Review decisions

Showing 230 results of 2295 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685724874375
Product Type: Drug
Control Number: 262756
DIN(s): 02489597
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2023-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1683309818342
DIN(s): 00004723, 02415275
Issued / Original Publication Date: 2023-05-10
Updated Date: 2023-05-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683810710858
Product Type: Drug
Control Number: 268311
DIN(s): 02470365, 02492504, 02510049, 02524252, 02526190
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683828447298
Product Type: Drug
Control Number: 255584
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-20
Decision / Authorization Date: 2023-04-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692038706127
Product Type: Drug
Control Number: 263826
DIN(s): 02537702
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-29
Decision / Authorization Date: 2023-05-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692293386336
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684952482271
Product Type: Drug
Control Number: 269388
DIN(s): 02537206, 02537214
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Decision / Authorization Date: 2023-04-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705595463519
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2023-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692372982357
Product Type: Drug
Control Number: 264825
DIN(s): 02451379, 02463040, 02483831, 02483858, 02537087
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-06
Decision / Authorization Date: 2023-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728656969053
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Issued / Original Publication Date: 2024-10-11