Information on opinions and decisions adopted by the European Medicines Agency's (EMA) Paediatric Committee (PDCO) on Paediatric Investigation Plans (PIPs) including deferrals and waivers.
A PIP is a medicine development plan aimed at ensuring the necessary data are obtained through studies in children to support the medicine's authorisation for use in children. The plan is submitted by a pharmaceutical company to the PDCO, which is responsible for agreeing or refusing the plan and for publishing an opinion with its decision.
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Europejska Agencja Leków
30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Tel: +44 (0)20 3660 6000