Budesonide/Formoterol Teva

budesonide / formoterol

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The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Summary for the public BG = bălgarski 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public ES = español 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public CS = čeština 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public DA = dansk 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public DE = Deutsch 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public ET = eesti keel 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public EL = elliniká 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public FR = français 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public IT = italiano 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public LV = latviešu valoda 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public LT = lietuvių kalba 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public HU = magyar 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public MT = Malti 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public NL = Nederlands 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public PL = polski 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public PT = português 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public RO = română 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public SK = slovenčina 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public SL = slovenščina 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public FI = suomi 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public SV = svenska 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Summary for the public HR = Hrvatski 2014-12-04 2017-01-31
Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Risk-management-plan summary (English only) 2014-12-04 2017-01-31

This EPAR was last updated on 31/01/2017 .

Authorisation details

Product details

Product details for Budesonide/Formoterol Teva
NameBudesonide/Formoterol Teva
Agency product numberEMEA/H/C/003951
Active substance

budesonide / formoterol fumarate dihydrate

International non-proprietary name (INN) or common name

budesonide / formoterol

Therapeutic area AsthmaPulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AK07

Publication details

Publication details for Budesonide/Formoterol Teva
Marketing-authorisation holder

Teva Pharma B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/11/2014

Contact address:

Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands

Product information

Product information

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

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - Product Information EN = English 2014-12-04 2017-01-31

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.


Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31
Budesonide/Formoterol Teva : EPAR - All Authorised presentations EN = English 2014-12-04 2017-01-31

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

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-10-09 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion EN = English 2016-07-15 2017-01-31
Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report - Article 31 EN = English 2016-07-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Budesonide/Formoterol Teva : EPAR - Public assessment report EN = English 2014-12-04 2017-01-31
CHMP summary of positive opinion for Budesonide / Formoterol Teva EN = English 2014-09-26 2017-01-31

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Budesonide/Formoterol Teva