Review decisions

Showing 190 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762194454927
Product Type: Drug
Control Number: 273870
DIN(s): 02556537, 02556545
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-02-25
Decision / Authorization Date: 2025-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1774884635609
Product Type: Drug
Control Number: 296499
DIN(s): 02564610
Manufacturer: Jazz Pharmaceuticals Ireland Limited
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-03-26
Issued / Original Publication Date: 2026-04-06
Decision / Authorization Date: 2026-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742490882984
Product Type: Drug
Control Number: 284125
DIN(s): 02555239
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-20
Decision / Authorization Date: 2025-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1748887083216
Product Type: Drug
Control Number: 285437
DIN(s): 02537532, 02552566, 02556146
Manufacturer: Arcutis Canada, Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2025-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1748888400434
Product Type: Drug
Control Number: 284195
DIN(s): 02247243, 02247244, 02305003, 02305011, 02554631, 02554658, 02554666, 02554674, 02554682
Manufacturer: Mylan Pharmaceuticals ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-22
Decision / Authorization Date: 2025-01-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747832845047
Product Type: Drug
Control Number: 289541
DIN(s): 02556219
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-08-13
Decision / Authorization Date: 2025-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747858729646
Product Type: Drug
Control Number: 284477
DIN(s): 02516241, 02516268
Manufacturer: Endo Ventures Ltd
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-29
Decision / Authorization Date: 2025-02-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752170610848
Product Type: Drug
Control Number: 283158
DIN(s): 02555735
Manufacturer: Biogen Canada Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-01-26
Decision / Authorization Date: 2025-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758805441754
Product Type: Drug
Control Number: 275599
Manufacturer: Tersera Therapeutics LLC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2024-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742236852652
Product Type: Drug
Control Number: 264181
DIN(s): 02534169
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-12
Decision / Authorization Date: 2022-12-29