Review decisions
Showing 300 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683129818889
Product Type: Drug
Control Number: 254426
DIN(s): 02534681, 02534703
Manufacturer: Apotex Inc
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2021-07-28
Decision / Authorization Date: 2023-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01098
Product Type: Drug
Control Number: 270857
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683135458461
Product Type: Drug
Control Number: 259246
DIN(s): 02491788, 02535696
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-01-25
Decision / Authorization Date: 2023-03-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683205896033
Product Type: Drug
Control Number: 254316
DIN(s): 02414295
Manufacturer: Celgene Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-06-30
Decision / Authorization Date: 2023-03-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01090
Product Type: Drug
Control Number: 262141
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-08
Decision / Authorization Date: 2023-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692035533107
Product Type: Drug
Control Number: 244695
DIN(s): 02535734, 02535742, 02535750
Manufacturer: B. Braun Melsungen AG
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-03
Decision / Authorization Date: 2023-02-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1725979957573
Product Type: Drug
Control Number: 272960
DIN(s): 02546078
Manufacturer: Vifor (International) Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-01
Issued / Original Publication Date: 2024-09-10
Decision / Authorization Date: 2024-03-11
Updated Date: 2025-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01086
Product Type: Drug
Control Number: 254715
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-07-21
Decision / Authorization Date: 2023-02-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715623184650
Product Type: Drug
Control Number: 272785
DIN(s): 02544040
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-27
Issued / Original Publication Date: 2024-05-10
Decision / Authorization Date: 2023-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707490019947
Product Type: Drug
Control Number: 272688
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-02-24
Issued / Original Publication Date: 2023-02-08
Decision / Authorization Date: 2024-02-08