Review decisions

Showing 10 results of 2294 total
Summary Safety Review - Ilaris (canakinumab) – Assessing the Potential Risk of Drug Reaction with Eosinophilia and Systemic Symptoms
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732291653402
DIN(s): 02344939, 02460351
Issued / Original Publication Date: 2024-11-27
Updated Date: 2024-11-27
Summary Safety Review - Cyclosporine - Assessing the Potential Risk of Hearing Impairment
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732114128847
DIN(s): 00593257, 02150662, 02150670, 02150689, 02150697, 02237671, 02242821, 02247073, 02247074, 02355655, 02462486, 02476835, 02484137, 02495805, 02495813, 02495821, 02512629
Issued / Original Publication Date: 2024-11-22
Updated Date: 2024-11-22
Summary Safety Review - Dasatinib - Assessing the Potential Risk of Delayed Growth In Children
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1731422768944
DIN(s): 02293129, 02293137, 02293145, 02320193, 02360810, 02360829, 02470705, 02470713, 02470721, 02478307, 02478315, 02478323, 02478331, 02478358, 02481499, 02481502, 02499282, 02499304, 02499312, 02499320, 02499339, 02499347, 02514737, 02514745, 02514753, 02514761, 02514788, 02514796
Issued / Original Publication Date: 2024-11-15
Updated Date: 2024-11-15
Regulatory Decision Summary for Tyenne
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729607296633
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2024-10-11
Regulatory Decision Summary for Wainua
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1730840018921
Product Type: Drug
Control Number: 274598
DIN(s): 02548909
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-21
Decision / Authorization Date: 2024-06-19
Regulatory Decision Summary for Zilbrysq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732026718824
Product Type: Drug
Control Number: 276757
DIN(s): 02549220, 02549239, 02549247
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-11
Regulatory Decision Summary for Cabtreo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732553051076
Product Type: Drug
Control Number: 271199
DIN(s): 02550423
Manufacturer: Bausch Heath Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-06
Decision / Authorization Date: 2024-08-14
Regulatory Decision Summary for Plenvu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732551487982
Product Type: Drug
Control Number: 273065
Manufacturer: Bausch Health Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-03-03
Decision / Authorization Date: 2024-08-16
Regulatory Decision Summary for Miebo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732548590090
Product Type: Drug
Control Number: 272066
DIN(s): 02551403
Manufacturer: Bausch & Lomb Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-23
Decision / Authorization Date: 2024-09-04
Regulatory Decision Summary for Imfinzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729085441755
Product Type: Drug
Control Number: 281318
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-20
Decision / Authorization Date: 2024-10-08

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