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

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Response

Reference numberEMA/CHMP/SWP/647258/2012
Published23/11/2012
KeywordsPolyethylene glycol, parenteral administration, ependymal cellular vacuolation
DescriptionThis 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.

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