No evidence that Fluad vaccine caused deaths in Italy - EMA Committee review reassures Member States over safety of flu vaccine
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no evidence that Fluad, a flu vaccine manufactured by Novartis, has caused serious events including deaths in Italy. These reports led the Italian Medicines Agency (AIFA) to suspend the use of two batches of Fluad as a precautionary measure on 27 November 2014.
Fluad is authorised in the European Union (EU) in a number of Member States. For the current vaccination campaign in Italy, about 4 million doses of Fluad have been distributed. The vaccine has also been used for the 2014/15 flu vaccination campaigns in Austria, Germany and Spain. Fluad is not on the Croatian market.
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