Standard rhabdomyosarcoma paediatric investigation plan

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Download document Standard rhabdomyosarcoma paediatric investigation plan
Reference number EMA/555130/2012
Status draft: consultation closed
First published 2013-02-22
Last updated 2013-02-22


The standard paediatric investigation plan (PIP) for rhabdomyosarcoma was prepared by the Paediatric Committee with external experts of the paediatric oncology task force of the European Medicines Agency. The aim is to highlight the persistent unmet therapeutic needs for rhabdomyosarcoma in children, to propose plausible targets and mechanisms of action that could address these needs, to set out the principal features of trials in children with rhabdomyosarcoma and to make the possible requirements for a PIP for rhabdomyosarcoma transparent.