Voncento
human coagulation factor VIII / human von willebrand factor
Table of contents
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.
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List item
Voncento : EPAR - Summary for the public (PDF/78.74 KB)
First published: 04/10/2013
Last updated: 16/01/2018 -
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List item
Voncento - EPAR - Risk-management-plan summary (PDF/72.93 KB)
First published: 21/07/2020
Authorisation details
Product details | |
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Name |
Voncento
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Agency product number |
EMEA/H/C/002493
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Active substance |
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International non-proprietary name (INN) or common name |
human coagulation factor VIII / human von willebrand factor
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B02BD06
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Publication details | |
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Marketing-authorisation holder |
CSL Behring GmbH
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
12/08/2013
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Contact address |
Emil-von-Behring-Straße 76 |
Product information
19/11/2021 Voncento - EMEA/H/C/002493 - IB/0050
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Blood coagulation factors
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von Willebrand factor and coagulation factor VIII in combination
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Antihemorrhagics
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.