Ixchiq - opinion on variation to marketing authorisation

On 27 February 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 Ixchiq. The marketing authorisation holder for this medicinal product is Valneva Austria GmbH.

The CHMP adopted an extension to the existing indication to include active immunisation of children from 12 years of age. The indication for Ixchiq will therefore be as follows:¹

Ixchiq is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 12 years and older.

The use of this vaccine should be in accordance with official recommendations.

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.

¹ New text in bold, removed text as strikethrough