Review decisions
Showing 630 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01046
Product Type: Drug
Control Number: 263432
DIN(s): 02533294
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-19
Decision / Authorization Date: 2022-12-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01049
Product Type: Drug
Control Number: 259880
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-31
Decision / Authorization Date: 2022-12-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01029
Product Type: Drug
Control Number: 265342
Manufacturer: Novavax Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-06-21
Decision / Authorization Date: 2022-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01100
Product Type: Drug
Control Number: 259302
DIN(s): 02533286
Manufacturer: VBI Vaccines Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-06
Decision / Authorization Date: 2022-12-06
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/SBD1718291599089
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044, 02553120
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
Updated Date: 2025-08-06
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/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