Review decisions

Showing 10 results of 2627 total
Summary Safety Review - Diosmin and Hesperidin - Assessing the Potential Increased Risk of Bleeding
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1775582460008
Issued / Original Publication Date: 2026-04-09
Updated Date: 2026-04-09
Summary Safety Review - Rylaze (crisantaspase) - Assessing the Potential Risk of Hepatic Sinusoidal Obstruction Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1774530206353
DIN(s): 02530406
Issued / Original Publication Date: 2026-03-31
Updated Date: 2026-03-31
Summary Safety Review - Glucagon-like Peptide 1 Receptor Agonists (GLP-1 RAs) (dulaglutide, liraglutide, lixisenatide, semaglutide and tirzepatide) - Assessing the Potential Increased Risk of Pulmonary Aspiration in Patients Undergoing Procedures Requiring General Anesthesia or Deep Sedation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1773942015728
DIN(s): 02351064, 02437899, 02448599, 02448602, 02471469, 02471477, 02474875, 02478293, 02497581, 02497603, 02497611, 02522551, 02522578, 02522586, 02522594, 02522608, 02523930, 02528509, 02528517, 02528525, 02528533, 02528541, 02530163, 02530171, 02532891, 02532905, 02532913, 02532921, 02532948, 02532956, 02540258, 02541041, 02541068, 02541076, 02541084, 02541092, 02541106, 02551012, 02551020, 02551039, 02551950, 02551969, 02551977, 02551985, 02551993, 02552000, 02552698, 02557509, 02557517, 02557525, 02557533, 02557541, 02557568, 02562618, 02562626, 02564041, 02564068, 02564076, 02564084, 02564106, 02564114, 02564122, 02564130, 02564149, 02564157, 02564165, 02564173, 02564181, 02564203, 02564211
Issued / Original Publication Date: 2026-03-27
Updated Date: 2026-03-27
Regulatory Decision Summary for Livmarli
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776440503744
Product Type: Drug
Control Number: 292796
DIN(s): 02565234, 02565242, 02565250, 02565269, 02565277
Manufacturer: Mirum Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-28
Decision / Authorization Date: 2026-01-29
Regulatory Decision Summary for Adstiladrin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774272110553
Product Type: Drug
Control Number: 295688
DIN(s): 02566680
Manufacturer: Ferring Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-03-04
Decision / Authorization Date: 2026-03-16
Regulatory Decision Summary for Maviret
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774886128760
Product Type: Drug
Control Number: 298254
DIN(s): 02467550, 02522470
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-05-22
Decision / Authorization Date: 2025-12-18
Regulatory Decision Summary for Recarbrio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774891408116
Product Type: Drug
Control Number: 296713
DIN(s): 02565323
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-04-01
Decision / Authorization Date: 2026-01-30
Summary Safety Review - Vitamin B6 Health Products - Assessing the Potential Risk of Peripheral Neuropathy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1773147434487
DIN(s): 00463469, 00609129, 02245215, 02263947, 02304503, 02406187, 02413248, 02451573, 02451581, 02535718, 02537478, 02552574, 02552620, 02552639, 02562766, 02562774
Issued / Original Publication Date: 2026-03-11
Updated Date: 2026-03-11
Regulatory Decision Summary for Adruxe
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1772568306882
Product Type: Drug
Control Number: 280385
Manufacturer: Dr. Reddy's Laboratories SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-27
Decision / Authorization Date: 2026-02-13
Regulatory Decision Summary for Imfinzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774274878641
Product Type: Drug
Control Number: 281503
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-14
Decision / Authorization Date: 2026-02-20

Displaying 1 - 10 of 2627 | Page 1 of 263
Date modified: