Fixed combination products - Scientific guideline | European Medicines Agency (EMA)

This guideline replaces the Guidelines on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).

Keywords: Veterinary medicinal products, fixed combinations, pharmaceuticals, combination packs

Current version - effective from 28/01/2022

Guideline on pharmaceutical fixed combination products - Revision 1

Adopted Reference Number: EMA/CVMP/83804/2005-Rev.1 Legal effective date: 28/01/2022

English (EN) (277.07 KB - PDF)

First published: 26/07/2021

Guideline on pharmaceutical fixed combination products

Adopted Reference Number: EMEA/CVMP/83804/2005 Legal effective date: 01/07/2007

English (EN) (52.24 KB - PDF)

First published: 18/12/2006 Last updated: 18/12/2006

Questions and answers on the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005)

Reference Number: EMA/CVMP/EWP/325284/2011 Rev.1

English (EN) (95.81 KB - PDF)

First published: 25/10/2011 Last updated: 20/05/2014

Overview of comments received on draft guideline on pharmaceutical fixed combination products

Reference Number: EMEA/CVMP/463526/2006

English (EN) (117.23 KB - PDF)

First published: 18/12/2006 Last updated: 18/12/2006