Aripiprazole Zentiva

Medicinal product

(Invented) name

Aripiprazole Zentiva

Active substance (s)

Aripiprazolas

Strength

5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AX12, Aripiprazole

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2015-06-25

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

Tablet	1 vnt.
Aripiprazolas	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
62945	77359	1077359	lizdinė plokštelė	N14		Receptinis	EU/1/15/1009/001	Netiekiama	-	-	No	-	-
62946	77360	1077360	lizdinė plokštelė	N28		Receptinis	EU/1/15/1009/002	Netiekiama	-	-	No	-	-
62947	77361	1077361	lizdinė plokštelė	N49		Receptinis	EU/1/15/1009/003	Netiekiama	-	-	No	-	-
62948	77362	1077362	lizdinė plokštelė	N56		Receptinis	EU/1/15/1009/004	Netiekiama	-	-	No	-	-
62949	77363	1077363	lizdinė plokštelė	N98		Receptinis	EU/1/15/1009/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-25	Registruotas