Aerivio Spiromax

RSS

salmeterol / fluticasone propionate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Aerivio Spiromax. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Aerivio Spiromax.

For practical information about using Aerivio Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/10/2017

Authorisation details

Product details
Name
Aerivio Spiromax
Agency product number
EMEA/H/C/002752
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
Publication details
Marketing-authorisation holder
Teva B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
18/08/2016
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

09/06/2017 Aerivio Spiromax - EMEA/H/C/002752 - IAIN/0003

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 β2 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 β2 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.

Assessment history

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