Review decisions
Showing 290 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00516
Product Type: Drug
Control Number: 230825
DIN(s): 02502895
Manufacturer: Elusys Therapeutics, Inc.
Submission Type: Extraordinary Use New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-16
Issued / Original Publication Date: 2021-01-28
Decision / Authorization Date: 2020-07-30
Updated Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00541
Product Type: Drug
Control Number: 229124
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-12
Issued / Original Publication Date: 2021-07-13
Decision / Authorization Date: 2020-11-24
Updated Date: 2025-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00505
Product Type: Drug
Control Number: 228708
DIN(s): 02504855
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-07
Issued / Original Publication Date: 2020-11-04
Decision / Authorization Date: 2020-09-14
Updated Date: 2023-07-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00477
Product Type: Drug
Control Number: 230001
DIN(s): 02496194
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-07-22
Issued / Original Publication Date: 2020-05-29
Decision / Authorization Date: 2020-02-28
Updated Date: 2025-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00502
Product Type: Drug
Control Number: 229866
DIN(s): 02502445
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-07-19
Issued / Original Publication Date: 2020-10-22
Decision / Authorization Date: 2020-07-27
Updated Date: 2024-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00509
Product Type: Drug
Control Number: 229245
DIN(s): 02498235, 02498243
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-06-28
Issued / Original Publication Date: 2020-12-08
Decision / Authorization Date: 2020-04-29
Updated Date: 2024-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00435
Product Type: Drug
Control Number: 212387
Manufacturer: Emergent BioDefense Operations Lansing LLC
Submission Type: New Drug Submission
Issued / Original Publication Date: 2019-06-18
Updated Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00476
Product Type: Drug
Control Number: 228368
DIN(s): 02495732
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-06-03
Issued / Original Publication Date: 2020-05-21
Decision / Authorization Date: 2020-01-20
Updated Date: 2025-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00469
Product Type: Drug
Control Number: 227918
DIN(s): 02495058
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-05-22
Issued / Original Publication Date: 2020-03-23
Decision / Authorization Date: 2019-12-23
Updated Date: 2025-03-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00506
Product Type: Drug
Control Number: 227804
DIN(s): 02503603
Manufacturer: Eckert & Ziegler Radiopharma GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-05-15
Issued / Original Publication Date: 2020-11-25
Decision / Authorization Date: 2020-08-19
Updated Date: 2024-11-20