Zalasta

Medicinal product

(Invented) name

Zalasta

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2007-09-27

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
28832	31347	1031347	lizdinė plokštelė	N14		Receptinis	EU/1/07/415/022	Netiekiama	-	-	No	-	-
28833	31348	1031348	lizdinė plokštelė	N28		Receptinis	EU/1/07/415/023	Netiekiama	-	-	No	-	-
28834	31349	1031349	lizdinė plokštelė	N35		Receptinis	EU/1/07/415/024	Netiekiama	-	-	No	-	-
28835	31350	1031350	lizdinė plokštelė	N56		Receptinis	EU/1/07/415/025	Netiekiama	-	-	No	-	-
28836	31351	1031351	lizdinė plokštelė	N70		Receptinis	EU/1/07/415/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-27	Registruotas