Fycompa

Medicinal product

(Invented) name

Fycompa

Active substance (s)

Perampanelis

Strength

10 mg

Pharmaceutical form

plėvele dengtos tabletės

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

Film-coated tablet	1 vnt.
Perampanelis	10 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
53207	67149	1067149	lizdinė plokštelė	N7		Receptinis	EU/1/12/776/011	Netiekiama	-	-	No	-	-
53208	67150	1067150	lizdinė plokštelė	N28		Receptinis	EU/1/12/776/012	Netiekiama	-	-	No	-	-
53209	67151	1067151	lizdinė plokštelė	N84		Receptinis	EU/1/12/776/013	Netiekiama	-	-	No	-	-
54424	68420	1068420	lizdinė plokštelė	N98		Receptinis	EU/1/12/776/022	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-23	Registruotas