Tadalafil product-specific bioequivalence guidance
This document provides product-specific guidance on the demonstration of the bioequivalence of tadalafil.
Keywords: Bioequivalence, generics, tadalafil
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
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Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 2 (PDF/165.47 KB)
Adopted
First published: 22/06/2023
Legal effective date: 01/01/2024
EMA/CHMP/315234/2014 Rev.2 -
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Overview of comments received on 'Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance' (EMA/CHMP/315234/2014 Rev.2) (PDF/667.87 KB)
First published: 22/06/2023
EMA/CHMP/779867/2022
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Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1 (PDF/82.41 KB)
Adopted
First published: 01/02/2018
Last updated: 01/02/2018
Legal effective date: 01/08/2018
EMA/CHMP/315234/2014 Rev.1 -
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Overview of comments received on 'Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance' (EMA/CHMP/315234/2014/Rev.1) - First version (PDF/98.99 KB)
First published: 01/02/2018
Last updated: 01/02/2018
EMA/CHMP/644909/2017 -
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Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1 (PDF/78.58 KB)
Draft: consultation closed
First published: 03/08/2017
Last updated: 03/08/2017
Consultation dates: 03/08/2017 to 31/10/2017
EMA/CHMP/315234/2014/Rev. 1
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Tadalafil film-coated tablets 2.5, 5, 10 and 20 mg product-specific bioequivalence guidance - First version (PDF/79.13 KB)
Adopted
First published: 25/05/2016
Last updated: 25/05/2016
Legal effective date: 01/12/2015
EMA/CHMP/315234/2014 -
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Overview of comments received on 'draft tadalafil product-specific bioequivalence guidance' - First version (PDF/425.38 KB)
First published: 07/07/2015
Last updated: 07/07/2015
EMA/CHMP/116444/2014 -
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Draft tadalafil product-specific bioequivalence guidance - First version (PDF/80.68 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/02/2014
CHMP/PKWP/EMA/423735/2013
