Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

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Current effective versionRevision 2 - Reflection paper
Reference numberCHMP/806058/2009/Rev. 02
Published13/03/2013
KeywordsIntravenous liposomes, comparability, pharmaceutical quality, pharmacokinetics, non-clinical, clinical
DescriptionThis document assists in the generation of relevant quality, non-clinical and clinical data to support a marketing authorisation of intravenous liposomal products developed with reference to an innovator liposomal product.


Document history

Revision 2

Current version

Reflection paper


Draft reflection paper

Published: 13/03/2013


Published: 26/07/2011


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