European Medicines Agency completes review of Pandemrix

Notice type: Advisory

Date: 21/07/2011


Product name or type:

Problem Or Issue:
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised its review of Pandemrix which was initiated to investigate a possible link between Pandemrix vaccination and narcolepsy. This followed an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden. 

While stressing that further research is necessary, the CHMP recommends that Pandemrix should only be used in people under 20 years of age if the recommended annual seasonal trivalent influenza vaccine is not available. 

The overall benefit-risk balance of Pandemrix remains positive.

Background Information Or Related Documents:
European Medicines Agency completes review of Pandemrix Document

Further Information:
See EMA Press Release and Q&A document for further information.

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