Arexvy - opinion on variation to marketing authorisation

Opinion

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

recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E

Opinion

On 11 December 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 Arexvy. The marketing authorisation holder for this medicinal product is GlaxoSmithKline Biologicals SA.

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

Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in:

adults 1860 years of age and older.;

• adults 50 through 59 years of age who are at increased risk for RSV disease.

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

For information, the full indication for Arexvy will be:

Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 18 years of age 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) 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, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Arexvy (EMA/VR/0000276225)

Adopted Reference Number: EMADOC-1700519818-2676032

Key facts

• Name of medicine:
  Arexvy
• EMA product number:
  EMEA/H/C/006054
• Active substance:
  Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology
• International non-proprietary name (INN) or common name:
  recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
• Therapeutic area (MeSH):
  Respiratory Syncytial Virus Infections
• Anatomical therapeutical chemical (ATC) code:
  J07
• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.
• Date of opinion:
  11/12/2025
• Status:
  Positive