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www.fdanews.com/articles/134715-ema-use-of-off-label-unauthorized-medicines-for-children-needs-attention

EMA: Use of Off-Label, Unauthorized Medicines for Children Needs Attention

March 2, 2011
The widespread use of off-label and unauthorized medicines to treat children in Europe requires regulatory review, according to a report published by the European Medicines Agency (EMA). Between 45 and 60 percent of the total number of prescriptions written are off-label and unauthorized in both hospital and outpatient settings, according to the report. The highest rates of off-label and unauthorized drug use were associated with premature, term neonates and infants, as well as children with very severe conditions.
International Pharmaceutical Regulatory Monitor