Opinions and decisions on paediatric investigation plans

This search allows you to find information on opinions and decisions on a Paediatric Investigation Plan (PIP) including deferrals and waivers. A PIP is a development plan aimed at ensuring that the necessary data is obtained through studies in children to support the authorisation of the medicine for children. The plan is submitted by a pharmaceutical company to the Paediatric Committee (PDCO) at the European Medicines Agency which is responsible for agreement or refusal of the plan and publishes an opinion with its decision.

Decision types
P: decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(s)
W: decision granting a waiver in all age groups for the listed condition(s)
PM: decision on the application for modification of an agreed PIP
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
RPM: decision refers to a refusal on the application for modification of an agreed PIP