Beyfortus
nirsevimab
Table of contents
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.
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List item
Beyfortus : EPAR - Medicine Overview (PDF/127.97 KB)
First published: 15/11/2022
Last updated: 30/01/2023
EMA/776857/2022 -
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List item
Beyfortus : EPAR - Risk management plan (PDF/407.11 KB)
First published: 15/11/2022
Authorisation details
Product details | |
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Name |
Beyfortus
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Agency product number |
EMEA/H/C/005304
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Active substance |
nirsevimab
|
International non-proprietary name (INN) or common name |
nirsevimab
|
Anatomical therapeutic chemical (ATC) code |
J06BD08
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Additional 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 | |
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Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
31/10/2022
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Contact address |
AstraZeneca AB |
Product information
23/06/2023 Beyfortus - EMEA/H/C/005304 - IB/0008
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Immune sera and immunoglobulins
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.