Budesonide/Formoterol Teva
budesonide / formoterol
Table of contents
Overview
The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.
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List item
Budesonide/Formoterol Teva : EPAR - Summary for the public (PDF/218.08 KB)
First published: 04/12/2014
Last updated: 31/01/2017
EMA/601019/2014 -
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List item
Budesonide/Formoterol Teva : EPAR - Risk-management-plan summary (PDF/411.39 KB)
First published: 04/12/2014
Last updated: 31/01/2017
EMA/639304/2014
Authorisation details
| Product details | |
|---|---|
| Name |
Budesonide/Formoterol Teva
|
| Agency product number |
EMEA/H/C/003951
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
budesonide / formoterol
|
| Therapeutic area (MeSH) |
|
| 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 | |
Product information
16/12/2016 Budesonide/Formoterol Teva - EMEA/H/C/003951 - A31/0002
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 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.