FYCOMPA (Eisai Australia Pty Ltd)
Product name
FYCOMPA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
197 (255 working days)
Active ingredients
perampanel hemisesquihydrate
Registration type
EOI
Indication
FYCOMPA (oral suspension, tablet) is indicated for the adjunctive treatment of:
- Partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age with epilepsy.
- Primary generalised tonic-clonic seizures (PGTCS) in patients from 7 years of age with idiopathic generalised epilepsy.