Review decisions

Showing 320 results of 2299 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01038
Product Type: Drug
Control Number: 259754
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-17
Decision / Authorization Date: 2022-11-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01045
Product Type: Drug
Control Number: 259175
DIN(s): 02453304
Manufacturer: Horizon Therapeutics Ireland DAC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-01
Decision / Authorization Date: 2022-11-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01047
Product Type: Drug
Control Number: 259103
DIN(s): 02532891, 02532905, 02532913, 02532921, 02532948, 02532956
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-29
Decision / Authorization Date: 2022-11-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690897580182
Product Type: Drug
Control Number: 270055
Manufacturer: Veru Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-11-24
Decision / Authorization Date: 2023-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-11-24
Issued / Original Publication Date: 2024-06-12
Decision / Authorization Date: 2023-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00613
Product Type: Drug
Control Number: 256188
DIN(s): 02529548, 02529556
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-11-21
Updated Date: 2022-11-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683208648343
Product Type: Drug
Control Number: 242176
DIN(s): 02522802
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-07-24
Decision / Authorization Date: 2021-11-30
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