Review decisions

Showing 170 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00632
Product Type: Drug
Control Number: 243026
DIN(s): 02532247, 02532255, 02532263, 02532271, 02532298, 02532301, 02532328
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-21
Issued / Original Publication Date: 2023-03-28
Decision / Authorization Date: 2022-10-26
Updated Date: 2025-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00615
Product Type: Drug
Control Number: 254548
DIN(s): 02529688
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-09-10
Issued / Original Publication Date: 2022-12-16
Decision / Authorization Date: 2022-08-16
Updated Date: 2023-08-28
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/SBD00613
Product Type: Drug
Control Number: 256188
DIN(s): 02529548, 02529556
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-27
Issued / Original Publication Date: 2022-11-21
Decision / Authorization Date: 2022-07-28
Updated Date: 2025-06-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00631
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
Issued / Original Publication Date: 2023-03-30
Decision / Authorization Date: 2022-11-10
Updated Date: 2026-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1691500592141
Product Type: Drug
Control Number: 255507
DIN(s): 02537435, 02537443
Manufacturer: Idorsia Pharmaceuticals Ltd
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-25
Issued / Original Publication Date: 2023-08-04
Decision / Authorization Date: 2023-04-28
Updated Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00602
Product Type: Drug
Control Number: 255972
DIN(s): 02527391, 02527405
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-08-20
Issued / Original Publication Date: 2022-08-30
Decision / Authorization Date: 2022-05-26
Updated Date: 2026-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00607
Product Type: Drug
Control Number: 255700
DIN(s): 02528320, 02528339
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-13
Issued / Original Publication Date: 2022-10-06
Decision / Authorization Date: 2022-06-22
Updated Date: 2025-03-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00582
Product Type: Drug
Control Number: 254598
Manufacturer: Medicago Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-08-09
Issued / Original Publication Date: 2022-04-11
Decision / Authorization Date: 2022-02-24
Updated Date: 2023-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684935203980
Product Type: Drug
Control Number: 255032
DIN(s): 02534622
Manufacturer: Chiesi Farmaceutici S.p.a.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-22
Issued / Original Publication Date: 2023-05-23
Decision / Authorization Date: 2023-01-20
Updated Date: 2024-11-20