EPMD - European Paediatric Medicines Database is a database set up in 2007 in the framework of FP6 TEDDY Project with the aim of creating a harmonised, integrated, and reliable panEuropean source of information on all paediatric medicines registered under the European Medicines Agency (EMA) Centralised Procedure
The data stored in this database shows the ‘state of the art’ of
paediatric medicines licensed by the EMA from October 1995 up
today.
Through this tool TEDDY supports the transparency of the
information provided by EMA concerning the rational use of
paediatric medicines and the ages groups for which the
medicines are approved. On the basis on the data stored,
regular reports are also provided, including drugs statistics,
description of innovative and orphan paediatric medicinal
products, new approved indications and details of ages groups
and therapeutic areas uncovered by paediatric medicinal
products.
The EPMD includes information on:
- year of approval
- active substance
- tradename
- Anatomical Therapeutic Chemical (ATC) code – first-level
- paediatric indication(s)
- ages for which the drug is intended
- orphan status
Additional information such as regulatory procedures (e.g., PIP1, OD2), regulatory status (i.e., new medicinal product, paediatric variation, repurposed product), type of product (i.e., chemical, biologic, ATMP) are made available on request