Zebinix

Medicinal product

(Invented) name

Zebinix

Active substance (s)

Eslikarbazepino acetatas

Strength

200 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AF04, Eslicarbazepine

Marketing authorisation holder

BIAL-Portela & C, SA, Portugalija

Date of authorisation

2009-04-21

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

Tablet	1 vnt.
Eslikarbazepino acetatas	200 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
53360	67341	1067341	lizdinė plokštelė	N20		Receptinis	EU/1/09/514/021	Netiekiama	-	-	No	-	-
53361	67342	1067342	lizdinė plokštelė	N60		Receptinis	EU/1/09/514/022	Netiekiama	-	-	No	-	-
53362	67343	1067343	buteliukas	N60		Receptinis	EU/1/09/514/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-04-21	Registruotas