Review decisions
Showing 10 results of 763 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1764093658678
Product Type: Drug
Control Number: 295463
DIN(s): 02561506
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-02-21
Issued / Original Publication Date: 2025-11-24
Decision / Authorization Date: 2025-09-29
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/SBD1766066698275
Product Type: Drug
Control Number: 294551
DIN(s): 02561492
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-01-27
Issued / Original Publication Date: 2025-12-17
Decision / Authorization Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1770913249373
Product Type: Drug
Control Number: 293878
DIN(s): 02564009
Manufacturer: BeOne Medicines I GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-12-30
Issued / Original Publication Date: 2026-02-11
Decision / Authorization Date: 2025-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766590132872
Product Type: Drug
Control Number: 293854
DIN(s): 02562006, 02562014
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-12-27
Issued / Original Publication Date: 2025-12-24
Decision / Authorization Date: 2025-12-24
Updated Date: 2025-12-24
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/SBD1770040802932
Product Type: Drug
Control Number: 293081
DIN(s): 02563509, 02563517
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-12-04
Issued / Original Publication Date: 2026-01-31
Decision / Authorization Date: 2025-12-05
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