Review decisions
Showing 120 results of 2295 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705502911003
Product Type: Drug
Control Number: 274717
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-04-26
Decision / Authorization Date: 2023-10-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705507252665
Product Type: Drug
Control Number: 273313
Manufacturer: Novavax Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-03-15
Decision / Authorization Date: 2023-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706812807082
Product Type: Drug
Control Number: 271065
DIN(s): 02543931
Manufacturer: Horizon Therapeutics Ireland DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-30
Decision / Authorization Date: 2023-12-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706819201300
Product Type: Drug
Control Number: 270801
DIN(s): 02379384
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-19
Decision / Authorization Date: 2023-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713201445261
Product Type: Drug
Control Number: 273575
DIN(s): 02397412, 02442612, 02442620, 02519364, 02543451
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-03-24
Decision / Authorization Date: 2023-11-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714574957940
Product Type: Drug
Control Number: 251688
DIN(s): 02542706
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-19
Decision / Authorization Date: 2023-11-03
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