Core summary for product characteristics for human albumin solution - Scientific guideline

This document describes the information to be included in the summary of product characteristics for medicinal products containing human albumin solution.

Keywords: Human albumin, restoration and maintenance of circulating blood volume, volume deficiency, colloid

Current effective version

Guideline on core summary for product characteristics for human albumin solution - Revision 3

Adopted Reference Number: EMA/CHMP/BPWP/494462/2011 Legal effective date: 01/02/2019

Document history

Draft guideline on core summary of product characteristics for human albumin solution

Draft: consultation closed Consultation dates: 01/07/2012 to 31/08/2012 Reference Number: EMA/CHMP/BPWP/494462/2011 Summary:

This guideline describes the information to be included in the summary of product characteristics (SmPC) for human albumin solution.

Guideline on the Core SPC for human Albumin solution (CPMP/PhVWP/BPWG/2231/99 rev.2)

Adopted Reference Number: CPMP/PhVWP/BPWG/2231/99/Rev. 2 Legal effective date: 01/06/2006