Voncento

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human coagulation factor VIII / human von willebrand factor

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

Overview

This is a summary of the European public assessment report (EPAR) for Voncento. 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 Voncento.

For practical information about using Voncento, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/05/2018

Authorisation details

Product details
Name
Voncento
Agency product number
EMEA/H/C/002493
Active substance
  • Human coagulation factor VIII
  • human von willebrand factor
International non-proprietary name (INN) or common name
human coagulation factor VIII / human von willebrand factor
Therapeutic area (MeSH)
  • Hemophilia A
  • von Willebrand Diseases
Anatomical therapeutic chemical (ATC) code
B02BD06
Publication details
Marketing-authorisation holder
CSL Behring GmbH
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
12/08/2013
Contact address
Emil-von-Behring-Straße 76
35041 Marburg
Germany

Product information

26/04/2018 Voncento - EMEA/H/C/002493 - R/0032

Contents

  • 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

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

  • Antihaemorrhagics: Blood coagulation factors
  • von Willebrand factor and coagulation factor VIII in combination

Therapeutic indication

Von Willebrand disease (VWD)

Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

Haemophilia A (congenital factor-VIII deficiency)

Prophylaxis and treatment of bleeding in patients with haemophilia A.

Assessment history

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