Aripiprazole Accord

Medicinal product

(Invented) name

Aripiprazole Accord

Active substance (s)

Aripiprazolas

Strength

10 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	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
64276	78758	1078758	dalomoji lizdinė plokštelė	N14x1		Receptinis	EU/1/15/1045/007	Netiekiama	-	-	No	-	-
64277	78759	1078759	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/15/1045/008	Netiekiama	-	-	No	-	-
64278	78760	1078760	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/15/1045/009	Netiekiama	-	-	No	-	-
64279	78761	1078761	dalomoji lizdinė plokštelė	N98x1		Receptinis	EU/1/15/1045/010	Netiekiama	-	-	No	-	-
64280	78762	1078762	buteliukas	N30		Receptinis	EU/1/15/1045/011	Netiekiama	-	-	No	-	-
64281	78763	1078763	buteliukas	N100		Receptinis	EU/1/15/1045/012	Netiekiama	-	-	No	-	-
65969	80483	1080483	dalomoji lizdinė plokštelė	N49x1		Receptinis	EU/1/15/1045/024	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-16	Registruotas