Vortioxetine Zentiva

Medicinal product

(Invented) name

Vortioxetine Zentiva

Active substance (s)

Vortioksetinas

Strength

5 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)

N06AX26, Vortioxetine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2026-06-05

Date of renewal

Documents

6063-64_pakuotes lapelis_2026-06-05.docx

6063-6064_Vortioxetine Zentiva.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1411/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Vortioksetinas	5 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
121291	107400	1107400	lizdinė plokštelė	N14		Receptinis	LT/1/26/6063/001	Netiekiama	-	-	No	-	-
121293	107402	1107402	lizdinė plokštelė	N28		Receptinis	LT/1/26/6063/002	Netiekiama	-	-	No	-	-
121295	107404	1107404	lizdinė plokštelė	N56		Receptinis	LT/1/26/6063/003	Netiekiama	-	-	No	-	-
121296	107405	1107405	lizdinė plokštelė	N98		Receptinis	LT/1/26/6063/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-05	Registruotas