Olanzapine Glenmark Europe

Medicinal product

(Invented) name

Olanzapine Glenmark Europe

Active substance (s)

Olanzapinas

Strength

5 mg

Pharmaceutical form

burnoje disperguojamos 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

Orodispersible 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
38831	52513	1052513	lizdinė plokštelė	N28		Receptinis	EU/1/09/588/001	Netiekiama	-	-	No	-	-
38832	52514	1052514	lizdinė plokštelė	N56		Receptinis	EU/1/09/588/002	Netiekiama	-	-	No	-	-
38833	52515	1052515	lizdinė plokštelė	N70		Receptinis	EU/1/09/588/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-03	Registruotas