Press Release: European Medicines Agency makes first recommendation for use of a medicine in children based on PIP data

The European Medicines Agency (EMEA), in September 2008, made its first recommendation for the use of a centrally-authorised medicine in children on the basis of clinical trial data generated in accordance with an agreed paediatric investigation plan (PIP). This is the first example of the changes brought in by the Paediatric Regulation benefiting children in Europe.