Description of composition of pegylated (conjugated) proteins in the summary of product characteristics

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Current effective version

Adopted guideline

Reference numberCPMP/BWP/3068/03
Published14/05/2003
Effective from01/07/2003
KeywordsSummary of product characteristics (SPC/SmPC), PEG, PEGylated, protein, conjugate, composition
DescriptionThis document provides guidance on the information to be included in the summary of product characteristics for pegylated proteins. It discusses pegylated proteins, which in their develpment have been declared and dosed based on their protein content. Principles of this guideline may also be adopted to other protein conjugates with the same characteristics i.e. where the dosing and filling of a product is based in the protein content.


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