Advate

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octocog alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 30/07/2018

Authorisation details

Product details
Name
Advate
Agency product number
EMEA/H/C/000520
Active substance
octocog alfa
International non-proprietary name (INN) or common name
octocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02
Publication details
Marketing-authorisation holder
Baxter AG
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
02/03/2004
Contact address
Industriestrasse 67
A-1221 Vienna
Austria

Product information

14/06/2018 Advate - EMEA/H/C/000520 - II/0091

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIHEMORRHAGICS
 

Therapeutic indication

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.

Assessment history

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