Review decisions

Showing 220 results of 2299 total
Summary Safety Review - Soliris (eculizumab) - Assessing the Potential Risk of Drug-induced Liver Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1685124881584
DIN(s): 02322285
Issued / Original Publication Date: 2023-06-07
Updated Date: 2023-06-07
Summary Basis of Decision for Beqvez
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
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
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
Regulatory Decision Summary for Vaxchora
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685545138786
Product Type: Drug
Control Number: 264995
DIN(s): 02538164
Manufacturer: Emergent Travel Health Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-08
Decision / Authorization Date: 2023-05-18
Summary Basis of Decision for Voydeya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733496891004
Product Type: Drug
Control Number: 274338
DIN(s): 02550040, 02550059
Manufacturer: Alexion Pharma GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-31
Issued / Original Publication Date: 2024-12-06
Decision / Authorization Date: 2024-07-19
Regulatory Decision Summary for Olumiant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686583434436
Product Type: Drug
Control Number: 256724
DIN(s): 02480018
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-16
Decision / Authorization Date: 2023-06-13
Summary Basis of Decision for Ixchiq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1731445138060
Product Type: Drug
Control Number: 275762
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Issued / Original Publication Date: 2024-11-12
Decision / Authorization Date: 2024-11-12
Summary Safety Review - Combination Sulfamethoxazole and Trimethoprim - Assessing the Potential Risk of Hemophagocytic Lymphohistiocytosis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1683728246915
DIN(s): 00445266, 00445274, 00445282, 00510637, 00510645, 00550086, 00726540, 00846465, 02525917, 02530023, 02534746
Issued / Original Publication Date: 2023-05-24
Updated Date: 2023-05-24
Summary of Cancellation for Botox Cosmetic
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722278310406
Product Type: Drug
Control Number: 275576
DIN(s): 02243721, 02531445
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2024-04-23
Regulatory Decision Summary for Spikevax Bivalent (Original / Omicron BA.4/5)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1684415510472
Product Type: Drug
Control Number: 273747
DIN(s): 02532352
Manufacturer: ModernaTX, Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-03-29
Decision / Authorization Date: 2023-05-18
Summary Safety Review – Proglycem (diazoxide) - Assessing the Potential Risk of Necrotizing Enterocolitis in Newborns and Infants
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1683741782629
DIN(s): 00503347
Issued / Original Publication Date: 2023-05-16
Updated Date: 2023-05-16

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