A new monograph, Amiodarone hydrochloride, capsules (5-200 mg), developed by the European Paediatric Formulary (PaedF) Working Party, been added to the European Paediatric Formulary (Formulary) following a successful public. With the publication of this monograph, the Formulary (which is not legally binding) has now reached an important milestone of 10 published monographs.

Amiodarone hydrochloride, capsules (5-200 mg) is the first monograph in the Formulary to describe a capsule formulation and also the first to describe different strengths, ranging from 5 mg to 200 mg. The capsules can be opened prior to administration.

The original qualitative and quantitative composition of the formulation, preparation instructions and analytical procedures were provided by the French "Formulaire National" (ANSM) and adapted for the purposes of this monograph.

The experts involved in the PaedF Working Party are committed to pursuing their efforts to provide age-appropriate formulations that can be prepared in pharmacies in the absence of an alternative licensed medicine. Stakeholders are invited to get in touch and to share proposals for any additional items to be covered in the Formulary via the EDQM Helpdesk.

To access the monograph, users must first create an account with a valid email address. Please register using the button at the top of the page. Further details on how to create your account and use the European Paediatric Formulary can be found here.