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Health Canada Health products

Importation of US-Authorized Fludarabine Phosphate Injection, USP due to the Current Shortage of Canadian-Authorized Fludarabine Phosphate Injection

Issued October 2, 2025
Issue
There is a shortage of Fludarabine Phosphate Injection in Canada. Given the medical necessity of Fludarabine Phosphate Injection and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of US-authorized Fludarabine Phosphate Injection , USP with English-only labels, by Septa Pharmaceuticals Inc. Healthcare professionals should be aware of important differences between the US-authorized and Canadian-authorized products ( see Information for healthcare professionals section) .
Hazard description
Supply - Labelling - Packaging
Product
Product name
Fludarabine Phosphate Injection
Reference
ID
RA-78170