Review decisions

Showing 150 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1754402562527
Product Type: Drug
Control Number: 276955
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-24
Decision / Authorization Date: 2025-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753294235039
Product Type: Drug
Control Number: 288709
DIN(s): 02478579
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-07-18
Decision / Authorization Date: 2025-06-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753984288289
Product Type: Drug
Control Number: 272063
DIN(s): 02448254
Manufacturer: Dermavant Sciences GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2025-04-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753468201948
Product Type: Drug
Control Number: 284667
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-05
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758909378800
Product Type: Drug
Control Number: 282375
DIN(s): 02458136
Manufacturer: Hoffman-La Roche Limited
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759759362199
Product Type: Drug
Control Number: 280615
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-01
Decision / Authorization Date: 2024-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760469114216
Product Type: Drug
Control Number: 279315
DIN(s): 02554070
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-20
Decision / Authorization Date: 2024-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760541328782
Product Type: Drug
Control Number: 282593
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-01-08
Decision / Authorization Date: 2024-12-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758637391058
Product Type: Drug
Control Number: 289990
DIN(s): 02557347
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-08-30
Decision / Authorization Date: 2025-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753284914670
Product Type: Drug
Control Number: 285395
DIN(s): 02557320
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2025-05-01