Olazax

Medicinal product

(Invented) name

Olazax

Active substance (s)

Olanzapinas

Strength

15 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	15 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
38909	52591	1052591	lizdinė plokštelė	N28		Receptinis	EU/1/09/597/004	Netiekiama	-	-	No	-	-
98239	84337	1084337	lizdinė plokštelė	N56		Receptinis	EU/1/09/597/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-11	Registruotas