Olanzapine Glenmark

Medicinal product

(Invented) name

Olanzapine Glenmark

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 Arzneimittel GmbH, Vokietija

Date of authorisation

2009-12-03

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
38817	52499	1052499	lizdinė plokštelė	N28		Receptinis	EU/1/09/587/004	Netiekiama	-	-	No	-	-
38818	52500	1052500	lizdinė plokštelė	N56		Receptinis	EU/1/09/587/005	Netiekiama	-	-	No	-	-
38819	52501	1052501	lizdinė plokštelė	N70		Receptinis	EU/1/09/587/006	Netiekiama	-	-	No	-	-
100858	86969	1086969	lizdinė plokštelė	N98		Receptinis	EU/1/09/587/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-03	Registruotas