The European Medicines Agency defines “off-label” the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration. The majority of marketed medicines world‐wide, including those commonly used or which could potentially be used in the paediatric population, have not been studied in the relevant paediatric age groups and are not approved by regulatory authorities for use in children. This topic is of particular interest for the TEDDY Network, because the off-label medicines use in paediatrics is widespread in Europe and often there is no alternative than off-label treatments. For this reason, ad hoc TEDDY Working Group (WG) has been created to discuss and promote initiatives in this framework. Currently, this WG is working on the Enpr-EMA proposal to add existing evidence in the paediatric drug label. A list of medicines used off label in children were already provided by the WG to draft a manuscript. The next step will be to update the bibliographic search on off-label use in paediatrics.
If you want to collaborate in this WG, you can express your interest by filling in the form and sending it to scientificsecretariat@teddynetwork.net