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Published on 22 February 2011

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CHMP speaks on possible link of Panemix and narcolepsy

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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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