Review decisions
Showing 270 results of 2299 total
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: 2024-09-10
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/SBD00626
Product Type: Drug
Control Number: 258231
DIN(s): 02531917, 02531925
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2023-02-27
Updated 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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695394418545
Product Type: Drug
Control Number: 256191
DIN(s): 02532530, 02532581
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-27
Decision / Authorization Date: 2022-11-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697043337700
Product Type: Drug
Control Number: 262122
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-03-04
Decision / Authorization Date: 2023-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01076
Product Type: Drug
Control Number: 269428
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-11-04
Decision / Authorization Date: 2023-02-17