Potency labelling for insulin analogue containing products with particular reference to the use of "international units" or "units" - Scientific guideline

This document provides guidance on the units to be used for expressing the potencies of medicinal products containing insulin analogues.

Keywords: Labelling, insulin, units, international units (IU), potency, summary of product characteristics (SPC), leaflet

Current effective version

Guideline on potency labelling for insulin analogue containing products with particular reference to the use of international units or units

Adopted Reference Number: EMEA/CHMP/BWP/124446/2005 Legal effective date: 01/12/2006

Document history

Overview of comments received on draft guideline on potency labelling for insulin analogue containing products with particular reference to the use of international units or units

Reference Number: EMEA/274509/2006

Draft guideline on potency labeling for insulin analogue containing products with particular reference to the use of international units or units

Draft: consultation closed Reference Number: EMEA/CHMP/BWP/124446/2005