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Irish Medicines Database · HPRA register

Fycompa 0.5 mg film-coated tablets

Authorisation EU/1/12/776/024 · Eisai GmbH

← All medicines
Fycompa 0.5 mg film-coated tablets
Licence EU/1/12/776/024 · Unknown
Licence holder
Eisai GmbH (all products →)
Active substance
Perampanel
Dosage form
Oral suspension
Route of administration
Oral use
ATC codes
N03AX, N03AX22
First authorised
19/06/2016
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.