Beyfortus

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nirsevimab

Authorised
This medicine is authorised for use in the European Union.

Overview

Beyfortus is a medicine used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) in newborns and children during their first RSV season.

Beyfortus contains the active substance nirsevimab.

This EPAR was last updated on 30/01/2023

Authorisation details

Product details
Name
Beyfortus
Agency product number
EMEA/H/C/005304
Active substance
nirsevimab
International non-proprietary name (INN) or common name
nirsevimab
Anatomical therapeutic chemical (ATC) code
J06B
Additional monitoringAdditional 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.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
31/10/2022
Contact address

AstraZeneca AB
Sodertalje
SE-151 85 Sodertalje
Sweden

Product information

Beyfortus - EMEA/H/C/005304 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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

Vaccines

Therapeutic indication

Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.

Beyfortus should be used in accordance with official recommendations.

Assessment history

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