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SIRDUPLA DPI (Alphapharm Pty Ltd)

Product name
SIRDUPLA DPI
Date registered
Evaluation commenced
Decision date
Approval time
252 working days (255)
Active ingredients
fluticasone propionate, salmeterol xinafoate
Registration type
New generic medicine
Indication

SIRDUPLA DPI (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,
  • Initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on 'as needed' reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring reliever medication every day.

For the symptomatic treatment of patients with severe COPD (FEV1 less than 50 percent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta- 2 agonist bronchodilator therapy. SIRDUPLA DPI is not indicated for the initiation of bronchodilator therapy in COPD.

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