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

This 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 development 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.

Keywords: Summary of product characteristics (SPC/SmPC), PEG, PEGylated, protein, conjugate, composition

Current effective version

Guidance on the description of composition of pegylated (conjugated) proteins in the SPC

Adopted Reference Number: EMEA/CPMP/BWP/3068/03 Legal effective date: 01/07/2003