Veyvondi

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vonicog alfa

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

Overview

An overview of Veyvondi and why it is authorised in the EU

Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective.

It is used ‘on demand’ to treat bleeding episodes and is also used to prevent and treat bleeding during surgery. Veyvondi contains the active substance vonicog alfa.

This EPAR was last updated on 20/09/2018

Authorisation details

Product details
Name
Veyvondi
Agency product number
EMEA/H/C/004454
Active substance
vonicog alfa
International non-proprietary name (INN) or common name
vonicog alfa
Therapeutic area (MeSH)
von Willebrand Diseases
Anatomical therapeutic chemical (ATC) code
B02BD10
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Baxalta Innovations GmbH
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
31/08/2018
Contact address
Industriestrasse 67
A-1221 Vienna
Austria

Product information

31/08/2018 Veyvondi - EMEA/H/C/004454 -

Contents

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Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Veyvondi is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the
- Treatment of haemorrhage and surgical bleeding
- Prevention of surgical bleeding.

Veyvondi should not be used in the treatment of Haemophilia A.

Assessment history

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