Budesonide/Formoterol Teva Pharma B.V.

Withdrawn

This medicine's authorisation has been withdrawn

budesonide / formoterol fumarate dihydrate

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for Budesonide/Formoterol Teva Pharma B.V. is updated accordingly to indicate that the marketing authorisation is no longer valid.

Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for the public

Reference Number: EMA/601025/2014

Budesonide/Formoterol Teva Pharma B.V. : EPAR - Risk-management-plan summary

Product information

Budesonide/Formoterol Teva Pharma B.V. : EPAR - Product Information

Budesonide/Formoterol Teva Pharma B.V. : EPAR - All Authorised presentations

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

Changes since initial authorisation of medicine

Budesonide/Formoterol Teva Pharma B.V. : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Budesonide/Formoterol Teva Pharma B.V. : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/707207/2014

CHMP summary of positive opinion for Budesonide / Formoterol Teva Pharma B.V.

AdoptedReference Number: EMA/CHMP/443986/2014