TRELEGY ELLIPTA (GlaxoSmithKline Australia Pty Ltd)
Product name
TRELEGY ELLIPTA
Date registered
Evaluation commenced
Decision date
Approval time
192 working days (255)
Active ingredients
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Registration type
EOI
Indication
New combination
TRELEGY ELLIPTA is now also indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with long-acting muscarinic receptor antagonists (LAMA), long-acting β2-adrenergic receptor agonists (LABA), and an inhaled corticosteroid (ICS). TRELEGY ELLIPTA is not indicated for the initiation of therapy in COPD.