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

Current effective version

PDF icon<b>Reflection paper</b>

Reference numberEMA/CHMP/SWP/620008/2012
KeywordsNano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution
DescriptionThis 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Superseded document PDF iconReflection paper Published: 07/04/2011

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