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
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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