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

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

Keywords: Polyethylene glycol, parenteral administration, ependymal cellular vacuolation

Current version

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

Reference Number: EMA/CHMP/SWP/647258/2012