Review decisions
Showing 150 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1682951781384
Product Type: Drug
Control Number: 263432
DIN(s): 02533294
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-04-19
Issued / Original Publication Date: 2023-04-13
Decision / Authorization Date: 2022-12-08
Updated Date: 2024-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1689944674439
Product Type: Drug
Control Number: 262080
DIN(s): 02537818
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-08
Issued / Original Publication Date: 2023-07-20
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00583
Product Type: Drug
Control Number: 248134
DIN(s): 02523191
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-04-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00627
Product Type: Drug
Control Number: 262999
DIN(s): 02532468, 02532476
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-06
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-02
Updated Date: 2025-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734963810994
Product Type: Drug
Control Number: 262990
DIN(s): 02550857
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Issued / Original Publication Date: 2024-12-22
Decision / Authorization Date: 2024-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1704300260963
Product Type: Drug
Control Number: 262740
DIN(s): 02541009
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-24
Issued / Original Publication Date: 2024-01-03
Decision / Authorization Date: 2023-08-31
Updated Date: 2024-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-23
Issued / Original Publication Date: 2024-11-07
Decision / Authorization Date: 2024-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736172049201
Product Type: Drug
Control Number: 260666
DIN(s): 02550679
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-18
Issued / Original Publication Date: 2025-01-02
Decision / Authorization Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1755873445495
Product Type: Drug
Control Number: 259183
DIN(s): 02535858, 02558238
Manufacturer: Biosimilar Collaborations Ireland Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-16
Issued / Original Publication Date: 2025-08-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684955300002
Product Type: Drug
Control Number: 262122
DIN(s): 02535270
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-03-04
Issued / Original Publication Date: 2023-05-09
Decision / Authorization Date: 2023-02-09
Updated Date: 2025-05-09