Medicines for children

Medicines for children
Opinions and decisions on PIP applications
European Medicines Agency decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP
Decision types:
W – decision granting a waiver in all age groups
P – decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(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 request on a waiver in all age groups

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abrir aquí para acceder al documento EMEA completo (extenso):
http://www.ema.europa.eu/htms/human/paediatrics/decisions.htm