Review decisions
Showing 730 results of 2631 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01019
Product Type: Drug
Control Number: 240368
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-12-18
Decision / Authorization Date: 2022-07-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01061
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
Decision / Authorization Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00594
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00973
Product Type: Drug
Control Number: 259725
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-20
Decision / Authorization Date: 2022-07-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00971
Product Type: Drug
Control Number: 259703
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-17
Decision / Authorization Date: 2022-07-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00609
Product Type: Drug
Control Number: 265656
DIN(s): 02530252
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-06-30
Issued / Original Publication Date: 2022-10-27
Decision / Authorization Date: 2022-09-01
Updated Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01102
Product Type: Drug
Control Number: 245854
DIN(s): 02528363, 02528371, 02528398
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-10-29
Decision / Authorization Date: 2022-06-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1693490140440
Product Type: Drug
Control Number: 265619
DIN(s): 02538881
Manufacturer: Sun Pharmaceutical Industries Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-06-29
Issued / Original Publication Date: 2023-08-30
Decision / Authorization Date: 2023-06-15
Updated Date: 2025-01-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01056
Product Type: Drug
Control Number: 253652
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-10
Decision / Authorization Date: 2022-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1685634038615
Product Type: Drug
Control Number: 265517
DIN(s): 02536552, 02536560
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-23
Issued / Original Publication Date: 2023-05-31
Decision / Authorization Date: 2023-03-24
Updated Date: 2025-01-15