Quality & use of medicines
European Paediatric Formulary
The European Paediatric Formulary (PaedForm) is a freely available, pan-European collection of formulations for unlicensed pharmaceutical preparations currently described in national formularies and formulations that are already well established in European countries. Its aim is to give clinicians, pharmacists and healthcare providers access to formulations of appropriate quality, allowing the preparation of medicinal products for children when no licensed alternative is available on the market.
Work programme
Three additional monographs were finalised and published in the European Paediatric Formulary in 2024: Flecainide acetate 10 mg/mL oral solution (F0021), Valaciclovir 20 mg/mL oral solution (F0023) and Amiodarone hydrochloride capsules (5-200 mg) (F0022). This not only brings the number of texts included in the formulary up to the symbolic milestone of ten, but the last of these texts describes a solid oral form for the first time – oral powder capsules for opening in this case. With each new text, the formulary continues to advance towards its objective of being a useful resource for pharmacists and clinicians.
Five new monographs, Spironolactone oral liquid (F0026), Amlodipine oral liquid (F0027), Prednisolone oral liquid (F0028), Warfarin oral liquid (F0029) and Pyridoxine, oral liquid (F0030) were added to the work programme. As in past years, the PaedF Working Party (WP) dedicated a significant amount of time to reviewing medicines intended to satisfy unmet paediatric needs and determine if products were actually available in the countries where they are licensed.
The PaedF WP has 17 members from all over Europe, including a member from the EMA Paediatric Committee (PDCO).
Communication with partners and stakeholders
The EDQM maintained its vital link with professional associations such as the EAHP. Continued communication with representative professional associations ensures that the PaedF WP’s priorities reflect actual needs in the field and content reaches relevant pharmacists and clinicians. The EDQM will work toward further publicising its contribution to the domain of unlicensed pharmaceutical preparations.
The EDQM looks forward to new and continued partnerships with national formularies, hospital pharmacies and universities and to developing connections with other stakeholders.
