Review decisions

Showing 30 results of 56 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1719417006477
Product Type: Drug
Control Number: 268384
DIN(s): 02543605
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-03
Issued / Original Publication Date: 2024-06-26
Decision / Authorization Date: 2023-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396
Product Type: Drug
Control Number: 268282
DIN(s): 02542943
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-29
Issued / Original Publication Date: 2024-06-11
Decision / Authorization Date: 2023-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1685635290781
Product Type: Drug
Control Number: 267120
DIN(s): 02536080, 02536099, 02536102, 02536110
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-08-19
Issued / Original Publication Date: 2023-05-31
Decision / Authorization Date: 2023-03-10
Updated Date: 2024-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695821197450
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Issued / Original Publication Date: 2023-09-25
Decision / Authorization Date: 2023-07-20
Updated Date: 2024-06-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1719939219034
Product Type: Drug
Control Number: 259953
DIN(s): 02543338
Manufacturer: Trimedic Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-30
Issued / Original Publication Date: 2024-07-02
Decision / Authorization Date: 2023-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00581
Product Type: Drug
Control Number: 255370
DIN(s): 02525364
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-27
Issued / Original Publication Date: 2022-04-08
Decision / Authorization Date: 2022-02-17
Updated Date: 2024-07-19
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/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/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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00574
Product Type: Drug
Control Number: 247369, 247724
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-11
Issued / Original Publication Date: 2022-02-04
Decision / Authorization Date: 2021-11-30
Updated Date: 2024-07-15