Atectura Breezhaler
indacaterol / mometasone
Table of contents
Overview
Atectura Breezhaler is a medicine that is used to keep the airways open in adults and children aged 12 years and older whose asthma is not adequately controlled with inhaled corticosteroids and inhaled short acting beta-2 agonists. Atectura Breezhaler is used for maintenance (regular) treatment.
The medicine contains the active substances indacaterol and mometasone.
-
List item
Atectura Breezhaler : EPAR - Medicine overview (PDF/114.76 KB)
First published: 23/06/2020
EMA/171417/2020 -
-
List item
Atectura Breezhaler : EPAR - Risk-management-plan summary (PDF/49.53 KB)
First published: 23/06/2020
Authorisation details
Product details | |
---|---|
Name |
Atectura Breezhaler
|
Agency product number |
EMEA/H/C/005067
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Asthma
|
Anatomical therapeutic chemical (ATC) code |
R03AK
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
30/05/2020
|
Contact address |
Vista Building |
Product information
07/01/2022 Atectura Breezhaler - EMEA/H/C/005067 - IB/0012/G
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
Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.