Draft guideline on core summary of product characteristics for human fibrinogen products

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Download document Draft guideline on core summary of product characteristics for human fibrinogen products
Reference number EMA/CHMP/BPWP/691754/2013 Rev. 1
Status draft: consultation open
First published 04/03/2014
Last updated 04/03/2014
Consultation start date 04/03/2014
Consultation end date 04/06/2014
Email address for submissions bpwpsecretariat@ema.europa.eu

Summary

This guideline describes the information to be included in the summary of product characteristics for human fibrinogen, which is indicated for the treatment and prophylaxis of bleeding in patients with congenital hypo-, dys- or afibrinogenaemia with bleeding tendency and as a complementary therapy to management of uncontrolled severe haemorrhage in acquired hypofibrinogenaemia.