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

This medicine is authorised for use in the European Union.


Arexvy is a vaccine for adults 60 years of age and older to protect them against lower respiratory tract disease (LRTD; diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV).

Arexvy contains a version of a protein found on the surface of the virus called RSVPreF3.

This EPAR was last updated on 22/06/2023

Authorisation details

Product details
Agency product number
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 therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A. 
Date of issue of marketing authorisation valid throughout the European Union
Contact address
GlaxoSmithKline Biologicals S.A.
89, rue de l'Institut
B-1330 Rixensart

Product information

06/06/2023 Arexvy - EMEA/H/C/006054 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.

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

Assessment history

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