Budesonide/Formoterol Teva Pharma B.V.
budesonide / formoterol fumarate dihydrate
Table of contents
Overview
The marketing authorisation for Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at the request of the marketing-authorisation holder.
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Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for the public (PDF/218.03 KB)
First published: 05/12/2014
Last updated: 30/01/2017
EMA/601025/2014 -
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Budesonide/Formoterol Teva Pharma B.V. : EPAR - Risk-management-plan summary (PDF/408.25 KB)
First published: 05/12/2014
Last updated: 30/01/2017
Authorisation details
| Product details | |
|---|---|
| Name |
Budesonide/Formoterol Teva Pharma B.V.
|
| Agency product number |
EMEA/H/C/003953
|
| Active substance |
|
| 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 | |
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
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Pharmacotherapeutic group
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.
- in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
or