Fycompa

Medicinal product

(Invented) name

Fycompa

Active substance (s)

Perampanelis

Strength

0,5 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AX22, Perampanel

Marketing authorisation holder

Eisai GmbH, Vokietija

Date of authorisation

2012-07-23

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral suspension	1 ml
Perampanelis	0,5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
67210	81755	1081755	buteliukas	340 ml, 2 švirkštai ir buteliuko adapteris N1		Receptinis	EU/1/12/776/024	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-23	Registruotas