INOVELON (Eisai Australia Pty Ltd)
Product name
INOVELON
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
240 working days (255)
Active ingredients
rufinamide
Registration type
NCE/NBE
Indication
INOVELON (film-coated tablets) is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.