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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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/96.35 KB)
First published: 20/09/2018
Last updated: 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 |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
31/08/2018
|
Contact address |
Product information
30/10/2020 Veyvondi - EMEA/H/C/004454 - IAIN/0015
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
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.