Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Scientific guideline
This 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.
Keywords: Intravenous liposomes, comparability, pharmaceutical quality, pharmacokinetics, non-clinical, clinical studies, liposomal products, generics
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Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2 (PDF/170.25 KB)
Adopted
First published: 13/03/2013
Last updated: 21/03/2013
EMA/CHMP/806058/2009/Rev. 2 -
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Overview of comments received on reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product (PDF/420.56 KB)
First published: 28/11/2013
Last updated: 28/11/2013
EMA/682105/2012 -
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Draft reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product (PDF/120.19 KB)
Draft: consultation closed
First published: 26/07/2011
Last updated: 26/07/2011
Consultation dates: 21/07/2011 to 31/01/2012
EMA/CHMP/806058/2009