Review decisions

Showing 80 results of 1317 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712843981486
Product Type: Drug
Control Number: 268111
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-09-23
Decision / Authorization Date: 2023-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708530494939
Product Type: Drug
Control Number: 272504
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-15
Decision / Authorization Date: 2023-12-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708630999500
Product Type: Drug
Control Number: 272981
DIN(s): 02511576, 02511584
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-02
Decision / Authorization Date: 2024-02-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708454547343
Product Type: Drug
Control Number: 275152
DIN(s): 02459787, 02459795, 02545136, 02545144, 02545152, 02545160
Manufacturer: Novartis Pharmaceuticals Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-10
Decision / Authorization Date: 2024-02-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708464933703
Product Type: Drug
Control Number: 273166
DIN(s): 01981501, 02531577, 02531585
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-10
Decision / Authorization Date: 2024-02-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708462789662
Product Type: Drug
Control Number: 266553
DIN(s): 02544334, 02544342
Manufacturer: B. Braun Medical Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-22
Decision / Authorization Date: 2024-01-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708532368148
Product Type: Drug
Control Number: 272746
DIN(s): 02545004
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2024-02-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708351809911
Product Type: Drug
Control Number: 258157
DIN(s): 02543745
Manufacturer: Xediton Pharmaceuticals
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-29
Decision / Authorization Date: 2023-12-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1712323528783
Product Type: Drug
Control Number: 268384
DIN(s): 02543605
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-12-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707836185816
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2023-12-27