Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products

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Download document Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products
Reference number EMA/CHMP/BPWP/1619/1999 Rev. 3
Status draft: consultation open
First published 2017-10-30
Last updated 2017-10-30
Consultation start date 2017-10-30
Consultation end date 2018-01-31
Email address for submissions BPWPsecretariat@ema.europa.eu

Summary

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).