Olanzapine Glenmark Europe

Medicinal product

(Invented) name

Olanzapine Glenmark Europe

Active substance (s)

Olanzapinas

Strength

10 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	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
38834	52516	1052516	lizdinė plokštelė	N28		Receptinis	EU/1/09/588/004	Netiekiama	-	-	No	-	-
38835	52517	1052517	lizdinė plokštelė	N56		Receptinis	EU/1/09/588/005	Netiekiama	-	-	No	-	-
38836	52518	1052518	lizdinė plokštelė	N70		Receptinis	EU/1/09/588/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-03	Registruotas