ONGENTYS (Maxx Pharma Pty Ltd)
Product name
ONGENTYS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
222 working days (255)
Active ingredients
opicapone
Registration type
NCE/NBE
Indication
ONGENTYS (hard capsule) is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.