Review decisions
Showing 80 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734969149034
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Issued / Original Publication Date: 2024-12-19
Decision / Authorization Date: 2025-01-02
Updated Date: 2025-01-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736956096867
Product Type: Drug
Control Number: 278913
DIN(s): 02551764, 02551772, 02551780, 02551799
Manufacturer: Blueprint Medicines Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-07
Issued / Original Publication Date: 2025-01-14
Decision / Authorization Date: 2024-09-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2025-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1757691075272
Product Type: Drug
Control Number: 276955
DIN(s): 02550628, 02550636
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-24
Issued / Original Publication Date: 2025-09-12
Decision / Authorization Date: 2023-08-24
Updated Date: 2025-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739909145014
Product Type: Drug
Control Number: 278712
DIN(s): 02550520, 02550539, 02550547
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-22
Issued / Original Publication Date: 2025-02-18
Decision / Authorization Date: 2024-08-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1732553847408
Product Type: Drug
Control Number: 278277
DIN(s): 02547392, 02547406
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-08-15
Issued / Original Publication Date: 2024-11-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1773770309039
Product Type: Drug
Control Number: 274179
DIN(s): 02563037, 02563045
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-03
Issued / Original Publication Date: 2026-03-17
Decision / Authorization Date: 2025-11-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1737486518137
Product Type: Drug
Control Number: 277139
Manufacturer: Servier Canada Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-11
Issued / Original Publication Date: 2025-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1688740135719
Product Type: Drug
Control Number: 259302
DIN(s): 02533286
Manufacturer: VBI Vaccines Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-07-08
Issued / Original Publication Date: 2023-07-06
Decision / Authorization Date: 2022-12-06
Updated Date: 2024-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739202346124
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Issued / Original Publication Date: 2025-02-10
Decision / Authorization Date: 2024-07-30