Review decisions
Showing 190 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715971891771
Product Type: Drug
Control Number: 251688
DIN(s): 02542706
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-19
Issued / Original Publication Date: 2024-05-17
Decision / Authorization Date: 2023-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00596
Product Type: Drug
Control Number: 251687
DIN(s): 02526247, 02526255, 02526263
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-14
Issued / Original Publication Date: 2022-07-13
Decision / Authorization Date: 2022-03-30
Updated Date: 2025-08-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00622
Product Type: Drug
Control Number: 251360
DIN(s): 02529602
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-13
Issued / Original Publication Date: 2023-01-26
Decision / Authorization Date: 2022-08-03
Updated Date: 2024-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1745405201062
Product Type: Drug
Control Number: 248255
DIN(s): 02526662
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-12
Issued / Original Publication Date: 2022-07-28
Decision / Authorization Date: 2022-04-14
Updated Date: 2025-04-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00573
Product Type: Drug
Control Number: 251438
DIN(s): 02521903, 02521911
Manufacturer: Seagen Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-04-06
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-10-29
Updated Date: 2025-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00548
Product Type: Drug
Control Number: 251285
DIN(s): 02518341
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-01
Issued / Original Publication Date: 2021-09-10
Decision / Authorization Date: 2021-07-30
Updated Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00611
Product Type: Drug
Control Number: 251277
DIN(s): 02527715
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-31
Issued / Original Publication Date: 2022-10-25
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00598
Product Type: Drug
Control Number: 251162
DIN(s): 02525852
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-03-29
Issued / Original Publication Date: 2022-08-12
Decision / Authorization Date: 2022-03-08
Updated Date: 2025-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00580
Product Type: Drug
Control Number: 251105
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-03-26
Issued / Original Publication Date: 2022-03-09
Decision / Authorization Date: 2021-12-23
Updated Date: 2024-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00588
Product Type: Drug
Control Number: 248874
DIN(s): 02525542
Manufacturer: Canadian Molecular Imaging Probe Consortium (CanProbe)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-03-12
Issued / Original Publication Date: 2022-05-26
Decision / Authorization Date: 2022-02-24
Updated Date: 2024-06-18