Fasenra

RSS

benralizumab

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

Overview

Fasenra is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma. It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists. Fasenra contains the active substance benralizumab.

This EPAR was last updated on 27/08/2019

Authorisation details

Product details
Name
Fasenra
Agency product number
EMEA/H/C/004433
Active substance
benralizumab
International non-proprietary name (INN) or common name
benralizumab
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03DX10
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
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address
SE-151-85 Sodertalje
Sweden

Product information

27/06/2019 Fasenra - EMEA/H/C/004433 - II/0014/G

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Fasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists.

Assessment history

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