Review decisions
Showing 170 results of 2627 total
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/SBD1776189181009
Product Type: Drug
Control Number: 297894
DIN(s): 02563886
Manufacturer: Theratechnologies Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-05-09
Issued / Original Publication Date: 2026-04-13
Decision / Authorization Date: 2025-12-16
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752861229146
Product Type: Drug
Control Number: 287772
DIN(s): 02557010
Manufacturer: Ipsen Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-19
Decision / Authorization Date: 2025-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758566878414
Product Type: Drug
Control Number: 285745
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-08
Decision / Authorization Date: 2025-04-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1745507324202
Product Type: Drug
Control Number: 285834
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-10
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753286280828
Product Type: Drug
Control Number: 284815
DIN(s): 02556898
Manufacturer: Amicus Therapeutics Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-08
Decision / Authorization Date: 2025-04-14