Review decisions
Showing 170 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750276558621
Product Type: Drug
Control Number: 279373
DIN(s): 02554283, 02554291, 02554305
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2025-06-18
Decision / Authorization Date: 2024-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702485830271
Product Type: Drug
Control Number: 270800
Manufacturer: Emergent Product Development Gaithersburg Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-12-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766090045444
Product Type: Drug
Control Number: 282015
DIN(s): 02560704
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-13
Issued / Original Publication Date: 2025-12-19
Decision / Authorization Date: 2025-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704223637070
Product Type: Drug
Control Number: 273519
DIN(s): 02543559, 02543567
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-03-21
Decision / Authorization Date: 2023-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739374529873
Product Type: Drug
Control Number: 281963
DIN(s): 02551551, 02551578
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-12-11
Issued / Original Publication Date: 2025-02-11
Decision / Authorization Date: 2024-09-11
Updated Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702069947544
Product Type: Drug
Control Number: 268590
DIN(s): 02324032, 02371081
Manufacturer: Merz Pharmaceuticals GmbH / Merz Pharma Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-07
Decision / Authorization Date: 2023-10-06
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/RDS1710783226359
Product Type: Drug
Control Number: 273741
DIN(s): 02542641, 02542676, 02542684, 02542692
Manufacturer: Medison Pharma Canada Inc.
Submission Type: New Drug Submission – Priority Review
Date Filed / Submission Date: 2023-04-05
Decision / Authorization Date: 2023-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710787451238
Product Type: Drug
Control Number: 268527
DIN(s): 02172739, 02172747, 02172755
Manufacturer: GE Healthcare Canada Inc.
Submission Type: Supplemental New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2023-12-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710791169293
Product Type: Drug
Control Number: 268723
DIN(s): 02543532
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-19
Decision / Authorization Date: 2023-11-29