Review decisions

Showing 70 results of 2107 total
Regulatory Decision Summary for Xeljanz
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687527077098
Product Type: Drug
Control Number: 264582
DIN(s): 02423898, 02470608, 02480786
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-26
Decision / Authorization Date: 2023-05-12
Regulatory Decision Summary for Veklury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686747902362
Product Type: Drug
Control Number: 266313
DIN(s): 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-02
Decision / Authorization Date: 2023-06-15
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
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
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 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
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
Regulatory Decision Summary for Imcivree
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687801209635
Product Type: Drug
Control Number: 268412
DIN(s): 02537745
Manufacturer: Rhythm Pharmaceuticals Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-10-04
Decision / Authorization Date: 2023-05-05
Regulatory Decision Summary for Rinvoq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686686460648
Product Type: Drug
Control Number: 264612
DIN(s): 02495155, 02520893
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-27
Decision / Authorization Date: 2023-05-02

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