Approval · Notice of Compliance 14269 · 2013

FYCOMPA: Notice of Compliance 14269

Issued April 4, 2013

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number: 14269
Date: April 4, 2013
Company: Eisai LimitedWoodcliff Lake, New Jersey, United States
Product type: Prescription Pharmaceutical
Submission: New Drug Submission (NDS)
Submission class: New Active Substance (NAS)
Therapeutic class: Antiepileptic agent

Products in this notice

Brand	DIN	Status today
FYCOMPA	02404516	Marketed
FYCOMPA	02404524	Marketed
FYCOMPA	02404532	Marketed
FYCOMPA	02404540	Marketed
FYCOMPA	02404559	Marketed
FYCOMPA	02404567	Marketed

Medicinal ingredients

PERAMPANEL 2 MG per TAB
PERAMPANEL 4 MG per TAB
PERAMPANEL 6 MG per TAB
PERAMPANEL 8 MG per TAB
PERAMPANEL 10 MG per TAB
PERAMPANEL 12 MG per TAB