Review decisions

Showing 50 results of 2227 total
Regulatory Decision Summary for Opdivo
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
Regulatory Decision Summary for Remsima SC
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
Regulatory Decision Summary for Xolair
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
Regulatory Decision Summary for Botox
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
Regulatory Decision Summary for Meropenem for Injection USP and Sodium Chloride Injection USP
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
Regulatory Decision Summary for Eylea HD
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
Regulatory Decision Summary for Levodexa
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
Regulatory Decision Summary for Nurtec ODT
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
Regulatory Decision Summary for Beqvez
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
Summary Safety Review - Ibrance (palbociclib) - Assessing the Potential Risk of Venous Thromboembolism
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1707157428464
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Issued / Original Publication Date: 2024-02-09
Updated Date: 2024-02-09

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