European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Apr 2014
The impact of legislation on drug substances used off-label in paediatric wards--a nationwide study.
This nationwide study is aimed at describing to what extent the European Paediatric Regulation has met therapeutic needs in children. ⋯ PIPs only cover a small proportion of the drugs found to be used off-label in this study. Despite waivers granted, drug substances were used nonetheless. Unmet regulatory needs are still considerable in some therapeutic areas in neonates as well as in children.