Zebinix

Medicinal product

(Invented) name

Zebinix

Active substance (s)

Eslikarbazepino acetatas

Strength

600 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	600 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
35223	37559	1037559	lizdinė plokštelė	N30 (alu/alu)		Receptinis	EU/1/09/514/007	Netiekiama	-	-	No	-	-
35224	37560	1037560	lizdinė plokštelė	N60 (alu/alu)		Receptinis	EU/1/09/514/008	Netiekiama	-	-	No	-	-
35225	37561	1037561	lizdinė plokštelė	N30 (PVC/alu)		Receptinis	EU/1/09/514/009	Netiekiama	-	-	No	-	-
35226	37562	1037562	lizdinė plokštelė	N60 (PVC/alu)		Receptinis	EU/1/09/514/010	Netiekiama	-	-	No	-	-
35227	37563	1037563	buteliukas	N90		Receptinis	EU/1/09/514/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-04-21	Registruotas