The European Medicines Agency has published a new database containing information on studies of medicines authorised in the European Union that were carried out in children and completed before the Paediatric Regulation came into force in 2007. The Article 45 paediatric studies database allows users to search for information on the studies’ names and aims, the medicines studied and the ages of patients included. For a subset of studies, documents summarising the study’s results are also available.
The database aims to improve the availability of information on the use of medicines in children, enabling healthcare professionals and investigators to be aware of the results studies that have been conducted on children in the past. It will also help them to avoid the unnecessary duplication of trials in children.
The Agency owns and manages the database, which has been published as part of its drive towards greater levels of transparency.
The information in the database was provided by marketing-authorisation holders. Users should direct any questions on the studies listed to the marketing-authorisation holder.
For further information, please visit:
http://art45-paediatric-studies.ema.europa.eu/clinicaltrials/