Potency labelling for insulin analogue containing products with particular reference to the use of "international units" or "units" - Scientific guideline
Table of contents
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
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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 (PDF/111.51 KB)
First published: 07/08/2006
Last updated: 07/08/2006
EMEA/274509/2006 -
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Draft guideline on potency labeling for insulin analogue containing products with particular reference to the use of international units or units (PDF/157.57 KB)
Draft: consultation closed
First published: 21/04/2005
Last updated: 21/04/2005
EMEA/CHMP/BWP/124446/2005