Zebinix

Medicinal product

(Invented) name

Zebinix

Active substance (s)

Eslikarbazepino acetatas

Strength

50 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)

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

Oral suspension	1 ml
Eslikarbazepino acetatas	50 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
67804	82361	1082361	buteliukas	200 ml, geriamasis švirkštas ir buteliuko adapteris N1		Receptinis	EU/1/09/514/024	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-04-21	Registruotas