Clinical development of fixed combination medicinal products - Scientific guideline
Table of contents
Revision 2 replaces 'Guideline on clinical development of fixed combination medicinal products' (CHMP/EWP/240/95 Rev. 1). This guideline covers fixed combination medicinal products containing two or more active substances within a single pharmaceutical form. The active substances may be authorised substances or substances that have not yet been authorised in the EU.
Keywords: Fixed combination medicinal products, guidance, clinical development
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Guideline on clinical development of fixed combination medicinal products - Revision 2 (PDF/134.24 KB)
Adopted
First published: 31/03/2017
Last updated: 31/03/2017
Legal effective date: 01/10/2017
EMA/CHMP/158268/2017 -
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Overview of comments on 'Draft guideline on clinical development of fixed combination medicinal products - Revision 2 (EMA/CHMP/281825/2015)' (PDF/555.07 KB)
First published: 17/12/2018
EMA/757184/2015 -
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Draft guideline on clinical development of fixed combination medicinal products - Revision 2 (PDF/163.71 KB)
Draft: consultation closed
First published: 13/05/2015
Last updated: 13/05/2015
Consultation dates: 13/05/2015 to 15/11/2015
EMA/CHMP/281825/2015 -
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Concept paper on the need to revise the guideline on the clinical development of fixed-dose combinations of medicinal products regarding dossier content requirements - Revision 2 (PDF/159.41 KB)
Draft: consultation closed
First published: 01/03/2013
Last updated: 01/03/2013
Consultation dates: 01/03/2013 to 31/05/2013
EMA/CHMP/779887/2012 -
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Guideline on clinical development of fixed combination medicinal products - Revision 1 (PDF/266.44 KB)
Adopted
First published: 19/02/2009
Last updated: 19/02/2009
Legal effective date: 01/09/2009
CHMP/EWP/240/95 Rev. 1 -
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Overview of comments received on draft guideline on fixed combinations - Revision 1 (PDF/275.32 KB)
First published: 19/02/2009
Last updated: 19/02/2009
EMEA/CHMP/EWP/533066/2008 -
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Draft guideline on fixed combination medicinal products - Revision 1 (PDF/52.37 KB)
Draft: consultation closed
First published: 21/02/2008
Last updated: 21/02/2008
CPMP/EWP/240/95 Rev. 1