DuoResp Spiromax
budesonide / formoterol
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for DuoResp Spiromax. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use DuoResp Spiromax.
For practical information about using DuoResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
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DuoResp Spiromax : EPAR - Summary for the public (PDF/77.99 KB)
First published: 20/05/2014
Last updated: 20/05/2014
EMA/121020/2014 -
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DuoResp Spiromax : EPAR - Risk-management-plan summary (PDF/70.41 KB)
First published: 20/05/2014
Last updated: 20/05/2014
Authorisation details
Product details | |
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Name |
DuoResp Spiromax
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Agency product number |
EMEA/H/C/002348
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Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
R03AK07
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Publication details | |
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Marketing-authorisation holder |
Teva Pharma B.V.
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
28/04/2014
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Contact address |
Product information
09/03/2020 DuoResp Spiromax - EMEA/H/C/002348 - II/0030
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Drugs for obstructive airway diseases
Therapeutic indication
DuoResp Spiromax is indicated in adults 18 years of age and older only.
Asthma
DuoResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
- in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists;
- in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
Chronic obstructive pulmonary disease
Symptomatic treatment of patients with severe chronic obstructive pulmonary disease - COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.