New Information on Old Medicinal Products: A Cross-Sectional Analysis of Guidance for Paediatric Use for Substances on the European Priority List of Off-Patent Medicinal Products.
Ann-Katrine Birkelund MogensenHelle ChristiansenMarie Louise De BruinChristine Erikstrup HallgreenPublished in: Paediatric drugs (2022)
Most active pharmaceutical ingredients from the priority list had guidance for paediatric use in the Summary of Product Characteristics. However, there is still an unmet need in relation to guidance for use for the youngest paediatric subpopulation.