DuoResp Spiromax

RSS

budesonide / formoterol

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

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.

This EPAR was last updated on 07/05/2019

Authorisation details

Product details
Name
DuoResp Spiromax
Agency product number
EMEA/H/C/002348
Active substance
  • budesonide
  • formoterol fumarate dihydrate
International non-proprietary name (INN) or common name
budesonide / formoterol
Therapeutic area (MeSH)
  • Pulmonary Disease, Chronic Obstructive
  • Asthma
Anatomical therapeutic chemical (ATC) code
R03AK07
Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
28/04/2014
Contact address
Computerweg 10
3542 DR Utrecht
The Netherlands

Product information

08/04/2019 DuoResp Spiromax - EMEA/H/C/002348 - R/0027

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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