Olazax

Medicinal product

(Invented) name

Olazax

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

Glenmark Pharmaceuticals s.r.o., Čekija

Date of authorisation

2009-12-11

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tablet	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
38906	52588	1052588	lizdinė plokštelė	N28		Receptinis	EU/1/09/597/001	Netiekiama	-	-	No	-	-
98236	84334	1084334	lizdinė plokštelė	N56		Receptinis	EU/1/09/597/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-11	Registruotas