Olanzapine Apotex

Medicinal product

(Invented) name

Olanzapine Apotex

Active substance (s)

Olanzapinas

Strength

5 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	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
41864	55626	1055626	lizdinė plokštelė	N28		Receptinis	EU/1/10/635/008	Netiekiama	-	-	No	-	-
41865	55627	1055627	lizdinė plokštelė	N56		Receptinis	EU/1/10/635/009	Netiekiama	-	-	No	-	-
51719	65616	1065616	lizdinė plokštelė	N98		Receptinis	EU/1/10/635/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-10	Registruotas