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Health
Canada
Sante
Canada
Health Products
and Food Branch
Direction generale des produits de sante et des aliments APR 23 2014
Biologics and Genetic
Therapies Directorate
200 Tunney's Pasture Driveway
Address Locator # 0702A
OTT AW A, Ontario
KIA OK9
14-105128 - 593
To: Establishments involved in the radiolabelling of blood components
Subject: Discontinued supply of Pentaspan® as a drug in Canada
Health Canada has been informed by Bristol Myers Squibb that they have discontinued the
availability of Pentaspan® as a drug in Canada. In addition to being used as a "drug" for
distribution under the Food and Drug Regulations, Health Canada is aware that Pentaspan® has
been used in Canada as a "reagent" in several types of cell processing techniques, one of which
is the radiolabelling of blood components.
The Food and Drug Regulations do not apply to drugs being imported by clinicians for use as
reagents during the radiolabelling of blood components. For this reason, the Health Products and
Food Branch Inspectorate will not recommend refusal of entry of reagents that are imported for
such use, provided the reagents meet the following criteria:
• the product is labelled as a "reagent", "for use as a reagent in the radiolabelling of blood
components"
• the product is distributed directly to the clinician performing the radiolabelling or to the
establishment where the radiolabelling will be performed
• the product is not re-distributed in Canada where it could be misrepresented as a drug and
then used for therapeutic indications that have not been approved
.. .12
Canada -2­
For additional information, please contact:
[email protected]
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Canada
Thank you for your continued cooperation.
~'--Robin Chiponski
Director General
HPFB Inspectorate
Director General
Biologics and Genetic
Therapies Directorate