Vacuna subunidad f estabilizada en prefusion frente al virus respiratorio sincitial.

Arexvy Polvo y Suspension Para Suspension Inyectable

120 µg polvo y suspensión para suspensión inyectableSpainMarketedAuthorised 12 Jun 2023

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

ArexvyEuropean UnionAuthorised

Packs

Pack	Code	Status
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 10 viales de polvo + 10 viales con suspensión	607675
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 10 viales de polvo + 10 jeringas precargadas con suspensión	607976
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 1 vial de polvo + 1 vial con suspensión	762747
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 1 vial de polvo + 1 jeringa precargada con suspensión	770528

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Vacuna subunidad f estabilizada en prefusion frente al virus respiratorio sincitial.

Arexvy Polvo y Suspension Para Suspension Inyectable

120 µg polvo y suspensión para suspensión inyectableSpainMarketedAuthorised 12 Jun 2023

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

ArexvyEuropean UnionAuthorised

Packs

Pack	Code	Status
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 10 viales de polvo + 10 viales con suspensión	607675
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 10 viales de polvo + 10 jeringas precargadas con suspensión	607976
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 1 vial de polvo + 1 vial con suspensión	762747
AREXVY POLVO Y SUSPENSION PARA SUSPENSION INYECTABLE, 1 vial de polvo + 1 jeringa precargada con suspensión	770528

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Package leafletAEMPS

Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Vacuna subunidad f estabilizada en prefusion frente al virus respiratorio sincitial.
Strength: 120 µg
Dosage form: polvo y suspensión para suspensión inyectable
Route: vía intramuscular
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 12 Jun 2023
Registration: 1231740001
Marketing authorisation holder: Glaxosmithkline Biologicals
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica
EU number: EU/1/23/1740