Fycompa

Medicinal product

(Invented) name

Fycompa

Active substance (s)

Perampanelis

Strength

12 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	12 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
53210	67152	1067152	lizdinė plokštelė	N7		Receptinis	EU/1/12/776/014	Netiekiama	-	-	No	-	-
53211	67153	1067153	lizdinė plokštelė	N28		Receptinis	EU/1/12/776/015	Netiekiama	-	-	No	-	-
53212	67154	1067154	lizdinė plokštelė	N84		Receptinis	EU/1/12/776/016	Netiekiama	-	-	No	-	-
54425	68421	1068421	lizdinė plokštelė	N98		Receptinis	EU/1/12/776/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-23	Registruotas