NUCALA (GlaxoSmithKline Australia Pty Ltd)
Product name
NUCALA
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
Mepolizumab
Registration type
EOI
Indication
Chronic Obstructive Pulmonary Disease (COPD)
NUCALA is indicated as an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils on stable inhaler triple therapy (or, where clinically required, an equivalent regimen) (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).