Fasenra
benralizumab
Table of contents
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.
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
08/01/2018
|
Contact address |
151 85 Sodertalje |
Product information
20/07/2023 Fasenra - EMEA/H/C/004433 - II/0047
This medicine’s product information is available in all official EU languages.
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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
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.