Review decisions
Showing 50 results of 139 total
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/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/RDS1700599569568
Product Type: Drug
Control Number: 274515
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-19
Decision / Authorization Date: 2023-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699385708073
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Decision / Authorization Date: 2023-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698843751956
Product Type: Drug
Control Number: 266249
DIN(s): 02482592
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-07-20
Decision / Authorization Date: 2023-07-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698761313167
Product Type: Drug
Control Number: 246125
DIN(s): 02536145
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-04
Decision / Authorization Date: 2023-05-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698780442306
Product Type: Drug
Control Number: 264296
DIN(s): 02537532
Manufacturer: Acutis Biotherapeutics, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-05-13
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701375559096
Product Type: Drug
Control Number: 265619
DIN(s): 02538881
Manufacturer: Sun Pharmaceutical Industries Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-29
Decision / Authorization Date: 2023-06-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695846822831
Product Type: Drug
Control Number: 276302
Manufacturer: Pfizer Canada ULC (on behalf of BioNTech Manufacturing GmbH)
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Decision / Authorization Date: 2023-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694116967823
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Decision / Authorization Date: 2023-09-12