Budesonide/Formoterol Teva Pharma B.V.

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budesonide / formoterol fumarate dihydrate

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 30/01/2017

Authorisation details

Product details
Name
Budesonide/Formoterol Teva Pharma B.V.
Agency product number
EMEA/H/C/003953
Active substance
  • budesonide
  • formoterol
International non-proprietary name (INN) or common name
budesonide / formoterol fumarate dihydrate
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03AK07
Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
1
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 Pharma B.V. - EMEA/H/C/003953 - IB/0004/G

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

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

Asthma
Budesonide/Formoterol Teva Pharma B.V. 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.

Assessment history

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