Review decisions
Showing 10 results of 87 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722532649097
Product Type: Drug
Control Number: 281914
DIN(s): 02549891
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-12-08
Decision / Authorization Date: 2024-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707836185816
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733494552846
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Issued / Original Publication Date: 2024-12-05
Decision / Authorization Date: 2024-08-27
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/RDS1699385708073
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
Decision / Authorization Date: 2023-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696010036746
Product Type: Drug
Control Number: 272688
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2023-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1725029128529
Product Type: Drug
Control Number: 275236
DIN(s): 02545713, 02545721
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-05-12
Issued / Original Publication Date: 2024-08-30
Decision / Authorization Date: 2024-02-28
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: 2024-08-08
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