Dabigatran etexilate product-specific bioequivalence guidance
Current version | |
Reference number | EMA/CHMP/805498/2016 |
Published | 22/12/2016 |
Effective from | 01/12/2018 |
Keywords | Bioequivalence, generics, dabigatran etexilate |
Description | This document provides product-specific guidance on the demonstration of the bioequivalence of dabigatran etexilate. This document should be read in conjunction with the questions and answers on product-specific bioequivalence, point 4.12. |
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Document history
First version Current version |
| Published: 26/06/2018
Published: 26/06/2018
Published: 22/12/2016 |