Review decisions
Showing 70 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734463856248
Product Type: Drug
Control Number: 281914
DIN(s): 02549891
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-12-08
Issued / Original Publication Date: 2024-12-16
Decision / Authorization Date: 2024-07-15
Updated Date: 2025-04-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1744723057257
Product Type: Drug
Control Number: 281695
DIN(s): 02552965, 02552973, 02552981
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-30
Issued / Original Publication Date: 2025-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1761230003309
Product Type: Drug
Control Number: 280174
DIN(s): 02559765, 02559773
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-14
Issued / Original Publication Date: 2025-10-22
Decision / Authorization Date: 2025-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1744035408183
Product Type: Drug
Control Number: 280730
DIN(s): 02554151
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-11-03
Issued / Original Publication Date: 2025-04-04
Decision / Authorization Date: 2024-12-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740491309253
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Issued / Original Publication Date: 2025-02-24
Decision / Authorization Date: 2024-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1742837642143
Product Type: Drug
Control Number: 273871
DIN(s): 02553945
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-18
Issued / Original Publication Date: 2025-03-23
Decision / Authorization Date: 2024-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739886817493
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Issued / Original Publication Date: 2025-02-17
Decision / Authorization Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750434053010
Product Type: Drug
Control Number: 274979
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-10-06
Issued / Original Publication Date: 2025-06-19
Decision / Authorization Date: 2025-03-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1741785597925
Product Type: Drug
Control Number: 279310
DIN(s): 02552914
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-21
Issued / Original Publication Date: 2025-03-11
Decision / Authorization Date: 2024-11-06
Updated Date: 2025-08-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1741184642625
Product Type: Drug
Control Number: 279315
DIN(s): 02554070
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-20
Issued / Original Publication Date: 2025-03-05
Decision / Authorization Date: 2024-12-18