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

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/BWP/124446/05
Published24/05/2006
Effective from01/12/2006
KeywordsLabelling, insulin, units, international units (IU), potency, summary of product characteristics (SPC), leaflet
DescriptionThis document provides guidance on the units to be used for expressing the potencies of medicinal products containing insulin analogues.  


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/12/2006–present


Published: 07/08/2006


Published: 21/04/2005


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