Fycompa

Medicinal product

(Invented) name

Fycompa

Active substance (s)

Perampanelis

Strength

8 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	8 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
53204	67146	1067146	lizdinė plokštelė	N7		Receptinis	EU/1/12/776/008	Netiekiama	-	-	No	-	-
53205	67147	1067147	lizdinė plokštelė	N28		Receptinis	EU/1/12/776/009	Netiekiama	-	-	No	-	-
53206	67148	1067148	lizdinė plokštelė	N84		Receptinis	EU/1/12/776/010	Netiekiama	-	-	No	-	-
54423	68419	1068419	lizdinė plokštelė	N98		Receptinis	EU/1/12/776/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-23	Registruotas