Review decisions
Showing 570 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734642660051
Product Type: Drug
Control Number: 273850
DIN(s): 02546205, 02546213, 02546221
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Issued / Original Publication Date: 2024-12-18
Decision / Authorization Date: 2024-03-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1722604848949
Product Type: Drug
Control Number: 273908
DIN(s): 02544555, 02544563, 02544571
Manufacturer: Amryt Pharmaceuticals DAC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-31
Issued / Original Publication Date: 2024-08-01
Decision / Authorization Date: 2024-01-17
Updated Date: 2025-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01109
Product Type: Drug
Control Number: 267448
Manufacturer: Medicago Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-08-30
Decision / Authorization Date: 2023-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1755266323193
Product Type: Drug
Control Number: 262121
Manufacturer: Pharma Stullin Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1738678252634
Product Type: Drug
Control Number: 272066
DIN(s): 02551403
Manufacturer: Bausch & Lomb Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-29
Issued / Original Publication Date: 2025-02-03
Decision / Authorization Date: 2024-09-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683131636864
Product Type: Drug
Control Number: 263702
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-26
Decision / Authorization Date: 2023-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1683132946136
Product Type: Drug
Control Number: 262810
DIN(s): 02468042
Manufacturer: Amicus Therapeutics UK Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1713457878482
Product Type: Drug
Control Number: 273741
DIN(s): 02542641, 02542676, 02542684, 02542692
Manufacturer: Medison Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-28
Issued / Original Publication Date: 2024-04-17
Decision / Authorization Date: 2023-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1715173505610
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Issued / Original Publication Date: 2024-05-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01101
Product Type: Drug
Control Number: 265517
DIN(s): 02536552, 02536560
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-23
Decision / Authorization Date: 2023-03-24