During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication are currently ongoing and medicinal products are also being used experimentally in clinical practice. Reference is made to the WHO information on “Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected.”
The European Paediatric Formulary (PaedF) Working Party, in this exceptional situation, wishes to serve pharmacists by compiling existing knowledge on paediatric formulations for active substances under investigation as well as known authorised medicinal products. Information on paediatric formulations of active substances used in clinical trials but also experimentally in clinical practice throughout the world will therefore be gathered and published in tables on the EDQM website, by the PaedF Working Party. These tables will be continuously updated and will be living documents.
In view of the exceptional circumstances and the emergency due to the COVID-19 pandemic, the PaedF Working Party is not in a position to verify the quality of the listed formulations as per the usual working procedures of the Working Party (see texts on Introduction to the Formulary and on General Principles).
We kindly ask all stakeholders to support this initiative and to submit additional safe and reliable information on formulations and products to the PaedF Working Party ([email protected]).
The tables will be deleted when the pandemic crisis is over and might subsequently be used as the basis for the elaboration of new monographs.
Neither the PaedF Working Party nor the EDQM make any recommendation to use the drugs listed below for experimental treatment of COVID-19. Available knowledge is limited. The prescriber remains responsible for making individual assessments of the risks and benefits for each patient.
Information on products and extemporaneous preparation of paediatric formulations that may be useful in the treatment of COVID-19 for:
- Dexamethasone (added 16/10/2020)
- Lopinavir/Ritonavir
Updating of the following tables has been discontinued as no beneficial effects were shown in treating COVID-19 in clinical trials (see information and advice by EMA and WHO):
- Chloroquine (stopped 16/10/2020)
- Hydroxychloroquine (stopped 16/10/2020)
See also: