Health Product InfoWatch, December 2025
Content: Safety brief: Bruton’s tyrosine kinase (BTK) inhibitors and the risk of serious hepatotoxicity; Notice of authorization with conditions: Lyvdelzi (seladelpar)
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Content: Safety brief: Bruton’s tyrosine kinase (BTK) inhibitors and the risk of serious hepatotoxicity; Notice of authorization with conditions: Lyvdelzi (seladelpar)
The list of new safety and effectiveness reviews has been updated and now includes safety reviews initiated between October 1 and 31, 2025. The next update is scheduled for January 2026.
The data presented in the Canada Vigilance Adverse Reaction Online Database has been updated and now includes information received by Health Canada up to August 31, 2025. The next update of data is scheduled for early January, 2026.
Content: Product monograph update: Braftovi (encorafenib); Notice of authorization with conditions: Jaypirca (pirtobrutinib); Notice of authorization with conditions: Leqembi (lecanemab)
The data presented in the Canada Vigilance Adverse Reaction Online Database has been updated and now includes information received by Health Canada up to July 31, 2025. The next update of data is scheduled for early December, 2025.
The list of new safety and effectiveness reviews has been updated and now includes safety reviews initiated between September 1 and 30, 2025. The next update is scheduled for December 2025.
Content: Announcement: Distribution of the reserve list for antimicrobial drugs via the Canadian Clinical Drug Data Set; Safety Brief: Change in the colour from teal to red for the ferrule / cap of marketed cisatracurium besylate injectable products; Notice of authorization with conditions: Amtagvi
Health Canada is holding a 60-day consultation on revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.
Health Canada is holding a 60-day consultation on revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.
The data presented in the Canada Vigilance Adverse Reaction Online Database has been updated and now includes information received by Health Canada up to June 30, 2025. The next update of data is scheduled for early November, 2025.
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