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

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.

Keywords: Nano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution

Current effective version

Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

AdoptedReference Number: EMA/CHMP/SWP/620008/2012

Document history - First version (current)

Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

AdoptedReference Number: EMA/CHMP/SWP/620008/2012

Overview of comments received on Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

Reference Number: EMA/179672/2014

Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

Consultation dates: 15/09/2013 to 28/02/2014Draft: consultation closedReference Number: EMA/CHMP/SWP/620008/2012

Document history - Superseded document

Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications

AdoptedReference Number: EMA/CHMP/SWP/100094/2011