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.
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