CHMP Safety Working Party's response to the Paediatric Committee regarding the use of PEGylated drug products in the paediatric population

Table of contents

This document addresses the risk for ependymal cell vacuolationuse after the use of PEGylated medicinal products in paediatric pupulation. It gives recommendations on the conduct of clinical trials with PEGylated drug products.

Keywords: Polyethylene glycol, parenteral administration, ependymal cellular vacuolation

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