Aripiprazole Accord

Medicinal product

(Invented) name

Aripiprazole Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2015-11-16

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
64270	78752	1078752	dalomoji lizdinė plokštelė	N14x1		Receptinis	EU/1/15/1045/001	Netiekiama	-	-	No	-	-
64271	78753	1078753	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/15/1045/002	Netiekiama	-	-	No	-	-
64272	78754	1078754	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/15/1045/003	Netiekiama	-	-	No	-	-
64273	78755	1078755	dalomoji lizdinė plokštelė	N98x1		Receptinis	EU/1/15/1045/004	Netiekiama	-	-	No	-	-
64274	78756	1078756	buteliukas	N30		Receptinis	EU/1/15/1045/005	Netiekiama	-	-	No	-	-
64275	78757	1078757	buteliukas	N100		Receptinis	EU/1/15/1045/006	Netiekiama	-	-	No	-	-
65968	80482	1080482	dalomoji lizdinė plokštelė	N49x1		Receptinis	EU/1/15/1045/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-16	Registruotas