Pharmacovigilance reports of drug-related harms in children should include details on age- and drug-specific factors

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The safety of medications in paediatric patients is influenced by age- and drug-specific features, but clinical information on specific risk of medicines in this population is limited. In order to provide essential information that will help prevent harm to children, pharmacovigilance reports should include data on the patient characteristics and circumstances involved in the reported adverse drug reaction.

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