Ixchiq - opinion on variation to marketing authorisation

Opinion

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

Chikungunya vaccine (live)

Opinion

On 25 June 2026, 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 a restriction to the existing indication to limit the use of Ixchiq to people aged 12 years and older who are at high risk of acquiring chikungunya infection, as follows:

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

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

A direct healthcare professional communication (DHPC) will be disseminated on or shortly after 14 July 2026 to healthcare professionals prescribing, dispensing or administering the medicine. The DHPC will also be made available published on the EMA website.

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 Ixchiq (PSUSA-00011058202511)

Adopted Reference Number: EMADOC-1700519818-3249573

Key facts

• Name of medicine:
  Ixchiq
• EMA product number:
  EMEA/H/C/005797
• Active substance:
  Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated
• International non-proprietary name (INN) or common name:
  Chikungunya vaccine (live)
• Therapeutic area (MeSH):
  Chikungunya virus
• Anatomical therapeutical chemical (ATC) code:
  J07BP01
• 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.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation holder:
  Valneva Austria GmbH
• Date of opinion:
  25/06/2026
• Status:
  Positive