Veyvondi - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

vonicog alfa

Opinion

On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Veyvondi. The marketing authorisation holder for this medicinal product is Baxalta Innovations GmbH.

The CHMP adopted an extension to an existing indication, as follows:

Prevention and treatment of haemorrhage or surgical bleeding in adults (aged 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

Treatment of haemorrhage in children (aged less than 18 years) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

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

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Veyvondi (EMAVR0000264863)

Adopted Reference Number: EMADOC-1700519818-2554896

Key facts

• Name of medicine:
  Veyvondi
• EMA 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 therapeutical chemical (ATC) code:
  B02BD10
• Marketing authorisation holder:
  Baxalta Innovations GmbH
• Date of opinion:
  13/11/2025
• Status:
  Positive