Back European Paediatric Formulary: Amlodipine 0.5 mg/mL oral solution monograph in public consultation

EDQM Strasbourg, France 15/01/2026
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European Paediatric Formulary: Amlodipine 0.5 mg/mL oral solution monograph in public consultation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 12 of Pharmeuropa PaedForm, containing the 13th monograph of the PaedF Working Party, Amlodipine 0.5 mg/mL oral solution, for public consultation. The deadline for comments is 31 March 2026. 

Amlodipine, a calcium channel blocker, can be used in paediatric populations for the treatment of hypertension. Although the need for age-appropriate formulations of this medicinal product was highlighted by the European Medicines Agency (EMA) in 2013, no licensed age-appropriate products are currently available in most member states.

The formulation described in the Amlodipine 0.5 mg/mL oral solution monograph was selected on the basis of the European Paediatric Formulary’s inclusion and evaluation criteria. Based on an existing unlicensed extemporaneous preparation developed in the Netherlands, this formulation is supported by validated test methods and stability data provided by the Erasmus Medical Centre in Rotterdam and by the Laboratory of the Dutch Pharmacists (LNA). The strength of the preparation, 0.5 mg/mL, yields a stable oral solution in simple syrup with methyl parahydroxybenzoate.

As per the original formula used as a source, the preservative agent, methyl parahydroxybenzoate, is incorporated using a stock solution of methyl parahydroxybenzoate in propylene glycol (Solutio methylparabeni 150 mg/mL FNA). The efficacy of the antimicrobial preservation for this formulation was tested and found to meet the requirements of European Pharmacopoeia general chapter 5.1.3.

In addition, the PaedF Working Party assessed the feasibility of directly incorporating methyl parahydroxybenzoate into the solution by dissolving it in hot water. The resulting propylene glycol-free formulation was tested and also complied with general chapter 5.1.3. However, as no stability data was provided for this new formulation, it is not described in the monograph.

The PaedF Working Party and the EDQM welcome all comments on the new monograph from users and interested parties by 31 March 2026.

Both the European Paediatric Formulary and Pharmeuropa PaedForm are available free of charge and can be accessed online after creating an account.