Zalasta

Medicinal product

(Invented) name

Zalasta

Active substance (s)

Olanzapinas

Strength

5 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	5 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
28852	31367	1031367	lizdinė plokštelė	N14		Receptinis	EU/1/07/415/032	Netiekiama	-	-	No	-	-
28853	4830	1004830	lizdinė plokštelė	N28		Receptinis	EU/1/07/415/033	Netiekiama	-	-	No	-	-
28854	31368	1031368	lizdinė plokštelė	N35		Receptinis	EU/1/07/415/034	Netiekiama	-	-	No	-	-
28855	31369	1031369	lizdinė plokštelė	N56		Receptinis	EU/1/07/415/035	Netiekiama	-	-	No	-	-
28856	31370	1031370	lizdinė plokštelė	N70		Receptinis	EU/1/07/415/036	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-09-27	Registruotas