Olanzapine Apotex

Medicinal product

(Invented) name

Olanzapine Apotex

Active substance (s)

Olanzapinas

Strength

5 mg

Pharmaceutical form

plėvele dengtos 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

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film - coated 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
41858	55620	1055620	lizdinė plokštelė	N28		Receptinis	EU/1/10/635/002	Netiekiama	-	-	No	-	-
41859	55621	1055621	lizdinė plokštelė	N56		Receptinis	EU/1/10/635/003	Netiekiama	-	-	No	-	-
51717	65614	1065614	lizdinė plokštelė	N98		Receptinis	EU/1/10/635/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-30	Išregistruotas
2010-06-10	Registruotas