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CHMP speaks on possible link of Panemix and narcolepsy


The suspected linkbetween narcolepsy and Pandemrix H1N1 vaccine is insufficiently supported by evidence, according to he Committee for Medicinal Products for Human Use (CHMP).

The conclusion is based on a review of the suspected link between narcolepsy in children and adolescents and Pandemrix (influenzavaccine (H1N1)), fromGlaxoSmithKline Biologicals S.A.

The results were presented at the CHMP meeting on 14-17 February 2011.

The Committee concluded that the newevidence added to the concern arising from case reports in Finland andSweden, but that the data were still insufficient to establish a causalrelationship between Pandemrix and narcolepsy.

Further analyses andstudy results are awaited to clarify the observations in Finland.

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