Olanzapine Apotex

Medicinal product

(Invented) name

Olanzapine Apotex

Active substance (s)

Olanzapinas

Strength

10 mg

Pharmaceutical form

disperguojamosios 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

Apotex Europe B.V., Nyderlandai

Date of authorisation

2010-06-10

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
41866	55628	1055628	lizdinė plokštelė	N28		Receptinis	EU/1/10/635/010	Netiekiama	-	-	No	-	-
41867	55629	1055629	lizdinė plokštelė	N56		Receptinis	EU/1/10/635/011	Netiekiama	-	-	No	-	-
51720	65617	1065617	lizdinė plokštelė	N98		Receptinis	EU/1/10/635/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-10	Registruotas