Review decisions
Showing 210 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00578
Product Type: Drug
Control Number: 247561
DIN(s): 02522772
Manufacturer: SIGA Technologies, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-22
Issued / Original Publication Date: 2022-02-21
Decision / Authorization Date: 2021-11-29
Updated Date: 2025-09-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00592
Product Type: Drug
Control Number: 247727
DIN(s): 02524368, 02524376, 02524384, 02524392, 02524406
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-18
Issued / Original Publication Date: 2022-06-28
Decision / Authorization Date: 2022-01-14
Updated Date: 2024-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00599
Product Type: Drug
Control Number: 247562
DIN(s): 02527138
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-17
Issued / Original Publication Date: 2022-08-16
Decision / Authorization Date: 2022-05-06
Updated Date: 2024-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00566
Product Type: Drug
Control Number: 247485
DIN(s): 02520834
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-16
Issued / Original Publication Date: 2022-01-04
Decision / Authorization Date: 2021-09-29
Updated Date: 2026-02-02
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00624
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US), Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-06
Issued / Original Publication Date: 2023-02-03
Decision / Authorization Date: 2022-10-13
Updated Date: 2025-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00553
Product Type: Drug
Control Number: 246955
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-10-16
Decision / Authorization Date: 2021-06-18
Updated Date: 2024-11-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00560
Product Type: Drug
Control Number: 247025
DIN(s): 02518627
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2021-11-25
Decision / Authorization Date: 2021-08-19
Updated Date: 2025-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00579
Product Type: Drug
Control Number: 247042
DIN(s): 02522403
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-04
Issued / Original Publication Date: 2022-02-25
Decision / Authorization Date: 2021-11-16
Updated Date: 2024-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00522
Product Type: Drug
Control Number: 246758
DIN(s): 02513153
Manufacturer: Janssen Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-03-19
Decision / Authorization Date: 2021-03-05
Updated Date: 2024-01-19