NUCALA (GlaxoSmithKline Australia Pty Ltd)
Product name
NUCALA
Date registered
Evaluation commenced
Decision date
Approval time
224 working days (255)
Active ingredients
mepolizumab
Registration type
EOI
Indication
NUCALA is now also indicated as an add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.