EPMD is a database containing information (indication, dosages, age of use, clinical studies, etc.) on paediatric drugs authorised by the European Medicines Agency (EMA) under the centralised procedure.
Through this tool TEDDY Network 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.
Based on the data stored, annual 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., PIP, OD), regulatory status (i.e., new medicinal product, paediatric variation, repurposed product), type of product (i.e., chemical, biologic, ATMP) are made available on request.
TEDDY Network is organising a workshop to present the EPMD to professionals, scientific communities, regulatory authorities, and relevant stakeholders. For more information, please send an email to info@teddynetwork.net