Review decisions
Showing 420 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714578062319
Product Type: Drug
Control Number: 248574
DIN(s): 02543907, 02543915
Manufacturer: Ethypharm Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-20
Decision / Authorization Date: 2023-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705588381487
Product Type: Drug
Control Number: 272785
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-27
Decision / Authorization Date: 2023-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125
Product Type: Drug
Control Number: 269097
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-27
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710785654782
Product Type: Drug
Control Number: 262030
DIN(s): 02543842, 02543850
Manufacturer: Emergent BioDefense Operations Lansing LLC
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2022-03-08
Decision / Authorization Date: 2023-12-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709225685625
Product Type: Drug
Control Number: 271750
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-01-26
Decision / Authorization Date: 2023-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713896533366
Product Type: Drug
Control Number: 267923
DIN(s): 02542420
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-31
Decision / Authorization Date: 2023-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763476617645
Product Type: Drug
Control Number: 282455
DIN(s): 02560917
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Issued / Original Publication Date: 2025-11-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763475745099
Product Type: Drug
Control Number: 278930
DIN(s): 02560895
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Issued / Original Publication Date: 2025-11-16
Decision / Authorization Date: 2025-09-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747922265616
Product Type: Drug
Control Number: 281005
Manufacturer: Medexus Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740062351552
Product Type: Drug
Control Number: 279053
DIN(s): 02553805, 02553813
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
Issued / Original Publication Date: 2025-02-19
Decision / Authorization Date: 2024-12-06