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

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Current effective version

Revision 2 - Reflection paper

Reference numberEMA/CHMP/806058/2009/Rev. 2
Published13/03/2013
KeywordsIntravenous liposomes, comparability, pharmaceutical quality, pharmacokinetics, non-clinical, clinical studies, liposomal products, generics
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


Overview of comments


Draft reflection paper

Published: 13/03/2013


Published: 28/11/2013


Published: 26/07/2011


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