Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins
| Current effective version |
|
| Reference number | EMEA/CHMP/BMWP/118264/2007 Rev. 1 |
| Published | 24/11/2016 |
| Effective from | 01/06/2017 |
| Keywords | Low molecular weight heparins, low molecular mass heparins, similar biological medicinal products, biosimilar, comparability, quality, non-clinical studies, clinical studies, extrapolation |
| Description | This document lays down the non-clinical and clinical requirements for low molecular weight heparins (LMWHs, low molecular mass heparins, LMMH) containing medicinal products claiming to be similar to another one already marketed. |
Document history
Revision 1 Current version
|
| Published: 24/11/2016
Effective from: 01/06/2017
Published: 31/01/2013 Published: 27/07/2011 |
| First version | In operation: 01/10/2009 - 01/06/2017 Published: 17/11/2009 Published: 24/04/2008 Published: 24/01/2007 |
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