ZOLAFREN

Medicinal product

(Invented) name

ZOLAFREN

Active substance (s)

Olanzapinas

Strength

10 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_3_4 Zolafren 10mg tab RPP 161019.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0100/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Olanzapinas	10 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
20641	4863	1004863	lizdinė plokštelė	N28		Receptinis	LT/1/08/1081/003	Netiekiama	-	-	No	-	-
20642	23617	1023617	lizdinė plokštelė	N56		Receptinis	LT/1/08/1081/004	Netiekiama	-	-	No	-	-

Stadijos

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