Veyvondi
vonicog alfa
Table of contents
Overview
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.
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List item
Veyvondi : EPAR - Medicine overview (PDF/76.83 KB)
First published: 20/09/2018
Last updated: 20/09/2018
EMA/475404/2018 -
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Veyvondi : EPAR - Risk-management-plan summary (PDF/214.95 KB)
First published: 20/09/2018
Last updated: 13/07/2023
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 |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
31/08/2018
|
Contact address |
Industriestrasse 67
A-1221 Vienna Austria |
Product information
31/08/2023 Veyvondi - EMEA/H/C/004454 - II/0031
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
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.