The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the revised monograph Phosphate 60 mg/mL Oral Solution in the European Paediatric Formulary (PaedForm). This revised monograph (the first PaedForm text to undergo revision) was published in Issue 4 of Pharmeuropa PaedForm, approved by the European Pharmacopoeia Commission (EPC) and recently adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH).
The purpose of the revision was to include a tailored annex comprising a list of known licensed possible alternatives that prescribers or pharmacists may consider when treating individual patients, providing the product name(s) and marketing authorisation holder for each product, as well as the countries in which it is licensed. Pharmacists and clinicians, particularly those from countries where these products are not marketed, have made it known that they greatly appreciate having access to this information, which is not readily available elsewhere.
The inclusion of this annex reaffirms that licensed products remain the gold standard, the aim being to draw attention to medicines that could be suitable for use and that are licensed in at least one European country. It is also an excellent way of compiling and making widely available the most recent licensing information for the medicinal products within the scope of the PaedF working party, especially since annexes can be amended without having to be published for public consultation. The EDQM therefore encourages users to submit any new information or suggestions for updates to annexes to European Paediatric Formulary monographs.
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 EPC and adopted by the CD-P-PH, they are made available to pharmacists and clinicians to help them prepare paediatric medicines when no authorised alternative is available.
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