Background: Optimal paediatric pharmacotherapy requires licensed, commercially available and ageappropriate medicines. In lack of these, health care professionals need to resort to extemporaneous preparations or off-label prescriptions. The EU Paediatric Regulation aims to improve this situation by incentives to increase the number of medicines approved for children. The aim of this study was to provide baseline information to evaluate the effect of the Paediatric Regulation by reviewing the availability and age-appropriateness of licensed, paediatric medicines in the Netherlands. Methods: The availability of licensed, paediatric medicines was studied with help of the Z-index, the Informatorium Medicamentorum and the Summary of Product Characteristics. The nature of the medicines and the data for adults was studied as well. The age-appropriateness for children was evaluated concerning age, the ability to follow the authorised dosing recommendation, the suitability of the dosage form and the inclusion of potentially harmful excipients. Results: 3542 licensed, paediatric medicines were identified containing 703 active chemical entities. The proportion of paediatric versus all human medicines increased with age from 37-96%. The proportion varied for the administration route from 22% (dermals) to 81% (inhalation products) and for the therapeutic category from 11% (genito-urinary medicines) to 89% (antiparasites). When considering the real age-appropriateness of licenced medicines the available formulations were acceptable for 27- 88%, depending on age. Conclusion: The current baseline information confirms a limited availability of paediatric medicines, especially for younger children. Health care professionals should realize that licensed, paediatric medicines may not be age-appropriate.