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BECLOFORM (Cipla Australia Pty Ltd)

Product name
BECLOFORM
Date registered
Evaluation commenced
Decision date
Approval time
147 (175 working days)
Active ingredients
beclometasone dipropionate, formoterol fumarate dihydrate
Registration type
New generic medicine
Indication

Asthma

BECLOFORM / CIPLA BECLOMETASONE/FORMOTEROL is indicated in adults (18 years and older) in the treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:

  • patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta2-agonist or
  • patients already adequately controlled on both ICS and long-acting beta2-agonists (LABA).
  • (see Section 4.2 Dose and method of administration for treatment approaches).

COPD (BECLOFORM / CIPLA BECLOMETASONE/FORMOTEROL 100/6 only)

Symptomatic treatment of adults with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

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