTC Therapeutics International Limited
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-06-24
Issued / Original Publication Date: 2025-12-18
Decision / Authorization Date: 2025-10-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1770748625931
Product Type: Drug
Control Number: 287986
DIN(s): 02563568, 02563576
Manufacturer: Chiesi Farmaceutici S.P.A
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-06-24
Issued / Original Publication Date: 2026-02-09
Decision / Authorization Date: 2025-12-09
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766087719555
Product Type: Drug
Control Number: 286134
DIN(s): 02561883, 02561891
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-05-28
Issued / Original Publication Date: 2025-12-22
Decision / Authorization Date: 2025-10-09