Vylaer Spiromax

Withdrawn

This medicine's authorisation has been withdrawn

budesonide / formoterol

Overview

On 9 January 2017, the European Commission withdrew the marketing authorisation for Vylaer Spiromax (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 to permanently discontinue the marketing of the product for commercial reasons. 

Vylaer Spiromax was granted marketing authorisation in the EU on 19 November 2014 for treatment of asthma and chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. Vylaer Spiromax was a duplicate of DuoResp Spiromax, which is marketed in several EU countries. 

The European Public Assessment Report (EPAR) for Vylaer Spiromax is updated accordingly to indicate that the marketing authorisation is no longer valid.

Vylaer Spiromax : EPAR - Summary for the public

Reference Number: EMA/601032/2014

Vylaer Spiromax : EPAR - Risk-management-plan summary

Reference Number: EMA/675937/2014

Product information

Vylaer Spiromax : EPAR - Product Information

Vylaer Spiromax : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Vylaer Spiromax
• Active substance:
  • Budesonide
  • formoterol fumarate dihydrate
• International non-proprietary name (INN) or common name:
  • budesonide
  • formoterol
• Therapeutic area (MeSH):
  • Pulmonary Disease, Chronic Obstructive
  • Asthma
• Anatomical therapeutic chemical (ATC) code:
  R03AK07

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Vylaer Spiromax is indicated in adults 18 years of age and older only.

Asthma
Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate:

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

Authorisation details

• EMA product number:
  EMEA/H/C/003952
• Marketing authorisation holder:
  Teva Pharma B.V.

  Computerweg 10; 3542 DR Utrecht; The Netherlands

• Marketing authorisation issued:
  19/11/2014
• Withdrawal of marketing authorisation:
  09/01/2017
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Vylaer Spiromax : EPAR - Procedural steps taken and scientific information after authorisation

Vylaer Spiromax-H-C-3952-A31-14165: EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/330021/2016

Vylaer Spiromax : EPAR - Scientific Conclusion

Initial marketing authorisation documents

Vylaer Spiromax : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/706811/2014

CHMP summary of positive opinion for Vylaer Spiromax

Adopted Reference Number: EMA/CHMP/436529/2014