Review decisions
Showing 80 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770215913714
Product Type: Drug
Control Number: 292379
DIN(s): 02541599, 02562634
Manufacturer: Argenx BV
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-15
Decision / Authorization Date: 2025-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765395299369
Product Type: Drug
Control Number: 287978
DIN(s): 02514931, 02560747
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-06-24
Decision / Authorization Date: 2025-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774984682517
Product Type: Drug
Control Number: 292164
DIN(s): 02552434
Manufacturer: Incyte Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-08
Decision / Authorization Date: 2025-10-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769800757146
Product Type: Drug
Control Number: 294551
DIN(s): 02561492
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-01-27
Decision / Authorization Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769788157961
Product Type: Drug
Control Number: 288760
DIN(s): 02561042
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-07-22
Decision / Authorization Date: 2025-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765982892086
Product Type: Drug
Control Number: 276541
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-23
Decision / Authorization Date: 2025-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762368793209
Product Type: Drug
Control Number: 278211
DIN(s): 02415992, 02505355
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-15
Decision / Authorization Date: 2025-05-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762352779744
Product Type: Drug
Control Number: 273840
DIN(s): 02562383
Manufacturer: Eisai Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2025-10-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1766512415266
Product Type: Drug
Control Number: 259861
DIN(s): 02558440, 02558459, 02558467, 02558475
Manufacturer: Teva Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-21
Decision / Authorization Date: 2025-06-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763665811944
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: Biocryst Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-30
Decision / Authorization Date: 2022-06-02