Canadian Association of Radiopharmaceutical Scientists

 

CARS Newsletter September 2018

October 22, 2018

Import and Release of US-Labelled Choletec (Mebrofenin)

Recently, Health Canada received a proposal from Bracco Imaging Canada to import and release US-labelled Choletec (Mebrofenin) into Canada in order to mitigate a shortage of hepatobiliary imaging agents. Given the medical necessity of this product and the significant impact that a prolonged shortage of hepatobiliary imaging agents could have on the Canadian health care system, Health Canada did not object to the one-time import and release of up to 1,250 vials of US-labelled Choletec.

Additionally, Bracco Imaging Canada has agreed to the following conditions for the import and release of the 1,250 vials of US-labelled Choletec:
·         The product will be distributed equitably across Canada and not for the purposes of eliminating a backorder;
·         A Health Professional Communication will be issued and included with every shipment of product to customers in Canada; and
·         The Canadian Package Insert will be included with every shipment of product to customers in Canada.

Should you have any questions about the availability of supply of the US-labelled Choletec, please contact Patrice Plourde at Bracco Imaging Canada directly at the following coordinates:

Email: Patrice.Plourde@bic.bracco.com
Office Phone: 514-353-5820 ext. 5303

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Last updated:22 October, 2018
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