European Medicines Agency - Regulatory - Regulation of medicines

Paediatric studies submitted in accordance with Article 45 of the Paediatric Regulation

• The Article 45 paediatric studies database allows you to search for information on studies of medicines authorised in the European Union that were carried out in children and completed before 2007.

• Users can find details of each study, including its name, its 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 database is owned and managed by the European Medicines Agency. The publication of this information is in accordance with the Agency’s policy 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. The Agency is unable to answer questions on individual studies.

• Because this database will include the results of a large number of studies, not all of the information is available immediately. New documents and information are being added to the database as they becomes available on a monthly basis.