Italian Medicines Agency lifts Fluad suspension following tests on batches under question
The Italian Medicines Agency (AIFA) and the Italian National Institute of health (ISS) have conducted tests on the batches of Fluad that the agency suspended in early December.
The flu vaccine is produced by Swiss drug major Novartis (NOVN: VX) and was potentially linked to 13 deaths across Italy among elderly patients taking the drug, though at the time there was no concrete evidence to support a causal link.
The investigation by the AIFA and ISS produced results in line with the standards expected, including tests on hemagglutinin and endotoxins. On the basis of these tests, the AIFA ban has been lifted on the use of the lots indicated.
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