Xenazine

Medicinal product

(Invented) name

Xenazine

Active substance (s)

Tetrabenazinas

Strength

25 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX06, Tetrabenazine

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2014-02-11

Date of renewal

Documents

3513_1 Xenazine tab II PL keit.docx

3513_1 Xenazine tab RPP 151223.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FI/H/0810/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Tetrabenazinas	25 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
53990	67976	1067976	buteliukas	N112		Receptinis	LT/1/14/3513/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-04-06	Išregistruotas
2014-02-11	Registruotas