This review aims to give an updated overview of the worldwide situation of off-label and
unlicensed drug use in the paediatric field, also taking into account the safety of this kind of …

Purpose The aim of this review is to assess the extent of the use of off-label and/or
unlicenced drugs among hospitalised children. Methods A systematic search was made in …

Background: Worldwide, in the absence of standard pediatric prescribing information,
clinicians often use medicines in children in a dosage form or for an indication that has not …

Objective Many drugs used for children are not licensed or are used off-label. An increased
risk of medication errors and unexpected adverse drug reactions (ADR) associated with off …

A significant number of children receive either an unlicensed or an off-label drug during their
stay in hospital. Studies throughout Europe have shown that at least one-third of children in …

The use of unlicensed and off-label medicines in children is common because trials in
children have not usually been performed during the drug development process …

The aim of this Delphi survey is to develop common definitions for unlicensed and off-label
drug use in children to be used for research and regulatory purposes. After a literature …

Background: Many medicines used in newborns, infants, children and adolescents are not
licensed (“unlicensed”) or are prescribed outside the terms of the marketing authorization …

The off‐label and unlicensed use of drugs to treat children is a common practice that occurs
either in hospital or in the community. This derives from the fact that research for establishing …

Health-care professionals who prescribe medicines have the professional duty to choose
medicines that are in the best interest of their individual patient, irrespective if that patient is …