AREXVY Powder for suspension for injection Ref.[50990] Active ingredients: RSV glycoprotein F antigen

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: GlaxoSmithKline Biologicals SA, Rue de lInstitut 89, 1330 Rixensart, Belgium

Product name and form

Arexvy powder and suspension for suspension for injection.

Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted).

Pharmaceutical Form
Powder and suspension for suspension for injection. The powder is white. The suspension is an opalescent, colourless to pale brownish liquid.

Qualitative and quantitative composition

After reconstitution, one dose (0.5 mL) contains: RSVPreF3¹ antigen^2,3 120 micrograms.

¹ Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation = RSVPreF3

² RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology

³ adjuvanted with AS01_E containing:

plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 25 micrograms

3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 25 micrograms

For the full list of excipients, see section 6.1.

Active Ingredient	Description
RSV glycoprotein F antigen	RSV glycoprotein F antigen is designed to enhance antigen-specific cellular immune response and neutralizing antibodies response in individuals with pre-existing immunity against RSV. The adjuvant AS01_E facilitates the recruitment and activation of antigen presenting cells carrying vaccine-derived antigens in the draining lymph node, which in turn leads to the generation of RSVPreF3-specific CD4+ T cells.

List of Excipients
Powder (RSVPreF3 antigen): Trehalose dihydrate Polysorbate 80 (E433) Potassium dihydrogen phosphate (E340) Dipotassium phosphate (E340) Suspension (AS01EAdjuvant System): Dioleoyl phosphatidylcholine (E322) Cholesterol Sodium chloride Disodium phosphate, anhydrous (E339) Potassium dihydrogen phosphate (E340) Water for injections For adjuvant see also section 2.

Pack sizes and marketing

Arexvy is presented as:

Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber) and a mustard green flip-off cap (antigen).
Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber) and a brown flipoff cap (adjuvant).

Arexvy is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Biologicals SA, Rue de l’Institut 89, 1330 Rixensart, Belgium

Marketing authorization dates and numbers

EU/1/23/1740/001
EU/1/23/1740/002

Drugs

Drug	Countries
AREXVY	Austria, Estonia, Finland, France, Croatia, Italy, Lithuania, United Kingdom, United States

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.