Aerivio Spiromax

Withdrawn

This medicine's authorisation has been withdrawn

salmeterol / fluticasone propionate

Overview

On 4 October 2019, the European Commission withdrew the marketing authorisation for Aerivio Spiromax (salmeterol / fluticasone propionate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Aerivio Spiromax was granted marketing authorisation in the EU on 18 August 2016 for treatment of asthma and COPD. 

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Public Assessment Report (EPAR) for Aerivio Spiromax is updated to indicate that the marketing authorisation is no longer valid.

Product information

Aerivio Spiromax : EPAR - Product Information

Aerivio Spiromax : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Aerivio Spiromax
• Active substance:
  • salmeterol xinafoate
  • fluticasone propionate
• International non-proprietary name (INN) or common name:
  • salmeterol
  • fluticasone propionate
• Therapeutic area (MeSH):
  • Pulmonary Disease, Chronic Obstructive
  • Asthma
• Anatomical therapeutic chemical (ATC) code:
  R03AK06

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Aerivio Spiromax is indicated for use in adults aged 18 years and older only.

Asthma

Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 agonist) is appropriate:

• patients not adequately controlled on a lower strength corticosteroid combination product or
• patients already controlled on a high dose inhaled corticosteroid and long-acting ?2 agonist.

Chronic Obstructive Pulmonary Disease (COPD)

Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Authorisation details

• EMA product number:
  EMEA/H/C/002752
• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Opinion adopted:
  23/06/2016
• Marketing authorisation issued:
  18/08/2016
• Withdrawal of marketing authorisation:
  04/10/2019
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Aerivio Spiromax : EPAR - Public assessment report

Adopted Reference Number: EMA/486136/2016

CHMP summary of opinion for Aerivio Spiromax

Adopted Reference Number: EMA/CHMP/431214/2016