Review decisions

Showing 730 results of 2627 total
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01060
Product Type: Drug
Control Number: 255700
DIN(s): 02528320, 02528339
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-08-13
Decision / Authorization Date: 2022-06-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01092
Product Type: Drug
Control Number: 225901
DIN(s): 02528096
Manufacturer: Taro Pharmaceuticals Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2019-04-30
Decision / Authorization Date: 2022-06-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01022
Product Type: Drug
Control Number: 257995
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-26
Decision / Authorization Date: 2022-06-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00962
Product Type: Drug
Control Number: 251157
DIN(s): 02528134, 02528142
Manufacturer: Croma Aesthetics Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-06-30
Decision / Authorization Date: 2022-06-16