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CHMP recommends interim changes to prescriber advice for GSK's Pandemrix

This article was originally published in Scrip

Executive Summary

Following a review of data from France and Sweden, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending that product information for Pandemrix should be amended to take into account of a potential link between the H1N1 influenza vaccine Pandemrix, from GlaxoSmithKline, and narcolepsy in children and adolescents. The recommendation is an interim measure until the ongoing European review is concluded in July 2011.



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