Review decisions
Showing 20 results of 768 total
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/SBD1770056464586
Product Type: Drug
Control Number: 292152
DIN(s): 02562928
Manufacturer: Valorum Biologics LLC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-11-29
Issued / Original Publication Date: 2026-02-02
Decision / Authorization Date: 2025-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1770217121121
Product Type: Drug
Control Number: 291745
DIN(s): 02562782
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-11-27
Issued / Original Publication Date: 2026-02-02
Decision / Authorization Date: 2025-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1768839124876
Product Type: Drug
Control Number: 290401
DIN(s): 02562510, 02562529
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-11-15
Issued / Original Publication Date: 2026-01-19
Decision / Authorization Date: 2025-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1765291966794
Product Type: Drug
Control Number: 290985
DIN(s): 02562219
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-11-01
Issued / Original Publication Date: 2025-12-08
Decision / Authorization Date: 2025-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766414303398
Product Type: Drug
Control Number: 291323
DIN(s): 02561433
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-10-15
Issued / Original Publication Date: 2025-12-22
Decision / Authorization Date: 2025-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1775850909553
Product Type: Drug
Control Number: 290788
DIN(s): 02564653, 02564661, 02564688
Manufacturer: BioMarin International Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-10-01
Issued / Original Publication Date: 2026-04-09
Decision / Authorization Date: 2026-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1771526934306
Product Type: Drug
Control Number: 290103
DIN(s): 02563525, 02563533, 02563541
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-09-04
Issued / Original Publication Date: 2026-02-19
Decision / Authorization Date: 2025-12-05
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