Budesonide/Formoterol Teva


budesonide / formoterol

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.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
Budesonide/Formoterol Teva
Agency product number
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
Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Computerweg 10
3542 DR Utrecht
The Netherlands

Product information

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

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

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

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

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.
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

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

How useful was this page?

Add your rating
2 ratings