The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 11 of Pharmeuropa PaedForm, containing the 12th monograph of the PaedF Working Party, Lorazepam 1 mg/mL oral solution, for public consultation. The deadline for comments is 30 September 2025.
Lorazepam, a benzodiazepine derivative, can be used in paediatric populations for the treatment of anxiety and as a premedication for anaesthesia. 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.
The formulation described in the Lorazepam 1 mg/mL oral solution monograph was selected on the basis of the European Paediatric Formulary’s inclusion and evaluation criteria, adopted at the end of 2015. 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). Due to the low solubility of lorazepam in water, the vehicle selected is glycerol-based with macrogol 400 and propylene glycol as co-solubilisers.
As part of the routine experimental verification step, 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.
The PaedF Working Party and the EDQM welcome all comments on the new monograph from users and interested parties by 30 September 2025.
Both the European Paediatric Formulary and Pharmeuropa PaedForm are available free of charge and can be accessed online after creating an account.
See also:
- Access the European Paediatric Formulary and the public consultation platform.
- More about the European Paediatric Formulary.