European Paediatric Medicines Database – EPMD

European Paediatric Medicines Database – EPMD

In line with European initiatives, in 2007 TEDDY set up the European Paediatric Medicines Database (EPMD), with the aim of creating a harmonised, integrated and reliable pan-European source of information.

The data stored in this database is the basis for examining the ‘state of the art’ of paediatric innovative medicines licensed by the European Medicines Agency (EMA) from October 1995.
Through this tool TEDDY supports the transparency of the information concerning the innovative drugs currently used in children, allows the identification of therapeutic areas uncovered by innovative drug treatments and provides health professionals, paediatricians, institutional bodies, companies, patients’ associations, parents and children with appropriate information concerning the rational use of paediatric medicines.

For all paediatric medicines registered in Europe under the EMA Centralised Procedure, the EPMD includes information on: year of approval, active substance, tradename, Anatomical Therapeutic Chemical (ATC) code – first-level, paediatric indication, ages for which the drug is intended, orphan status, paediatric studies included in the EPAR at the time of approval.

To date the database contains a total of 411 medicinal products, including vaccines, corresponding to 256 different active substances.

Moreover, since 2015, a report is prepared at the end of each year to summarize the status of paediatric medicines licensed by EMA.

Periodic report on drugs approved for children under the EU Centralised Procedure:

The European Paediatric Medicines Database – EPMD is available here.