Review decisions
Showing 430 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1703188857510
Product Type: Drug
Control Number: 264439
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-20
Decision / Authorization Date: 2023-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704984251239
Product Type: Drug
Control Number: 271030
DIN(s): 02539888
Manufacturer: Mirum Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-12-28
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706285264505
Product Type: Drug
Control Number: 270386
DIN(s): 02409623, 02409658, 02539993
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1754919110925
Product Type: Drug
Control Number: 282152
DIN(s): 02554178, 02554194
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-18
Issued / Original Publication Date: 2025-08-11
Decision / Authorization Date: 2025-06-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740407272003
Product Type: Drug
Control Number: 282144
DIN(s): 02553996
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2024-02-19
Decision / Authorization Date: 2024-12-13
Updated Date: 2025-08-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750276558621
Product Type: Drug
Control Number: 279373
DIN(s): 02554283, 02554291, 02554305
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2025-06-18
Decision / Authorization Date: 2024-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702485830271
Product Type: Drug
Control Number: 270800
Manufacturer: Emergent Product Development Gaithersburg Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-12-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766090045444
Product Type: Drug
Control Number: 282015
DIN(s): 02560704
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-13
Issued / Original Publication Date: 2025-12-19
Decision / Authorization Date: 2025-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704223637070
Product Type: Drug
Control Number: 273519
DIN(s): 02543559, 02543567
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-03-21
Decision / Authorization Date: 2023-12-06