Review decisions
Showing 10 results of 343 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762525671043
Product Type: Drug
Control Number: 262828
DIN(s): 02323273
Manufacturer: Galderma Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-02-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764950027991
Product Type: Drug
Control Number: 281695
DIN(s): 02552965, 02552973, 02552981
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-30
Decision / Authorization Date: 2024-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764698444664
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
Decision / Authorization Date: 2024-09-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764699279574
Product Type: Drug
Control Number: 276210
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-06-14
Decision / Authorization Date: 2024-10-28
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/RDS1764950755465
Product Type: Drug
Control Number: 279138
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-09-15
Decision / Authorization Date: 2024-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1761918610510
Product Type: Drug
Control Number: 282121
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-15
Decision / Authorization Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1761915947577
Product Type: Drug
Control Number: 273871
DIN(s): 02553945
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-18
Decision / Authorization Date: 2024-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759496180715
Product Type: Drug
Control Number: 279991
Manufacturer: Kye Pharmaceuticals
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-13
Decision / Authorization Date: 2025-07-28