SEROFLO MULTIHALER 250/50, SEROFLO CIPHALER 250/50, FLUTICASONE SALMETEROL CIPHALER 250/50, FLUTICASONE SALMETEROL MULTIHALER 250/50 (Cipla Australia Pty Ltd)
Product name
SEROFLO MULTIHALER 250/50, SEROFLO CIPHALER 250/50, FLUTICASONE SALMETEROL CIPHALER 250/50, FLUTICASONE SALMETEROL MULTIHALER 250/50
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
186 (255 working days)
Active ingredients
fluticasone propionate; salmeterol xinafoate
Registration type
New generic medicine
Indication
SEROFLO MULTIHALER 250/50, SEROFLO CIPHALER 250/50, FLUTICASONE SALMETEROL CIPHALER 250/50, FLUTICASONE SALMETEROL MULTIHALER 250/50 (powder for inhalation) is indicated for the regular treatment of asthma, where the use of a combination product is appropriate. This may include:
- Patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids.
- Patients who are symptomatic on current inhaled corticosteroid therapy.
For the symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. SEROFLO MULTIHALER 250/50 is not indicated for the initiation of bronchodilator therapy in COPD.