ZOLAFREN

Medicinal product

(Invented) name

ZOLAFREN

Active substance (s)

Olanzapinas

Strength

5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AH03, Olanzapine

Marketing authorisation holder

Adamed Sp. z o o., Lenkija

Date of authorisation

2008-04-07

Date of renewal

Documents

1081_1_2 Zolafren 5mg tab RPP 161019.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0100/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Olanzapinas	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
20639	4864	1004864	dvisluoksnė juostelė	N28		Receptinis	LT/1/08/1081/001	Netiekiama	-	-	No	-	-
20640	23616	1023616	dvisluoksnė juostelė	N56		Receptinis	LT/1/08/1081/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2008-04-07	Registruotas