CanadaBONKY Injection, 1 mcg/mL Calcitriol — an intravenous injection (Republic of Korea 199801831) with Korean-only labels, marketed by YuYu Pharma Inc. and imported by Septa Pharmaceuticals Inc. — has been authorized for exceptional, temporary importation and sale in Canada. Health Canada did this to mitigate a shortage of Canadian-authorized Calcitriol Injection USP, 1 mcg/mL, and notes there are differences between the South Korean-authorized and Canadian-authorized products.
How to identify it
Brand name: Dosage form and route of administration: Country of authorization and identifying code: Marketed By: Importer in Canada
BONKY Injection, 1 mcg/mL Calcitriol: Injection Intravenous: Republic of Korea 199801831: YuYu Pharma Inc.: Septa Pharmaceuticals Inc.
The hazard
There is a shortage of Calcitriol Injection USP in Canada. Given the medical necessity of Calcitriol Injection USP, 1 mcg/mL and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of South Korean-authorized BONKY Injection, 1 mcg/mL Calcitriol, with Korean-only labels to mitigate the shortage.
Healthcare professionals should be aware that there are differences between the South Korean-authorized and Canadian-authorized products (see Information for healthcare professionals section).
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What to do
See Key Messages below
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)