Review decisions
Showing 180 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00590
Product Type: Drug
Control Number: 254883
DIN(s): 02525755
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-07-19
Issued / Original Publication Date: 2022-06-21
Decision / Authorization Date: 2022-03-07
Updated Date: 2025-03-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00616
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-07-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-07-11
Updated Date: 2026-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00604
Product Type: Drug
Control Number: 253904
DIN(s): 02527618
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-18
Issued / Original Publication Date: 2022-08-31
Decision / Authorization Date: 2022-05-27
Updated Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00619
Product Type: Drug
Control Number: 253502
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-07
Issued / Original Publication Date: 2022-12-23
Decision / Authorization Date: 2022-06-10
Updated Date: 2025-02-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00608
Product Type: Drug
Control Number: 253182
DIN(s): 02527677
Manufacturer: FORUS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Issued / Original Publication Date: 2022-10-12
Decision / Authorization Date: 2022-05-31
Updated Date: 2023-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684957849549
Product Type: Drug
Control Number: 253186
DIN(s): 02533979, 02533987, 02533995
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Issued / Original Publication Date: 2023-04-20
Decision / Authorization Date: 2022-12-22
Updated Date: 2026-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00603
Product Type: Drug
Control Number: 253111
DIN(s): 02527049
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-25
Issued / Original Publication Date: 2022-08-31
Decision / Authorization Date: 2022-05-09
Updated Date: 2025-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00610
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-30
Issued / Original Publication Date: 2022-10-19
Decision / Authorization Date: 2022-06-02
Updated Date: 2025-06-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00600
Product Type: Drug
Control Number: 252068
DIN(s): 02526441
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-26
Issued / Original Publication Date: 2022-08-23
Decision / Authorization Date: 2022-04-08
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00593
Product Type: Drug
Control Number: 252065
DIN(s): 02524627, 02524635, 02524643, 02524651, 02524678
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2021-04-23
Issued / Original Publication Date: 2022-06-30
Decision / Authorization Date: 2022-01-21
Updated Date: 2025-10-03