AIRFLUSAL FORSPIRO (fluticasone/salmeterol), corticosteroid/β2 agonist
Reason for request
No clinical benefit demonstrated in asthma and COPD by comparison with SERETIDE DISKUS 500 µg/50 µg/dose.
- AIRFLUSAL FORSPIRO has Marketing Authorisation in:
- Maintenance treatment of asthma in situations where the administration by inhalation of a product combining a corticosteroid and a long-acting β2 agonist bronchodilator is justified:
in patients who are inadequately controlled by inhaled corticosteroid therapy and “as-needed” dosing with an inhaled short-acting β2 agonist bronchodilator or
in patients controlled by inhaled corticosteroid therapy in combination with maintenance treatment with a long-acting inhaled β2 agonist.
- Symptomatic treatment of chronic obstructive pulmonary disease (COPD) in patients with an FEV1 (measured prior to administration of a bronchodilator) < 60% of the theoretical value and who have a history of repeated exacerbations and significant symptoms despite maintenance bronchodilator treatment.
- No clinical benefit has been demonstrated by comparison with SERETIDE DISKUS 500 µg/50 µg/dose.
Clinical Benefit
Substantial |
- |
Moderate |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |