lunes, 19 de abril de 2010

European Medicines Agency - Human Medicines - Medicines for children - EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP



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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European Medicines Agency - Human Medicines - Medicines for children - EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP

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