Olanzapine Glenmark Europe

Medicinal product

(Invented) name

Olanzapine Glenmark Europe

Active substance (s)

Olanzapinas

Strength

15 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	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
38837	52519	1052519	lizdinė plokštelė	N28		Receptinis	EU/1/09/588/007	Netiekiama	-	-	No	-	-
38838	52520	1052520	lizdinė plokštelė	N56		Receptinis	EU/1/09/588/008	Netiekiama	-	-	No	-	-
38839	52521	1052521	lizdinė plokštelė	N70		Receptinis	EU/1/09/588/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-03	Registruotas