Budesonide/Formoterol Teva

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budesonide / formoterol

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 31/01/2017

Authorisation details

Product details
Name
Budesonide/Formoterol Teva
Agency product number
EMEA/H/C/003951
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
2
Date of issue of marketing authorisation valid throughout the European Union
19/11/2014
Contact address
Computerweg 10
3542 DR Utrecht
The Netherlands

Product information

16/12/2016 Budesonide/Formoterol Teva - EMEA/H/C/003951 - A31/0002

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.

Asthma
Budesonide/Formoterol Teva 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.
    or
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

COPD
Symptomatic treatment of patients with severe 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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