Review decisions
Showing 1040 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00788
Product Type: Drug
Control Number: 235705
Manufacturer: Kye Pharmaceuticals Inc., Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00762
Product Type: Drug
Control Number: 235994
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-02-11
Decision / Authorization Date: 2021-01-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00606
Product Type: Drug
Control Number: 238499
DIN(s): 02525267, 02525275
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-01-18
Issued / Original Publication Date: 2022-10-03
Decision / Authorization Date: 2022-02-14
Updated Date: 2024-04-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00753
Product Type: Drug
Control Number: 231019
DIN(s): 02510987
Manufacturer: Apotex Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2019-08-23
Decision / Authorization Date: 2021-01-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00754
Product Type: Drug
Control Number: 235672
DIN(s): 02510936
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00761
Product Type: Drug
Control Number: 235685
DIN(s): 02511045, 02511053, 02511061, 02511088, 02511096
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-01-31
Decision / Authorization Date: 2021-01-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00562
Product Type: Drug
Control Number: 248435
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2021-01-14
Issued / Original Publication Date: 2021-12-07
Decision / Authorization Date: 2021-09-10
Updated Date: 2026-02-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692978760470
Product Type: Drug
Control Number: 240372
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-13
Decision / Authorization Date: 2023-05-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00584
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779, 02535076, 02535084
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-12
Issued / Original Publication Date: 2022-04-14
Decision / Authorization Date: 2021-12-24
Updated Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00745
Product Type: Drug
Control Number: 233288
DIN(s): 02510839
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-03
Decision / Authorization Date: 2021-01-11