This is a summary of the European public assessment report (EPAR) for Advate. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Advate. For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.
Advate : EPAR - Summary for the public (PDF/77.55 KB)
First published: 16/04/2009
Last updated: 15/01/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
14/06/2018 Advate - EMEA/H/C/000520 - II/0091
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).
Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.