Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

Current effective version

PDF iconReflection paper

Reference number EMA/CHMP/SWP/620008/2012
Published 27/03/2015
Keywords Nano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution
Description This document assists in the generation of relevant quality, non-clinical and pharmacokinetic clinical comparative data to support a marketing authorisation for an intravenous iron-based nano-colloidal product developed with reference to an innovator product.


Document history

First version

Current version

PDF iconReflection paper

 

PDF iconOverview of comments

 

PDF iconDraft reflection paper

Published: 27/03/2015

 

Published: 27/03/2015

 

Published: 16/09/2013

Superseded document PDF iconReflection paper Published: 07/04/2011


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