Zalasta

Medicinal product

(Invented) name

Zalasta

Active substance (s)

Olanzapinas

Strength

20 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	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
28842	31357	1031357	lizdinė plokštelė	N14		Receptinis	EU/1/07/415/052	Netiekiama	-	-	No	-	-
28843	31358	1031358	lizdinė plokštelė	N28		Receptinis	EU/1/07/415/053	Netiekiama	-	-	No	-	-
28844	31359	1031359	lizdinė plokštelė	N35		Receptinis	EU/1/07/415/054	Netiekiama	-	-	No	-	-
28845	31360	1031360	lizdinė plokštelė	N56		Receptinis	EU/1/07/415/055	Netiekiama	-	-	No	-	-
28846	31361	1031361	lizdinė plokštelė	N70		Receptinis	EU/1/07/415/056	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-27	Registruotas