Zalasta

Medicinal product

(Invented) name

Zalasta

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

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

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
28816	31334	1031334	lizdinė plokštelė	N14		Receptinis	EU/1/07/415/042	Netiekiama	-	-	No	-	-
28817	4828	1004828	lizdinė plokštelė	N28		Receptinis	EU/1/07/415/043	Tiekiama	-	-	No	-	-
28818	31335	1031335	lizdinė plokštelė	N35		Receptinis	EU/1/07/415/044	Netiekiama	-	-	No	-	-
28819	31336	1031336	lizdinė plokštelė	N56		Receptinis	EU/1/07/415/045	Netiekiama	-	-	No	-	-
28820	31337	1031337	lizdinė plokštelė	N70		Receptinis	EU/1/07/415/046	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-27	Registruotas