Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product
| Current effective version |
|
| Reference number | EMA/CHMP/806058/2009/Rev. 2 |
| Published | 13/03/2013 |
| Keywords | Intravenous liposomes, comparability, pharmaceutical quality, pharmacokinetics, non-clinical, clinical studies, liposomal products, generics |
| Description | 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. |
Document history
Revision 2 Current version | Published: 13/03/2013 Published: 28/11/2013 Published: 26/07/2011 |
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