The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Coordinating Group has issued a statement to say they have received many requests to share information on the dosing of medicines used in children across Europe.
They clarify that they are not in a position to share information on dosing regimens in clinical trials and cannot take any responsibility for the content shared, as it has not been assessed and therefore cannot be endorsed or rejected.
They note that the dosing of unauthorised medicines and medicines used off-label for children with COVID-19 may differ between different treatment protocols and vary between countries and hospitals (or other health care units).
In the case of remdesivir, the dosing recommendation for adolescents is provided in the context of the recently agreed Committee for Medicinal Products for Human Use (CHMP) Opinion on Compassionate Use.
The Dutch Pediatric Formulary has established dose recommendations for medicines being studied for COVID-19, which can be found in the Dutch formulary for children. (The information is in Dutch and will be updated as research continues. Further information can be obtained from info@nkfk.nl.)
Networks are encouraged to consult the EU-CTR and EU PAS Register for further details on trials and studies on COVID-19, as the information on new trials is registered in these repositories. (Search for COVID-19, and apply the filter for the paediatric age group.)
