Zalasta

Medicinal product

(Invented) name

Zalasta

Active substance (s)

Olanzapinas

Strength

20 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	20 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
28847	31362	1031362	lizdinė plokštelė	N14		Receptinis	EU/1/07/415/027	Netiekiama	-	-	No	-	-
28848	31363	1031363	lizdinė plokštelė	N28		Receptinis	EU/1/07/415/028	Netiekiama	-	-	No	-	-
28849	31364	1031364	lizdinė plokštelė	N35		Receptinis	EU/1/07/415/029	Netiekiama	-	-	No	-	-
28850	31365	1031365	lizdinė plokštelė	N56		Receptinis	EU/1/07/415/030	Netiekiama	-	-	No	-	-
28851	31366	1031366	lizdinė plokštelė	N70		Receptinis	EU/1/07/415/031	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-27	Registruotas