The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 6 of Pharmeuropa PaedForm, in which the draft text for Clonidine Hydrochloride 10 micrograms/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary. The deadline for comments is 30 June 2023. This is the seventh monograph elaborated by the PaedF Working Party.
The formulation described in the Clonidine Hydrochloride 10 micrograms/mL Oral Solution monograph was selected on the basis of the criteria for inclusion and evaluation of monographs established for the European Paediatric Formulary that were adopted at the end of 2015. The need for an age-appropriate formulation was highlighted by the European Medicines Agency (EMA) in 2013 and no authorised product is currently available. Experts in the Working Party chose the 10 micrograms/mL strength as it was the most commonly used concentration and would support typical administered doses. The experts are aware that other concentrations – ranging from 5 to 50 micrograms/mL – are prepared throughout Europe. The original qualitative and quantitative composition of the solution and validated analytical procedures were provided by Dr Büttner from the University Hospital Carl Gustav Carus of the Technical University of Dresden. The protocols for preparation of the solution and performance of the analytical procedures were determined to be suitable following practical verification.
The EDQM welcomes all comments on this new monograph from users and interested parties.
The European Paediatric Formulary gathers together, at a European level, monographs on formulations for extemporaneous preparations that are either described in national formularies or well established in Europe. Once these monographs, which are not legally binding, have been approved by the European Pharmacopoeia Commission and adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care, they are made available to pharmacists and clinicians to help them prepare paediatric medicines when no authorised alternative is available.
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