Review decisions
Showing 190 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699548065621
Product Type: Drug
Control Number: 269852
DIN(s): 02491559, 02533448, 02533456
Manufacturer: Alexion Pharma GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-17
Decision / Authorization Date: 2023-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740491309253
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Issued / Original Publication Date: 2025-02-24
Decision / Authorization Date: 2024-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723138153805
Product Type: Drug
Control Number: 280378
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-26
Decision / Authorization Date: 2024-05-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697811489202
Product Type: Drug
Control Number: 268288
DIN(s): 02542250
Manufacturer: Teva Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-04
Decision / Authorization Date: 2023-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699032842238
Product Type: Drug
Control Number: 271331
DIN(s): 02542293, 02542307
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-01-12
Decision / Authorization Date: 2023-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1742837642143
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
Issued / Original Publication Date: 2025-03-23
Decision / Authorization Date: 2024-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698157968254
Product Type: Drug
Control Number: 272451
DIN(s): 02542315, 02542323, 02542331, 02542358, 02542366
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-27
Decision / Authorization Date: 2023-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739886817493
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Issued / Original Publication Date: 2025-02-17
Decision / Authorization Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698845236805
Product Type: Drug
Control Number: 267554
DIN(s): 02495155, 02520893, 02539721
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-16
Decision / Authorization Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1715716170652
Product Type: Drug
Control Number: 268982
DIN(s): 02435462, 02435470
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-24
Decision / Authorization Date: 2023-10-12