Review decisions
Showing 640 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01024
Product Type: Drug
Control Number: 266285
Manufacturer: Novavax Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-08-05
Decision / Authorization Date: 2022-11-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721675750511
Product Type: Drug
Control Number: 269097
DIN(s): 02544180, 02544199, 02544202, 02544210
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-15
Issued / Original Publication Date: 2024-07-22
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683123488934
Product Type: Drug
Control Number: 259979
DIN(s): 02511045, 02511053, 02511061, 02511088, 02511096
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-01-17
Decision / Authorization Date: 2022-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01035
Product Type: Drug
Control Number: 259726
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-17
Decision / Authorization Date: 2022-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00288
Issued / Original Publication Date: 2022-11-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1755537964152
Product Type: Drug
Control Number: 269568
DIN(s): 02558912, 02558920, 02558939
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-10
Issued / Original Publication Date: 2025-08-18
Decision / Authorization Date: 2025-07-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01027
Product Type: Drug
Control Number: 256568
DIN(s): 02532603
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-09-10
Decision / Authorization Date: 2022-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01059
Product Type: Drug
Control Number: 261904
DIN(s): 02532611
Manufacturer: Mitsubishi Tanabe Pharma Corporation
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-03-02
Decision / Authorization Date: 2022-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01073
Product Type: Drug
Control Number: 258772
DIN(s): 02532549, 02532557, 02532565, 02532573
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-18
Decision / Authorization Date: 2022-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01020
Product Type: Drug
Control Number: 267589
DIN(s): 02532352
Manufacturer: ModernaTX, Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-09-12
Decision / Authorization Date: 2022-11-03