Budesonide/Formoterol Teva Pharma B.V.

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Withdrawn

This medicine's authorisation has been withdrawn

budesonide / formoterol fumarate dihydrate
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 16 December 2016, the European Commission withdrew the marketing authorisation for Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva Pharma B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Budesonide/Formoterol Teva Pharma B.V. was granted marketing authorisation in the EU on 19 November 2014 for treatment of asthma. The marketing authorisation was initially valid for a 5-year period. Budesonide/Formoterol Teva Pharma B.V. was of DuoResp Spiromax, which is marketed in several EU countries. 

The European Public Assessment Report (EPAR) for Budesonide/Formoterol Teva Pharma B.V. is updated accordingly to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IB/0004/G
16/12/2016
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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:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Suomi (FI) (149.84 KB - PDF)

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svenska (SV) (152.07 KB - PDF)

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Product details

Name of medicine
Budesonide/Formoterol Teva Pharma B.V.
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

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 ?2 adrenoceptor agonist) is appropriate:

 

or

  • in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists.

 

Authorisation details

EMA product number
EMEA/H/C/003953
Marketing authorisation holder
Teva Pharma B.V.

Computerweg 10
3542 DR Utrecht
The Netherlands

Marketing authorisation issued
19/11/2014
Withdrawal of marketing authorisation
16/12/2016
Revision
1

Assessment history

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