Affiliations: Consorzio per Valutazioni Biologiche e Farmacologiche,
Pavia, Italy | I.RI.D.I.A. srl, Health Care Engineering, Bari,
Italy | Charité Universitätsmedizin Berlin, Berlin,
Germany | Department of Clinical Pharmacology, Linkopings
Universitet, Linkopings, Sweden | Department of Paediatrics, Hospital Carlos III,
Madrid, Spain | Romanian Angel Appeal, Budapest, Romania | Department of Neurophysiology of Memory and
Computational Neuroscience, Institute of Physiology, Academy of Sciences,
Prague, Czech Republic | Pharmacoepidemiology Unit, Departments of Medical
Informatics and Epidemiology & Biostatistics, Erasmus University Medical
Center, Rotterdam, The Netherlands
Note: [] Corresponding author: Adriana Ceci, Consorzio per Valutazioni
Biologiche e Farmacologiche, Via Palestro, 26–27100 Pavia, Italy. Tel.: +39
0382 25075; Fax: +39 0382 536544; E-mail: [email protected]
Abstract: In line with European initiatives, TEDDY set up a new database, the
European Paediatric Medicines Database, with the aim of creating a harmonised,
integrated and reliable pan-European source of information. The data stored in the Database were the basis for examining the
'state of the art' of paediatric medicines licensed by the European Medicines
Agency between October 1995 and December 2007. The results of the study show that 33% of medicinal products
approved by the European Medicines Agency are intended for the paediatric
population, and that this percentage has remained more or less constant in the
12 years of activity of the Agency. This trend is expected to increase rapidly in the future as a
result of the adoption of the Paediatric Regulation. Nevertheless, it is essential that information on medicinal products
for paediatric use are made publicly accessible and data should be verified and
controllable. The European Medicines Agency has recently made public many
information on medicines authorised in EU through the EudraPharm database. The TEDDY European Paediatric Medicines Database grants access also
to information related to paediatric medicines, some of which are not available
elsewhere. We deem this aspect a useful service to end users and a valid
support to Regulatory Authorities.
