- Application under evaluation
- CHMP opinion
- European Commission decision
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Public Assessment Report (EPAR) for Aerivio Spiromax is updated to indicate that the marketing authorisation is no longer valid.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
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).
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 diseasesTherapeutic 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.