OTTAWA, Sept. 14, 2012 /CNW/ - As a follow-up to our July 11, 2012 communication on the cancer bladder treatment ImmuCyst, Health Canada has cleared for release one lot of the product that was
being held due to problems in the facility where it was produced. The
lot contains 1,500 doses for Canadian patients across Canada.
Health Canada has authorized the release of lot #C4040AA after
Departmental experts' thorough review determined that there is no
direct evidence of microbial contamination.
There have been no reports of infection that might be caused by
contamination. In the post-marketing surveillance of ImmuCyst, patients
who receive ImmuCyst are under active medical supervision and as such,
any possible health impacts related to the manufacturing problems would
be identified by their health care practitioner.
Sanofi Pasteur has informed Health Canada of its decision to temporarily
suspend manufacturing in order to renovate the facility where ImmuCyst
is manufactured to improve the quality of the environment of the
manufacturing facility. Patients and Canadian health care practitioners
are advised to contact Sanofi Pasteur (1-800-268-4171) for any updates
on product availability.
Consumers requiring more information about this advisory can contact
Health Canada's public enquiries line at (613) 957-2991, or toll free
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SOURCE: Health Canada
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